Effects of a nurse-led peer support intervention for stroke survivors: protocol for a randomised controlled trial by Ying Wu, Janita Pak Chun Chau, Xiaojuan Wan, Limei Xu, Weijuan Gong

“…Generalised Estimation Equation models will be used to assess the intervention effect.Ethics and dissemination This protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. …”
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Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial by Yue Zhao, Guang Yang, Yun-Qiong Lu, Mei-Yan Li, Jue Hong, Yan-Ting Yang, Xue-Jun Wang, Xie-He Kong, Zhao Ma, Xin-Yun Huang, Yue-Lan Zou, Xing-Tao Zhou, Xiao-Peng Ma

“…The secondary outcomes include tear meniscus height, the Schirmer I test, corneal and conjunctival sensation, the ocular surface disease index, corneal fluorescein staining, the numerical rating scale and the Chinese DE-related quality of life scale.Ethics and dissemination The trial protocol and informed consent were approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (identifier: 2021–119), Shanghai Eye Disease Prevention and Treatment Center (identifier: 2022SQ003) and Eye and ENT Hospital of Fudan University (identifier: 2022014).Trial registration number NCT05552820.…”
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Modular-based psychotherapy (MoBa) versus cognitive–behavioural therapy (CBT) for patients with depression, comorbidities and a history of childhood maltreatment: study protocol fo... by Elisabeth Schramm, Martin Hautzinger, Carolin Jenkner, Moritz Elsaesser, Sabine Herpertz, Hannah Piosczyk

“…Crucial feasibility aspects include targeted psychopathological mechanisms, selection (treatment algorithm), sequence and application of modules, as well as training and supervision of the study therapists.Ethics and dissemination This study obtained approval from the independent Ethics Committees of the University of Freiburg and the University of Heidelberg. …”
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Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial by Jing Li, Fei Chen, Wei Xiao, Feng Li, Lan Chen, Ting He, Yanxiong Mao, Aiping Zou, Bo Fan, Weihao Ni, Huimin You, Wenjiang Fu

“…The primary outcome is the mean rate of protocol-defined pulmonary exacerbation at 6 months.Ethics and dissemination Ethical approval was obtained from the First People’s Hospital of Jiashan Ethics Committee. …”
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Therapy of genomic unstable solid tumours (WHO grade 3/4）in clinical stage III/IV using individualised neoantigen tumour peptides-INP trial (individualised neoantigen tumour peptid... by Ling Wang, Xia Chen, Juan Zhao, Jiaxi Tang, Wanyan Tang, Bin Liao, Weiqi Nian

“…Secondary endpoints are progression-free survival, objective response rate, objective duration of remission, 1-year survival rate and overall survival.Ethics and dissemination This study has received approval from the Ethics Committee of Chongqing University Cancer Hospital on 21 November 2019 (207/2019). …”
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Cognitive behavioural therapy plus Kiesler Circle Training (CBT+) versus CBT only for patients with interpersonal problems: study protocol for a randomised controlled feasibility t... by Stephan Köhler, Philipp Sterzer, Eva-Lotta Brakemeier, Karen Ollrogge, Daniel Schulze, Eva Friedel, Nina Romanczuk-Seiferth, Anna-Lena Siegerist, Anne Guhn

“…This study aims to provide evidence for the feasibility of KCT as a modular transdiagnostic add-on approach for patients with interpersonal difficulties.Ethics and dissemination This study obtained approval from the ethics committees at the Charité Berlin, the Medical School of Berlin and the University of Greifswald. …”
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Steroid use for established bronchopulmonary dysplasia: study protocol for a systematic review and meta-analysis by Roy K Philip, Joanna Seliga-Siwecka, Eduardo Villamor, Maria Pierro, Niazy Al Assaf, Sabina Strashun, Roberto Chioma, Kinga Zielińska, Krzysztof Włodarczyk

“…We will perform subgroup analysis based on the a priori determined covariate of interest.Ethics and dissemination Systematic reviews are exempted from approval by an ethics committee. …”
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Socioeconomic position across the life course and falls among middle- and older-aged adults: protocol for a systematic review by Stéphane Cullati, Anita van Zwieten, Catherine Sherrington, Fiona M Blyth, Saman Khalatbari-Soltani, Marcia R Franco, Frerik Smit

“…Otherwise, a narrative synthesis of results will be undertaken.Ethics and dissemination As this is a review of published literature, no ethics approval is required. …”
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Multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira) as a novel treatment in patients with high-grade squamous intraep... by Fei Chen, Jinghe Lang, Peter Hillemanns, Youzhong Zhang, Zoltán Novák, Long Sui, Ling Han, Christian Dannecker, Ctirad Mokráš, Zhixue You

“…All patients in the Cevira group will be enrolled in an open, long-term extension study for 6 months to collect additional efficacy and safety data (study extension endpoints).Ethics and dissemination The study was approved by the ethics committee of the Peking Union Medical College Hospital and Hannover Medical University, Germany. …”
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Web-based interventions for pregnant women with gestational diabetes mellitus: a systematic review and meta-analysis protocol by Ping Xu, Wei Zhang, Xiaojuan Wang, Dan Dan Chen, Pingping Guo, Yin Jin, Zhenzhen Xiang, Minna Mao, Qiong Zheng, Suwen Feng

“…We will conduct a qualitative synthesis for studies that cannot be quantitatively synthesised.Ethics and dissemination Ethics approval is not required for this review as no human participants will be involved. …”
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The association of dietary approaches to stop hypertension measured by the food frequency questionnaire with metabolic syndrome and some inflammatory biomarkers in adolescents with... by Maryam Behrooz, Alireza Ostadrahimi, Samaneh Hajjarzadeh, Mirhadi Mousavi, Afshin Ghalegolab Behbahani, Siamak Shiva

“…Further prospective studies are needed to confirm these findings. Trial registration Ethics approval was obtained from the research ethics committee of Tabriz University of Medical Sciences (IR.TBZMED.REC.1397.179.).…”
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Minimal clinical data sets for spine-related musculoskeletal disorders in primary care and outpatient settings: a scoping review protocol by Pierre Côté, Andrea C Tricco, Cesar A Hincapié, Léonie Hofstetter, Jérémie Mikhail, Isabelle Pagé

“…Findings will be synthesised and presented as a descriptive summary using PRISMA ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews).Ethics and dissemination Ethics review and approval is not required for this scoping review. …”
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Reduction effect of oral pravastatin on the acute phase response to intravenous zoledronic acid: protocol for a real-world prospective, placebo-controlled trial by Qi Liu, Min Zhang, Liyuan Tao, Chunli Song, Haiyan Li, Gengyu Han, Runting Li, Dongwei Fan, Guohong Du, Dongyang Liu

“…This study protocol was reviewed and approved by the Peking University Third Hospital Medical Science Research Ethics Committee. The results will be published in scientific peer-reviewed journals.Trial registration number NCT04719481.…”
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Effect of folic acid supplementation on diminished ovarian reserve: study protocol of a single-centre, open-label, randomised, placebo-controlled clinical trial by Yan Wang, Ling Zheng, Kaijun Liao, Dongli Lu, Jiaxin Wu, Binjin Wu, Zhaochun Wu, Zhenghua Jiang

“…The primary outcome is antral follicle count, and the secondary outcomes are ovarian reserve markers, ovarian low-dose stimulation responses and safety.Ethics and dissemination This study was approved by the Ethics Review Committee of Nanping First Hospital Affiliated to Fujian Medical University on 10 February 2021 (approval number: NPSY202002042). …”
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Effects of message framing on self-management behaviour among patients with type 2 diabetes: a randomised controlled trial protocol by Xin Zhang, Feng Li, Hui Guo, Yue Pang, Yandi Liu, Ruitong Gao, Xiaoqian Lian, Tianyue Yu, Lanyu Zhu

“…All outcomes will be measured at baseline and 12 weeks.Ethics and dissemination This study was approved by the Ethics Committee of School of Nursing, Jilin University (No. 2020101501). …”
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Effectiveness of a personal health coaching intervention (diabetescoach) in patients with type 2 diabetes: protocol for an open-label, pragmatic randomised controlled trial by Oliver Faude, Fiona Streckmann, Lukas Zahner, Markus Gerber, Vivien Hohberg, Jan-Niklas Kreppke, Jan Kohl, Eleonora Seelig, Daniel König

“…Linear mixed-effects models will be applied for each outcome variable to analyse the intervention effects.Ethics and dissemination This study was approved by the Ethics Committee North-western and Central Switzerland in February 2021 (ref: 2020-02755). …”
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Virtual online consultations: advantages and limitations (VOCAL) study by Trisha Greenhalgh, Joe Wherton, Sara Shaw, Charles Gutteridge, Emma Byrne, Isabel Hodkinson, Shanti Vijayaraghavan, Desirée Campbell-Richards, Satya Bhattacharya, Philippa Hanson, Seendy Ramoutar, Anna Collard, Joanne Morris

“…Data will be analysed and synthesised using a sociotechnical framework developed from structuration theory.Ethics approval City Road and Hampstead NHS Research Ethics Committee, 9 December 2014, reference 14/LO/1883.Planned outputs We plan outputs for 5 main audiences: (1) academics: research publications and conference presentations; (2) service providers: standard operating procedures, provisional operational guidance and key safety issues; (3) professional bodies and defence societies: summary of relevant findings to inform guidance to members; (4) policymakers: summary of key findings; (5) patients and carers: ‘what to expect in your virtual consultation’.Discussion The research literature on video consultations is sparse. …”
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Prehospital triage of patients with acute cardiac complaints: study protocol of HART-c, a multicentre prospective study by Jan Bosch, Charles JHJ Kirchhof, Mark J Boogers, Enrico de Koning, Tom E Biersteker, Saskia Beeres, Barbra E Backus, Reza Alizadeh Dehnavi, Helen AM Silvius, Martin Schalij

“…To evaluate safety, all patients left at home and their general practitioners (GPs) are contacted for 30-day adverse events.Ethics and dissemination The study is approved by the LUMC’s Medical Ethics Committee. …”
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Prediction of postoperative myocardial injury in patients undergoing laparoscopic pheochromocytoma/paraganglioma resection: protocol for an ambispective cohort study by Yuguang Huang, Yuelun Zhang, Ling Lan, Yi Zhang, Ye Ma, Le Shen, Yifei Zhao, Yaohan Li

“…For external validation, we will use an independent prospective cohort (validation cohort) of patients from 1 March 2023 to 31 May 2025.Ethics and dissemination The study protocol has been approved by the Research Ethics Committee of PUMCH (IRB-K2893). …”
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Body composition, mitochondrial oxygen metabolism and metabolome of patients with obesity before and after bariatric surgery (COMMITMENT): protocol for a monocentric prospective co... by Sina M Coldewey, Charles Neu, Philipp Baumbach, Utz Settmacher, Kornel Skitek, Hermann Kissler, Ricardo Esper Treml

“…Outcomes will be assessed using paired t-tests, Wilcoxon signed-rank tests and regression analyses.Ethics and dissemination The study was approved by the Ethics Committee of Friedrich Schiller University Jena (2018-1192-BO). …”
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