Trials[JOURNAL]
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200 papers
The 1-year obesity treatment intervention can improve fasting plasma glucose in children aged 6-12 years: randomized controlled trial.
Martikainen A, Eloranta AM, Schwab U … +1 more , Örmälä T
Trials · 2026 May · PMID 42152130 · Full text
BACKGROUND: Lifestyle interventions can reduce the risk of becoming an overweight adult and reduce the risk of health problems. The aim was to investigate the effects of obesity treatment on BMI-for-age, metabolic marker...
BACKGROUND: Lifestyle interventions can reduce the risk of becoming an overweight adult and reduce the risk of health problems. The aim was to investigate the effects of obesity treatment on BMI-for-age, metabolic markers, and quality of life in children with overweight or obesity. METHODS: A randomized 1-year lifestyle intervention, including appointments every 3 months, a total of 5 sessions. A multidisciplinary team consisting of a pediatrician, a nurse, and a clinical nutritionist conducted the study. The participants were 6-12-year-old children with overweight or obesity in the Hyvinkää area, Finland. The inclusion criteria were weight for height at least + 40% or ≥ 30% and ascending growth curve. Participants were randomized to the intervention group (n = 21) or the control group (n = 19). The intervention group received lifestyle counseling with an emphasis on nutritional guidance. The control group continued in the primary care and did not have any intervention during the study period. Laboratory values and anthropometric measurements were measured at baseline and at 12 months. In addition, quality of life was evaluated by a questionnaire. RESULTS: In the intervention group fasting plasma glucose decreased statistically significantly (p = 0.017) and the difference in the change between the groups approached statistical significance (p = 0.080). No other significant changes were found between the intervention and the control groups at the end of the intervention. The increase of BMI-for-age stopped in both groups. CONCLUSION: Encouragement to healthy lifestyle can improve glucose metabolism in children with obesity and to stop excessive weight gain. TRIAL REGISTRATION: 18.12.2018 (§142/2018, HUS/2666/2018). CLINICALTRIALS: gov Identifier: NCT06126679.
Direct warming and rehydration method in frozen embryo transfer: study protocol for a pragmatic, multi-center, double-blinded, two-arm randomized controlled trial.
Wu W, Xu M, Fung KK … +5 more , Zhang L, Wan HM, Chan CPS, Chung JPW, Chan DYL
Trials · 2026 May · PMID 42152121 · Full text
BACKGROUND: Embryo cryopreservation through vitrification is widely used to store surplus embryos for future transfer. Traditional multi-step warming methods are both time-consuming and costly. This study evaluates the c...
BACKGROUND: Embryo cryopreservation through vitrification is widely used to store surplus embryos for future transfer. Traditional multi-step warming methods are both time-consuming and costly. This study evaluates the clinical outcomes and the effectiveness of a novel direct warming method for frozen embryo transfer (FET) in comparison to the conventional multi-step method. METHODS: This is a pragmatic, two-arm, double-blinded randomized controlled trial (RCT) comparing the new direct warming method with the conventional multi-step method. Participants undergoing FET will be randomly assigned to either the direct warming method or the conventional warming protocol. The primary outcomes are the clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), the live birth rate (LBR), miscarriage rate, and cost-effectiveness. Secondary outcomes include identifying clinical differences among various brands of warming media, embryo storage devices, and embryo culture media through subgroup analyses. A sample size of 578 participants is planned, allowing for a 5% loss to follow-up. DISCUSSION: Preliminary studies have shown that the direct warming method offers comparable or slightly higher live birth rates than conventional methods. Moreover, it significantly reduces thawing time and associated costs, offering a faster, cost-effective option for FET. This trial has the potential to improve accessibility to ART by reducing procedural costs and increasing efficiency without compromising clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT06741748. Registered on 19 November 2024.
Cross-training digital therapeutics for pediatric ADHD: study protocol for a randomized controlled trial.
Zhao X, Cai Y, Zhang X … +9 more , Xu T, Qian Y, Hao W, Wang Y, Yuan J, Cai T, Zhou L, Li H, Lei L
Trials · 2026 May · PMID 42152117 · Full text
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) in children can result in academic and occupational failure, poor socialization, and an increased risk of accidental injuries. Digital therapeutics (DTx) levera...
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) in children can result in academic and occupational failure, poor socialization, and an increased risk of accidental injuries. Digital therapeutics (DTx) leverage computers and smartphones to provide game-based treatments targeting ADHD's cognitive and behavioral aspects. Although the evidence base for DTx in ADHD is expanding, most DTx focus on a single mechanism without leveraging potential synergies between them. This study aims to evaluate the effectiveness of a cross-training DTx for children aged 6-12 with ADHD. METHODS: The DTx study is a multicenter, open-label, randomized controlled trial that employs a cross-training approach integrating neurofeedback and executive function training. A total of 210 participants will be randomly assigned to one of three groups: the medication group (MED), the DTx group (DTX), or the combination group (COM). DTX will receive home‑based digital training, MED will receive methylphenidate, and COM will receive both. The primary outcome is change in Swanson, Nolan, and Pelham Rating Scale (SNAP‑IV) total score from baseline to 8 weeks post-randomization. Non‑inferiority will be tested between DTX and MED with a non-inferiority margin of Δ = 4 points; superiority between COM and MED will be defined as the lower bound of the two‑sided 95% confidence interval for the difference being greater than 0. DISCUSSION: The clinical trial protocol presented here outlines a randomized controlled trial that evaluates DTx utilizing cross-training approach. The aim of this trial is to assess the efficacy and acceptability of the cross-training DTx for children aged 6 to 12 years with ADHD. The primary outcome is the degree of improvement in the core symptoms of ADHD (measured by SNAP‑IV). Additionally, we will evaluate compliance and potential side effects associated with the DTx. The results of this study may provide an optional non-pharmacological intervention/supplementary treatment option for children with ADHD. TRIAL REGISTRATION: NCT06369714. Registered on 17 April 2024. https://clinicaltrials.gov/study/NCT06369714.
Full-time bracing versus hybrid bracing in adolescent idiopathic scoliosis: study protocol for a randomised controlled trial.
Lau AYC, Kee HM, Yang KG … +6 more , Kwan ECK, Hung ALH, Lee WYW, Wong MS, Cheng JCY, Lam TP
Trials · 2026 May · PMID 42152027 · Full text
BACKGROUND: Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional spinal deformity affecting 2-4% of adolescents. During the peripubertal stage, untreated AIS may progress rapidly and lead to adverse outco...
BACKGROUND: Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional spinal deformity affecting 2-4% of adolescents. During the peripubertal stage, untreated AIS may progress rapidly and lead to adverse outcomes such as back pain and poor body image. Full-time bracing, such as the underarm brace (UAB), is indicated for skeletally immature patients with a Cobb angle greater than 20°. Nighttime lateral bending braces (LBB) aim to achieve overcorrection by positioning the patient in a supine bending position opposite to the curve convexity. Despite bracing, 20-30% of patients experience progression requiring surgery. In-brace correction (IBC) is a key determinant of bracing effectiveness. To enhance IBC, we propose a Hybrid Bracing Protocol (HyBP) combining daytime UAB and nighttime LBB. OBJECTIVE: The objective of this trial is to determine whether the Hybrid Bracing Protocol achieves greater in-brace correction (IBC) compared with the conventional bracing at 3 months and 18 months after brace initiation. This 18-month study represents the first phase, followed by a second phase assessing curve outcomes at brace completion and 2 years post-bracing. METHODS: This is a prospective, randomised, parallel-group trial comparing the Hybrid Bracing Protocol (HyBP) with conventional bracing for enhancing in-brace correction (IBC). Skeletally immature female patients with adolescent idiopathic scoliosis and a single thoracolumbar or lumbar curve newly prescribed for bracing will be randomly allocated to either the HyBP group or conventional brace group (CB group). DISCUSSION: To our knowledge, this will be the randomised trial to evaluate the potential synergistic effect of combining two different bracing designs within a hybrid protocol. If effective, this approach may improve bracing outcome, reduce curve progression, and decrease the need for surgical intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT07045337. Registered on July 9, 2025.
Artificial intelligence-assisted integrated care to promote colonoscopy uptake (AICC) in China: study protocol for a cluster randomized controlled trial.
Wang X, Zhou H, Zhang N … +5 more , Liu Y, Wang H, Tang J, Sun Z, Hou Z
Trials · 2026 May · PMID 42152022 · Full text
BACKGROUND: Colorectal cancer (CRC) leads to heavy disease and economic burdens globally. Early screening such as colonoscopy has been demonstrated to reduce both CRC incidence and mortality. However, uptake of colonosco...
BACKGROUND: Colorectal cancer (CRC) leads to heavy disease and economic burdens globally. Early screening such as colonoscopy has been demonstrated to reduce both CRC incidence and mortality. However, uptake of colonoscopy among high-risk individuals is low in China, limiting screening efficacy. To improve screening uptake, it is necessary to ensure the engagement of both specialist and general practitioners. And recently, AI techniques show considerable promise in delivering personalized health education. This study aims to evaluate the effectiveness of AI-assisted integrated care, compared with specialty care in improving uptake of colonoscopy among CRC high-risk individuals in China. METHODS: A two-arm, parallel cluster randomized controlled trial will enroll 400 high-risk residents for CRC aged 40-64 years from 40 communities/villages across one urban district and two rural counties in Shandong Province, China. Communities/villages as clusters will be randomized within counties to either a specialty care group or an AI-assisted integrated care group. Participants will be those initially identified as high risk for CRC through a risk assessment questionnaire or fecal immunochemical test. The primary outcomes are colonoscopy uptake at 3 and 6 months post-intervention and the time to colonoscopy. Secondary outcomes encompass CRC screening literacy, beliefs, and intention to undergo colonoscopy. Additionally, we will also conduct a process evaluation and health economic evaluation. DISCUSSION: This study proposes a novel strategy integrating a multidisciplinary team with digital health solutions. We expect that this strategy will provide a feasible approach to improve colonoscopy uptake. The findings could offer practical insights for informing and advancing cancer prevention and control initiatives in China. TRIAL REGISTRATION: ClinicalTrial.gov NCT07261059. Registered on December 2, 2025.
The impact of dexmedetomidine on postoperative delirium in obstructive sleep apnea patients (DPOD-OSA): study protocol for a prospective randomized controlled trial.
Li Y, Zhang R, Li N … +4 more , Wang XY, Zheng L, Xing MW, Zou Y
Trials · 2026 May · PMID 42144647 · Full text
BACKGROUND: Recent studies suggest that patients at intermediate-high risk of obstructive sleep apnea (OSA) are at greater risk of developing postoperative delirium (POD). The administration of dexmedetomidine (DEX) is s...
BACKGROUND: Recent studies suggest that patients at intermediate-high risk of obstructive sleep apnea (OSA) are at greater risk of developing postoperative delirium (POD). The administration of dexmedetomidine (DEX) is suggested to prevent POD in the normal population. However, few studies have investigated the impact of DEX on POD in OSA patients. METHODS/DESIGN: A prospective, randomized controlled trial will be conducted at a single center. Patients scheduled for elective laparoscopic surgery will be screened with the STOP-Bang questionnaire (SBQ). Patients who are intermediate-high risk for OSA (SBQ score ≥ 3) will be suggested to take a portable monitoring device for the diagnosis of OSA. Apner-Hyponea Index (AHI) values > 5/h are considered OSA. All the recruited OSA patients are randomly assigned to three treatment groups. The high dose of DEX group was treated with DEX at a loading dose of 0.5 μg/kg over 10 min followed by a maintenance dose of 0.2~0.7 μg/kg/h. The low dose of DEX group was treated with DEX at a maintenance dose of 0.5 μg/kg/h. The control group was not treated with DEX. POD was assessed using the 3-min diagnostic Confusion Assessment Method (3D-CAM) or the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for 7 consecutive days or until discharge. We used the Richmond Agitation and Sedation Scale (RASS) to assess the level of sedation and drowsiness. The primary outcome will be the occurrence of POD. The secondary outcomes include pain at rest and provoked pain during postoperative day 1-7, length of stay (LOS) and postoperative complications within 30 days. DISCUSSION: The result of this study will demonstrate whether the application of DEX could reduce the incidence of POD in OSA patients. We are of the conviction that the outcomes of this trial will afford a highly efficacious modality for preventing the occurrence of POD. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2500108088. Registered on 25 August 2025.
Language-related eligibility criteria in UK randomised trials: a systematic review of extended research reports.
Isaacs T, Vaughan A, Burnett E … +9 more , Demjén Z, Durand MA, Gillies K, Khunti K, Noor NM, Shiely F, Sydes MR, Treweek S, Biggs K
Trials · 2026 May · PMID 42143316 · Full text
BACKGROUND: Trial teams frequently make language-related, non-clinical eligibility decisions during recruitment. They need to ensure that patients understand the conditions and implications of trial participation and eit...
BACKGROUND: Trial teams frequently make language-related, non-clinical eligibility decisions during recruitment. They need to ensure that patients understand the conditions and implications of trial participation and either have the necessary language skills to participate, or receive appropriate accommodations (e.g. translation or interpreting). Fair and consistent assessments are necessary to avoid unduly excluding patients, which could limit external validity and exacerbate inequalities. This study examines how trial teams make language-related eligibility decisions. METHODS: We conducted a systematic review of National Institute for Health and Care Research (NIHR) research reports (2010-2022) for UK-based randomised controlled trials (RCTs) recruiting adults for two conditions that disproportionately affect ethnic minority populations: clinical depression and type 2 diabetes mellitus (T2DM). Two researchers independently screened titles and abstracts and extracted data. We analysed the communication demands of the interventions and primary outcome measures in relation to how language screening was reported, including procedures or instruments used as proxies for language-related gatekeeping. RESULTS: We assessed 185 titles and abstracts from NIHR monographs. Thirty-two RCTs (23 depression, 9 T2DM) ultimately met our inclusion criteria. Ethnic diversity was minimal, particularly in the depression RCTs, where the median proportion of White participants was 97%. Language screening practices were inconsistent across studies and were often poorly aligned with the actual linguistic demands of the trial. Half of the included RCTs explicitly reported a language-based eligibility criterion, including 63% of trials evaluating talking therapies for depression compared to 27% of trials assessing pharmacological, device-based, or surgical interventions. Explicit and implicit language-related gatekeeping measures included the ability to complete research assessments involving language (sometimes to a prespecified score cut-point), provide informed consent, and engage in the intervention as judged by recruiters. Translation and interpreting support were mentioned in one depression study. CONCLUSIONS: This review exposes methodological practices that may impede diverse patients' participation. Linguistic demands of the interventions and outcomes need to be considered in justifying language-related screening and accommodations. Participants' language variables need to be disentangled from ethnicity through routine data collection. A purpose-built screening tool that is universally applied to all participants could lead to fairer, more consistent assessments. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42021267905. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=267905. Registered on October 21 2021.
Vincular Project: study protocol for a randomized controlled trial with changes in 24-h movement behaviors targeting the reduce of depressive symptoms in adults.
Bertuol C, Alves DK, Del Duca GF
Trials · 2026 May · PMID 42141487 · Full text
BACKGROUND: A better understanding of how behavior change interventions work to reduce depressive symptoms, as well as their effects and potential mediators, is needed. This paper described the methods of the Vincular Pr...
BACKGROUND: A better understanding of how behavior change interventions work to reduce depressive symptoms, as well as their effects and potential mediators, is needed. This paper described the methods of the Vincular Project, an intervention based on Self-Determination Theory with changes in 24-h movement behaviors (physical activity, sedentary behavior, and sleep) to reduce depressive symptoms in Brazilian adults. METHODS: This is a randomized, controlled, blinded clinical trial with adults aged 20 to 59 years, of both sexes, with depressive symptoms. The sample was intentional and non-probabilistic and participants were allocated to a control group and an intervention group. The intervention was carried out twice a week, for 16 weeks, and consisted of face-to-face and online meetings. The activities aimed to make participants more aware of their living and health conditions, exploring 24-h movement behaviors, especially physical activity, and their relationships with depressive symptoms. The contents were different in each meeting and the activities were organized into four blocks, the first being contextualization, the second with general and specific guidelines on 24-h movement behaviors, the third with opportunities to practice physical activity in different contexts and situations, and the fourth with strategies for maintaining healthy behaviors in the short and long term. Baseline (January 2023), post-intervention (May 2023), and maintenance (November 2023) evaluations included depressive symptoms as primary outcome, and 24-h movement behaviors and basic psychological needs as secondary outcomes. The variables of autonomy, competence, and relatedness were also tested as mediators related to the effectiveness of the intervention on depressive symptoms. Depressive symptoms were measured by the Patient Health Questionnaire-9 (PHQ-9), 24-h movement behaviors by self-report and accelerometry, and basic psychological needs by the translated and adapted version of the Basic Psychological Needs in Exercise Scale (BPNES). To verify the effect of the intervention, per-protocol and intention-to-treat analyses will be conducted using generalized estimating equations (GEE). Structural equation models (SEMs) will be employed in the mediation analysis. DISCUSSION: The results of this trial will involve valuable information about the effect of a behavioral intervention to reduce depressive symptoms carried out in a middle-income country. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC): RBR-7466htj. Approved 14 April 2023, https://ensaiosclinicos.gov.br/rg/RBR-7466htj.
Understanding trial designs and acceptability of participation in an HIV vaccine trial with concurrent randomisation to oral pre-exposure prophylaxis in East and Southern Africa: a longitudinal qualitative study.
Kawuma R, Nakamanya S, Tarimo E … +11 more , Chimukuche RS, Ambindwile J, Pamba D, Kusemererwa S, Munseri P, Singh N, Dubé K, McCormack S, Ruzagira E, Seeley J, PrEPVacc trial team
Trials · 2026 May · PMID 42141483 · Full text
INTRODUCTION: This qualitative study was conducted to assess participants' understanding of the PrEPVacc trial design and factors that influenced decisions to participate in the trial. PrEPVacc was a phase IIb, three-arm...
INTRODUCTION: This qualitative study was conducted to assess participants' understanding of the PrEPVacc trial design and factors that influenced decisions to participate in the trial. PrEPVacc was a phase IIb, three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to oral pre-exposure prophylaxis. The main objective was to assess the safety and efficacy of two HIV-1 prophylactic vaccine regimens, each compared to placebo, in preventing the acquisition of HIV. METHODS: Using a longitudinal approach, qualitative data were collected between October 2021 and September 2023. A sample of 105 participants (7% of trial participants) was purposively selected to participate in three in-depth interviews at 2, 6, and 12 months during the trial. Another 111 (92 females and 19 males) participated in 14 focus group discussions across four sites. Data were analyzed thematically. RESULTS: Repeated information sharing sessions facilitated by health workers helped participants understand key trial concepts and the design. Pre-exposure prophylaxis (PrEP) was widely recognised as a protective measure alongside experimental vaccines. While vaccines were preferred for convenience and minimal side effects, individual perceived HIV risk was a main motivation for adhering to PrEP. Supportive relationships with health workers and close family members encouraged engagement in the trial, including acceptance to use the products. However, misinformation and stigma in communities created barriers to participation, with some participants facing social harm. CONCLUSION: Overall, participants demonstrated a good understanding of randomisation, double-blinding, and placebo control, facilitated by clear, repeated communication from health workers. Strengthening strategies to enhance informed consent, reduce stigma, and promote trial acceptance is crucial for successful implementation and retention. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT04066881. Registered on December 15, 2020.
Effectiveness of Benson's relaxation and Mitchell's relaxation along with conventional physiotherapy exercise on pain, urinary incontinence, sleep quality, and activities of daily living in lower segmental cesarean section: a comparative study.
Yadav NK, Lashkari R, Deshpande S
Trials · 2026 May · PMID 42141474 · Full text
BACKGROUND: Therapeutic exercises that help reduce stress and anxiety, both mentally and physically, are called relaxation techniques. In order to ascertain the benefits of the two relaxation techniques on pain, urine in...
BACKGROUND: Therapeutic exercises that help reduce stress and anxiety, both mentally and physically, are called relaxation techniques. In order to ascertain the benefits of the two relaxation techniques on pain, urine incontinence, sleep quality, and activities of daily living, this study will compare them with the conventional physiotherapy exercise in lower segmental cesarean sections (LSCS). METHODS: Forty-six LSCS subjects with pain, urine incontinence, sleep quality, and activities of daily life will participate in a comparative study that is a blinded (statistical) analysis. The participants will be divided into two groups following randomization: (1) Benson's relaxation and (2) Mitchell's relaxation, and both groups will receive exercises from conventional physiotherapy. Every group will go through the initial evaluation and a post-intervention assessment. DISCUSSION: This study is anticipated to improve pain, urinary incontinence, sleep quality, and activities of daily living following a lower segmental cesarean section. Following the completion of the study, the data will be published. If the benefits are demonstrated, Benson's or Mitchell's relaxation approach is used in conjunction with conventional physiotherapy exercises after lower-segmental cesarean sections. RESULT: The protocol would be given for 4 weeks. The initial assessment would be conducted before the intervention, and the post-assessment would be performed after the completion of the 4 weeks of intervention. TRIAL REGISTRATION: Trial REF/2025/03/102462, Registration number- CTRI/2025/04/085318. Date of registration-22/04/2025.
Methods for measuring implementation fidelity to the transitional care model.
Ahrens ML, Hanlon AL, Hirschman KB … +7 more , McHugh M, Osokpo OH, McCauley K, Shaid EC, Pauly MV, Toles M, Naylor MD
Trials · 2026 May · PMID 42135827 · Full text
BACKGROUND: Fidelity is defined as the extent to which an intervention is delivered as intended. Without a clear understanding of fidelity to an intervention, variability in implementation may be confounded with observed...
BACKGROUND: Fidelity is defined as the extent to which an intervention is delivered as intended. Without a clear understanding of fidelity to an intervention, variability in implementation may be confounded with observed outcomes, making valid conclusions about the intervention's efficacy challenging. The MIRROR-TCM (Multisite Replication of a Randomized Controlled Trial - Transitional Care Model) implementation evaluation, discussed here, sought to examine the delivery of the transitional care model (TCM) intervention and factors that influenced fidelity to the implementation of the intervention protocol over time. The TCM includes 10 core components, which aim to support older adults transitioning from the hospital back to the community. The objective of this paper is to describe the operationalization of a fidelity measure for the TCM intervention. METHODOLOGICAL DEVELOPMENT OF THE FIDELITY SCORE: Fidelity was operationalized at the element, component, and overall intervention levels. The TCM fidelity score examines 38 elements, which are broken into 8 components. Rules to evaluate an element-level, binary (0/1) fidelity scores were established by the study team, which consisted of clinicians and statisticians, and updated through feedback from the advanced practice registered nurses delivering the intervention. Component-level fidelity was assessed as the proportion of total elements completed from each component. Finally, overall fidelity is calculated as the proportion of required elements completed multiplied by 38 or the total possible elements to complete. CONCLUSION: Proper evaluation of fidelity to the delivery of an intervention is key in evaluating its implementation. This paper provides new methods to calculate fidelity for a complex intervention, which required the incorporation of 38 elements and nuances that did not require all patients to receive all elements, requiring the creation of clear rules for the exclusion of elements for a participant. The fidelity measure was employed throughout implementation and used to give feedback to the study team and improve fidelity. This paper outlines a novel methodology for flexible fidelity scoring in multicomponent interventions, incorporating rule-based exemptions to accommodate variability in real-world implementation. Future work needs to include validation of the metric through evaluation of fidelity at the participant level to examine its association with clinical outcomes in the parent MIRROR-TCM study, overall and by site.
Pitfalls in the reporting of clinical events in unblinded device trials: analysing performance bias in the BIO|GUARD-MI trial.
Jøns C, Søgaard P, Smilde T … +13 more , Táborský M, Faluközy J, Wiemer M, Christensen PD, Erglis A, Khan M, Marti Almor J, Del Prado Diaz S, Rybar I, Vitali Serdoz L, Schrader J, Behrens S, BIO|GUARD-MI study group
Trials · 2026 May · PMID 42129909 · Full text
BACKGROUND: The BIO|GUARD-MI study was an unblinded trial that investigated the clinical effect of continuous arrhythmia monitoring with an implantable cardiac monitor in patients after myocardial infarction. Unexpectedl...
BACKGROUND: The BIO|GUARD-MI study was an unblinded trial that investigated the clinical effect of continuous arrhythmia monitoring with an implantable cardiac monitor in patients after myocardial infarction. Unexpectedly, a pre-specified interim analysis identified a higher incidence of non-cardiovascular adverse events in the treatment group. This was assumed due to a performance bias and ultimately led to premature study termination. By study protocol, participants were expected to visit the study site only when invited after detected arrhythmias. Here, we provide a secondary analysis of participant initiated contacts to the investigational site, which may be the basis of the presumed bias, and employ it to identify a subgroup of participants that may be responsible for the bias. METHODS: We compare the numbers of participants with self-initiated contacts between the study groups in the total cohort and in 24 subgroups, 14 of them based on the country and 10 on clinical or demographic characteristics. RESULTS: In the total cohort, similar percentages of participants of the treatment and control groups visited the investigational site on their own initiative (13.3% vs. 9.7%; P = 0.12). However, the subgroup analysis revealed a statistically significant difference in participants from Denmark (24.4% vs. 2.3%) after correction for multiple testing (P = 0.0004). Other variables support the assumption that this affected the reporting of adverse events. CONCLUSIONS: In the BIO|GUARD-MI trial, a performance bias is evident in participants from Denmark. In the Danish health system, the general practitioner acts as a gate keeper for secondary and tertiary care, which treatment group participants could bypass. This led to more clinical events being reported in them. When conducting an unblinded diagnostic trial, continuous assessment of characteristics that indicate unexpected participant behaviour is important. Such differences may be driven by characteristics of national health systems. TRIAL REGISTRATION: https://www. CLINICALTRIALS: gov/ct2/show/NCT02341534, First registered at ClinicalTrials.gov on January 14, 2015.
A study protocol for a randomised controlled trial investigating the clinical effectiveness, cost effectiveness and acceptability of Behavioural Activation for Young people (BAY) in CAMHS settings.
Standley E, Ellison R, Bee P … +23 more , Bhardwaj A, Blackwell J, Carter LA, Yilmaz GC, Cowling A, Elvins R, Hewitt C, Hull P, Marwedel S, McCulloch A, Mitchell A, Piccolo-Lawrance C, Sayal K, Strange H, Street M, Wakefield E, Wakefield T, Wallis P, Wang HI, Whelan P, White C, Young S, Dubicka B
Trials · 2026 May · PMID 42121255 · Full text
BACKGROUND: Emotional disorders in young people have been increasing, leading to a high demand for support and long waiting times for UK child and adolescent mental health services (CAMHS). Consequently, access to eviden...
BACKGROUND: Emotional disorders in young people have been increasing, leading to a high demand for support and long waiting times for UK child and adolescent mental health services (CAMHS). Consequently, access to evidence-based psychological therapy is limited; in addition, many young people do not respond to existing treatments. Blended delivery of therapy, which combines face-to-face and digital interventions, offers a promising solution to improve the reach and effectiveness of mental health support. However, the efficacy of blended behavioural activation (BA) for young people with depression is not yet established. METHODS: This randomised controlled trial will investigate the clinical and cost effectiveness of blended behavioural activation intervention for adolescents aged 11-17 years with moderate to severe depression. We will recruit 446 participants from CAMHS across 6 sites in the UK. Participants will be randomised to receive either BA with psychoeducation (PE) and treatment as usual (TAU) or PE and TAU. The primary outcome measure will be depressive symptoms, assessed using the child-completed Mood and Feelings Questionnaire (MFQ-C) at 6 months. A range of secondary outcome measures will be collected to estimate the clinical and cost effectiveness and acceptability of the intervention. A nested qualitative investigation exploring provider and young people/carer perspectives will be included. DISCUSSION: The findings from this trial will provide crucial evidence on the effectiveness of blended BA for young people with moderate to severe depression. If effective, this intervention could offer a scalable and accessible treatment option, potentially transforming the delivery of mental health services for adolescents. The large sample size and pragmatic approach will enhance the generalisability of the results, informing future clinical practice and policy. TRIAL REGISTRATION: ISCRTN12315118. Registered on August 29, 2023.
Assessing a biomarker platform for stratifying indeterminate pulmonary nodules, protocol for the SPOT IT randomized trial.
Paez R, Khalil TA, Forero Y … +14 more , Woodhouse P, Antic S, Holmes H, Fremont RD, Brandt W, Chen H, Chen SC, Kaizer A, Shojaee S, Lentz RJ, Deppen SA, Barón AE, Grogan EL, Maldonado F
Trials · 2026 May · PMID 42121244 · Full text
BACKGROUND: Millions of lung nodules are detected every year during routine computed tomography imaging. While most are benign, some represent early-stage lung cancer and require prompt diagnosis as survival worsens with...
BACKGROUND: Millions of lung nodules are detected every year during routine computed tomography imaging. While most are benign, some represent early-stage lung cancer and require prompt diagnosis as survival worsens with advanced stages. The Lung Cancer Prediction score is a computed tomography-based radiomic biomarker used to risk-stratify pulmonary nodules. Observational studies have shown promising results, but it remains unclear if the use of this biomarker improves patient management. METHODS: SPOT IT is a multicenter, open-label, randomized controlled superiority trial. Adult patients (35 years and older) referred for evaluation of an incidentally detected lung nodule 8-30 mm in size who meet all eligibility criteria are currently being enrolled. Participants are randomized in a 1:1 ratio to receive either usual care combined with the Lung Cancer Prediction score or usual care alone. Randomization is conducted using permuted blocks of variable size, stratified by study center and nodule size (≤1.5 cm, >1.5 cm). The primary outcome is appropriate initial nodule management, defined as imaging surveillance for benign nodules and additional diagnostic procedures or definitive therapy for malignant nodules. Secondary outcomes include change in management, unnecessary invasive procedures for benign nodules, and time to diagnosis for malignant nodules. The study was approved by the Vanderbilt University Medical Center (single Institutional Review Board) and is being conducted with waiver of consent. Enrollment began in October 2024 and approximately 400 patients are expected to be enrolled by the time of completion. DISCUSSION: SPOT IT is an ongoing multicenter randomized controlled trial assessing the impact of a commercially available radiomic prediction score on patient management. Results from this trial might help inform the care of patients with pulmonary nodules and clarify the role of the biomarker in routine clinical practice. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov (NCT06638398) prior to opening. Registered on October 09 2024.
Effect of ultrasound-guided interscalene brachial plexus block using liposome bupivacaine combined with continuous esketamine infusion on quality of recovery in patients undergoing arthroscopic rotator cuff repair: study protocol for a randomized controlled trial.
Yue J, Wang Q, Tang Q … +2 more , Zhou R, Zhou L
Trials · 2026 May · PMID 42121214 · Full text
BACKGROUND: Arthroscopic rotator cuff repair is the standard of care for rotator cuff tears. However, postoperative pain and recovery remain a significant clinical challenge. While ultrasound-guided interscalene brachial...
BACKGROUND: Arthroscopic rotator cuff repair is the standard of care for rotator cuff tears. However, postoperative pain and recovery remain a significant clinical challenge. While ultrasound-guided interscalene brachial plexus block with liposomal bupivacaine provides sustained analgesia for up to 72 h, the addition of esketamine intravenous infusion may offer further benefits through enhanced pain control, mood stabilization, and cognitive support. This study aims to evaluate the synergistic effect of this combination on the quality of postoperative recovery in patients undergoing arthroscopic rotator cuff repair. METHODS: This single center, randomized controlled trial will enroll 278 patients undergoing arthroscopic rotator cuff repair. Participants will be randomly allocated at a 1:1 ratio to either the intervention or control group. The intervention group will receive a combination of an ultrasound-guided interscalene brachial plexus block with liposomal bupivacaine and a continuous intravenous esketamine infusion, while the control group will receive a saline infusion. The primary outcome is the 15-item Quality of Recovery (QoR-15) score at 24 h postoperatively. Secondary outcomes include QoR-15 scores at various time points within 30 days, pain scores, total opioid consumption, need for rescue analgesia, incidence of postoperative delirium, hospital anxiety and depression scale scores, sleep quality, length of hospital stay, and adverse events. DISCUSSION: Guided by Enhanced Recovery After Surgery principles, this randomized controlled trial investigates a novel combination of liposomal bupivacaine block and esketamine infusion to enhance postoperative recovery after arthroscopic rotator cuff repair. It specifically assesses patient-reported recovery through the QoR-15 score, a validated tool encompassing pain, physical comfort, independence, and psychological well-being. As a single-center initiative, this work represents a pivotal step in generating preliminary evidence for this multimodal strategy. TRIAL REGISTRATION: This study has been approved by the Ethics Committee at West China Hospital, Sichuan University (approval no. 2025-1908). The trial was prospectively registered with the Chinese Clinical Trial Registry (ChiCTR2500112854) on November 20, 2025.
Digital cognitive behavioral therapy and peer support for adolescents and young adults with sickle cell disease and chronic pain: study protocol of a parallel, three-arm, randomized controlled trial (PRESENCE).
O'Brien JA, Colvin AB, Radovic A … +9 more , Oluwole OB, Smith WR, Palermo TM, Rollman BL, Dampier C, Zempsky W, DeCastro LM, Stinson J, Jonassaint CR
Trials · 2026 May · PMID 42121176 · Full text
BACKGROUND: Sickle cell disease (SCD) affects millions globally, with pain being the most prevalent symptom. Adolescents and young adults (AYAs) with SCD face high rates of pain crises and healthcare encounters. Digital...
BACKGROUND: Sickle cell disease (SCD) affects millions globally, with pain being the most prevalent symptom. Adolescents and young adults (AYAs) with SCD face high rates of pain crises and healthcare encounters. Digital cognitive behavioral therapy (CBT) shows promise for pain management but faces engagement challenges. The PRESENCE study aims to enhance engagement in and benefit from digital CBT for SCD by adding personalized peer support. METHODS: This multisite, randomized controlled trial is recruiting 470 AYAs (ages 16-30) with SCD who report chronic pain. Participants are randomized 3:3:2 respectively to one of three groups: (1) CBT with peer support (CBT + Peer), (2) CBT alone (CBT), or (3) usual care (UC). Participants are provided access to the study mobile application, which is used for intervention delivery and data collection. Peer support is provided weekly by trained peer coaches who are individuals with lived experience. Evaluations are completed at baseline, 3, 6, and 12 months post randomization. The primary study aim is to determine whether AYAs receiving any digital CBT have greater reductions in pain intensity and pain interference at 6 months post randomization compared to those receiving UC. The secondary aim is to determine whether CBT + Peer is superior to CBT in reducing pain intensity and interference at 6 months. Secondary outcomes include reductions in mean daily pain intensity, pain days, average weekly opioid dose, emergency department visits, healthcare utilization, internalized stigma, and depression and anxiety symptoms, and improvements in sickle cell self-efficacy. DISCUSSION: Findings from the PRESENCE trial will inform patients, parents, and providers on how digital CBT and peer support will improve pain management. Ultimately, this study will advance our understanding of how digital interventions can be optimized for populations with complex chronic conditions like SCD, where stigma and healthcare navigation can be barriers to effective care delivery. This approach could offer a scalable, accessible, and culturally responsive strategy to improve pain outcomes, reduce opioid reliance, and enhance overall health and well-being for AYAs with SCD. TRIAL REGISTRATION: Clinicaltrials.gov NCT06374238. Registered on April 2025.
Effects of digital exercise therapy and cognitive behavioral therapy on body image and social distance of postoperative patients with breast cancer: study protocol for a randomized controlled trial.
Peng M, Wu X, Chen X … +5 more , Yao B, Ke Q, Sun Y, Wu X, Liu S
Trials · 2026 May · PMID 42116180 · Full text
BACKGROUND: Modified radical mastectomy is a widely used operative method for patients with breast cancer. Although it can significantly improve the survival rate, it can also lead to various adverse reactions, such as t...
BACKGROUND: Modified radical mastectomy is a widely used operative method for patients with breast cancer. Although it can significantly improve the survival rate, it can also lead to various adverse reactions, such as the loss of sexual characteristics, skin damage, and hair loss, which in turn can cause body image disorders and social avoidance among postoperative patients. Exercise therapy and cognitive behavior therapy are frequently employed as rehabilitation treatments to increase the mental well-being and stress coping styles of patients with breast cancer. However, no studies have directly explored the impact of exercise therapy and cognitive behavior therapy on the body image and social distance of patients with breast cancer. METHODS: This is a three-arm randomized controlled trial. A total of 60 patients who underwent modified radical mastectomy for breast cancer will be recruited and divided into three groups: the exercise therapy group, the cognitive behavior therapy group, and the combined treatment group. The intervention will be delivered in a hybrid mode combining online and offline sessions. All participants will receive a 60-min intervention twice a week for 8 weeks. The primary outcomes are the Body Image Scale and the Social distancing test, which will be conducted before and after the intervention, as well as at the 3-month follow-up. DISCUSSION: This study aims to evaluate a rehabilitation program combining digital exercise therapy and cognitive behavioral therapy for postoperative breast cancer patients, focusing on improving body-image disturbances and abnormal social-distance adjustment following modified radical mastectomy. The intervention is expected to help patients return to family and society in a positive and confident state, achieving psychophysiological-social rehabilitation. The use of digital remote intervention in research can not only ensure the security of patients' personal information but also reduce the time and money spent on commuting and seeing doctors, providing new ideas for clinical treatment. TRIAL REGISTRATION: This trial was registered with Chinese Clinical Trial Registry (ChiCTR2400084427) on May 16, 2024.
Skipping rope and pamphlet intervention to promote physical activity among young adolescents in South Africa: study protocol for a randomized controlled trial.
Ferrero E, Ncayiyana J, Machanyangwa S … +10 more , Partap U, Shinde S, Bajaria S, Sivewright N, Neumann C, Sando MM, Laxy M, Bärnighausen T, Fawzi W, Burns J
Trials · 2026 May · PMID 42116092 · Full text
BACKGROUND: The World Health Organization (WHO) recommends that adolescents engage in at least 60 min of moderate-to-vigorous physical activity (MVPA) daily across the week to support healthy growth and development. Desp...
BACKGROUND: The World Health Organization (WHO) recommends that adolescents engage in at least 60 min of moderate-to-vigorous physical activity (MVPA) daily across the week to support healthy growth and development. Despite this guideline, physical inactivity is prevalent among adolescents in South Africa. This is concerning given the increasing burden of overweight and obesity. While nutrition is a critical driver of these conditions, physical activity represents a complementary and scalable strategy to improve overall adolescent health. This study aims to assess the effect of providing a skipping rope and an informational pamphlet to adolescents aged 10-14 years in South Africa on their physical activity intentions and behaviors. METHODS: This study is a two-arm parallel-group, individual 1:1, unblinded randomized trial, nested within the Design and Evaluation of Adolescent Health Interventions and Policies in Sub-Saharan Africa (DASH) project. The intervention consists of providing adolescents 10-14 years old in a community setting in South Africa with a skipping rope and a pamphlet with general instructions for rope skipping and messages emphasizing the importance of regular physical activity. About 700 adolescent boys and girls are enrolled as part of this study. The intervention was administered during the first wave of data collection for the DASH study, or baseline, and outcomes will be assessed at both baseline and endline (12 months), during the second wave of data collection for DASH. As a primary outcome, the trial will test whether providing skipping ropes and pamphlets to intervention participants will increase their amount of weekly MVPA over 12 months, compared to participants in the control group, who will receive no materials. Secondary outcomes will be intention to do physical activity, assessed toward the end of the baseline interview, and meeting the WHO recommendations for physical activity, assessed at endline. The physical activity questionnaire was developed from the Physical Activity Questionnaires for Adolescents. DISCUSSION: Improving physical activity behaviors and reducing sedentary time among adolescents are critical for fostering healthy lifestyles into adulthood. Assessing the effectiveness of this intervention to enhance physical activity intention and behaviors in South Africa is particularly important given the increasing burden of overweight and obesity. TRIAL REGISTRATION: ClinicalTrials.gov NCT06516549. Registered on July 17th 2024. https://clinicaltrials.gov/study/NCT06516549 .
Optimizing soft tissue injury rehabilitation: PEACE & LOVE with vs without cryotherapy-protocol for a sham-controlled randomized trial in acute lateral ankle sprain.
Halder P, Hossain MZ, Akash MAA … +7 more , Saha J, Kabir MF, Hossain KMA, Jahan S, Hossain K, Hossain T, Rahman E
Trials · 2026 May · PMID 42116058 · Full text
BACKGROUND: Acute lateral ankle sprains, especially those affecting the anterior talofibular ligament (ATFL), are one of the most frequent injuries in athletes and active adults. These injuries cause pain, swelling, func...
BACKGROUND: Acute lateral ankle sprains, especially those affecting the anterior talofibular ligament (ATFL), are one of the most frequent injuries in athletes and active adults. These injuries cause pain, swelling, functional restriction, and high recurrence. The PEACE & LOVE framework discourages the use of cryotherapy, yet ice remains widely used in sports and rehabilitation practice. To date, there is limited high-quality evidence evaluating the effect of cryotherapy within this framework. This trial is designed to investigate whether adding cryotherapy to PEACE & LOVE rehabilitation improves outcomes compared with sham cryotherapy. METHODS: This single-center, parallel-group, sham-controlled randomized clinical trial will include 60 physically active adults (aged 18-40 years) with grade I-II acute lateral ankle sprains sustained within 48 h. Recruitment has not commenced and is planned from March to May 2026. Follow-up assessments will continue through 12 weeks post-randomization. Participants will be randomly assigned (1:1) to receive either PEACE & LOVE plus cryotherapy (0-4 °C, 20 min, three times daily for 72 h) or PEACE & LOVE plus sham cryotherapy (identical packs at ~20-25 °C with insulation). The primary outcome is pain intensity measured by the Numeric Pain Rating Scale (NPRS) at day 7. Secondary outcomes are functional recovery measured by the Lower Extremity Functional Scale (LEFS) at day 14, week 4, and week 12; ankle swelling assessed by figure-of-eight measurement at baseline and day 7; ankle dorsiflexion via the Weight-Bearing Lunge Test (WBLT) at baseline, week 4, and week 12; short-term analgesic use (paracetamol log, day 0-7); and re-injury rates assessed at week 4 and week 12. Analyses will follow the intention-to-treat principle using ANCOVA adjusted for baseline scores, reporting effect sizes and 95% confidence intervals. DISCUSSION: This trial will be the first sham-controlled randomized study to evaluate cryotherapy as an adjunct to the PEACE & LOVE framework in acute ankle sprain. Findings will clarify whether cryotherapy provides clinically meaningful benefits in pain relief, function, and recurrence prevention, and may guide evidence-based rehabilitation practice. TRIAL REGISTRATION: Clinical Trial Registry India (CTRI): CTRI/2024/09/073357. Registered on April 9, 2024.
Patient and clinician perspectives on clinical trials in transplant failure: a qualitative interview study.
Venter B, Noyes J, Selman LE … +6 more , Exley C, Griffin S, Hancock A, McLaughlin L, Hole B, Bailey PK
Trials · 2026 May · PMID 42115901 · Full text
BACKGROUND: Transplant failure is associated with increased morbidity, mortality and poor quality of life. There is limited evidence to inform treatment decision-making when and after kidney transplants fail: randomised...
BACKGROUND: Transplant failure is associated with increased morbidity, mortality and poor quality of life. There is limited evidence to inform treatment decision-making when and after kidney transplants fail: randomised controlled trials are needed. We investigated the feasibility and acceptability of clinical trials into the management of kidney transplant failure, and explored research facilitators and barriers. METHODS: We undertook in-depth interviews with adults (aged ≥ 18 years) who had failing kidney transplants or had experienced kidney transplant failure, their relatives/friends, and healthcare professionals (HCPs). Participants were recruited from three UK NHS hospitals. Iterative purposive sampling of patient participants was undertaken, aiming for diversity with respect to personal characteristics, the type of transplant received (living/deceased-donor), whether the transplant was failing or had failed, and current kidney disease treatment. Purposive sampling of HCPs ensured diversity in sex, age, ethnicity, and role. Family and friends were recruited via posters and snowball sampling. Interviews investigated perspectives on clinical trials at the time of transplant failure. Sample size was determined by reaching theoretical saturation. We undertook inductive analysis according to constructivist grounded theory. RESULTS: Forty-one participants (17 HCPs/15 patients/9 relatives or friends) were interviewed. We identified the following categories: Facilitators to clinical trials: analytical thinking i. Recognition of the lack of evidence-individual and community equipoise ii. Motivation to advance stratified and personalised medicine Challenges to clinical trials: cognitive biases and heuristics iii. Status quo bias-preference for existing treatment regimens iv. Loss and risk aversion-fear of harm from research v. Experiential learning and the availability heuristic-decisions based on recent or memorable cases These 5 categories were considered within the core category of 'Personal reasoning and clinical gatekeeping'. There was strong support for immunosuppression reduction trials, with stratification of people according to clinical and immunological subtypes. HCPs and patients supported trials after transplant failure but were reticent to engage in trials as a transplant was failing. CONCLUSIONS: Acknowledged individual and community equipoise appear to support trial delivery and recruitment. Umbrella trials may be needed to evaluate therapies in multiple patient subgroups.
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