Trials最新文献

Background: Postoperative nausea and vomiting (PONV) is the most common complication following general anesthesia. Currently, pharmaceutical therapy is the primary method of treatment, but it has reached a plateau, and it is accompanied by inherent adverse reactions and high costs. Stimulation of the wrist acupuncture point PC6 is recommended as an effective means of preventing PONV. Our previous study suggests that the wearable transcutaneous electrical acupoint stimulation (TEAS) bracelet can prevent PONV, but its effectiveness in treating moderate-to-severe PONV that has already occurred remains unknown. This trial aims to include female patients who have suffered from PONV after general anesthesia in real-world settings to investigate the therapeutic effect of the TEAS bracelet.

Methods: This trial will be conducted in Shanghai and Tianjin, China, with a total of 232 participants recruited from four academic hospitals. Participants will be randomly allocated into the TEAS group or the control group in a 1:1 ratio. Participants in the TEAS group will wear an EmeTerm bracelet and be injected with normal saline, while participants in the control group will wear a model bracelet and be injected with 10 mg of metoclopramide. Follow-up will be conducted 2 h later, and participants who do not experience relief will be randomly allocated into two groups and given cross-intervention. The primary outcome of the trial is the response rate of moderate-to-severe PONV after 2 h of intervention. Secondary outcomes include the recurrence rate of moderate-to-severe PONV within 24 h after intervention and the response rate of moderate-to-severe PONV at 2 h after cross-intervention in a population insensitive to the initial intervention.

Discussion: This multi-center randomized controlled trial aims to reveal the therapeutic effect of the wearable TEAS bracelet on PONV. It is expected that this bracelet will become an effective supplement for the clinical treatment of PONV, reducing medical expenditure and improving anesthesia quality and patient satisfaction.

Trial registration: Chinese Clinical Trial Registry ChiCTR2400084329. Registered on May 14, 2024.

Background: Paranoia, the belief that you are at risk of significant physical or emotional harm from others, is a common difficulty, which causes significant distress and impairment to daily functioning, including in psychosis-spectrum disorders. According to cognitive models of psychosis, paranoia may be partly maintained by cognitive processes, including interpretation biases. Cognitive bias modification for paranoia (CBM-pa) is an intervention targeting the bias towards interpreting ambiguous social scenarios in a way that is personally threatening. This study aims to test the efficacy and safety of a mobile app version of CBM-pa, called STOP (successful treatment of paranoia).

Methods: The STOP study is a double-blind, superiority, three-arm randomised controlled trial (RCT). People are eligible for the trial if they experience persistent, distressing paranoia, as assessed by the Positive and Negative Syndrome Scales, and show evidence of an interpretation bias towards threat on standardised assessments. Participants are randomised to either STOP (two groups: 6- or 12-session dose) or text-reading control (12 sessions). Treatment as usual will continue for all participants. Sessions are completed weekly and last around 40 min. STOP is completely self-administered with no therapist assistance. STOP involves reading ambiguous social scenarios, all of which could be interpreted in a paranoid way. In each scenario, participants are prompted to consider more helpful alternatives by completing a word and answering a question. Participants are assessed at baseline, after each session, and at 6, 12, 18 and 24 weeks post-randomisation. The primary outcome is the self-reported severity of paranoid symptoms at 24 weeks, measured using the Paranoia Scale. The target sample size is 273 which is powered to detect a 15% symptom reduction on the primary outcome. The secondary outcomes are standardized measures of depression, anxiety and recovery and measures of interpretation bias. Safety is a primary outcome and measured by the Negative Effects Questionnaire and a checklist of adverse events completed fortnightly with researchers. The trial is conducted with the help of a Lived Experience Advisory Panel.

Discussion: This study will assess STOP's efficacy and safety. STOP has the potential to be an accessible intervention to complement other treatments for any conditions that involve significant paranoia.

Trial registration: ISRCTN registry, ISRCTN17754650. Registered on 03/08/2021.  https://doi.org/10.1186/ISRCTN17754650 .

Background: Hemorrhoidal disease (HD) is associated with substantial economic burden and negative effects on health-related quality of life (HRQoL). The aCute HaemORrhoids treatment with MESoglycan (CHORMES) study aims to evaluate the effects of orally administered mesoglycan, a natural preparation of glycosaminoglycans with antithrombotic and profibrinolytic properties, as an acute treatment in patients with HD.

Methods: CHORMES is a phase 2, double-blind, randomized controlled trial being conducted at two centers in Italy. Adults aged 18-75 years with Grade I-III HD according to Goligher classification or external thrombosed hemorrhoids, and a Hemorrhoidal Disease Symptom Score (HDSS) of ≥ 5, will be randomly allocated in a 1:1 ratio to mesoglycan or placebo and will be treated for 40 days (two capsules for the first 5 days and one capsule for the subsequent 35 days twice daily [after breakfast and dinner], equivalent to 200 mg in the first 5 days and 100 mg subsequently). Concomitant use of analgesics is permitted in both treatment groups. The trial aims to enroll 50 patients, with 25 patients in each treatment group. The primary objective of the trial is to evaluate the efficacy of mesoglycan in reducing symptoms of HD, assessed via change in HDSS from baseline (day 0) to day 40 in the intention-to-treat population. Secondary objectives include changes in HRQoL from baseline to day 40 using the Short Health Scale for Hemorrhoidal Disease, safety (adverse effects, physical assessments, vital signs and laboratory parameters in the safety population), fecal continence assessed using the Vaizey score, bleeding assessed using the Bleeding score, the amount and type of analgesic taken, and pain. Patient enrolment began on 11 December 2023, and trial completion is expected by December 2024.

Discussion: The CHORMES trial will evaluate the efficacy and safety of mesoglycan, in addition to its impact on HRQoL, analgesic use and pain, in patients with HD. The results of the trial will assist clinicians in determining the most effective treatment for patients with HD.

Trial registration: ClinicalTrials.gov NCT06101992. Prospectively registered on 26 October 2023 at https://clinicaltrials.gov/ct2/show/NCT06101992 .

Background: Clinical trial success hinges on efficient participant recruitment and retention. However, slow accrual and attrition frequently hinder progress. To address these challenges, a novel dashboard tool with control charts has been developed to provide investigators on the multi-site study of Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE study) with timely information to improve trial recruitment.

Methods: A quality monitoring Excel dashboard with control chart functionality developed by the principal investigator's (PI) group and implemented in a department of a large hospital was re-engineered for research study recruitment purposes. The dashboard provides the PIs and other stakeholders with timely, actionable, and unbiased information on the count of participants who have completed each stage or action within the process, the rates of completion and trends, both for the current week and cumulatively.

Results: The DANE dashboard was prototyped using Microsoft Excel for accessibility and rapid development. The tool integrates with a REDCap database, simplifying data import and analysis. By facilitating informed decision-making throughout the recruitment process, the DANE dashboard has significantly enhanced clinical trial efficiency and led to changes in the eligibility criteria and improvements in the approach and consent processes.

Conclusions: The DANE dashboard for monitoring participant recruitment and attrition in research studies represents a significant step towards enhancing study management and decision-making processes. It can be adapted to other clinical studies and other staged processes with attrition. The generic version, currently under development, holds promise for evolving into a valuable simulator by incorporating a spreadsheet for generating random data and accounting for resource constraints. This enhancement could further be augmented by integrating forecasting capabilities into the control charts.

Trial registration: The Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE) study (NCT05373017, 1R01AG076489-01) is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate the efficacy of the Emergency General Surgery (EGS) Delirium Recovery Model to improve the cognitive, physical, and psychological recovery of EGS delirium survivors over 65. The DANE study received approval from the University of Wisconsin-Madison/University of Wisconsin Hospitals and Clinics Institutional Review Board (IRB, no. 2022-0545, approval date September 14, 2022), and Indiana University agreed to cede IRB review to University of Wisconsin-Madison/University of Wisconsin Hospital and Clinics (September 29, 2022).

Background: Opisthorchis viverrini (OV) and soil-transmitted helminths (STH) are two of the most common helminths contributing to the Neglected Tropical Disease (NTDs) burden in the Lower Mekong Basin. Although mass drug administration is the cornerstone of control programs to reduce morbidity caused by these infections, this approach has limitations in preventing re-infections. Elimination requires additional measures such as reservoir host treatment, improved hygiene and health education to reinforce MDA's impact. This study aims to examine the impact of a scalable multi-component One Health Helminth Elimination program in the Lower Mekong Basin (HELM) that combines human praziquantel (PZQ) and albendazole (ALB) treatment with a program that includes the "Magic Glasses" and the "Lawa Model" interventions with health promotion at their core.

Methods: This study will employ a cluster randomized controlled trial (cRCT) in 18 rural communities (with sub-district or villages as cluster units) across Cambodia, Laos and Thailand. The control arm will receive one round of PZQ/ALB treatment, while in the intervention arm, multi-component HELM program will be implemented, which includes PZQ/ALB treatment together with the Magic Glasses and Lawa Model interventions. OV and STH infections levels will be evaluated in individuals aged 5-75 years at baseline and will be repeated at follow-up (12 months after the HELM intervention), using modified formalin ethyl-acetate concentration technique and quantitative PCR. The primary outcome of the study will be cumulative incidence of human OV and STH infections. Outcomes between the study arms will be compared using generalized linear mixed models, accounting for clustering.

Discussion: Evidence from this trial will quantify the impact of a multi-component One Health control strategy in interrupting Ov and STH infections in the Lower Mekong Basin.

Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000353796. Prospectively registered 28 February 2022.

Background: Hepatic encephalopathy (HE) represents a critical complications of end-stage liver disease, serving as an independent predictor of mortality among patients with cirrhosis. Despite effective treatment with rifaximin, some patients with HE still progress to recurrent episodes, posing a significant therapeutic challenge. Recurrent HE is defined as experiencing two or more episodes within a 6-month period. Previous research has suggested that FMT may emerge as a promising treatment for recurrent HE. However, there remains a critical need to explore the optimal dosage. This trial aims to abscess the efficacy and safety of two FMT dosages: 800 ml or 400 ml total bacterial count, including mortality and quality of life.

Methods: This multicenter, prospective, randomized controlled trial will enroll 100 eligible patients from 31 hospitals in China. Participants will be randomly assigned in a 1:1 ratio to either the high-dose group (800 ml total bacterial count) or the low-dose group (400 ml total bacterial count). The primary objective is to assess the efficacy and safety of both dosages on outcomes at 24 and 48 weeks, including mortality and quality of life.

Discussion: If either or both dosages of FMT demonstrate safe and effective treatment of recurrent HE, leading to improve quality of life and survival at 24 and 48 weeks, this trial would address a significant gap in the management of recurrent HE, carrying innovative and clinically significant implications.

Trial registration: NCT05669651 on ClinicalTrials.gov. Registered on 29 December 2022. CHiCTR2200067135 on China Registered Clinical Trial Registration Center. Registered on 27 December 2022.

Background: Cancer navigation programs aim to support, educate, and empower patients and families, addressing barriers to diagnostics, treatment, and care. Navigators engage with people to ensure timely access to services and resources. While promising for older people with cancer, these programs are scarce in Europe, and research on their effectiveness and implementation is limited. We describe the protocol of the EU NAVIGATE randomized controlled trial, aimed to evaluate (1) effectiveness and cost-effectiveness of NavCare-EU, an intervention that aims to support older people with cancer throughout their illness trajectory, spanning the continuum of supportive, palliative, and end-of-life care, and (2) the intervention's implementation processes and feasibility of its integration into different health care systems in Europe, contextual barriers and facilitators for effective and sustainable implementation, and mechanisms involved in reaching the outcomes.

Methods: We will conduct a multisite pragmatic fast-track randomized controlled trial with embedded convergent mixed-method process evaluation in Belgium, Ireland, Italy, Netherlands, Poland, and Portugal. The study targets people with cancer and declining health, 70 years or older, and their close family caregivers. The trial compares the NavCare-EU intervention plus standard care with standard care alone. We will perform a baseline measurement prior to randomization and follow-up measurements at 12 weeks, 24 weeks, and 48 weeks in intervention and control group, and an additional measurement at 72 weeks in the control group. Primary outcomes, measured at 24 weeks are (1) the older person's global health status/quality of life, a 2-item subscale from EORTC-QLQ-C30 (revised) measuring health-related quality of life, (2) level of social support measured with Medical Outcomes Study Social Support Survey (MOS-SSS scale). The study will include at least 246 older persons with completed global health status/quality of life at 24 weeks.

Discussion: The EU NAVIGATE trial will cross-nationally test the effectiveness and cost-effectiveness of a navigation intervention for older people with cancer and their family caregivers, and its implementation in different health care systems in Europe. As continuity and access to health, social, and community care is a priority for patients and caregivers, the trial is timely and critically needed.

Trial registration: Clinicaltrials.gov: identifier NCT06110312 (2023/10/31).

Background: Osteoarthritis in the thumb base (trapeziometacarpal joint, CMC-1 joint) is prevalent, particularly among middle-aged and elderly women, causing significant disability. Conservative treatments, including steroid injections, have been questioned for their efficacy, prompting exploration into alternative therapies such as platelet-rich plasma (PRP) injections. This randomized, double-blinded, controlled trial aims to evaluate the effectiveness of high-concentration PRP (platelet-rich plasma) injection compared to saline (placebo) in reducing pain and disability in patients with thumb base osteoarthritis.

Methods: Patients meeting inclusion criteria will be randomized and blinded, with injections administered under sterile conditions and radiological guidance. With a planned sample size of 90 patients recruited from the Department of Hand Surgery at Södersjukhuset, Stockholm, the study will assess pain relief and functional improvement at 3, 6, and 12 months post-injection. The primary outcome measure is pain on load (numerical rating scale) at 6 months, with secondary outcomes including patient-reported outcomes, key pinch, grip strength, abduction of the thumb, and time to intervention within 1 year. Statistical analyses will employ non-parametric tests, chi-square tests, and generalized estimating equations to compare outcomes between the PRP and placebo groups.

Discussion: The study aims to provide evidence regarding the efficacy of high-concentration PRP injections for thumb base osteoarthritis. If PRP proves superior to saline in reducing pain and improving function, it could offer a promising alternative treatment. Conversely, if PRP does not demonstrate significant benefits over placebo, its use for this condition is not justified. This study seeks to address the current gap in evidence regarding the efficacy of PRP injections for thumb base osteoarthritis.

Trial registration: The study has been approved by the Swedish Ethical Review Authority (2023-06860-01 and 2024-01238-02) and is registered on ClinicalTrials.gov (NCT06193499) 2024-01-04.