Conectar
Harms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment.
We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people.
This protocol was first approved by the St Vincent’s Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable.
ACTRN12624001061527.
Childhood cancer survivors (CCSs) experience educational disruptions during and following treatment, yet robust, longitudinal evidence on educational performance remains limited. We will investigate differences in educational outcomes between CCSs and non-cancer peers during primary and secondary school. We will also explore how sociodemographic factors and age at diagnosis contribute to potential differences in General Certificate of Secondary Education (GCSE) examinations, a critical indicator of future academic and employment prospects.
We will use the Education and Child Health Insights from Linked Data (ECHILD) to capture linked health and education data for children born in National Health Service (NHS)-funded hospitals in England. We will generate birth cohorts spanning September 1997 to August 2015 (estimated sample size: ~10 million), formed of pupils expected to have undertaken national curriculum assessments between academic years 2004/2005 and 2021/2022 including Key Stage (KS) 1, 2 and 4, corresponding to ages 7, 11 and 16 respectively. Cancer diagnosis will be identified from inpatient hospital records, using International Classification of Diseases, 10th Revision codes (ICD-10). We will investigate differences between CCS and their non-cancer peers in terms of their sociodemographic characteristics and describe trends in educational performances at all KSs, recorded Special Educational Needs and Disabilities (SEND) and school absences. Differences in KS4 (GCSE) performances between CCS and non-cancer peers will be quantified, according to and accounting for geographic region, sex, deprivation, ethnicity and birth characteristics. To assess whether cancer diagnosis disrupts academic trajectories, we will restrict analysis to those with KS2 attainment data and investigate KS4 performance. We will finally explore the influence of age at diagnosis on educational performance at KS4.
Ethics approval was granted by NHS Health Research Authority Research Ethics Committee (20/EE/0180). Findings will be shared with academics, policymakers, children and families affected by childhood cancer, and published in journals. Code/metadata will be shared on ECHILD GitHub repository.
To explore how parents of children with de novo retinoblastoma (RB) experience the diagnostic process and acute treatment phase, and to identify factors that may support parental coping and adaptation.
A qualitative interview study using reflexive thematic analysis.
National Retinoblastoma Unit at Aarhus University Hospital, Denmark.
Thirty-one parents (21 mothers, 10 fathers) of 21 children diagnosed with de novo RB were recruited via hospital follow-up clinics and a support group day.
For most parents, the diagnostic process was short. In cases of diagnostic delay, parents described frustration and guilt due to missed symptoms. Receiving the RB diagnosis was described as a surreal experience, accompanied by feelings of shock, grief and loss of control. Parents faced challenges in adapting to rapid medical decisions and the unfamiliar demands of hospital protocols. However, meeting the clinical experts was a relief, as parents felt they were in capable hands, experiencing empathetic communication and a clearly framed treatment plan. Parents emphasised the importance of support systems, including family, healthcare professionals and the child’s resilience, as crucial for coping with and managing the diagnosis.
Parents faced a sudden and disruptive transition from symptom recognition to life-altering diagnosis and treatment. While professional care and communication were experienced as supportive, they did not eliminate the emotional impact. Clinical pathways should prioritise early validation of parental concerns and provide transparent communication, both prior to referral and throughout treatment. Future research should examine longer-term parental adjustment and identify interventions that support emotional resilience beyond the acute phase.
In Tanzania, acute myocardial infarction (AMI) is underdiagnosed, and uptake of evidence-based care is suboptimal. Using an implementation science approach, an intervention was developed to address local barriers to care: the Multicomponent Intervention for Improving Myocardial Infarction Care in Tanzania (MIMIC).
This sequential cohort design trial was conducted in a single northern Tanzanian emergency department (ED). During the preintervention phase (February–August 2023) and the postintervention phase (September 2023–August 2024), adults presenting with chest pain and/or dyspnoea were prospectively enrolled and their ED care was observed. AMI was defined by the Fourth Universal Definition criteria. Telephone follow-ups were conducted to ascertain 30-day mortality. Pearson’s ² was used to compare care before and after MIMIC implementation.
A total of 275 participants were enrolled in the preintervention phase and 577 were enrolled in the postintervention phase. Following MIMIC implementation, significant increases were observed in ECG testing (89.4% of postintervention participants vs 55.3% preintervention, OR 6.82, 95% CI 4.79 to 9.79, p
The MIMIC intervention was associated with large increases in uptake of AMI testing, case identification and evidence-based treatment in a single Tanzanian ED. Multisite studies are needed to evaluate the effect of MIMIC on AMI care in diverse settings across Tanzania.
Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.
A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p
The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.
Children with medical complexity (CMC) are a subset of children with special healthcare needs, defined by high healthcare utilisation, severe single or multisystem organ dysfunction, and in many cases, reliance on medical technology. In the emergency care setting, known challenges for this population include poor quality of care, avoidable admissions and high caregiver and provider burden. While experts and professional societies recommend emergency care planning tools to address these concerns, evidence to support effectiveness and implementation of such tools is lacking. Through a human-centred design approach, we recently engaged key partners to create and optimise an emergency care action plan (ECAP) for infants with medical complexity. Here, we describe the protocol for a pilot type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) for infants with medical complexity aimed to evaluate ECAP effectiveness and implementation.
Infants with medical complexity and their caregivers will be randomly assigned to the intervention group (ECAP) or control group (standard care) in a pilot type 1 hybrid effectiveness-implementation RCT. The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency department (ED) visits, healthcare costs, caregiver stress and self-efficacy. Preliminary implementation outcomes include acceptability, feasibility, appropriateness and usability, as well as contextual barriers and facilitators to reach, adoption and implementation. Key partners, including caregivers of CMC and healthcare providers, will be engaged throughout the implementation of the ECAP and execution of the trial.
This study was approved by the University of Vermont Institutional Review Board (STUDY00002937). Findings will be disseminated through peer-reviewed publications, conference presentations, and focus groups and interviews with key stakeholders.
Fractures over venous sinuses (FOVSs) are associated with difficulties in diagnosis and treatment resulting in a high level of morbidity and mortality. Despite its importance, there are limited aggregate data to guide the management of these fractures ultimately inflicting a major callenge to neurosurgeons. This protocol describes the methodology of a scoping review that aims to synthesise contemporary evidence on the management and outcomes of FOVSs.
The proposed study will be conducted in accordance with the Arksey and O’Malley’s framework for scoping reviews. The research question, eligibility criteria and search strategy were developed based on the population, intervention, comparator and outcome strategy. The following electronic bibliographic databases will be searched without restrictions on language and date of publication: PubMed, WHO Global Index Medicus, African Journals Online, SCOPUS, Embase, Cochrane and ProQuest Central. All peer-reviewed studies of primary data reporting on the management and outcomes of FOVSs will be included. The data extracted from included articles will be presented through descriptive statistics, pooled statistics and a narrative description.
Because this study did not directly involve human individuals, ethical approval was not necessary. Dissemination strategies will include publication in a peer-reviewed journal, oral and poster presentations at local, regional, national and international conferences and promotion over social media.
Current treatments for alcohol use disorders (AUD) have limited efficacy. A previous 28-day pilot trial of N-acetyl cysteine (NAC) vs placebo found NAC to be feasible and safe, with evidence of improvement on some measures of alcohol consumption. Thus, the primary aim of the NAC-AUD study is to examine the therapeutic and cost-effectiveness of NAC vs placebo in improving treatment outcomes for AUD. We will also examine the (i) effect of NAC vs placebo on mood, markers of liver injury, cognition and hangover symptoms; and (ii) predictors of any response.
This double-blind trial will randomise participants with AUD to a 12-week regimen of either NAC (2400 mg/day) or placebo. All participants will receive medical management. The primary drinking outcome will be the number of heavy drinking days (HDDs) per week, validated by phosphatidylethanol (PEth). Secondary alcohol-related outcomes will include standard drinks per drinking day (SDDD) per week and absence of any HDDs. Other secondary outcomes will include markers of liver injury, depression, anxiety, craving, hangover symptoms, cognition and blood oxidative stress markers. We will also examine the cost-efficacy of NAC vs placebo.
Ethics approval for the study has been granted by The Sydney Local Health District Ethics Review Committee (X21-0342& HREC2021/ETH11614). There are no restrictions on publication from the sponsor or other parties.
The study was conducted to assess the diagnostic performance of the Hightop Syphilis Rapid Diagnostic Test (RDT) in comparison with the ELISA test used as a reference method.
A laboratory-based cross-sectional and comparative study was conducted to assess the diagnostic performance of the Hightop Syphilis RDT.
Blood samples obtained from adult participants in eight health facilities were analysed at the National Public Health Laboratory (NPHL), Ministry of Public Health, Yaounde, Cameroon.
From 29 April to 25 August 2023, 583 adult participants of both sexes (aged ≥21 years), including both syphilis positive and syphilis negative, were recruited consecutively in eight health facilities in eight regions of Cameroon.
Blood samples were screened for the detection of anti-Treponema pallidum antibodies using the One Step Rapid Test (Qingdao Hightop Biotech), a non-treponemal test and ELISA (Biorex Diagnostics, UK), a treponemal test used as a reference method. Diagnostic performance of the Syphilis RDT was analysed using Epi Info V.7 and validated through online statistical tools such as StatPages, GraphPad, QuickCalcs and MedCalc software.
Of the 583 samples tested, the Hightop Syphilis RDT revealed a sensitivity of 84.6% (95% CI: 74.8% to 91.1%) and specificity of 98.5% (95% CI: 97.5% to 99.1%). The positive predictive value (PPV) and negative predictive value (NPV) were 84.6% (95% CI: 74.8% to 91.1%) and 98.5% (95% CI: 97.5% to 99.1%), respectively. Regarding the stratification of diagnostic performance by clinical stage, the test showed a sensitivity of 100.0% (95% CI: 71.51% to 100.0%) and specificity of 99.06% (95% CI: 94.86% to 99.98%). The PPV and NPV were 91.67% (95% CI: 61.00% to 98.72%) and 100.0% (95% CI: 96.55% to 100.0%), respectively, in symptomatic individuals. Among asymptomatic individuals, sensitivity was 97.56% (95% CI: 87.14% to 99.94%) and specificity was 100.0% (95% CI: 99.14% to 100.0%). The PPV and NPV were 100.0% (95% CI: 91.19% to 100.0%) and 99.77% (95% CI: 98.40% to 99.97%), respectively.
The Hightop Syphilis RDT demonstrated adequate diagnostic performance, particularly among symptomatic individuals, supporting its utility as a reliable tool for syphilis detection in clinical settings.
Ischaemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively affects patient and graft outcomes. Anaesthetic conditioning (AC) refers to the use of anaesthetic agents to mitigate IRI. AC is particularly associated with volatile anaesthetic (VA) agents and to a lesser extent to intravenous agents like propofol. VA like sevoflurane interferes with many of the processes underlying IRI and exerts renal protective properties in various models of injury and inflammation. We hypothesise that a sevoflurane-based anaesthesia is able to induce AC and thereby reduce post-transplant renal injury, reflected in improved graft and patient outcome, compared with a propofol-based anaesthesia in transplant recipients of a deceased donor kidney.
Investigator-initiated, multicentre, randomised, controlled and prospective clinical trial with two parallel groups. The study will include 488 kidney transplant recipients from donation after brain death (DBD) or donation after circulatory death (DCD) donors. Participants are randomised in a 1:1 design to a sevoflurane (intervention) or propofol (control) group. The primary endpoint is the incidence of delayed graft function in recipients of DCD and DBD donor kidneys and/or 1-year biopsy-proven and treated acute rejection. Secondary endpoints include functional delayed graft function defined as failure of serum creatinine levels to decrease by at least 10% per day for three consecutive days; primary non-function is defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kinds, estimated glomerular filtration rate at 1 week and 3 and 12 months calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; readmissions at 3 and 12 months, graft survival and all-cause mortality at 12 months.
The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2025.
The prevalence of cardiovascular diseases (CVDs) is rapidly increasing across Asia, with the burden particularly high among individuals aged ≥50 years. Elevated low-density lipoprotein cholesterol (LDL-C) level is a well-established causal risk factor for CVDs. Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) diet is a cardioprotective diet, which is rich in plant-based foods. Combining it with stress-reducing practices, including forest bathing (FB), which involves immersive exposure to forest environments, has been shown to reduce LDL-C levels and other cardiovascular risk factors by modulating pro-inflammatory responses. However, existing evidence is limited due to small sample sizes and poor study design. Therefore, this study aims to investigate whether the MIND diet combined with FB can reduce CVD risks among Chinese adults in Hong Kong. It also compares the effects of the MIND diet combined with FB on cardiovascular and mental health.
A single-blind, randomised controlled trial involving three groups will be used to assess the impact of the MIND diet combined with FB on LDL-C levels in adults aged 50–75 years with elevated LDL-C levels. Participants (n=273) from local community centres will be randomly assigned to the MIND-plus-FB (who will receive nutrition education, follow the MIND diet for 12 weeks and participate in regular FB sessions), MIND-alone (who will receive nutrition education and follow the MIND diet for 12 weeks) or routine care (who will continue their usual activities and receive a general health talk along with pamphlets on cardiovascular risks) group. The change in LDL-C levels will be measured at weeks 4 and 12 (primary outcome). Additionally, changes in high-density lipoprotein cholesterol level, triglyceride level, glucose level, systolic blood pressure, waist circumference, body mass index, anxiety levels and emotional state will also be assessed at weeks 4 and 12. Statistical analyses will include intent-to-treat, 2 test, analysis of variance and generalised estimating equations.
This study has been approved by the Research Ethics Committee of Tung Wah College, Hong Kong (reference number: REC2023164). Research findings will be disseminated through publication in peer-reviewed journals and presentations at academic and primary healthcare conferences.
ClinicalTrials.gov ID: NCT06222632, registered on 25 January 2024. The ClinicalTrials.gov data are available at:
Recent studies have demonstrated a beneficial role of steroids in severe community-acquired pneumonia, severe COVID-19 infection and acute respiratory distress syndrome (ARDS) of diverse aetiology. This multicentre randomised controlled trial in severe scrub typhus pneumonitis and ARDS will compare the effects of 6 mg of dexamethasone once per day with placebo, in addition to standard treatment, on ventilator-free days (VFD), mortality and ventilatory requirement.
The study, involving six sites, will recruit 440 patients with severe scrub typhus pneumonitis or ARDS to concealed, block-randomised, site-specific assignment of dexamethasone or placebo for 4–7 days. The primary outcome will be VFD, defined as days alive and free of ventilation at 28 days. Secondary outcomes will include 28-day mortality, need and duration of ventilation, and treatment failure, defined as death, or escalation of respiratory support from simple devices (nasal cannula, mask) to non-invasive or invasive ventilation, or the use of open-labelled steroids for worsening shock. The study will also ascertain if antinuclear antibody (ANA) expression during the acute phase of illness will predict steroid responsiveness. Subgroup analyses will be conducted a priori on ANA expression and the need for ventilation. All analyses will be conducted on an intention-to-treat basis. The trial, which commenced in April 2025, would clarify the role of corticosteroids in scrub typhus pneumonitis.
The Institutional Review Board and Ethics Committee of the lead site, Christian Medical College, Vellore, India, has approved the study (IRB Min No 15920 (INTERVE) dated 22 November 2023). The remaining five sites have obtained approval from their respective ethics committees. Study results will be published in an international peer-reviewed journal.
CTRI/2024/12/077709. Registered 5 December 2024.
FreshRSS 