Enhancing patient engagement: the influence of an in-consult patient decision aid on shared decision-making for lung tumour radiation – protocol for the randomised trial ‘SDM Lung SBRT’ by Karina Dahl Steffensen, Signe Timm, Torben Frøstrup Hansen, Thomas Leth Fink, Charlotte Kristiansen, Torben Schjødt Hansen, Rune Slot Thing

“…Results from this study will be presented at scientific meetings and published in English peer-reviewed journals.Trial registration number ClinicalTrials.gov (NCT04940936).…”
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Cardiopulmonary fitness in children/adolescents with chronic kidney disease and the impact of exercise training: a systematic review and meta-analysis of observational study and randomized controlled trials by Fan Zhang, Yan Bai, Liuyan Huang, Yifei Zhong

“…Given the low evidence certainty, additional high-quality trials are necessary.…”
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Transcatheter edge-to-edge mitral valve repair <i>versus</i> medical therapy for secondary mitral regurgitation: a meta-analysis of randomized controlled trials by Emídio Mata, Bárbara Lage Garcia, Mariana Tinoco, Margarida Castro, Luísa Pinheiro, João Português, Francisco Ferreira, Silvia Ribeiro, Bruno Melica, António Lourenço

“… Secondary mitral regurgitation (SMR) is associated with increased hospitalizations and mortality. Clinical trials comparing mitral valve transcatheter edge-to-edge repair (M-TEER) with guideline-directed medical therapy (GDMT) show conflicting results, but the RESHAPE-HF2 trial offers new insights. …”
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Effects of Exergaming on Morphological Variables, Biochemical Parameters, and Blood Pressure in Children and Adolescents with Overweight/Obesity: A Systematic Review with Meta-Analysis of Randomized Controlled Trials by Jordan Hernandez-Martinez, Joaquín Perez-Carcamo, Hassan Melki, Izham Cid-Calfucura, Edgar Vasquez-Carrasco, Pedro Delgado-Floody, Claudio Romero, Tomás Herrera-Valenzuela, Braulio Henrique Magnani Branco, Pablo Valdés-Badilla

“…Results: Out of 72 records, 6 randomized controlled trials with 191 children and adolescents with overweight/obesity were included. …”
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Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2) by Heather M Foran, Marija Raleva, Nina Heinrichs, Graham Moore, Yulia Shenderovich, Xiang Zhao, Judith Simon, Antonio Piolanti, Viorel Babii, Janina Mueller, Franziska Waller, Dennis Wienand, Swetha Sampathkumar, Ivo Kunovski

“…Cyril and Methodius University in North Macedonia (approval number: 03-2144/4) and the National Committee of Ethical Expertise for Clinical Trials in Moldova (approval number: 1476). The results will be disseminated through peer-reviewed journals, conferences, webinars in multiple languages, regional forums, stakeholder meetings with policymakers and practitioners, public communication through media engagement and open access platforms, including data sharing and early release of findings.Trial registration details Trial registration: NCT06562244; Project page: https://www.flourish-study.org/about.html…”
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Evaluating the Impact of Simulated Patients on Knowledge, Skills and Attitudes of Laypeople Following a Basic First Aid Course: Protocol for a Cluster-Randomized Controlled Trial

“…Methods: This study will be a cluster-randomized controlled trial, that will take place from September 2018 to June 2020. …”
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Post-therapeutic support and rehabilitation for breast cancer women in complete remission in a thermal resort: study protocol for the PACThe Real-Life conditions observational trial by Mélanie Godiveau, Judith Passildas, Emilie Thivat, Mélanie Casile, Céleste Pinard, Alexia Giro, Marie-Ange Mouret-Reynier, Ioana Molnar, Catherine Abrial, Claude-Eugène Bouvier, Yves-Jean Bignon, Xavier Durando

“…This study has been registered on ClinicalTrials.gov: NCT05433077. Protocol: version 4, 22 December 2022.…”
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Enhancing postoperative analgesia in carotid endarterectomy patients: The potential of ultrasound-guided carotid sheath block combined with superficial cervical plexus block: A randomised trial by Anamarija Kruc, Lada Lijovic, Matteo Skrtic, Iva Pazur, Nikola Perisa, Tomislav Radocaj

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Phase I trial on the safety of olprinone for low central venous pressure management aimed at haemorrhage control during open and laparoscopic hepatectomy: a study protocol by Katsuhiko Uesaka, Yuya Miura, Teiichi Sugiura, Ryo Ashida, Katsuhisa Ohgi, Mihoko Yamada, Shimpei Otsuka, Yoshiyasu Kato, Takuya Oyakawa, Eiji Ando, Sunao Tamai

“…The trial employs a 3+3 cohort study design to determine the maximum tolerated dose (MTD) and identify dose-limiting toxicities. …”
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Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal by Min Kim, David Macleod, Michael Gichangi, Andrew Bastawrous, Matthew J Burton, Jacqueline Ramke, Oathokwa Nkomazana, James R Carpenter, Sailesh Mishra, Shalinder Sabherwal, Luke Allen, Sarah Karanja, Ari Ho-Foster, Nigel Bolster, Malebogo Tlhajoane, Bakgaki Ratshaa

“…The access rate is even lower for certain population groups. This platform trial aims to test multiple, iterative, low-risk public health interventions and simple service modifications with a series of individual randomised controlled trials (RCT) conducted in each country, with the aim of increasing the proportion of people attending.Methods and analysis We will set up a platform trial in each country to govern the running of a series of pragmatic, adaptive, embedded, parallel, multiarm, superiority RCTs to test a series of service modifications suggested by intended service users. …”
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Supplementation with Korean Red Ginseng Improves Current Perception Threshold in Korean Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Trial by Kahui Park, YuSik Kim, Junghye Kim, Shinae Kang, Jong Suk Park, Chul Woo Ahn, Ji Sun Nam

“…This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. …”
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Hypofractionated partial breast irradiation after breast-conserving surgery for patients with early stage breast cancer in China Mainland: a single-arm prospective trial by Xiaomeng Zhang, Xiaofang Wang, Zhuohua Xu, Yajuan Chu, Xingxing Chen, Li Zhang, Jin Meng, Wei Shi, Zhaozhi Yang, Xin Mei, Xiaoli Yu, Zhen Zhang, Xiaomao Guo, Miao Mo, Guangyu Liu, Jiong Wu, Zhimin Shao, Jinli Ma

“…The primary endpoint was 3-year cosmetic deterioration, and secondary endpoints included adverse events, ipsilateral breast tumor recurrence (IBTR), regional recurrence, and survivals. This trial is registered with ClinicalTrials.gov (registration No. …”
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Response to Comment on: “Prognostic Relevance of Primary Tumor Sidedness in Early-Stage Colorectal Cancer: An Integrated Analysis of 4 Randomized Controlled Trials (JCOG2003A)” by Akira Ouchi, MD, PhD, Shunsuke Tsukamoto, MD, PhD, Atsuo Takashima, MD, PhD, Yasuhiro Shimada, MD, Tetsuya Hamaguchi, MD, PhD, Masafumi Inomata, MD, PhD, Yasumasa Takii, MD, Ryo Sadachi, PhD, Yukihide Kanemitsu, MD

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Comparing Treatment with Nebulized 3% Hypertonic Saline Versus Nebulized 0.9% Saline In Patients With Acute Bronchiolitis: A Double-Blind Randomized Controlled Trial by Uzma Abid, Ayesha Afzal, Nahdia Zaman, Ammara Farooq, Sidrah Yousaf, Sonia Fazal

“…Methods: This randomized control trial was conducted in the Pediatric department of Holy Family Hospital, Rawalpindi for 8 months from September 2021 to April 2022 after ethical approval. …”
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Comparing the effects of computerized versus manual methods of identifying point-specific acupuncture as an adjunct to physiotherapy in the management of knee osteoarthritis: A randomized controlled trial protocol. by Lee Chai Li, Mohd Azzuan Ahmad, Tan Chee Hou, Angeline Low Ann Je, Lee Zi Lin, Tay Yan Ling, Peng Yan

“…<h4>Methods</h4>A randomized, double-blind controlled trial will be conducted with 50 participants diagnosed with mild to moderate KOA. …”
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Impact of ELKa, the Electronic Device for Prandial Insulin Dose Calculation, on Metabolic Control in Children and Adolescents with Type 1 Diabetes Mellitus: A Randomized Controlled Trial by Agnieszka Kowalska, Katarzyna Piechowiak, Anna Ramotowska, Agnieszka Szypowska

“…The ELKa system improves metabolic control in children with T1DM under regular usage. The trial is registered at ClinicalTrials.gov, number NCT02194517.…”
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Investigating the implementation of a Trial of Labour After Caesarean (TOLAC) delivery bundle with respect to decreasing caesarean delivery rates: a multisite quality improvement initiative by Eliane M Shore, Elizabeth Miazga, Cheyanne Reed, Alisha Olsthoorn, Isabella Fan, Eliya Zhao, Jodi Shapiro, Amanda Cipolla, Modupe Tunde-Byass

“…Secondary outcomes included rates of trial of labour after caesarean delivery, vaginal birth after caesarean delivery and induction of labour. …”
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Effect of Vaginal Cream with the Combination of Honey, Olive, and Propolis on the Symptoms of Uterine Cervicitis Symptoms in Women: A Double-Blind Randomized Controlled Clinical Trial Study by Hamideh Parsapour, Arezoo Shayan, Mehrnoosh Hosseinpoor, Seyedeh Zahra Masoumi, Farideh Kazemi, Shirin Moradkhani, Seyed Mohammad Hossein Oliaei, Zeinab Assareh, Mohammad Kazem Rashidi

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Predictive value of bedside diaphragmatic ultrasonography for extubation success in critically ill patients after general anaesthesia: A meta-analysis with trial sequential analysis (TSA) by Lan Ma, Na Zhou, Kaiming Yuan, Zihao Xue, Kai Lv, Jingying Huang

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High immunoproteasome and low constitutive proteasome subunit levels correlate with sensitivity to bortezomib-containing chemotherapy: update from the Children’s Oncology Group AALL1231 trial by Margot S. F. Roeten, Johan van Meerloo, Suzanne N. van Dijk, Zinia Kwidama, Gaye Jenkins, David T. Teachey, Meenakshi Devidas, Mignon L. Loh, Gertjan J. L. Kaspers, Sonja Zweegman, Gerrit Jansen, Terzah M. Horton, Jacqueline Cloos

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