Data quality in epidemiological studies is a basic requirement for good scientific research. The aim of this study was to examine an important indicator of data quality, data completeness, by investigating predictors of missing data.

Baseline data of a cohort study, the population-based Hamburg City Health Study, were used. Missingness was investigated at the levels of a whole research unit, on the two segments of health service utilisation and psychosocial variables, and two sensitive items (income and number of sexual partners). Predictors for missingness were sociodemographic variables, cognitive abilities and the mode of data collection. Associations were estimated using binary and multinomial logistic regression models.

Of 10 000 participants (mean age=62.4 years; 51.1% women), 32.9% had complete data at the unit level, 66.8% had partially missing data and 0.3% missed all items. The highest proportions of missing values were found for income (27.8%) and the number of sexual partners (36.7%). At both the unit, segment and item level, older age, female sex, low education, a foreign mother language and cognitive impairment were significant predictors for missingness.

For analysing population-based data, dealing with missingness is equally important at all levels of analysis. During the design and conduct of the study, the identified groups may be targeted to reach higher levels of data completeness.

A substantial number of patients with major depressive disorder experience non-remission despite treatment with psychotherapy and several antidepressant drugs. This has increased the interest in new treatment strategies, including non-invasive brain stimulation methods. This randomised controlled trial examines a new treatment method using transcranial-pulsed electromagnetic fields (T-PEMF) delivered via a MoodHeadBand (MHB). The main study objective is to examine the antidepressant effect of T-PEMF on moderate to severe depression.

A double-blinded, randomised (1:1), sham-controlled trial with 96 participants diagnosed with moderate to severe depression without psychotic symptoms, recruited from Psychiatric Center Copenhagen. Participants receive daily 30 min at-home T-PEMF or sham treatment for 8 weeks with the MHB. Depressive symptomatology is examined using the Inventory of Depressive Symptomatology (Self-Report) (primary outcome) and Hamilton-D-17 Items Rating Scale at baseline and treatment completion. Cognitive functions are examined using a battery of emotion-laden and non-emotion-laden tests at baseline, after 1 week and at treatment completion. The participants fill out the Quick Inventory of Depressive Symptomatology (Self-Report) and sleep logs weekly. Summary statistics, generalised linear models, proc mixed models, mixed model repeated measures and Kaplan-Meier analysis will be applied as appropriate to analyse data on depressive symptoms, cognition and sleep.

The Danish Medicines Agency (CIV-23-01-041987) and the Medical Research Ethics Committee (2215332) have approved the trial. The project concurs with the EU directive for medical devices 2017/745 of 5 April 2017 and the ISO 14155 standard. Participants give written informed consent before any trial-related activities. Results will be published in peer-reviewed journals and presented at relevant conferences.

NCT06005103.

Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis are sexually transmitted pathogens that are highly prevalent in developing countries and are strongly associated with pregnancy complications. In Chad, screening for these sexually transmitted infections (STIs) in pregnant women is based solely on patient-reported symptoms, even though these infections are frequently asymptomatic. This study aims to determine the prevalence of M. genitalium, C. trachomatis, N. gonorrhoeae and T. vaginalis infections, as well as their associated risk factors.

In this cross-sectional study, we recruited pregnant women attending antenatal clinics at seven hospitals in N’Djamena. Endocervical swabs were collected, and DNA was extracted. Infections were diagnosed using PCR. Risk factors were identified using a structured questionnaire, and associations were assessed using logistic regression.

A total of 525 pregnant women were enrolled, of whom 78.5% resided in urban areas, with a mean age of 25.16±5.54 years. Overall, 23.99% of the study population were diagnosed with at least one STI. The individual prevalence of M. genitalium, N. gonorrhoeae, C. trachomatis and T. vaginalis infections was 13.33%, 5.14%, 0.95% and 4.57%, respectively. Coinfections were low, with M. genitalium-T. vaginalis at 0.95%, M. genitalium-N. gonorrhoeae at 0.38% and other combinations at 0.19% each. Women residing in rural areas had nearly two times the odds of M. genitalium infection compared with urban residents (OR=1.98), indicating a higher risk. AgeM. genitalium infection (OR=1.71) were also associated with significantly increased risk.

This study demonstrates a high prevalence of STIs among pregnant women in Chad, underscoring the need for systematic screening rather than solely relying on syndromic management.

Parkinson’s disease is a neurological disease with a rising incidence and prevalence. Patients with Parkinson’s disease may receive antipsychotics, for example, due to Parkinson’s disease psychosis. Parkinson’s disease psychosis is characterised by visual hallucinations and other psychotic symptoms. To date, no systematic review has evaluated the effects of antipsychotics in patients with Parkinson’s disease. Therefore, this review aims to assess the beneficial and harmful effects of antipsychotics for Parkinson’s disease.

This is a protocol for a systematic review. A search specialist will perform a search in major medical databases (eg, MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica database), CENTRAL (Cochrane Central Register of Controlled Trials)) and clinical trial registries. Published and unpublished randomised clinical trials comparing antipsychotics to any control (placebo, standard care or other antipsychotics) in patients with Parkinson’s disease will be included. Two review authors will independently extract data and conduct risk of bias assessments with the Cochrane Risk of Bias tool—V.2. Primary outcomes will be all-cause mortality, serious adverse events and significant falls. Secondary outcomes will be hospitalisations, non-serious adverse events, Unified Parkinson’s Disease Rating Scale total score and psychotic symptoms using any valid symptom scale. Data will be synthesised by aggregate meta-analysis, trial sequential analysis and network meta-analysis. Several subgroup analyses are planned. An eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, and the certainty of the evidence will be assessed by GRADE (Grading of Recommendations Assessment, Development and Evaluations) and CiNeMA (Confidence in Network Meta-Analysis) approach.

This protocol does not include results, and ethics approval is not required for the project. The findings from the systematic review will be published in international peer-reviewed scientific journals.

PROSPERO ID: CRD42025633985. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD42025633985.

Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).

The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of

Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.

ISRCTN61218504. EU CT: 2025-520538-49-00.

Publication based on the UK protocol V.3.0, 08 May 2025