TrialsPub Date : 2025-07-01DOI: 10.1186/s13063-025-08935-2
Ying Zhou, Ziyi Shen, Jinbiao Li, Hui Cao, Xinggen Zhou, Weicheng Jin, Ming Yao, Jing Chi, Jie Wang, Chao Zhang
{"title":"Combination of dexmedetomidine and esketamine for postoperative nausea and vomiting in patients undergoing laparoscopic surgery: study protocol for a prospective, randomized, controlled trial.","authors":"Ying Zhou, Ziyi Shen, Jinbiao Li, Hui Cao, Xinggen Zhou, Weicheng Jin, Ming Yao, Jing Chi, Jie Wang, Chao Zhang","doi":"10.1186/s13063-025-08935-2","DOIUrl":"https://doi.org/10.1186/s13063-025-08935-2","url":null,"abstract":"<p><strong>Background: </strong>Laparoscopic surgery has gained widespread acceptance due to its advantages over traditional open procedures, including less postoperative pain and faster recovery. However, postoperative nausea and vomiting (PONV) remains a prevalent complication, affecting up to 80% of high-risk patients and significantly reducing patient satisfaction and recovery quality. Although opioids are frequently used for intraoperative analgesia, their side effects, particularly PONV, highlight the need for opioid-sparing strategies. Dexmedetomidine and esketamine are two agents with analgesic and anesthetic-sparing properties that have shown promise individually in reducing PONV and postoperative pain. However, evidence remains limited, and no study has systematically evaluated the combined use of dexmedetomidine and esketamine for PONV prevention in laparoscopic surgery. This trial aims to fill this knowledge gap by assessing the efficacy and safety of this novel combination strategy, potentially offering an improved anesthetic regimen for enhanced postoperative recovery.</p><p><strong>Methods: </strong>To address this gap, we propose a prospective, randomized, controlled trial (RCT) at a single center to evaluate the effects of dexmedetomidine and esketamine on PONV in laparoscopic surgery patients. Patients will be randomly assigned to either the combination therapy group or the control group in a 1:1 ratio. The combination therapy group (n = 70) will receive intravenous dexmedetomidine (0.5 μg/kg), esketamine (0.3 mg/kg), sufentanil (0.2 μg/kg) and propofol (1.5-2.0 mg/kg) for anesthesia induction, with sevoflurane (2-3%) used for maintenance during surgery. Conversely, the control group (n = 70) will receive sufentanil (0.5 μg/kg) and propofol (1.5-2.0 mg/kg) for anesthesia induction, followed by sevoflurane (2-3%) inhalation and continuous remifentanil infusion (0.1 μg/kg/min) for maintenance. The primary outcome is the incidence of PONV within 48 h postoperatively, assessed during three predefined intervals: 0-6 h, 6-24 h, and 24-48 h. Secondary outcomes include Apfel PONV risk score, pain scores at 0, 6, 12, 24, and 48 h postoperatively, time to first PONV episode and first rescue antiemetic, time to first rescue analgesic, total dosage and frequency of rescue analgesics and antiemetics within 48 h, patient satisfaction score at discharge, length of hospital stay, discharge condition, and the incidence and classification of adverse events.</p><p><strong>Discusssion: </strong>This study aims to evaluate the safety and feasibility of combining dexmedetomidine and esketamine to prevent PONV in patients undergoing laparoscopic surgery. The findings may offer evidence for an effective opioid-reducing anesthesia strategy that enhances analgesia and supports recovery, with potential value for broader clinical application. TRIAL REGISTRATION {2A,2B}: Chinese Clinical Trial Register, ChiCTR2300072455. Registered on June 14, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"230"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TrialsPub Date : 2025-07-01DOI: 10.1186/s13063-025-08922-7
Alexander Viktor Eriksen, Sanne Have Beck, Dorthe Nielsen, Katja Thomsen, Josefine Oredson Krone, Karen Andersen-Ranberg
{"title":"Cross-sectoral follow-up after hospital discharge from a geriatric ward: a study protocol of a randomised controlled trial (G-UD).","authors":"Alexander Viktor Eriksen, Sanne Have Beck, Dorthe Nielsen, Katja Thomsen, Josefine Oredson Krone, Karen Andersen-Ranberg","doi":"10.1186/s13063-025-08922-7","DOIUrl":"https://doi.org/10.1186/s13063-025-08922-7","url":null,"abstract":"<p><strong>Background: </strong>Advancing age is associated with multimorbidity, polypharmacy and functional impairments and older adults with these characteristics are at increased risk of acute admission and readmission. Readmission rate of geriatric patients is high, especially within the first week after discharge. Previous studies on transitional care interventions have mainly showed positive effects, but no study has assessed the effect of a home visit done jointly by a geriatric nurse and a community nurse, with a systematic review of health functions, objective clinical assessment and bedside blood analyses.</p><p><strong>Methods: </strong>A single-centre two-arm parallel group randomised controlled trial using permuted block randomisation will be conducted. Randomisation occurs at discharge. The intervention consists of a follow-up visit within 2-5 days by a geriatric nurse and a community nurse. A systematic review of bodily functions is carried out, and solutions of identified problems are discussed taking into consideration the patient's view. If the patient shows signs of worsened health since discharge vital status and bedside blood analyses using point-of-care-testing (POCT) can be carried out at the discretion of the geriatric nurse. As required the patients will be conferred with a senior geriatrician by video consultation. The patient's primary care physician is invited to participate online. The control group will receive usual discharge. Endpoints are readmission, mortality rates and financial costs. User perspectives include focus group interviews with patients, geriatric nurses, community nurses, geriatricians and primary care physicians.</p><p><strong>Discussion: </strong>The intervention is multifactorial to match the needs of complex geriatric patients. We will thus not be able to discern, which part of the intervention has the greatest impact, but the intervention will encompass most of the clinical situation that may potentially lead to acute readmission. If a positive effect is found the intervention may be scaled up to include all departments discharging vulnerable geriatric patients, as well as implemented in guidelines for the discharge of older medical patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, Identifier: NCT05139823, Registered 1 December 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"234"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TrialsPub Date : 2025-07-01DOI: 10.1186/s13063-025-08926-3
Corneel Vandelanotte, Stewart Trost, Danya Hodgetts, Tasadduq Imam, M D Mamunur Rashid, Quyen G To, Carol Maher
{"title":"MoveMentor-examining the effectiveness of a machine learning and app-based digital assistant to increase physical activity in adults: protocol for a randomised controlled trial.","authors":"Corneel Vandelanotte, Stewart Trost, Danya Hodgetts, Tasadduq Imam, M D Mamunur Rashid, Quyen G To, Carol Maher","doi":"10.1186/s13063-025-08926-3","DOIUrl":"https://doi.org/10.1186/s13063-025-08926-3","url":null,"abstract":"<p><strong>Background: </strong>Physical inactivity is prevalent, leading to a high burden of disease and large healthcare costs. Thus, there is a need for affordable, effective and scalable interventions. However, interventions that are affordable and scalable are beset with modest effects and engagement. Interventions that integrate machine learning with real-time data to offer unprecedented levels of personalisation and customisation might offer solutions. The aim of this study is to conduct a randomised controlled trial to evaluate the effectiveness of a machine learning and app-based digital assistant to increase physical activity.</p><p><strong>Methods: </strong>One hundred and ninety-eight participants will be recruited through Facebook advertisements and randomly allocated to an intervention or control group. Intervention participants will gain access to an app-based physical activity digital assistant that can learn and adapt in real-time to achieve high levels of personalisation and user engagement by virtue of applying a range of machine learning techniques (i.e. reinforcement learning, natural language processing and large language models). The digital assistant will interact with participants in 3 main ways: (1) educational conversations about physical activity; (2) just-in-time personalised in-app notifications ('nudges'), cues to action encouraging physical activity and (3) chat-based questions and answers about physical activity. Additionally, the app includes adaptive goal setting and an action planning tool. The control group will gain access to the intervention after the last assessment. Outcomes will be measured at baseline, 3 and 6 months. The primary outcome is device-measured (Axivity AX3) moderate-to-vigorous physical activity. Secondary outcomes include app engagement and retention, quality of life, depression, anxiety, stress, sitting time, sleep, workplace productivity, absenteeism, presenteeism and habit strength.</p><p><strong>Discussion: </strong>The trial presents a unique opportunity to study the effectiveness of a new generation of digital interventions that use advanced machine learning methods to improve physical activity behaviour. By addressing the limitations of existing conversational agents, we aim to pave the way for more effective and adaptable interventions.</p><p><strong>Trial registration: </strong>Australian New Zealand Clinical Trial Registry ACTRN12624000255583p. Registered on 14 March 2024. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=387332 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"233"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TrialsPub Date : 2025-07-01DOI: 10.1186/s13063-025-08917-4
Esra Teresa Sünkel, Marie Neubert, Alla Machulska, Tim Klucken
{"title":"Smoking cessation treatment prior to psychotherapy for patients with diagnosed mental disorders: study protocol for a randomized controlled trial.","authors":"Esra Teresa Sünkel, Marie Neubert, Alla Machulska, Tim Klucken","doi":"10.1186/s13063-025-08917-4","DOIUrl":"https://doi.org/10.1186/s13063-025-08917-4","url":null,"abstract":"<p><strong>Background: </strong>Tobacco use is a leading risk factor for premature mortality. Individuals with mental disorders exhibit a smoking prevalence twice that of the general population and engage in higher levels of tobacco consumption, thereby elevating their risk for tobacco-related health complications. Unlike with other substance use disorders, clinical practice in Germany neglects tobacco dependence as a risk factor prior to the initiation of psychotherapy, despite a clear need for intervention: Prolonged cigarette smoking exacerbates mental health symptoms and influences processes central to psychotherapy, such as implicit cognitive processes and emotion regulation. Moreover, short-term nicotine withdrawal associated with tobacco dependence can undermine motivation, reduce positive reinforcement, and cause emotional instability, potentially hindering efforts to improve mental health or the effectiveness of psychotherapeutic interventions. These factors underscore the importance of integrating smoking cessation strategies prior to formal psychotherapy to optimize the therapeutic process and patient outcomes. This study investigates the effects of initiating an intensified smoking cessation program prior to starting psychotherapy. Main measure outcomes of interest are the degree of tobacco dependence, smoking behavior, and mental health outcomes in smokers with mental disorders. By addressing smoking behavior prior to therapy, this trial seeks to establish a more solid foundation for therapeutic work, potentially improving mental health outcomes and promoting a comprehensive approach to mental health care.</p><p><strong>Methods: </strong>A single-center randomized controlled trial in an outpatient psychotherapeutic clinic will examine the effects of an intensified smoking cessation intervention versus a waiting control condition. The primary outcome measures include smokers' nicotine dependence, smoking behavior, and mental health symptoms related to their primary mental disorder, analyzed using variance analysis methods. The smoking intervention consists of a common guideline-based cognitive-behavioral program supplemented by a digital health application. Secondary outcomes include changes in self-reported self-efficacy and implicit cognitive biases. In addition, motivational measures, self-efficacy, implicit approach tendencies, and attitudes toward online interventions will be assessed as secondary measures and examined as potential predictors, moderators, or mediators in exploratory analyses. Attitudes toward online interventions will be measured once at baseline, while all other measures will be assessed before the intervention, post-treatment, and at 6-week and 6-month follow-up sessions.</p><p><strong>Discussion: </strong>Addressing smoking behavior before psychotherapy holds potential to significantly enhance mental health outcomes. This study investigates the integration of smoking cessation strategies prior to psychotherape","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"231"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TrialsPub Date : 2025-07-01DOI: 10.1186/s13063-025-08934-3
Jennifer Condie, Matthew Franklin, Katie Aafjes-van Doorn, Paula Foscarini-Craggs, Iain McKinnon, Toni Leigh Harrison, Arman Iranpour, Ania Zubala, Sophie Rose, Elizabeth Randell, Rachel McNamara, Muhammad Riaz, Simon Hackett
{"title":"Statistical and health economic analysis plan for a secure care hospital evaluation of manualised (interpersonal) art-psychotherapy: the SCHEMA randomized controlled trial.","authors":"Jennifer Condie, Matthew Franklin, Katie Aafjes-van Doorn, Paula Foscarini-Craggs, Iain McKinnon, Toni Leigh Harrison, Arman Iranpour, Ania Zubala, Sophie Rose, Elizabeth Randell, Rachel McNamara, Muhammad Riaz, Simon Hackett","doi":"10.1186/s13063-025-08934-3","DOIUrl":"https://doi.org/10.1186/s13063-025-08934-3","url":null,"abstract":"<p><strong>Background: </strong>The SCHEMA trial evaluates whether interpersonal art psychotherapy reduces the frequency/severity of aggressive incidents or patient distress associated with psychiatric symptoms, compared to usual care.</p><p><strong>Objective: </strong>To describe the statistical and health economic analysis plan.</p><p><strong>Methods: </strong>A multicentre, two-arm, parallel-group, single blind individually randomised controlled trial with 150 adults within NHS secure care who have borderline to mild/moderate intellectual disability. The primary outcome is the frequency/severity of aggressive behaviour, measured on the Modified Overt Aggression Scale (MOAS) 19 weeks post-randomisation, analysed using a linear mixed-effect model, adjusted for baseline MOAS and stratification by gender and psychosis diagnosis. Changes in aggressive behaviour will be evaluated using weekly MOAS scores between 19 and 38 weeks. Patient distress relating to psychiatric symptoms will be assessed using the Brief Symptom Inventory Positive Symptom Distress Index across baseline, 19, and 38 weeks. Health-related quality-of-life will be assessed using self- and proxy-reported EQ-5D three-level (EQ-5D-3L) and Recovering Quality of Life 10-item measures, the latter to estimate the ReQoL Utility Index, across baseline, 19, and 38 weeks. The self-reported EQ-5D-3L is collected using an adapted version for people with intellectual disabilities. Resource-use is collected based on secure care records, to estimate intervention and healthcare costs over 19 and 38 weeks. HRQoL and cost data will inform cost-effectiveness based on the incremental cost per quality-adjusted life year over 38 weeks.</p><p><strong>Discussion: </strong>This paper details the planned analyses and discusses recruitment challenges, sample size implications, and effect size assumptions. The plan was developed prior to database lock and unblinding to minimise analytical bias.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN57406593 . Registered on 18/01/2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"227"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and safety of augmented-reality pathway-specific binocular training in patients with unilateral amblyopia (ARPSBT): study protocol for a multicenter randomized controlled trial.","authors":"Yulian Zhou, Shuyang Guo, Ling Ling, Yige Gao, Xinyan Duan, Yan Liu, Rui Liu, Hu Liu, Huihang Wang, Jing Lin, Chen Zhao, Peng Zhang, Wen Wen","doi":"10.1186/s13063-025-08927-2","DOIUrl":"https://doi.org/10.1186/s13063-025-08927-2","url":null,"abstract":"<p><strong>Background: </strong>Amblyopia is a common developmental disorder with reduced visual acuity and impairment in binocular functions. Patching the fellow eye, as the gold standard therapy in amblyopia, sometimes fails to achieve satisfactory outcomes because of poor adherence or delayed intervention. Recently, dichoptic/binocular digital therapy in amblyopia has been developed, but no evidence-based binocular treatments with superiority are available. Based on our previous study findings in neural deficits of unilateral amblyopia, we develop a paradigm of pathway-specific visual training using augmented-reality techniques, in which functions of the parvocellular pathway in the amblyopic eye are selectively pushed under binocular viewing. The aim of this trial is to assess the efficacy and safety of this innovative binocular, home-based treatment for children and adults with unilateral amblyopia. We hypothesize that augmented-reality pathway-specific binocular training will significantly improve visual functions compared with traditional patching.</p><p><strong>Methods: </strong>This is a superiority, multi-center, randomized, controlled trial involving 114 patients, aged between 5 and 55 years, with a diagnosis of unilateral amblyopia. Participants will be randomized 1:1 to either binocular training or patching, and will receive home-based treatment for 2 hours per day over a 13-week period. Their visual functions will be assessed at baseline, mid-treatment (week 2, week 4, week 9), and the end of treatment (week 13). The primary outcome is the change in best-corrected visual acuity at distance in the amblyopic eye from baseline to 13 weeks after treatment. Secondary outcomes include contrast sensitivity, near and far stereoacuity, interocular suppression, treatment adherence, and the incidence of adverse events at each visit.</p><p><strong>Discussion: </strong>This study is the first multi-center randomized controlled trial investigating a home-based augmented-reality binocular therapy targeting neural deficits in children and adults with unilateral amblyopia. We expect that the trial will generate findings that can provide an evidence-based basis for the efficacy and safety of this innovative approach to amblyopia treatment.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT06498206. Registered on July 12, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"232"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TrialsPub Date : 2025-07-01DOI: 10.1186/s13063-025-08936-1
Rosalie Hayes, Melanie Smuk, Bakita Kasadha, Nishat Halim, Vanessa Apea, Sara Paparini, Chloe M Orkin
{"title":"Achieving equitable recruitment through inclusive protocol design: lessons learned from the ILANA study.","authors":"Rosalie Hayes, Melanie Smuk, Bakita Kasadha, Nishat Halim, Vanessa Apea, Sara Paparini, Chloe M Orkin","doi":"10.1186/s13063-025-08936-1","DOIUrl":"https://doi.org/10.1186/s13063-025-08936-1","url":null,"abstract":"<p><p>The importance of conducting inclusive research is well-established, yet recruiting a sample which reflects the distribution of a disease or condition within a target population has proven elusive for many triallists. We draw on our experiences of achieving inclusive recruitment through the intentional protocol design and delivery in the ILANA (Implementing Long-Acting Novel Antiretrovirals) study to highlight some tangible steps that could be extrapolated to trials to aid inclusive recruitment to research and produce findings which can contribute to tackling health inequities. These include the importance of meaningful public involvement from start to finish, drawing on existing data to determine appropriate targets, factoring targets into analysis plans through pre-specified analyses and triangulation with qualitative data, and making targets mandatory (rather than aspirational) through a range of strategies. We believe ILANA offers a proof of concept for triallists seeking to radically improve representation and conduct more equitable RCTs that engage all those who could benefit.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"229"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TrialsPub Date : 2025-07-01DOI: 10.1186/s13063-025-08940-5
F Azizi, A Amouzegar, H Abdi, M Tohidi, S Masoumi, D Khalili, Y Mehrabi, A Zadehvakili, M Hedayati, A A Momenan, L Mehran
{"title":"Treatment of hypothyroidism with levothyroxine plus slow-release liothyronine: a study protocol for a randomized controlled double-blinded clinical trial.","authors":"F Azizi, A Amouzegar, H Abdi, M Tohidi, S Masoumi, D Khalili, Y Mehrabi, A Zadehvakili, M Hedayati, A A Momenan, L Mehran","doi":"10.1186/s13063-025-08940-5","DOIUrl":"https://doi.org/10.1186/s13063-025-08940-5","url":null,"abstract":"<p><strong>Background: </strong>There are emerging controversies regarding the priority of T4 + T3 combination therapy over standard care with levothyroxine (LT4) monotherapy in the management of hypothyroid subjects. Combination therapy with a slow-release form of liothyronine (SRT3) and levothyroxine may restore T3 concentrations and provide better outcomes, especially in individuals with persistent complaints despite having normal serum TSH levels.</p><p><strong>Methods: </strong>One hundred patients aged ≥ 20 years with hypothyroidism who have achieved and maintained euthyroidism under LT4 monotherapy for at least 3 months will be randomized into two groups of LT4 + SRT3 combined therapy (75 µg LT4 + 25 µg SRT3) and LT4 monotherapy for 48 weeks. Participants will be evaluated at baseline and three subsequent follow-ups, 12, 24, and 48 weeks after treatment allocation. Before and after the intervention, body weight, heart rate, blood pressure, ECG, quality of life (by ThyPRO-39 and SF-12), resting energy expenditure, and body composition will be evaluated. Also, serum TSH, total T3, total T4, free T4, free T3, total cholesterol, LDL, HDL, triglycerides, fasting blood sugar (FBS), insulin, HbA1C, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), sex hormone-binding globulin (SHBG), enolase, lactate dehydrogenase (LDH), creatin kinase (CK), ferritin, and metabolomics will be assessed at baseline and compared with their corresponding values at 24 and 48 weeks. Epigenetic-related markers will be measured and compared between the responders and non-responders.</p><p><strong>Conclusion: </strong>It is expected that LT4 + SRT3 combined therapy more closely mimics the serum levels of T3, T4, and the T3/T4 ratio of euthyroid subjects than LT4 monotherapy, and improves health outcomes and quality of life, especially in hypothyroid patients with persistent symptoms under LT4 monotherapy. Genetic polymorphism sequencing may identify hypothyroid patients who are not responding well to levothyroxine alone. TRIAL REGISTRATION : Trial ID: 44220 ID: IRCT20100922004794N12 IRCT ID: IRCT20100922004794N12 Registration date: 2020-02-27 Expected recruitment start date: 2024-10-06 Expected recruitment end date: 2025-10-23.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"228"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction: Effects of trehalose on bone healing, physical function, and pain in patients with pertrochanteric fractures: a randomized controlled trial protocol.","authors":"Reza Zandi, Hosna Omidi Razani, Amir Mehrvar, Mohammad-Reza Jowshan, Amirhossein Sahebkar, Bahar Nikooyeh, Hoda Zahedi, Shahin Talebi","doi":"10.1186/s13063-024-08714-5","DOIUrl":"https://doi.org/10.1186/s13063-024-08714-5","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"225"},"PeriodicalIF":2.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144529643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TrialsPub Date : 2025-06-30DOI: 10.1186/s13063-025-08730-z
Inês A Trindade, Andreia Soares, David Skvarc, Diogo Carreiras, Joana Pereira, Óscar Lourenço, Filipa Sampaio, Bruno de Sousa, Teresa C Martins, Paula Boaventura, Joana Marta-Simões, Helena Moreira
{"title":"Correction: Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials {1}.","authors":"Inês A Trindade, Andreia Soares, David Skvarc, Diogo Carreiras, Joana Pereira, Óscar Lourenço, Filipa Sampaio, Bruno de Sousa, Teresa C Martins, Paula Boaventura, Joana Marta-Simões, Helena Moreira","doi":"10.1186/s13063-025-08730-z","DOIUrl":"https://doi.org/10.1186/s13063-025-08730-z","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"226"},"PeriodicalIF":2.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144529644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}