Gendered impact of COVID-19 containment measures on unpaid care work and mental health in Europe: a scoping review protocol by Kathleen Pöge, Hande Gencer, Regina Brunnett, Maria A Marchwacka, Petra Rattay, Tobias Staiger, Hürrem Tezcan-Güntekin

“…Results will be synthesized narratively.Ethics and dissemination This study is a review of published literature; ethics approval is not warranted. …”
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Realist inquiry into Maternity care @ a Distance (ARM@DA): realist review protocol by Andrew Booth, Catrin Evans, Stephen Timmons, Helen Spiby, Mark Clowes, Nia Jones, Kerry Evans, Benash Nazmeen, Candice Sunney, Georgia Clancy

“…The review will follow the Realist and Meta-narrative Evidence Synthesis Evolving Standards quality procedures and reporting guidance.Ethics and dissemination Ethical approval has been obtained from the University of Nottingham, Faculty of Medicine and Health Sciences Ethics Committee (FMHS 426–1221). …”
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Safety and tumour-specific immunological responses of combined dendritic cell vaccination and anti-CD40 agonistic antibody treatment for patients with metastatic pancreatic cancer:... 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

“…Secondary endpoints include radiographic response according to the RECIST (V.1.1) and iRECIST criteria, and the detection of antitumour specific immune responses.Ethics and dissemination The Central Committee on Research Involving Human Subjects (CCMO; NL76592.000.21) and the Medical Ethics Committee (METC; MEC-2021-0566) of the Erasmus M.C. …”
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A prospective, cross-sectional study to establish age-specific reference intervals for neonates and children in the setting of clinical biochemistry, immunology and haematology: th... by Susan M Donath, Monsurul Hoq, Vicky Karlaftis, Susan Mathews, Janet Burgess, John Carlin, Paul Monagle, Vera Ignjatovic

“…Where possible, sample aliquots from the same patients are analysed for an analyte across multiple commercially available analysers.Ethics and dissemination The study protocol was approved by The Royal Children’s Hospital, Melbourne, Ethics in Human Research Committee (34183 A). …”
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Comparing the effectiveness, safety and tolerability of interventions for depressive symptoms in people with multiple sclerosis: a systematic review and network meta-analysis proto... by Amalia Karahalios, Allan G Kermode, Yvonne C Learmonth, Julia Lyons, Stephanie Campese, Alexandra Metse, Claudia H Marck

“…Otherwise, a narrative review will be provided.Ethics and dissemination Ethics is not required for a systematic review and network meta-analysis. …”
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Study protocol of the PRINCESS trial—PReoperative INtermittent fasting versus CarbohydratE loading to reduce inSulin resiStance versus standard of care in orthopaedic patients: a r... by Markus W Hollmann, Abraham H Hulst, Benedikt Preckel, Jeroen Hermanides, Ayla Y Stobbe, Eline S de Klerk, Robert van Wilpe, Arthur J Kievit, Kee Fong Choi, Mireille F M van Stijn

“…Statistical analyses are performed using Student’s t-tests or Mann-Whitney U tests.Ethics and dissemination The local medical ethics committee of the Amsterdam UMC, the Netherlands, approved the trial protocol in January 2023 (NL81556.018.22). …”
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Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial... by Claus Thorn Ekstrøm, Patrick MacDonald Fisher, Gitte Moos Knudsen, Dea Siggaard Stenbæk, Anders Fink-Jensen, Mathias Ebbesen Jensen, Tobias Søgaard Juul

“…Key secondary outcomes are as follows: (1) total alcohol consumption, (2) phosphatidyl-ethanol, an objective biomarker for alcohol, (3) plasma psilocin, the active metabolite, to establish a possible therapeutic range, (4) the acute subjective drug experience as a possible predictor of treatment outcome and (5) neuronal response to alcohol cues and cognitive flexibility within corticostriatal pathways by use of functional MR brain imaging 1-week postdosing.Ethics and dissemination Ethical approval has been obtained from the Committee on Health Research Ethics of the Capital Region of Denmark (H-20043832). …”
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Efficacy and safety of Xiongzhitongluo granules in the treatment of acute ischemic stroke: study protocol for a randomized controlled trial by Yunmeng Chen, Jingjing Wei, Xiao Liang, Yue Liu, Lina Miao, Di Zhao, Yunfan Zhang, Hongxi Liu, Yunling Zhang

“…Data will be recorded using Epidata V3.1 and analyzed with SPSS 26.0.Ethics and disseminationThis study received approval from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences (2021XLA102-2). …”
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Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial by Bo Chen, Xu Wang, Hong He, Xiaojie Huang, Qian Du, Shaoyong Xu, Xiaomin Qin, Tongting Kang

“…Secondary outcome measures are the time to first bowel movement, the incidence of moderate to severe bloating, the incidence of bowel obstruction or venous thromboembolism, the incidence of adverse events (nausea, vomiting, dizziness), patient satisfaction, sleep quality scores, patient compliance with activities, hospital costs and days in hospital.Ethics and dissemination This study was approved by the Independent Ethics Committee of Xiangyang Central Hospital affiliated with Hubei University of Arts and Sciences and registered with the China Clinical Trials Registry in May 2021. …”
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Self-Harm in Eating Disorders (SHINE): a mixed-methods exploratory study by Maria Michail, Helen Bould, Anna Lavis, Sheryllin McNeil, Anthony Winston, Kalen Reid, Christina L Easter, Rosina Pendrous

“…Results from both phases will be integrated using a mixed-methods matrix, with each participant’s data from both phases compared alongside comparative analysis of the datasets as a whole.Ethics and dissemination The study gained ethical approval from the NHS HRA West Midlands–Black Country Research Ethics Committee (number: 296032). …”
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Anthropometrics Analysis of Mental Foramen and Accessory Mental Foramen in Zambian Adult Human Mandibles by Balakrishnan Subramanian, Severine N. Anthony, Lumamba Mubbunu, Chitinti Hachombwa, Majuto S. Mlawa, Mudhihiri M. Majambo, Rajab M. Sasi

“…The study aimed at evaluating anthropometrics of MF and AMF in Zambian adult human mandibles and it was cleared for ethics from TDRC Ethics Review Committee (Reg. No.: 00002911; FWA: 00003729). …”
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Effects of cardiovascular health, musculoskeletal health and physical fitness on occupational performance of firefighters: protocol for a systematic review and meta-analysis by Andre Pascal Kengne, Denise Smith, Jaron Ras, Elpidoforos Soterakis Soteriades, Lloyd Leach

“…The synthesis of quantitative data (using a meta-analysis methodology) will involve the integration of quantitative findings from multiple studies to achieve coherence.Ethics and dissemination This study obtained ethical clearance from the University of the Western Cape Biomedical Research Ethics Committee (BM21/10/9). …”
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Comparison of glycosylated fibronectin versus soluble fms-like tyrosine kinase/placental growth factor ratio testing for the assessment of pre-eclampsia: protocol for a multicentre... by Marcus Green, Chao Wang, Sarah Fisher, Amarnath Bhide, Ramesh Ganapathy, Basky Thilaganathan, Nouran Elbarbary

“…Maternal and neonatal outcome data will be collected to compare the sensitivity and specificity of the tests, with the primary outcome being delivery for pre-eclampsia within 4 weeks.Ethics and dissemination Ethical approval has been obtained from the Health Research Authority and Health and Care Research Wales Ethics Committee. …”
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Participant Contributions to Person-Generated Health Data Research Using Mobile Devices: Scoping Review by Shanshan Song, Micaela Ashton, Rebecca Hahn Yoo, Zoljargal Lkhagvajav, Robert Wright, Debra J H Mathews, Casey Overby Taylor

“…A significant deficiency in reporting completeness was observed for the “data” and “ethics” dimensions (5 reporting factors were missing in over half of the research publications). …”
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Developing a set of key principles for care planning within older adult care homes: study protocol for a modified Delphi survey by Madalina Toma, Jonathan Taylor, Nick Smith, Sarah Jasim, Jacqueline Damant, Yuri Hamashima, Thais Caprioli

“…Consensus will be considered if ≥75% of participants rate an item as 4–5.Ethics and dissemination This study to which this protocol relates has been granted ethical approval by the University of Kent’s Division for the Study of Law, Society and Social Justice Research Committee Ethics Panel (reference: 1006) on 9 April 2024. …”
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Effects of community family doctors-led intervention for self-management and medication adherence in type 2 diabetes mellitus patients: study protocol of a cluster randomised contr... by Yue Chen, Biqi Ren, Ningsheng Wang, Shuang Lei, Shuzhi Lin, Lianye Liu, Yufang Xiang, Bianling Feng

“…The secondary outcome is the proportion of people whose blood sugar and glycosylated haemoglobin are under control in the 3rd and 6th months.Ethics and dissemination The study proposal was approved by the Biomedical Ethics Committee of the Medical Department of Xi’an Jiaotong University (no. 2021-1371). …”
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cfDNA as a surrogate marker for COVID-19 severity in patients with influenza-like symptoms with and without SARS-CoV-2 infections in general practice: a study protocol for a prospe... by Dorothea Dehnen, Elmo Neuberger, Jürgen in der Schmitten, Ekaterini Giagkou, Perikles Simon, Suzan Botzenhardt

“…The secondary objective is to determine whether there is a correlation between cfDNA concentrations on the one hand, and laboratory and clinical parameters on the other hand. cfDNA, differential blood count, high-sensitive CRP and erythrocyte sedimentation rate will be measured in blood samples, concomitant symptoms will be surveyed via a self-assessment questionnaire, and oxygen saturation, breathing rate and examination of the lungs will be reported by treating physicians.Ethics and dissemination Ethical approval was issued on 1 March 2021 by the Ethics Committee Essen under the number 21-9916-BO. …”
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Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial by Lucíola da Cunha Menezes Costa, Shaiane Silva Tomazoni, Leonardo Oliveira Pena Costa, Layana de Souza Guimarães, Amanda Costa Araujo, Dafne Port Nascimento, Flávia Cordeiro de Medeiros, Marina Athayde Avanzi

“…The secondary outcomes will be pain intensity and disability measured at 3, 6 and 12 months after randomisation, in addition to specific disability and global perceived effect in all time points.Ethics and dissemination The study was approved by the Research Ethics Committee of Universidade Cidade de São Paulo. …”
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Melatonin supplementation for the treatment of infantile spasms: protocol for a randomised placebo-controlled triple-blind trial by Jing Wang, Tao Xu, Miao Liu, Jian Chen, Guang Yang, Weiwei Feng, Yulin Sun, Xiuyu Shi, Liping Zou

“…Sleep quality and safety will also be assessed.Ethics and dissemination The protocol for this study was approved by the Ethics Committee of Chinese PLA General Hospital (reference number S2020-337-01) and was reported according to the Standard Protocol Items: Recommendations for Interventional Trials statement. …”
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Controlled ovarian hyperstimulation with or without letrozole for fertility preservation in breast cancer patients: study protocol for a randomised controlled trial by Ping Li, Kun Wang, Qi Fan, Peng Sun, Yuhua Shi, Yanqiu Xie, Weifen Deng, Jiajing Kang

“…The secondary outcomes are the number of high-quality embryos, incidence of ovarian hyperstimulation syndrome(OHSS) and recurrence rate of breast cancer.Ethics and dissemination Ethical approval was obtained from the Ethics Review Committee of Guangdong Provincial People’s Hospital (KY-Q-2023-840-02). …”
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