Lorin

This research aims to evaluate how demand-side incentives DSIs impact immunisation coverage and reduce the number of zero-dose children aged 0 to 23 months in selected areas of Nigeria. The study focuses on improving vaccination rates and timeliness while addressing barriers like access, misinformation, and socio-economic challenges in underserved communities. It uses a cluster Randomised Controlled Trial cRCT design to understand the effects of DSIs in real-world settings by December 2025. The study involves four groups of clusters in Oyo and Kwara states one group receives transportation vouchers for caregivers after vaccination, another receives direct monthly funding to primary healthcare facilities, a third group receives both transportation vouchers and direct funding, and the fourth group serves as a control with no intervention. The interventions also include community engagement and support for microplanning at health facilities to strengthen immunisation services. Participants include caregivers of children aged 0 to 23 months living in selected clusters, who will be followed during the study period from August 2024 to December 2025. Researchers will monitor vaccination coverage, zero-dose reduction, timeliness of immunisation, and caregiver knowledge and perceptions. Outcomes will be assessed through household interviews, health facility data, and stakeholder engagement measures. The study also tracks costs and behavioural factors influencing vaccination uptake to inform sustainable immunisation strategies.

Researchers are establishing the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer IRONMAN as a prospective, global group of at least 5,000 men with advanced prostate cancer, including those with metastatic hormone-sensitive prostate cancer mHSPC and metastatic castration-resistant prostate cancer M0M1 CRPC. This study aims to better understand variations in care and treatment across different countries and medical settings by collecting detailed patient data over time. Participants will receive standard care drugs routinely used for metastatic prostate cancer based on local practices. Data collection begins at enrollment and continues for at least five years. Blood samples and tumor tissue, when possible, will be collected at enrollment, treatment changes, and follow-ups to study molecular markers linked to treatment response and resistance. Patient-reported outcome measures PROMs will be gathered every three months, and physicians will provide treatment and follow-up information regularly. During the study, participants will provide health and treatment information through questionnaires, with regular monitoring of survival, adverse events, and comorbidities. Blood samples will support future research to identify biomarkers. The main outcome is observing practice patterns over five years to help improve understanding of treatment sequences that optimize survival and quality of life for men with advanced prostate cancer.

Researchers are investigating the effects of pre-operative mouthwash and varying oxygen levels during surgery on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This trial focuses on patients in low and middle-income countries, where postoperative complications are more common and often more severe. The study aims to find ways to reduce these serious complications, which can cause pain, disability, and increased healthcare costs. Participants will be randomly assigned to one of four groups pre-operative chlorhexidine mouthwash combined with high oxygen levels 80-100% FiO2, no mouthwash with high oxygen levels, mouthwash with low oxygen levels 21-30% FiO2, or no mouthwash with low oxygen levels. Treatments are given around the time of surgery, with oxygen delivered during the operation and mouthwash used before surgery. The study includes an internal pilot phase lasting six months to check recruitment and compliance, followed by a larger trial aiming to enroll nearly 13,000 participants. During the study, researchers will monitor participants for up to 30 days after surgery, assessing rates of pneumonia and surgical site infections using CDC definitions. They will also track other outcomes like mortality, repeat surgeries, hospital stay length, return to normal activities, critical care admissions, and healthcare resource use. Follow-up includes evaluating patient recovery and safety, with all data collected to understand how these interventions impact surgical outcomes in these settings.

Researchers are evaluating the use of surfactant given by a less invasive surfactant administration LISA technique to treat respiratory distress syndrome in preterm infants in low- and middle-income African countries. This pragmatic clinical trial aims to determine whether this method improves survival compared to standard care, especially where invasive ventilators are not available. The study focuses on preterm neonates with respiratory distress who are managed with continuous positive airway pressure CPAP and caffeine citrate. The trial compares two groups one receiving standard care with CPAP and caffeine citrate, and the other receiving surfactant therapy administered through the LISA technique, which involves instilling surfactant into the lungs via a thin catheter during laryngoscopy while on CPAP. Participants are preterm infants born between 24 and 35 weeks gestation or weighing between 750 and 2000 grams with respiratory distress defined by a Silverman Anderson Score of 5 or greater. The study includes monitoring for complications and follows infants throughout hospitalization. Participants will be observed during their hospital stay, which averages about six months, to assess survival and other health outcomes such as incidence of major preterm neonatal morbidity and pneumothorax. Researchers will monitor participants from admission within 24 hours of life until discharge, evaluating hospital survival and complications related to respiratory distress and surfactant treatment. The primary outcome is all-cause in-hospital survival.

Researchers are evaluating the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II SMAART-II study, which aims to test a polypill strategy to reduce vascular risk in patients who recently experienced a stroke. This Phase 3 trial seeks to compare the effectiveness of a fixed-dose combination pill against usual care over 24 months, with a focus on improving cardiovascular outcomes in an under-resourced healthcare setting in Ghana. The study involves two groups one receiving the polypill Polycapae, which combines aspirin, simvastatin, hydrochlorothiazide, ramipril, and atenolol taken as two capsules once daily, and the other receiving standard care with treatments at the discretion of their doctors. Patients already on similar medications will have their treatments replaced by the polypill if assigned to that group. Both groups providers receive training on recommended biomarker targets for stroke secondary prevention. Participants will be monitored for up to 24 months, with regular assessments of vascular risk factor control, adherence to medical therapy, safety, and quality of life using specific health-related questionnaires. Researchers will track major adverse cardiovascular events and measure composite vascular risk at 12 and 24 months. The study includes safety and tolerability monitoring throughout the period and aims to develop strategies for integrating this treatment approach into routine care.

Researchers are evaluating a training program for Nigerian radiologists to perform ultrasound-guided breast biopsies using mobile health mHealth devices. This approach aims to create a practical and sustainable method to integrate ultrasound-guided biopsies into clinical practice for women with suspicious breast masses. The study focuses on improving diagnostic accuracy compared to current biopsy methods used in Nigerian hospitals. Women with a solid breast mass detected by ultrasound and suspected of breast cancer are included in the study. Instead of the usual blind biopsy or surgical excision, participants will receive an ultrasound-guided breast biopsy performed by a trained radiologist using the mHealth technology. This method is considered the standard of care in the United States due to its improved accuracy. Participants will be assessed based on the number of successful ultrasound-guided breast biopsies within one year. The study involves monitoring the biopsy procedures and outcomes to evaluate the training programs effectiveness. The study runs from September 2022 to September 2027 and is sponsored by Memorial Sloan Kettering Cancer Center.