HEalth-Related Quality of Life-Intervention in Survivors of Breast and Other Cancers Experiencing Cancer-Related Fatigue and Associated Cognitive Symptoms Using TraditionAL Chinese Medicine: The ‘HERBAL’ Trial by Alexandre Chan PharmD, Daniella Chan BS, Ding Quan Ng BSPharm, Huang Fang Zheng MD, Quan Ming Tan MCM, Chia Jie Tan PhD, Jolene Hui Min Toh BS, Ning Yi Yap PhD, Yi Long Toh PhD, Yu Ke PhD, Edmund Chun Ann Wang BS, Queenie Pei Ni Lim BSocSc, Han Kiat Ho PhD, Lita Chew MMS, Tira J. Tan MBBS

“…Difficulties with recruitment limited the generalizability of trial findings, thus findings should be verified through a larger, multi-centered trial.…”
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The Effect of Breathing Exercise Using Bubble Blower on Anxiety and Pain during Inferior Alveolar Nerve Block in Children Aged 7 to 10 Years: A Crossover Randomized Clinical Trial by Zahra Bahrololoomi, Tahereh Sadeghiyeh, Maedeh Rezaei, Nahid Maghsoudi

“…In this randomized crossover clinical trial, thirty-five children with moderate to severe anxiety requiring bilateral pulp therapy of mandibular primary molars were enrolled. …”
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A comparative study between central quadrantectomy and nipple resection with areola preservation Versus Grisotti flap mammoplasty in central breast lesions extending to nipple: a randomized clinical trial by Philobater Bahgat Adly Awad, Basma Hussein Abdelaziz Hassan, Abanoub Adel Shafek Awad, Abdelrahman Ahmed Younis Mohamed Attaia, Kerolos Bahgat Adly Awad, Dina Mohamed Hanafy, Ahmed Gamal El Din Osman

“…This trial involved 40 individuals who had central breast lesions that extended to the nipple and were monitored for two years following surgery. …”
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Erratum to ‘Efficacy and safety of local fibrinolytic therapy in intracranial hemorrhages: A systematic review and meta-analysis of randomised controlled trials’ [World Neurosurgery: X (22C) (2024) 100316] by Arun Babu Rajeswaran, Arshad Ali, Saleh Safi, Ahmed Eid Abdulghani Saleh

“…Methods: Medline, Embase, CINAHL Plus, Cochrane, Scopus, Web of science, clinical trials.gov, WHO and EU Clinical Trials Register were searched for RCTs only, on intra-clot fibrinolytics vs standard treatments for ICH and IVH. …”
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Twenty-four weeks of combined training in different environments, aquatic and land, in the type 2 diabetes management (Aquatic and Land Exercise for Diabetes -ALED): protocol of a randomized clinical trial by Larissa dos Santos Leonel, Ingrid Alessandra Victoria Wolin, Angélica Danielevicz, Mabel Diesel, Marina Isolde Constantini, João Batista de Oliveira Junior, Allana Andrade Souza, Thaís Reichert, João Gabriel Silveira-Rodrigues, Danusa Dias Soares, Marcelo Fernando Ronsoni, Simone Van De Sande Lee, Alex Rafacho, Guilherme Fleury Fina Speretta, Karla Siqueira Lottermann, Josefina Bertoli, Alexandre Pastoris Muller, Aline Mendes Gerage, Cíntia de La Rocha Freitas, Rodrigo Sudatti Delevatti

“…Trials…”
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Barriers and facilitators of loaded self-managed exercises and physical activity in people with patellofemoral pain: understanding the feasibility of delivering a multicentred randomised controlled trial, a UK qualitative study by Michael Skovdal Rathleff, Phillipa Logan, Marcus Bateman, Benjamin E Smith, Fiona Moffatt, Paul Hendrick, James Selfe, Toby O Smith

“…Participants’ improvements in pain and function may have been mediated, in some part, by greater self-efficacy and locus of control.Trial registration number ISRCTN35272486; Pre-results.…”
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Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial by CW Lee, K Park, JE Ahn, Y Jang, YS Park, H Yu, D Lee, HK Ihm, J Lee, J Kim, YI Lee, S-E Lim, SS Kwon, HY Park, TH Ha, I-Y Yoon, Woojae Myung, Ji Hyun Baek

“…Adverse events were monitored. This trial was registered with ClinicalTrials.gov (NCT04709952). …”
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Comprehensive self-tracking of blood glucose and lifestyle with a mobile application in the management of gestational diabetes: a study protocol for a randomised controlled trial (eMOM GDM study) by Henri Vähä-Ypyä, Harri Sievänen, Seppo Heinonen, Sari Niinistö, Suvi M Virtanen, Ilkka Korhonen, Mikko Kytö, Lisa Torsdatter Markussen, Pekka Marttinen, Giulio Jacucci, Tuuli E Korhonen, Saila B Koivusalo

“…The results will be presented in peer-reviewed journals and at conferences.Trial registration number NCT04714762.…”
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IoC2 monitoring versus standard practice in reducing opioid consumption in elderly patients undergoing laparoscopic colorectal surgery: a study protocol for a randomised controlled trial by Zhe Li, Jing Zhao, Xiaowen Liu, Huamei Cai, Yun Yan

“…The primary outcome will be to compare intraoperative sufentanil consumption between the two groups to assess the potential role of IoC2 in optimising perioperative analgesia in elderly patients.Ethics and dissemination This study has been approved by the ethics committee of China-Japan Friendship Hospital (2024-KY-148-3) and registered in the Chinese Clinical Trial Registry (ChiCTR2400089115). The findings will be disseminated through academic presentations and peer-reviewed journal publications, providing valuable data and insights into the role of IoC2 in guiding intraoperative pain management.Trial registration number ChiCTR2400089115.…”
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A Commentary on “Effect of Acupuncture Intervention on Chronic Musculoskeletal Pain in Hemodialysis-Dependent Kidney Failure Patients: Study Protocol for a Randomized Controlled Clinical Trial” [Letter] by Li S, Kong D, Gao H

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Benefit from regular versus leakage-related exchange of voice prostheses in patients post-laryngectomy considering complication rates and patient satisfaction feedback—a randomized case−controlled trial by Michał Żurek, Małgorzata Czesak, Daniel Majszyk, Anna Rzepakowska

“…Randomized case−controlled trials. Setting. Tertiary hospital.MethodsThe study included patients who underwent total laryngectomy with primary voice prosthesis insertion between 2020 and 2021 and were randomly assigned to one of two arms: regular exchange (REA) every 3 months or leakage-dependent exchange (LEA). …”
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A comparison of the efficacy of the effect of online versus face-to-face group counseling based on positive-approach on sexual intimacy of women after benign abdominal hysterectomy: a clinical trial by Orly Nazanin Kalimi, Tayebeh Mokhtari Sorkhani, Ali Dehghani, Mahshid Bokaie

“…Iranian Registry of Clinical Trials - IRCT20230209057373N1…”
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Effects of a 12-Week Semi-Immersive Virtual Reality-Based Exercise Program on the Quality of Life of Older Adults Across Different Age Groups: A Randomized Controlled Trial by Li-Ting Wang, Yu-Wen Wang

“…This study was a randomized controlled trial involving older adults aged 65–85 years. Methods: Two age groups were each randomly assigned to experimental (EG) and control (CG) groups. …”
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Investigating the impact of couple counseling based on the CHARMS model on sexual quality of life and marital satisfaction of wives of men suffering from myocardial infarction: a randomized clinical trial study by Delniya Ghafuri, Soheila Rabeipoor, Kamal Khademvatani, Samira Barjasteh, Atefeh Yas

“…Method This two-group randomized clinical trial study with a parallel design was conducted in 2024 in Urmia, Iran. …”
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Association between terminal pleural elastance and radiographic lung re-expansion after therapeutic thoracentesis in patients with symptomatic pleural effusion: a post-hoc analysis of a randomised trial by Fabien Maldonado, Michael Lester, Otis B Rickman, Lance J Roller, Sameer K Avasarala, James M Katsis, Robert J Lentz

“…Clinical management of patients with recurrent symptomatic pleural effusions guided by manometry rather than post-thoracentesis imaging might produce better outcomes, which should be investigated by future clinical trials.Trial registration number NCT02677883; Post-results.…”
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Increasing Access to Mental Health Supports for 18- to 25-Year-Old Indigenous Youth With the JoyPop Mobile Mental Health App: Study Protocol for a Randomized Controlled Trial by Angela MacIsaac, Teagan Neufeld, Ishaq Malik, Elaine Toombs, Janine V Olthuis, Fred Schmidt, Crystal Dunning, Kristine Stasiuk, Tina Bobinski, Arto Ohinmaa, Sherry H Stewart, Amanda S Newton, Aislin R Mushquash

“…Positive findings may support the integration of the app into mental health services as a waitlist management tool. Trial RegistrationClinicalTrials.gov NCT05991154; https://clinicaltrials.gov/study/NCT05991154 International Registered Report Identifier (IRRID)DERR1-10.2196/64745…”
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It’s safe to move! A protocol for a randomised controlled trial investigating the effect of a video designed to increase people’s confidence becoming more active despite back pain by Ian A Harris, Adrian C Traeger, James H McAuley, Siobhan M Schabrun, Benedict Martin Wand, Aidan Cashin, Christopher Michael Williams, Edel O'Hagan, Sean O'Neill

“…We will compare group mean of the three arms of the trial using univariate analyses of variance.Ethics and dissemination This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry. …”
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Representativeness of the dabigatran, apixaban and rivaroxaban clinical trial populations to real-world atrial fibrillation patients in the United Kingdom: a cross-sectional analysis using the General Practice Research Database by Gregory Y H Lip, Sally Lee, Brigitta U Monz, Andreas Clemens, Martina Brueckmann

“…However, assessing representativeness is not a substitute for assessing generalisibility, that is, how well clinical trial results would translate into effectiveness and safety in everyday routine care.…”
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Iterative delivery of an implementation support package to increase and sustain the routine provision of antenatal care addressing alcohol consumption during pregnancy: study protocol for a stepped-wedge cluster trial by John Attia, Luke Wolfenden, Nicole Nathan, Melanie Kingsland, Olivia Wynne, Penny Reeves, Alix Hall, John Wiggers, Elizabeth J Elliott, Tameka McFadyen, Tracey W Tsang, Emma Doherty, Belinda Tully, Adrian John Dunlop, Ian Symonds

“…Although a number of implementation trials have reported significant increases in such care, the majority of women still did not receive all recommended care elements, and improvements dissipated over time. …”
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Correction: Effectiveness of nicotine salt vapes, cytisine, and a combination of these products, for smoking cessation in New Zealand: protocol for a three-arm, pragmatic, community-based randomised controlled trial by Natalie Walker, Amanda Calder, Joanne Barnes, George Laking, Varsha Parag, Chris Bullen

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