Trials[JOURNAL]
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200 papers
Effects of manual lymphatic drainage combined with Kinesio taping on post-stroke shoulder-hand syndrome: a study protocol for a randomized controlled trial in the Southwest China region.
Yin L, Chang J, Gao S … +6 more , Yuan C, Zhu Y, Tao Y, Li S, Liao L, Gao C
Trials · 2026 Apr · PMID 42021349 · Full text
BACKGROUND: Shoulder-hand syndrome (SHS) is a common upper limb complication following stroke. It is associated with poor functional recovery of the upper limb and reduced mobility. Both kinesiology tape (KT) and manual...
BACKGROUND: Shoulder-hand syndrome (SHS) is a common upper limb complication following stroke. It is associated with poor functional recovery of the upper limb and reduced mobility. Both kinesiology tape (KT) and manual lymphatic drainage (MLD) are considered effective interventions for treating pain and swelling associated with SHS. However, there is currently no research examining the limitations and safety profile of combining K-tape with MLD for SHS management. This study aims to investigate the efficacy of KT combined with MLD in patients with post-stroke shoulder-hand syndrome. METHODS: This study will be a prospective, single-center, randomized, factorial, controlled clinical trial. This exploratory randomized controlled trial aimed to investigate the efficacy of MLD combined with KT for post-stroke SHS. This study used a blinded design. Ninety-six patients with post-stroke SHS are randomly divided into four groups: (n = 24 per group): Experimental Group 1: Conventional Rehabilitation (CR) + KT, Experimental Group 2: Conventional Rehabilitation (CR) + MLD, Experimental Group 3 (EG3): KT + MLD, Control Group: CR alone. All participants will receive CR as the baseline intervention. All subjects are first‑ever stroke patients diagnosed with unilateral limb paralysis by CT and/or MRI and meet the diagnostic criteria for SHS. The informed consent process is carried out by a trained researcher not involved in the patients' clinical care in a private room. Therapists participating in this study must hold a rehabilitation therapist qualification. Unified training will be provided to the treating therapists on MLD, KT, and conventional rehabilitation techniques. This study is conducted at the Army Specialized Medical Center. The Army Specialized Medical Center is a tertiary Grade A hospital located in Southwest China. In China's hierarchical medical system, tertiary Grade A hospitals represent the highest level in the hospital classification system. Outcome measures will be assessed at four time points: baseline (T0), 4 weeks after initiating the intervention (T1), 3 months post-treatment (T2), 6-month follow-up (T3). The primary endpoints will be as follows: pain intensity measured by the Visual Analogue Scale (VAS) at T1, volume difference between the affected and unaffected upper limbs at T1. Secondary endpoints will include the following: upper limb motor function assessed by the Fugl-Meyer assessment for upper extremity (FMA-UE), activities of daily living evaluated using the modified Barthel index (MBI), joint range of motion (ROM) measurements, quality of life measured by the Stroke-specific quality of life scale (SS-QOL). Safety is assessed by monitoring vital signs (blood pressure and heart rate) before and after treatment, examining skin integrity at the tape application site for any adverse reactions (e.g., redness, rash), and recording any patient-reported increases in pain or other unexpected discomfort potentially related to the intervention. DISCUSSION: The efficacy of personalized rehabilitation therapy prescription interventions will be assessed through changes in primary and secondary outcome measures at the 4-week intervention point and during the 12-week follow-up period. To analyze whether MLD combined with KT for post-stroke shoulder-hand syndrome is superior to conventional rehabilitation in terms of pain, swelling, and motor function. TRIAL REGISTRATION: Clinical Trial Registry-China ChiCTR2300074140. https://www.chictr.org.cn/ . First submitted on 31 July 2023.
Effects of transcranial direct current stimulation (tDCS) on cognition in older adults with mild cognitive impairment: a study protocol for a randomized controlled trial.
Kuo MCC, Tan GHD, Hu X … +2 more , Yau MYC, Yip CK
Trials · 2026 Apr · PMID 42021325 · Full text
BACKGROUND: Mild cognitive impairment (MCI) is an intermediate stage between normal cognitive aging and dementia. People with MCI have a higher risk of developing dementia than normal healthy people. Improving their cogn...
BACKGROUND: Mild cognitive impairment (MCI) is an intermediate stage between normal cognitive aging and dementia. People with MCI have a higher risk of developing dementia than normal healthy people. Improving their cognitive functions may delay dementia onset. The aim of this project is to conduct a randomized controlled trial to assess the effects of transcranial direct current stimulation (tDCS) on cognition in adults with mild cognitive impairment. METHODS/DESIGN: Forty-eight MCI participants will be recruited from four local day centers for the elderly and assigned to experimental or control groups randomly in a 1:1 ratio. Participants and assessors are blinded to their group assignment. The experiment will consist of pre- and post-assessments and a 1-month follow-up assessment. Participants will receive 8 sessions (2×/week for 4 weeks) of tDCS intervention (either real or sham, 20 min per session). Primary outcome measures will include digit span test, color trail test, verbal fluency, Chinese version of the Verbal Learning Test, and the Hong Kong version of Montreal Cognitive Assessment. Participants will also have their brain waves recorded while completing a computer memory task at each assessment point. The task will require them to study and memorize certain Chinese characters and take a recognition memory test. Secondary outcomes include scores from the Geriatric Depression Scale and the Modified Barthel Index. DISCUSSION: The study addresses the shortcomings in previous studies and investigates multiple domains of cognition (e.g., attention, memory, executive function), the sustainability of the effects, and includes electroencephalography as an outcome measure with application to people with MCI. The results of this proposed project are expected to have an impact on the long-term care and rehabilitation of older and clinical populations and to increase general knowledge about tDCS and related cognitive enhancement in MCI. TRIAL REGISTRATION: ClinicalTrials.gov NCT05584748 ( https://clinicaltrials.gov/study/NCT05584748 ). Registered on October 10, 2022.
AI-driven navigated hematoma aspiration vs. conservative treatment for spontaneous intracerebral hemorrhage: study protocol for a randomized controlled trial.
Xu X, Zhang J, Yuan Q … +4 more , Lang S, Gan Z, Jin H, Chen X
Trials · 2026 Apr · PMID 42021277 · Full text
BACKGROUND: Spontaneous intracerebral hemorrhage (ICH) remains one of the most devastating types of stroke, with high mortality and long-term disability. Minimally invasive hematoma evacuation techniques have been develo...
BACKGROUND: Spontaneous intracerebral hemorrhage (ICH) remains one of the most devastating types of stroke, with high mortality and long-term disability. Minimally invasive hematoma evacuation techniques have been developed to improve outcomes by reducing hematoma volume while minimizing surgical trauma compared with conventional craniotomy or conservative treatment. Artificial intelligence (AI) and neuronavigation enable optimized trajectory planning, real-time intraoperative guidance, and individualized treatment strategies, potentially leading to improved clinical outcomes compared with conservative treatment. This study aims to compare the efficacy and safety of AI-driven navigated hematoma aspiration with conservative therapy. METHODS: This multicenter, prospective, randomized controlled, open-label trial with blinded outcome assessment will enroll approximately 680 patients with spontaneous supratentorial ICH (20-50 mL) within 24 h of onset and a Glasgow Coma Scale (GCS) score ≥ 8. Eligible patients aged 18-80 years will be randomly assigned in a 1:1 ratio to receive either AI-assisted, navigation-guided hematoma aspiration plus best medical therapy or best medical therapy alone. Randomization will be centralized and stratified by center. The primary outcome is functional status at 6 months, assessed by the modified Rankin Scale, with mRS 0-2 defined as a favorable outcome. Secondary outcomes include mortality, hematoma volume reduction, neurological function, complications, quality of life, length of hospital stay, and cost-effectiveness. DISCUSSION: This trial is designed to provide robust evidence on the efficacy and safety of AI-guided hematoma aspiration for ICH. If successful, it has the potential to support a precise and minimally invasive treatment strategy and improve clinical outcomes. TRIAL REGISTRATION: Clinical Trials NCT07077343. Registered on July 21, 2025.
A diagnostic randomized controlled trial to validate novel dried blood spot (DBS) based technology for prognosis and screening of leukemia transcripts: study protocol.
Sharma S, Swain SK, Rishi B … +13 more , Kaur M, Joseph GT, George NG, Kushwaha N, Dhanda H, Rajkamal, Surbhi, Chaudhry S, Sahoo D, Jain A, Singh A, Siraj F, Misra A
Trials · 2026 Apr · PMID 42015297 · Full text
BACKGROUND: Leukemia is the most common subtype of cancer in Indian children and ranks among the top ten cancers in the adult population according to ICMR cancer registry 2022 (National Cancer Registry Programme, Cancer...
BACKGROUND: Leukemia is the most common subtype of cancer in Indian children and ranks among the top ten cancers in the adult population according to ICMR cancer registry 2022 (National Cancer Registry Programme, Cancer incidence and mortality in India 2022, 2022). Current leukemia diagnostics rely on sophisticated molecular tests that are not available at all healthcare centers, particularly in remote and tier-two cities. Access to specialized molecular diagnostics and prognostic tests is limited to fewer than 20 centers across India, serving a population of approximately 1.3 billion people (National Cancer Registry Programme, Cancer incidence and mortality in India 2022, 2022). This restricted accessibility results in delayed diagnosis, suboptimal risk stratification, increased economic burden, and higher mortality rates compared to high-income countries. METHODS: This is a multicenter, randomized, double-blind diagnostic interventional trial designed to validate a novel dried blood spot (DBS) based technology for leukemia transcript determination. The study will be conducted across five sites in India. Newly diagnosed acute leukemia patients (n = 300; 200 ALL and 100 AML) will be randomized into two arms: interventional arm (DBS-based testing) and comparator arm (conventional testing). The primary outcome is the sensitivity, specificity, and positive predictive value of the DBS-based method compared to conventional diagnostic methods. Secondary outcomes include overall survival, event-free survival, and relapse rates over one year of follow-up. DISCUSSION: This study addresses a critical gap in leukemia diagnostic accessibility in low- and middle-income countries. The novel DBS-based technology has the potential to withstand tropical temperature and humidity conditions for 24-48 h, making it suitable for transport from remote areas. Preliminary work has shown 100% specificity and 99% sensitivity compared to standard reference methods (PLoS One 13(1):e0191421, 2019). If validated, this technology could significantly improve leukemia outcomes through earlier diagnosis, better risk stratification, and reduced abandonment rates. TRIAL REGISTRATION: Clinical Trials Registry-India (CTRI): CTRI/2024/06/069601.
Treating suicidality remotely (TREASURE): study protocol for a remote randomized controlled trial comparing personalized cognitive behavioral therapy for suicide prevention with a guided self-help course in adolescents and adults.
Janssen W, Mérelle S, Gilissen R … +1 more , Bockting C
Trials · 2026 Apr · PMID 42015291 · Full text
BACKGROUND: Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to obtain professional help. Remote interventions have the potential to overcome many of these bar...
BACKGROUND: Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to obtain professional help. Remote interventions have the potential to overcome many of these barriers, but the remote interventions to date have produced small or short-lived effects and only reduced suicidal thoughts, not behaviors. AIMS: This study therefore aims to evaluate the effectiveness of remotely delivered brief cognitive behavioral therapy for suicide prevention (BCBT) in preventing suicide attempts in a fully remote randomized controlled trial, in which it will be compared to an online self-help course that has previously been found to be effective in reducing suicidal thoughts. METHODS: A randomized controlled trial will be conducted in which 364 participants aged 16 years and older will be recruited through the website of the Dutch suicide prevention helpline and randomized at a ratio of 1:1 to one of two interventions, both delivered via chat or phone. Participants in the experimental condition will receive BCBT. This intervention consists of approximately 12 sessions in which a narrative assessment of a recent suicidal crisis is used to create a personalized treatment plan out of several modules, such as cognitive restructuring, mindfulness and means restriction. Participants in the control group will receive a semiguided self-help course, which includes 6 lessons and 6 feedback sessions with a therapist, focusing predominantly on psychoeducation and cognitive restructuring. The primary outcome of the study is the number of suicide attempts, measured with the Columbia Suicide Severity Rating Scale (C-SSRS). Secondary outcomes are the self-reported severity of suicidal ideation, treatment satisfaction, adverse effects, and quality of life. All outcomes will be assessed at baseline, immediately after treatment and at 18-month follow-up. DISCUSSION: If remote BCBT proves effective, the findings of this study will add to the evidence base of BCBT as one of few replicated psychological interventions that can reduce suicide attempts and pave the way for the wider dissemination of this remote intervention. TRIAL REGISTRATION: Clinicaltrials.gov NCT06370104. Registered on April 8, 2024.
NEO-HYPORT: does neoadjuvant radiotherapy improve breast cancer outcomes? An open label, randomised, parallel group, superiority trial to compare the disease-free survival following neoadjuvant versus adjuvant hypofractionated radiotherapy in breast cancer (NEO-HYPORT).
Chatterjee S, Chakraborty S, Ahmed R … +5 more , Agarwal SK, Arun I, Sharma A, Maulik S, Mahajan S
Trials · 2026 Apr · PMID 42015277 · Full text
BACKGROUND: In the setting of curative treatment of breast carcinoma, radiotherapy is usually administered after surgery (adjuvant radiotherapy). We intend to evaluate the impact of delivering radiation therapy prior to...
BACKGROUND: In the setting of curative treatment of breast carcinoma, radiotherapy is usually administered after surgery (adjuvant radiotherapy). We intend to evaluate the impact of delivering radiation therapy prior to surgical intervention in the treatment of these patients. METHODS: The NEO-HYPORT trial is designed as a randomised, controlled, parallel group, open-label, single-centre, superiority trial comparing neoadjuvant and adjuvant radiotherapy after neoadjuvant chemotherapy. The primary endpoint is 3-year disease-free survival. A secondary randomisation will evaluate two hypofractionated radiotherapy schedules (40 Gy / 15 fractions / 3 weeks vs 26 Gy / 5 fractions / 1 week) in the two settings. DISCUSSION: Conventionally radiation therapy is delivered following surgery as adjuvant radiation therapy. The reasons for the same have been manifold including the hypothesis that surgical wound healing following radiation therapy may be delayed. Various biological arguments and outcomes from the utilisation of neoadjuvant radiation in other tumour sites suggest that neoadjuvant radiation may provide superior disease control as compared to adjuvant radiation therapy. Emerging evidence on wound healing safety following radiotherapy to the breast is also reported. The NEO-HYPORT trial will provide high-quality evidence about the efficacy of neoadjuvant radiotherapy and establish the safety of ultra hypofractionated radiotherapy in this setting.
Antibiotic therapy in viral airway infections (ATHENIAN): study protocol for an open labeled randomized controlled pragmatic trial to evaluate the efficacy and safety of discontinuing antibiotic therapy in adult patients infected with respiratory viruses.
Hovind MJ, Berdal JE, Benth JŠ … +2 more , Dalgard O, Lyngbakken MN
Trials · 2026 Apr · PMID 42015169 · Full text
BACKGROUND: Reducing inappropriate use of antibiotics is essential to combat antimicrobial resistance. Antibiotics are widely prescribed upon hospital admission for acute respiratory infections, but it remains unknown wh...
BACKGROUND: Reducing inappropriate use of antibiotics is essential to combat antimicrobial resistance. Antibiotics are widely prescribed upon hospital admission for acute respiratory infections, but it remains unknown whether it is safe to discontinue antibiotics when a respiratory virus is detected in these patients. With this randomized trial, we aim to assess the efficacy and safety of discontinuing antibiotic therapy in patients admitted to the hospital with a polymerase chain reaction test positive for respiratory virus and no clear evidence of bacterial infection. METHODS: ATHENIAN is an ongoing multicenter, open-label, pragmatic, randomized non-inferiority trial. We aim to recruit 400 adult patients initiated on antibiotic therapy at admittance to one of the 10 study sites in Norway and with a positive polymerase chain reaction test for influenza virus, human metapneumovirus, respiratory syncytial virus, or parainfluenza virus. The participants are randomized to intervention, discontinuation of antibiotic therapy, or control, continuation of antibiotic therapy at the discretion of the treating physician. We hypothesize that discontinuation of antibiotic therapy is safe and non-inferior to continuation of antibiotic therapy. The primary outcome, assessed at 120 h after randomization, is early clinical response, defined as survival with symptom improvement without receipt of rescue antibacterial therapy. Secondary outcomes include all-cause in-hospital and 30-day mortality, duration of hospital admission, days of therapy with antibiotics, rescue antibiotic therapy during hospital admission, new antibiotic therapy for presumed airway infection up to 30 days after hospital discharge, and hospital readmissions within 30 days after hospital discharge. DISCUSSION: To our knowledge, ATHENIAN is the first randomized controlled trial assessing the safety and efficacy of antimicrobial de-escalation based on multiplex nucleic acid amplification test results. Addressing this knowledge gap using a pragmatic study design will provide valuable insights that may influence treatment algorithms and antibiotic prescription practices. The study has the potential to contribute to a reduction in the inappropriate use of antibiotics and the emergence of antimicrobial resistance. TRIAL REGISTRATION: ClinicalTrials.gov NCT05045612. Registered on September 7, 2021.
EMERGE Mothers and Kids: a longitudinal cohort study of mothers and children enrolled in the randomized placebo-controlled trial of metformin in women with GDM (EMERGE): study protocol.
Scairati R, Newman C, Alvarez-Iglesias A … +7 more , Smyth A, O'Shea PM, Devane D, Gillespie P, Egan AM, O'Donnell M, Dunne FP
Trials · 2026 Apr · PMID 42010697 · Full text
BACKGROUND: Pregnancies complicated by gestational diabetes mellitus (GDM) are associated with increased risks of adverse perinatal outcomes and with long-term metabolic and cardiovascular consequences for both mother an...
BACKGROUND: Pregnancies complicated by gestational diabetes mellitus (GDM) are associated with increased risks of adverse perinatal outcomes and with long-term metabolic and cardiovascular consequences for both mother and child. The original EMERGE randomized controlled trial (RCT) evaluated the effectiveness of early metformin in addition to usual care in women with GDM on glycemic control and perinatal outcomes. The primary objective of the EMERGE Mothers and Kids study is to evaluate long-term maternal cardiometabolic health and child anthropometric and neurodevelopmental outcomes following participation in the EMERGE trial. METHODS: This is a prospective, observational longitudinal cohort follow-up study of women and their children previously enrolled in the EMERGE trial (NCT06327191). Participants are invited to attend a follow-up visit in a single-site hospital-based clinical research setting at the Clinical Research Facility Galway, Ireland. Key inclusion criteria are women and their children who participated in the EMERGE trial and consent to follow-up. Key exclusion criteria include participants who did not provide consent for future follow-up studies. The planned follow-up sample is a pragmatic convenience sample of up to 321 mother-child pairs. A single follow-up visit will be conducted up to 6 years after the index pregnancy. Maternal assessments include anthropometric data, glucose tolerance, and metabolic parameters. Child assessments include growth metrics, adiposity measured via skinfold thickness, and neurodevelopmental status assessed through validated questionnaires. Additional data on quality of life, mental health, breastfeeding, and health economics will also be collected. DISCUSSION: This study aims to provide insights into the long-term safety and efficacy of metformin use during pregnancy, addressing the evidence gap in maternal cardiometabolic outcomes after metformin-treated GDM while also assessing child anthropometric and neurodevelopmental outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT06327191. Registered on November 21, 2023. First planned enrollment in this follow-up study: July 2024. Trial record available at https://clinicaltrials.gov/study/NCT06327191 .
Effectiveness of nudge and motivational interview interventions to improve influenza vaccine uptake among healthcare workers in China: study protocol for a two-phase randomized trial.
Wang Q, Hou Q, Xu H … +5 more , Ma R, An Z, Hao L, Hou Z, Yin Z
Trials · 2026 Apr · PMID 42010692 · Full text
BACKGROUND: Seasonal influenza poses a significant public health challenge in China, yet vaccination uptake remains low even among healthcare workers. This study evaluates the effectiveness of multi-component interventio...
BACKGROUND: Seasonal influenza poses a significant public health challenge in China, yet vaccination uptake remains low even among healthcare workers. This study evaluates the effectiveness of multi-component interventions to improve influenza vaccination uptake, aiming to inform targeted public health strategies. METHODS: A two-phase randomized controlled trial will be conducted in community hospitals across China targeting healthcare workers as participants. In phase 1, community hospitals will be randomized as units into one of three arms: standard nudge group, personalized nudge group, and control group. In phase 2, healthcare workers who remain unvaccinated after phase 1 will be individually randomized to either a motivational interview group or a control group. The primary outcome is influenza vaccination uptake, verified by official vaccination records. All data will be analyzed upon study completion. DISCUSSION: Nudge and motivational interview interventions are anticipated to significantly improve vaccination uptake among healthcare workers, and facilitate scale up of the effective interventions. By targeting healthcare workers, these interventions can also indirectly enhance vaccination coverage in the general population. TRIAL REGISTRATION: ClinicalTrials.gov NCT07157163. Registered on September 4, 2025.
The wood and the trees: estimands in cluster randomised trials.
Hooper R, Hemming K, Li F
Trials · 2026 Apr · PMID 42010658 · Full text
BACKGROUND: The estimand framework was introduced into guidance on good clinical practice to address a variety of shortcomings and ambiguities in the reporting of trials, including the use of terms such as "intention to...
BACKGROUND: The estimand framework was introduced into guidance on good clinical practice to address a variety of shortcomings and ambiguities in the reporting of trials, including the use of terms such as "intention to treat" and the handling of non-adherence to treatment. The framework was primarily grounded in individually randomised trials, and some thorny issues still cloud understanding of its application to cluster randomised trials. ESTIMANDS IN CLUSTER RANDOMISED TRIALS: This commentary addresses some of the challenges in thinking about the estimands behind cluster randomised trials. These challenges include informative cluster size-the possibility that a treatment effect may be modified by the size of the cluster. In particular, we consider the perspectives of different actors-a population-level decision maker or politician, a cluster manager, and a patient-and examine possible estimands for each, and how they differ. CONCLUSIONS: In the cluster randomised trial context, the estimand framework can be complex to navigate. Different perspectives lead to different estimands. We caution against abandoning careful statistical modelling. This is particularly true in the presence of informative cluster size, where modelling any interaction between cluster size and treatment effect could be useful from a number of perspectives.
Trauma-informed intervention to reduce substance use and to support community transition [TRUST]: Study protocol for a type 1 effectiveness-implementation hybrid trial to reduce overdose risk among justice-involved women.
Staton M, Annett J, Carey P … +7 more , Yang Y, Jones O, Bills L, Logan TK, Tillson M, Oser C, Knight K
Trials · 2026 Apr · PMID 42010616 · Full text
BACKGROUND: The integration of trauma-informed interventions for justice-involved women into SUD treatment is a key strategy for mitigating overdose risk. Coupling the unique overdose risk factors for women with their hi...
BACKGROUND: The integration of trauma-informed interventions for justice-involved women into SUD treatment is a key strategy for mitigating overdose risk. Coupling the unique overdose risk factors for women with their histories of violent victimization and related trauma, overdose intervention approaches for women must be engaging, targeted, and trauma-informed. METHODS: This study utilizes a type 1 hybrid effectiveness and implementation trial to examine an innovative trauma-inforned intervention for justice-involved women (N = 264) in corrections-based substance use treatment during the transition from jail to the community. By equipping women with relational, coping, and emotional regulation skills to manage trauma-related reactions, they are expected to gain the tools and strategies needed to reduce their risk of returning to substance use after release. DISCUSSION: The importance of knowledge gained through this study is grounded in the national public health crisis associated with overdose deaths, largely associated with the opioid epidemic, but also related to unique issues faced by women and the limited, targeted, trauma-informed overdose prevention interventions for this population. This study that has the potential to significantly reduce overdose risk among justice-involved women with a history of violent victimization and related trauma. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov under protocol identifier-NCT06651528 with an original submission date of October 16, 2024, and updated December 12, 2025 (clinicaltrials.gov/study/NCT06651528).
Suprapapillary stent-by-stent deployment using slim fully covered metal stents versus plastic stents for unresectable malignant hilar biliary obstruction (SBSFLUX Trial): protocol for a multicenter randomized controlled trial.
Inoue T, Yoshida M, Okumura F … +12 more , Hori Y, Kato A, Kachi K, Toyohara T, Kito Y, Kitano R, Yamada N, Sasaki K, Kitada T, Futagami S, Yano M, Naitoh I
Trials · 2026 Apr · PMID 42002818 · Full text
BACKGROUND: Biliary drainage is essential for patients with malignant hilar biliary obstruction (MHBO) to relieve obstructive jaundice and cholangitis and improve survival and quality of life. Uncovered metal stents (MS)...
BACKGROUND: Biliary drainage is essential for patients with malignant hilar biliary obstruction (MHBO) to relieve obstructive jaundice and cholangitis and improve survival and quality of life. Uncovered metal stents (MS) are recommended for unresectable cases because of their superior duration of patency; however, their removal is technically difficult once an occlusion occurs. Plastic stents (PS) have regained attention owing to being easily removable, particularly as advances in antitumor therapies have led to prolonged survival and increased need for reintervention; however, their patency remains limited. Recently, slim fully covered MS (FCMS) have been reported to reduce the risk of side branch occlusion and may combine long-term patency with removability. This trial aims to evaluate the efficacy and safety of suprapapillary stent-by-stent (SBS) deployment of slim FCMS compared with PS deployment in patients with unresectable MHBO. METHODS: This is a multicenter, randomized, open-label, parallel-group study. Patients with unresectable MHBO classified as Bismuth type II or higher are eligible for inclusion. After informed consent is obtained, the patients will be randomized (1:1) to undergo suprapapillary SBS deployment (placement above the duodenal papilla) with either a slim FCMS or PS. The slim FCMS that will be used in this study have a 6-mm diameter, and both the FCMS and PS are equipped with a distal retrieval string to facilitate stent removal during reintervention. The primary endpoint is the rate of non-recurrent biliary obstruction (RBO) at 6 months following the intervention. Secondary endpoints include the time to RBO, overall survival, procedure success rate, clinical success rate, procedure time, adverse events, and reintervention outcomes. The target sample size is 70 patients (35 patients per group). DISCUSSION: Suprapapillary SBS deployment using slim FCMS may provide longer stent patency while preserving the feasibility of reintervention, potentially establishing a new standard biliary drainage method for unresectable MHBO. TRIAL REGISTRATION: Japan Registry of Clinical Trials: jRCT1040250073 registered on August 5, 2025. ( https://jrct.mhlw.go.jp/en-latest-detail/jRCT1040250073 ).
Fostering Infant Responsivity and Reciprocity - Support to Thrive (FIRRST): a multisite randomized control trial of a pre-emptive telehealth intervention for infants with early signs of Autism Spectrum Disorders in Italy.
Colombi C, Calderoni S, Chericoni N … +7 more , Conti E, Costanzo V, Marchi V, Di Rosa G, Lombardo MV, Ruta L, Guzzetta A
Trials · 2026 Apr · PMID 42001120 · Full text
BACKGROUND: Early prodromal signs of Autism Spectrum Disorder (ASD) can be detected within the first year of life, a period of heightened neuroplasticity. Pre-emptive, parent-mediated interventions delivered during this...
BACKGROUND: Early prodromal signs of Autism Spectrum Disorder (ASD) can be detected within the first year of life, a period of heightened neuroplasticity. Pre-emptive, parent-mediated interventions delivered during this window may improve developmental outcomes and reduce ASD symptom severity, but evidence from adequately powered randomized trials in Europe remains limited. Early prodromal signs of Autism Spectrum Disorder (ASD) can be detected within the first year of life, a period of heightened neuroplasticity. Pre-emptive, parent-mediated interventions delivered during this window may improve developmental outcomes and reduce ASD symptom severity, but evidence from adequately powered randomized trials in Europe remains limited. OBJECTIVES: The primary objective of this trial is to determine the efficacy of FIRRST (Fostering Infant Responsivity and Reciprocity - Support to Thrive), a parent-mediated pre-emptive telehealth intervention, in reducing ASD symptom severity in infants with ASD prodromes, as measured by change in Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) Calibrated Severity Scores. Secondary objectives are to evaluate effects on infant developmental skills, caregiver-child interaction, parental well-being, neurophysiological markers, and cost-effectiveness. METHODS: This is a multicenter, single-blinded, randomized, parallel-group superiority trial conducted in Italy. A total of 132 infants aged 9-14 months with ASD prodromes will be recruited by clinicians at participating university hospital-based centers and randomly allocated (1:1) to FIRRST or a Parent Education control condition. Key inclusion criteria include risk-range scores on the Social Attention and Communication Surveillance-Revised (SACS-R); exclusion criteria include known genetic, neurological, or severe sensory impairments. Randomization will be stratified by age (< 12 vs ≥ 12 months), sex, and ASD symptom severity. FIRRST consists of weekly telehealth sessions delivered by trained licensed health professionals over 24 weeks. Outcomes will be assessed at baseline, post-intervention (24 weeks), and follow-up (48 weeks). OUTCOMES: The primary outcome is change in ADOS-2 Calibrated Severity Scores from baseline to post-intervention. Secondary outcomes include developmental level (Griffiths-III), caregiver-child interaction (MONSI-CC), parental well-being (PSI-4), and neurophysiological measures derived from high-density electroencephalography. Safety outcomes include monitoring and descriptive reporting of adverse events. A cost-effectiveness analysis will be conducted from the healthcare system perspective. TRIAL REGISTRATION: ClinicalTrials.gov NCT06817746 . Registered on November 2024.
Randomized, double-blind, placebo-controlled study of oral duloxetine in prevention of acute pain syndrome in breast cancer patients receiving paclitaxel (DOPA study).
Banotra J, Shetty VV, Bakhshi S … +13 more , Srivastava AK, Gupta S, Kumar A, Bhargava P, Gangadhar B, Vasudeva P, Pallavi K, Bhati K, Singh S, Verma N, Divakar MK, Baskarane H, Batra A
Trials · 2026 Apr · PMID 42001111 · Full text
BACKGROUND: Acute pain syndrome (APS) is a common side effect of paclitaxel therapy. To date, there is no standard of care to prevent APS in patients receiving paclitaxel. Through this study, we aim to assess whether ora...
BACKGROUND: Acute pain syndrome (APS) is a common side effect of paclitaxel therapy. To date, there is no standard of care to prevent APS in patients receiving paclitaxel. Through this study, we aim to assess whether oral duloxetine reduces the incidence of paclitaxel-induced APS (P-APS) as compared to placebo. METHODS: This is a multi-centric, randomized (1:1), double-blind, placebo-controlled, parallel-group superiority trial. A total of 204 patients with breast cancer planned to receive paclitaxel will be randomly assigned to receive either oral duloxetine or a matched placebo for 7 days after paclitaxel infusions for 4 cycles. The primary objective of the study is to compare the proportion of patients who develop P-APS in two groups. Key secondary objectives are to compare the quality of life (using the FACT-B scale), the incidence of peripheral neuropathy, the safety profile, and adherence with duloxetine. Patient-reported outcomes for P-APS and neuropathy will be assessed at the end of each cycle using BPI-SF and EORTC-CIPN20 questionnaires, respectively. DISCUSSION: The DOPA study is designed to evaluate whether oral duloxetine can reduce the occurrence of APS in patients receiving paclitaxel chemotherapy for breast cancer. Limited trials have assessed P-APS prevention using etoricoxib, dexamethasone, and pregabalin, but no pharmacological measure is effective. If the trial successfully meets its primary endpoint, oral duloxetine could become the new standard of care for preventing paclitaxel-induced APS. TRIAL REGISTRATION: Clinical Trials Registry of India - CTRI/2024/10/075636. Registered on 22 October 2024.
Two different distal protections on cerebral microembolization of vulnerable plaque during carotid artery stenting (CASH-ES): study protocol for a randomized controlled trial.
Yan L, Shu L, Xinyi S … +11 more , Zhang N, Lu Y, Feng Y, Wang Y, Gao P, Ma Y, Chen J, Yang B, Feng Y, Chen Y, Jiao L
Trials · 2026 Apr · PMID 42001098 · Full text
BACKGROUND: Carotid artery stenting (CAS) is a widely used procedure for patients with high-risk carotid stenosis, particularly in the Chinese population. However, there are no randomized trials examining the comparative...
BACKGROUND: Carotid artery stenting (CAS) is a widely used procedure for patients with high-risk carotid stenosis, particularly in the Chinese population. However, there are no randomized trials examining the comparative efficacy and safety of different embolic protection devices (EPDs) used during CAS. This study aims to evaluate the safety and effectiveness of two newer-generation EPDs, Spider FX™ and Emboshield NAV6™, using a comprehensive approach that includes intraoperative monitoring, postoperative imaging, and clinical outcomes. Given the specific focus on a Chinese population, caution should be applied when generalizing findings to other ethnic groups. METHODS: This is a prospective, single-center, randomized, controlled, and blinded-endpoint trial designed to compare the performance of Spider FX™ and Emboshield NAV6™ in high-risk carotid stenosis patients undergoing CAS. A total of 172 patients will be enrolled, accounting for an estimated 20% dropout rate. The randomization will be performed in a 1:1 ratio between the two devices. The primary outcome is new ipsilateral ischemic lesions on diffusion-weighted imaging (DWI) within 7 days after CAS. Secondary outcomes include the number, size, and location of new cerebral ischemic lesions on DWI, and the count of microembolic signals (MES) detected by TCCD monitoring during the procedure. Safety assessments will include procedural complications, myocardial infarction, and mortality within 7 days. DISCUSSION: The results of this trial will provide crucial evidence on whether the Emboshield NAV6™ device offers superior distal embolic protection compared to the Spider FX™ in patients undergoing CAS. This could potentially guide clinicians in selecting the most effective EPD for high-risk carotid stenosis patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04904250 (URL: http://www. CLINICALTRIALS: gov ) Registered on May 27, 2021.
Statistical analysis plan for Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial; a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery.
Walker NJ, Forbes G, Kahan BC … +5 more , Smuk M, Phillips R, Quintin O, Lee KM, Edwards MR
Trials · 2026 Apr · PMID 41998794 · Full text
BACKGROUND: FLO-ELA is a multi-centre, parallel-group, open-label, randomised controlled trial (RCT) looking at the effect of minimally invasive cardiac output monitoring in the management of patients aged 50 years and a...
BACKGROUND: FLO-ELA is a multi-centre, parallel-group, open-label, randomised controlled trial (RCT) looking at the effect of minimally invasive cardiac output monitoring in the management of patients aged 50 years and above undergoing emergency gastrointestinal surgery. The primary outcome is days alive and out of hospital within 90 days of randomisation (DAOH-90). This article describes the statistical analysis plan (SAP) for this trial. The estimand and analytical approach presented here may be appropriate for clinical trials in a similar setting (critical care surgery). METHODS AND DESIGN: FLO-ELA is a superiority trial, incorporating an early-stage pilot phase, conducted at 63 UK hospitals. Participants are randomised on a 1:1 basis to the intervention or control group using a minimisation algorithm which balances on the following two factors (i) age, split into 3 groups, and (ii) American Society of Anesthesiologists (ASA) category, 5 categories on an ordinal scale reflecting participants' baseline co-morbidities. In this SAP, we define the estimands and strategies for handling intercurrent events for each study outcome, then give a detailed description of planned analyses including general analytical principles, analytical framework for primary, secondary and process measure outcomes, approach to missing data and supplementary analyses looking at heterogeneity in treatment effect between key subgroups and potential differences in outcomes pre and post onset of Covid pandemic in the UK. TRIAL REGISTRATION: ISRCTN 14729158. Registered on 02 May 2017.
Efficacy and safety of a particulate yeast β-glucan preparation in the treatment of seasonal allergic rhinitis (BETALL): a randomised placebo-controlled crossover trial protocol.
Briskey D, Pellow J, Beatson G … +3 more , Tremblay A, Rao A, Tompkins TA
Trials · 2026 Apr · PMID 41998746 · Full text
BACKGROUND: Allergic rhinitis (AR) has been shown to be a significant global health burden. Despite the existence of pharmacological treatments, mainly antihistamines, nasal corticosteroids, and decongestants, many indiv...
BACKGROUND: Allergic rhinitis (AR) has been shown to be a significant global health burden. Despite the existence of pharmacological treatments, mainly antihistamines, nasal corticosteroids, and decongestants, many individuals with seasonal allergies turn to alternative herbal medicines and nutritional supplements for the management of symptoms. The primary objective of the current study is to evaluate the efficacy and safety of a 500 mg daily dose of a yeast β-glucan preparation (M-Gard®) on reducing the severity of nasal and ocular symptoms in a population with seasonal AR. METHODS: This randomised placebo-controlled crossover trial will evaluate the effect of 500 mg of a 14-day M-Gard® or placebo (microcrystalline cellulose) supplementation period on the relief of grass pollen-induced AR symptoms in 20 generally healthy adults (18-65 years) with a history of recurrent seasonal AR. Participants will consume M-Gard® or placebo during 14 days, starting 12 days before the antigen challenge and ending 2 days after. Each supplementation period will be separated by a 2-week washout period. Allergy symptoms will be assessed at baseline (day 0) and on days 12-14 using a visual analogue scale (VAS) rating AR symptom severity as primary outcome (nasal congestion, sneezing, itchy nose, runny nose and watery eyes) and validated questionnaires as secondary outcomes (Reflective Total Nasal Symptom Scores (rTNSS), Reflective Total Ocular Symptom Scores (rTOSS), Rhinitis Control Scoring System (RCSS), and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)). In addition, onset of relief, use of rescue medication, and adverse events will be monitored for up to 2 days after the grass allergen challenge. Peak nasal inspiratory flow (PNIF) and pathology markers (cytokines, histamine, tryptase, and allergen-specific IgE) will also be measured. All outcomes will be analysed as the change from baseline and between-group comparisons will be assessed using appropriate models. DISCUSSION: The study hypothesis is that M-Gard® supplementation will be more effective than placebo in reducing AR symptoms. This research will strengthen the evidence base supporting the use of M-Gard® as a supplement for the management of AR. TRIAL REGISTRATION: ClinicalTrials.gov NCT06907680. Registered on March 27, 2025.
Cognitive behavioral therapy for insomnia vs. standard cognitive behavioral therapy for sleep and circadian disturbances in treatment-resistant schizophrenia: study protocol for the randomized controlled trial (COSTS).
Johansen JF, Nielsen MØ, Kragh M … +1 more , Nielsen J
Trials · 2026 Apr · PMID 41998739 · Full text
BACKGROUND: A subset of patients with schizophrenia do not respond sufficiently to conventional antipsychotic treatment and often have a more complex clinical course, including high rates of sleep disturbances, which can...
BACKGROUND: A subset of patients with schizophrenia do not respond sufficiently to conventional antipsychotic treatment and often have a more complex clinical course, including high rates of sleep disturbances, which can contribute to further worsening of symptoms. However, sleep disturbances are often overlooked in clinical psychiatric settings, and non-pharmacological treatment options are not initiated. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to effectively ameliorate sleep disturbances in schizophrenia but is yet to be assessed in treatment-resistant schizophrenia. In the present study, we aim to investigate the efficacy of CBT-I versus standard cognitive behavioral therapy (CBT), an active control intervention. METHODS: Sixty patients diagnosed with treatment-resistant schizophrenia and comorbid sleep disturbance will be included in this randomized intervention study. Included patients will be randomized to 8-10 sessions of psychotherapy with either CBT-I (active intervention) or regular CBT (active control) following baseline. At baseline and 12-week follow-up, patients will be assessed with clinical interviews (Positive and Negative Syndrome Scale), self-reported measures (e.g., Insomnia Severity Index), and polysomnography. The 24-week follow-up will include the same assessments apart from polysomnography. The active intervention group will receive an individual course of treatment with CBT-I focused on the patients' sleep patterns, while the active control group will receive an individual course of treatment with standard cognitive behavioral therapy (CBT) focused on patients' psychopathology. It is hypothesized that while both groups will show improvements on central outcome measures, CBT-I will show greater improvements in sleep disturbances. Further, it is hypothesized that the improvement in sleep disturbances will correlate with an improvement in positive symptoms. Lastly, it is anticipated that the CBT-I group will show objective improvements in sleep architecture, such as sleep latency, wake after sleep onset, sleep efficiency, and total sleep time, compared to the CBT group. DISCUSSION: Should CBT-I prove efficacious in improving sleep disturbances in treatment-resistant schizophrenia, it would provide an avenue for a cost-beneficial, short-term, and implementable non-pharmacological treatment of a severe comorbidity in complex schizophrenia patients. Potential issues pertaining to the completion of the study are discussed. TRIAL REGISTRATION: ClinicalTrials.gov NCT06749444. Registered on December 27, 2024.
Efficacy of distress tolerance techniques of dialectical behavior therapy in persons with obsessive-compulsive disorder: a study protocol for a randomized controlled trial.
Kumar M, Singh V, Kumar R … +6 more , Rozatkar AR, Soni AK, Kumar S, Khusboo, Singh VK, Chatterjee R
Trials · 2026 Apr · PMID 41998696 · Full text
BACKGROUND: Obsessive-compulsive disorder (OCD) is a chronic and debilitating mental health condition that significantly impairs the quality of life. Although cognitive-behavioral therapy (CBT), particularly exposure and...
BACKGROUND: Obsessive-compulsive disorder (OCD) is a chronic and debilitating mental health condition that significantly impairs the quality of life. Although cognitive-behavioral therapy (CBT), particularly exposure and response prevention (ERP), is considered the gold standard, many patients remain symptomatic or find these approaches challenging due to emotional and cognitive barriers. Distress tolerance techniques (DTT), a component of dialectical behavior therapy (DBT), have demonstrated efficacy in various conditions, including substance dependence, binge eating, and depression, by managing negative emotional states and enhancing coping mechanisms beyond their original focus on borderline personality disorder. However, the application of DTT in the treatment of patients with OCD has not been extensively explored. This study aims to evaluate the efficacy of DTT in reducing OCD severity and improving psychological outcomes. METHODS: This prospective, single-center, open-label randomized controlled trial will recruit 80 adults (18-40 years) diagnosed with OCD (ICD-10 criteria, Y-BOCS score ≥ 16) from the Department of Psychiatry, All India Institute of Medical Sciences, Bhopal. Participants will be randomized 1:1 using a random number table to either the intervention or active control group. Participants in the intervention group will engage in a 12-week structured DTT program specifically tailored for obsessive-compulsive disorder (OCD), whereas those in the active control group will undergo standard treatment of exposure and response prevention (ERP). The primary outcome will be OCD severity, measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Secondary outcomes included distress tolerance (measured using the Distress Tolerance Scale), depressive symptoms (measured using the Beck Depression Inventory), coping strategies (measured using the Dialectical Behavior Therapy-Ways of Coping Checklist), mindfulness (measured using the Kentucky Inventory of Mindfulness Skills), and acceptance (measured using the Acceptance and Action Questionnaire-II). Outcomes for the treatment groups will be evaluated before randomization (baseline, T1) and 12 weeks (end of treatment, T2). The protocol was approved by the Institute Ethical Committee (approval number) and was performed in strict adherence to the Declaration of Helsinki formulated by the World Medical Association. DISCUSSION: This trial will explore the efficacy of distress tolerance techniques in patients with OCD. This study will provide evidence for a therapeutic approach that addresses the limitations of traditional CBT and improves outcomes for patients with OCD. TRIAL REGISTRATION: Central Trial Register of India CTRI/2024/09/073672. Registered on 21 December 2024.
Effectiveness of shoulder symptom modification approaches in managing patients with frozen shoulder: study protocol for a randomized sham-controlled trial.
Seemab A, Arulsingh W, Muthukrishnan R … +2 more , Kandakurti PK, Saiyad R
Trials · 2026 Apr · PMID 41992361 · Full text
BACKGROUND: Symptom modification approaches in musculoskeletal physiotherapy practice reduce pain and enhance movement. In our study two symptom modification approaches, shoulder symptom modification procedure (SSMP) and...
BACKGROUND: Symptom modification approaches in musculoskeletal physiotherapy practice reduce pain and enhance movement. In our study two symptom modification approaches, shoulder symptom modification procedure (SSMP) and mobilization with movement (MWM) along with sham mobilization are compared. This study aimed to compare the effectiveness of the above approaches in managing pain and shoulder disability and improving shoulder movement in patients with frozen shoulder. METHODS: A total of 36 patients with frozen shoulder, will be randomly allocated for 8 weeks into three groups: (a) the SSMP group (n = 12) (b) the mobilization with movement (MWM) group(n = 12) and (c) sham mobilization group (n = 12). Patients with frozen shoulder aged 40-65 and meeting the inclusion criteria will be eligible. Each group will receive 3 sessions in a week for 8 weeks along with different exercises including isometric, eccentric and concentric followed by the functional program. Measurements will occur at four time points: before the initiation of treatment sessions (week 0), followed by 12 treatment sessions (week 4), then 18 treatment sessions (week 6) and two months from the beginning of the trial (week 8). The primary outcome was functional disability (SPADI). Secondary outcomes included pain intensity (NPRS), active shoulder range of motion (ROM), and the Patient Global Impression of Change (PGIC). DISCUSSION: This pilot study is the first to examine the effectiveness of symptom-modification approaches in patients with frozen shoulder. The study aims to provide preliminary data on feasibility, safety, and early clinical outcomes, as well as to document challenges encountered during implementation. Findings from this investigation will inform the design, methodology, and sample size estimation for a future large-scale randomized controlled trial assessing the efficacy of symptom-modification interventions in this population. TRIAL REGISTRATION: Clinical Trials.gov NCT06763601. Registered on 12/11/2024. URL of trial registry record: https://register. CLINICALTRIALS: gov/prs/beta/studies/S000F7NU00000067/recordSummary .
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