Trichomonas vaginalis is estimated to be the most common non-viral sexually transmitted infection (STI) worldwide with 156 million new cases each year. In 2021, the United States Centres for Disease Control and Prevention (CDC) updated their STI Treatment Guidelines to recommend multi-dose oral metronidazole (MTZ) for all T. vaginalis-infected women. Although multi-dose oral MTZ 500 mg twice daily was found to be superior to single-dose 2 g oral MTZ in multiple trials in women, multi-dose oral MTZ still had unacceptably high rates of breakthrough infection (9%–11%) at test-of-cure. With approximately 156 million cases of T. vaginalis worldwide per year, over 17 million persons per year are estimated to be insufficiently treated with multi-dose oral MTZ. Moreover, past trials only included women, and single-dose 2 g oral MTZ remains the recommended treatment for men. Thus, there is a critical need to further refine T. vaginalis treatment in women and men. A single dose of 2 g of oral secnidazole (SEC), a next generation 5-nitroimidazole with a longer half-life than oral MTZ and improved tolerability, may be a good option. This study will examine the effectiveness of multi-dose oral MTZ versus single-dose oral SEC in both men and women infected with T. vaginalis.

This is a multi-centred open-label effectiveness trial comparing oral multi-dose MTZ (500 mg twice daily for 7 days) to 2 g of single-dose oral SEC. This trial aims to enrol 1200 T. vaginalis-infected women and men aged 18 years and older at four clinical sites: the University of Alabama at Birmingham (UAB) Sexual Health Clinic and the UAB Gynaecology Clinics in Birmingham, AL, LSU-CrescentCare Sexual Health Centre (LSUHSC-NO) in New Orleans, LA, and HealthCare Clinical Data, Inc. in Miami, FL. Those who are pregnant/lactating, have been treated with a 5-nitroimidazole within the last 28 days, used intra-vaginal boric acid or any other intra-vaginal treatment for T. vaginalis within the last 14 days, have a history of a type 1 hypersensitivity reaction to 5-nitroimidazoles, are taking phenytoin and/or warfarin, use any medications which may alter the metabolism of oral MTZ, or have previously been enrolled will be excluded from the study. Participants will be randomised in a 1:1 fashion to either multi-dose oral MTZ or single-dose oral SEC. A test-of-cure (TOC) visit will be performed 4 weeks after completion of treatment (window 1 week before and 2 weeks after scheduled TOC visit).

This protocol is approved through a single Institutional Review Board (IRB) mechanism by the Tulane Human Research Protection Programme (Protocol # 2024–101 SPHTM). External relying sites are the UAB IRB (including both the UAB Sexual Health Research Clinic and Gynaecology Clinics; Protocol ID IRB-300012617), the LSUHSC-NO IRB (LSU-CrescentCare Sexual Health Centre; Protocol ID 6979) and the Advarra IRB (Healthcare Clinical Data Inc; Protocol ID Pro00085531). This study is also approved for referral purposes only by the Research Review Committee at the Jefferson County Department of Health (JCDH) Sexual Health Clinic in Birmingham, AL (JCDH Research Number 2024–03). Study findings will be presented in scientific conferences and peer-reviewed journals, shared with treatment advisory boards, as well as disseminated to providers and patients in communities of interest. The study Data Safety and Monitoring Board (DSMB) will meet twice a year to review patient safety data and study progress and provide recommendations on the study’s continuation or modification.

NCT06261840.

Insomnia disorder imposes a significant burden on children and adolescents; however, treatment options are limited. This paper describes the first controlled study to investigate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in children and adolescents with or without comorbid neurodevelopmental disorders, allowing its evaluation in a broad paediatric population.

This multicentre, double-blind, randomised, placebo-controlled, parallel-group, dose-finding Phase 2 trial includes male and female participants aged ≥10 to

This study has been approved by the respective health authorities and institutional review boards/independent ethics committees for each participating site and country and is conducted in accordance with the Declaration of Helsinki. Ethics approval has been obtained for each participating country/site. Regardless of the outcomes, the results will be published in an international peer-reviewed scientific journal.

NCT05423717.

Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.

This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.

This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.

To assess the magnitude and associated factors of suicidal behaviour and non-suicidal self-injury (NSSI) among youth of the Gurage Zone, Southern Nations, Nationalities, and Peoples Regional, Ethiopia, 2024.

A community-based cross-sectional study was conducted.

This research was carried out in the Gurage Zone.

This study was conducted among 719 Gurage Zone youths from 1 January 2024 to 1 February 2024.

Suicidal behaviours and non-suicidal self-injury were assessed using a pretested, interviewer-administered, structured questionnaire. Data were entered in EpiData V,3.1 and exported to SPSS V.25 for analysis. A binary logistic regression model was used to identify significant factors associated with suicidal behaviours and NSSI. Variables with a p-value less than 0.05 and adjusted ORs with 95% CI were used to declare association with the outcome variable in the final model.

Out of the total 820 study participants, 719 participants participated in the study, giving a response rate of 88%. Among 719 respondents 465 (64.7%) were males. The prevalence of high risk of suicidal behaviours was 11.7% (95% CI 8.14 to 14.30) and it is significantly associated with substance use in the last 3 months (adjusted OR (AOR)=6.84; 95% CI 3.48 to 13.47), having moderate insomnia (AOR=3.09; 95% CI 1.30 to 7.31) and having depression (AOR=6.84; 95% CI 3.48 to 13.47).

The prevalence of NSSI among youths was 38% (95% CI 34.52 to 41.86). Substance use in the last 3 months (AOR=2.459; 95% CI 1.59 to 3.81), youths having depression (AOR=3.348; 95% CI 2.29 to 4.91), youths who were exposed to stressful life events (AOR=9.86; 95% CI 6.46 to 15.07) were significantly associated with NSSI.

Nearly 1 in 10 youths in the Gurage Zone exhibited high-risk suicidal behaviour, and over one-third reported NSSI. Suicidal behaviour was significantly associated with substance use, depression and moderate insomnia, while NSSI was significantly associated with substance use, depression and exposure to stressful life events. These findings highlight the prevalence of self-harm and the key factors associated with these behaviours among youth in this region.