Yishenyangsui granule for degenerative cervical myelopathy: a randomized, double-blind, placebo-controlled trial with long-term follow-up by He Yin, Xin Chen, Zhiwei Liu, Zhiwei Liu, Bo Xu, Zhefeng Jin, Yan Liu, Baoyu Qi, Bin Tang, Ping Wang, Fanping Xu, Xu Wei, Jie Yu, Liguo Zhu, Liguo Zhu

“…This trial was approved by the ethics committee of WangJing Hospital of China Academy of Chinese Medical Sciences (WJEC-KT-2016-004-P001) and was registered at the Chinese Clinical Trials Registry (ChiCTR-INR-16009723) on 03 November 2016 (Check out at https://www.chictr.org.cn/indexEN.html for a more comprehensive overview).ResultsThe results showed that the improvement in JOA score at week 8 was significantly better in the Yishenyangsui granule group than in the placebo group (1.47 vs. 0.43; P < 0.001). …”
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Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skill... by Nick Sevdalis, Khalida Ismail, Tayana Soukup, Trevor Murrells, Dulmini Kariyawasam, Stephen Thomas, Judith Parsons, Angus Forbes, Rita Forde, Maria Baldellou Lopez, Marie Jones, Martha Ford-Adams, Nardos Yemane, Siobhan Pender, Alex Silverstien

“…Study findings will be used to optimise the intervention components, outcome measures and recruitment methods to inform a subsequent definitive trial.Ethics and dissemination The protocol has ethical approval from the UK Health Research Authority (approval IRAS project ID: 279877). …”
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Surgical Outcomes and Sociodemographic Disparities Across All Races: An ACS-NSQIP and NHIS Multi-Institutional Analysis of Over 7.5 Million Patients by Dany Y. Matar, BA, Samuel Knoedler, Anthony Y. Matar, BS, Sarah Friedrich, PhD, Harriet Kiwanuka, MD, Ryoko Hamaguchi, MD, Carla M. Hamwi, BS, Gabriel Hundeshagen, MD, MMS, Valentin Haug, MD, Ulrich Kneser, MD, PhD, Keisha Ray, PhD, Dennis P. Orgill, MD, PhD, Adriana C. Panayi, MD, PhD

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Estimating the global cost of vision impairment and its major causes: protocol for a systematic review by Nathan Congdon, Thomas Butt, Peng Tee Khaw, Andrew Bastawrous, Tasanee Braithwaite, Rupert R A Bourne, Matthew J Burton, Serge Resnikoff, Jacqueline Ramke, Kevin Frick, Hugh Taylor, Iris Gordon, Ana Patricia Marques, John Cairns, Justine H Zhang, Hannah B Faal, Iain Jones, Marty Jovic, Allyala Nandakumar

“…This protocol has been prepared following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocols and has been published prospectively in Open Science Framework.Ethics and dissemination Formal ethical approval is not required, as primary data will not be collected in this review. …”
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Implementing and evaluating the comprehensive integration of physical activity into a major health system: study design and protocol by Alex Ewing, Mark Stoutenberg, Jennifer L Trilk, Christopher Wichman, Paul A Estabrooks, John M Brooks, Meenu Jindal, James Rosemeyer, Leah M Schumacher, Lia K McNulty, Stephanie Eskuri, Frankie Bennett

“…The Reach, Effectiveness, Adoption, Implementation and Maintenance framework will inform the assessment of implementation outcomes, while the integrated Promoting Action on Research Implementation in Health Services framework will be used to explore contextual factors influencing patient-level and clinic-level outcomes.Ethics and dissemination We received ethical approval to conduct this study from the Prisma Health IRB Committee A (#1963762). …”
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Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial by Brian E McGuire, Lina Bunketorp-Käll, Eva Lendaro, Liselotte Hermansson, Helena Burger, Corry K Van der Sluis, Monika Pilch, Katarzyna Kulbacka-Ortiz, Ingrid Rignér, Anita Stockselius, Lena Gudmundson, Cathrine Widehammar, Wendy Hill, Sybille Geers, Max Ortiz-Catalan

“…Follow-up interviews are conducted up to 6 months after the treatment.Ethics and dissemination The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. …”
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Prospective study of factors associated with asthma attack recurrence (ATTACK) in children from three Ecuadorian cities during COVID-19: a study protocol by Cristina Ardura-Garcia, Max Bachmann, Alejandro Rodriguez, Philip Cooper, Michael Richard Perkin, Irina Chis Ster, Natalia Cristina Romero, Martha E Chico, Alvaro Cruz, Diana Morillo, Santiago Mena-Bucheli, Angélica Ochoa, Claudia Rodas, Augusto Maldonado, Karen Arteaga, Jessica Alchundia, Karla Solorzano, Camila Figueiredo

“…Data will be analysed using logistic regression and survival analyses.Ethics and dissemination Ethical approval was obtained from the Hospital General Docente de Calderon (CEISH-HGDC 2019-001) and Ecuadorian Ministry of Public Health (MSP-CGDES-2021-0041-O N° 096-2021). …”
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Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial by Robert Clarke, Emma J Crosbie, Basil G Issa, John Belcher, Helen Clarke, Anthony Howell, Michelle Harvie, Hannah Harrison, Cheryl Lombardelli, Suzanne Krizak, Katharine Sellers, Yit Y Lim, Caroline Parkin, Shruthi Patel, Anthony J Maxwell, Julie Wisely, Sacha J Howell

“…The trial will also assess longer-term adherence and weight loss success across the 12-month programme in both the immediate and control groups.Ethics and dissemination Approval for this study has been obtained from the Health Research Authority and Health and Care Research Wales (approval 20/NW/0095). …”
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Evaluation of the implementation in primary care of genetic testing for the screening of MODY2 (iMOgene): protocol for an implementation pilot study by Marie-Ève Poitras, Luigi Bouchard, Samuel Legeay, Vanessa Tremblay-Vaillancourt, Amélie Fournier, Josianne Leblanc, Philippe Caron, Catherine Savard, Nathalie Bettez, Karine Tremblay

“…This study will document the implementation process of genetic testing in primary care by identifying facilitating and limiting factors to establish specifications for scaling up.Ethics and dissemination The present protocol has been approved by the research ethic committee of the ‘Centre intégré universitaire de santé et de services sociaux of Saguenay-Lac-Saint-Jean’ (CIUSSS-SLSJ) on 9 January 2024 and by the ‘Comité central d’éthique de la recherche’ (CCER) of the ‘Ministère de la Santé et des Services Sociaux’ of Quebec (Canada) on 30 January 2024. …”
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Informatization of the processes of administration of the quality of medical services in surgical hospitals by Ya.S. Bereznytskyi, V.Ya. Bereznytskyi, O.V. Hudoshyna, N.D. Chuhrienko, G.V. Bereznytska, Ye.V. Zalyhina, Yu.B. Dianova, E.A. Rynska, L.N. Ksykevich

“…The research was approved by the Biomedical Ethics Committee. For the first time, as a result of the work of the internal quality commission, daily and summarized forms of reports on the work of the medical center, which have five sections are obtained. …”
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Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol... by Zhuo Chen, Yefeng Cai, Wenjun He, Yiyuan Cai, Lingrui Liu, Qing Zhao, Sensen lv, Dong (Roman) Xu, Chun Hao, Lanping Zhang, Pengfei Guo, Yuning Shi

“…Additionally, a cost-effectiveness analysis will be conducted to assess the economic feasibility of the implementation strategies.Ethics and dissemination This trial has been approved by the Institutional Review Board of Southern Medical University (approval number: #202261) and follows all relevant ethical guidelines for research involving human participants. …”
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Effects of MyBFF@school, a multifaceted obesity intervention program, on anthropometry and body composition of overweight and obese primary schoolchildren by Ruziana Mona Wan Mohd Zin, Abdul Halim Mokhtar, Abqariyah Yahya, Fuziah Md. Zain, Rusidah Selamat, Zahari Ishak, Muhammad Yazid Jalaludin

“…The intervention program was approved by the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia and the Educational Planning and Research Division (EPRD), Ministry of Education Malaysia. …”
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Newborn signal functions in Bangladesh: identification through expert consultation and assessment of readiness among public health facilities—study protocol using Delphi technique... by Afsana Karim, Joby George, Sanjoy Kumer Dey, Mohammod Shahidullah, Shams El Arifeen, Mahbuba Khan, Ahmed Ehsanur Rahman, Goutom Banik, Shema Mhajabin, Tazeen Tahsina, Md. Jahurul Islam, Farid Uddin Ahmed, Mushair Ul Islam, Md Abdul Mannan, Shamina Sharmin, Fida Mehran, Anisuddin Ahmed, Ahmed Al Sabir, Shahin Sultana, Ziaul Ahsan, Sayed Rubayet

“…Descriptive statistics (proportion) with a 95% CI will be used to report the level of service availability and readiness of public facilities regarding NSFs.Ethics and dissemination Ethical approval was obtained from Research Review and Ethical Review Committee of icddr, b (PR-17089). …”
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Mamá Empoderada: study protocol for a pilot trial of a novel parenting and mental health prevention intervention for migrant mothers with young children at the Mexico-US border by Gudelia Rangel, Shira M Goldenberg, Eileen Pitpitan, Kaylee Ramage, Ietza Bojorquez-Chapela, Cecilia Martinez-Torteya, Katherine Rosenblum, Chelsie Hernandez, Monica Alvarez

“…Statistical analyses will compare primary (ie, symptoms of depression and anxiety; parenting stress) and intermediate outcomes (eg, resilience, service utilisation) by exposure to intervention condition.Ethics and dissemination This study is approved by the San Diego State University and El Colegio de la Frontera Norte Institutional Research Boards. …”
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Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno–ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypa... by Delphine Maucort-Boulch, Maud Robert, Tigran Poghosyan, Dominique Delaunay, Elise Pelascini, Sylvain Iceta, Adrien Sterkers, Charles Barsamian, Litavan Khamphommala, Sylvie Bin Dorel, Sebastien Czernichow, Emmanuel Disse

“…With a drop-out rate of 10%, it will be necessary to include 183 patients per group.Ethics and dissemination The study was approved by Institutional Review Board of Centre Hospitalier Universitaire Morvan (CPP1089-HPS1). …”
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Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after s... by Derek C Angus, Jennifer Holder-Murray, Katherine Moll Reitz, Christopher W Seymour, Jennifer Vates, Melanie Quintana, Kert Viele, Michelle Detry, Michael Morowitz, Alison Morris, Barbara Methe, Jason Kennedy, Brian Zuckerbraun, Timothy D Girard, Oscar C Marroquin, Stephen Esper, Anne B Newman, Scott Berry, Matthew Neal

“…A subset of patients will be selected for substudies evaluating the microbiome, cognition, postoperative delirium and strength.Ethics and dissemination The Core Protocol of SPRY REMAP and associated SPRY-Metformin Domain-Specific Appendix have been ethically approved by the Institutional Review Board and are publicly registered. …”
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Rationale, design, and methodology of My Body Is Fit and Fabulous at school (MyBFF@school) study: a multi-pronged intervention program to combat obesity among Malaysian schoolchild... by Abdul Halim Mokhtar, Ruziana Mona Wan Mohd Zin, Abqariyah Yahya, Fuziah Md. Zain, Rusidah Selamat, Zahari Ishak, Muhammad Yazid Jalaludin

“…The intervention program was approved by the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia and Educational Planning and Research Division (EPRD), Ministry of Education Malaysia. …”
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Prevalence and factors associated with potential clinically significant drug-drug interactions in patients with cardiovascular diseases at hospital admission by Marović Iva, Udovičić Mario, Rudan Diana, Manola Šime, Samardžić Ivana, Vrca Vesna Bačić, Hadžiabdić Maja Ortner, Marinović Ivana

“…The research was approved by the Hospital’s Ethics Committee and each patient involved in the study signed an informed consent. …”
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The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study by Daniel Woo, Richard Thompson, Carl D Langefeld, Nichol McBee, Daniel Hanley, Matthew L Flaherty, Lauren Sansing, Karen Lane, Lee A Gilkerson, Achala Vagal, Nathan Walborn, Wendy Ziai, Noeleen Ostapkovich, Kevin Triene, Timothy David Howard

“…If successful, the REASSESS study could demonstrate that reduction of ICH volume is a critical target to reduce the risk of progressive cognitive decline, establish targets for residual haematoma volume reduction and determine if greater residual haematoma volume leads to a long-term inflammatory state.Ethics and dissemination Approval of this study was obtained from the Johns Hopkins University Institutional Review Board (IRB00311985). …”
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Effects of the MyBFF@school obesity intervention program with nutrition education intervention on nutrition knowledge and attitude of secondary schoolchildren: a cluster randomized... by Rusidah Selamat, Junidah Raib, Nur Azlina Abdul Aziz, Norlida Zulkafly, Ainan Nasrina Ismail, W Nurul Ashikin W Mohamad, Ainol Aizuddin Zulkiply, Muhammad Yazid Jalaludin, Fuziah Md. Zain, Zahari Ishak, Abqariyah Yahya, Abdul Halim Mokhtar

“…The intervention program was approved by the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia and Educational Planning and Research Division (EPRD), Ministry of Education Malaysia. …”
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