There are about 351 clinical studies being (or have been) conducted in Nigeria. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
One in ten babies are born preterm (<37 weeks gestation) globally. Complications of prematurity are the leading cause of death in children under 5 years, with the highest mortality rate in Sub-Saharan Africa (SSA). Low flow oxygen, and respiratory support - where an oxygen/air mixture is delivered under pressure - are life saving therapies for these babies. Bubble Continuous Positive Airway Pressure (bCPAP) is the mainstay of neonatal respiratory support in SSA. Oxygen in excess can damage the immature eyes (Retinopathy of Prematurity [ROP]) and lungs (Chronic Lung Disease) of preterm babies. Historically, in well-resourced settings, excessive oxygen administration to newborns has been associated with 'epidemics' of ROP associated blindness. Today, with increasing survival of preterm babies in SSA, and increasing access to oxygen and bCPAP, there are concerns about an emerging epidemic of ROP. Manually adjusting the amount of oxygen provided to an infant on bCPAP is difficult, and fearing the risks of hypoxaemia (low oxygen levels) busy health workers often accept hyperoxaemia (excessive oxygen levels). Some well resourced neonatal intensive care units globally have adopted Automated Oxygen Control (AOC), where a computer uses a baby's oxygen saturation by pulse oximetry (SpO2) to frequently adjust how much oxygen is provided, targetting a safe SpO2 range. This technology has never been tested in SSA, or partnered with bCPAP devices that would be more appropriate for SSA. This study aims to compare AOC coupled with a low cost and robust bCPAP device (Diamedica Baby CPAP) - OxyMate - with manual control of oxygen for preterm babies on bCPAP in two hospitals in south west Nigeria. The hypothesis is that OxyMate can significantly and safely increase the proportion of time preterm infants on bCPAP spend in safe oxygen saturation levels.
The research is studying the effect of a mHealth psychoeducational intervention on self-efficacy, coping and psychological distress of Nigerian women diagnosed with breast cancer receiving chemotherapy The study is a two-arm assessor-blinded randomised controlled trial which will be conducted in two University Teaching Hospitals in Nigeria.
This randomized controlled trial is designed to determine the effect of administration of azithromycin compared to amoxicillin as part of the treatment of uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months on weight gain and nutritional recovery. The investigators will randomize children presenting to Taimaka-run nutritional programs at health centers in Gombe State, Nigeria to a single dose of oral azithromycin or a short course of oral amoxicillin upon admission into the program. Apart from the administration of antibiotics, all children will receive standard outpatient treatment for uncomplicated SAM as specified in the guidelines of the government of Nigeria, which includes therapeutic feeding with ready-to-use therapeutic food (RUTF). Enrolled children will be followed weekly at each routine clinic follow-up visit up until nutritional recovery. All enrolled children will return for a final study visit at 8 weeks following enrollment. Anthropometric and vital status data will be collected at each follow-up visit. Weight gain and nutritional recovery over the 8-week study period will be compared by arm as a primary outcome and at 12 weeks as a secondary outcome.
Palatal fistulas are a major burden to surgeons and patients in the management of cleft palate. Their high rate of occurrence and recurrence makes them particularly challenging even to the highly skilled surgeon. Prevention of postoperative palatal fistula is therefore of paramount importance. Closure of the nasal mucosa under tension has been proposed as a major cause of palatal fistula formation. However, depending on the presentation of the cleft palate, it may be impossible to achieve surgical closure with minimal tension. Till date, there is no universally acceptable method of preventing palatal fistula formation following cleft palate repair. And although the use of pre-surgical appliances such as Latham appliance and the use of local and distant tissues to achieve two layer closure have been proposed, the use of a superpositional collagen graft may also be used to achieve closure of the nasal mucosa with minimal or no tension during cleft palate repair. Collagen grafts have the added advantage of being more patient friendly compared to the Latham appliance which requires an initial surgery for appliance insertion before surgical cleft palate repair. They are also less technique sensitive compared to the use of local and distant tissues. The investigators therefore aim to provide high level scientific evidence of the effectiveness of collagen graft in the prevention of postoperative palatal fistula.
The proposed study is a Phase 1/2 multi-center study evaluating the safety and efficacy of erythropoietin (EPO) in combination with hydroxyurea in the treatment of chronic anemia in patients with sickle cell disease (SCD).
This study will evaluate the effectiveness of an artificial intelligence-enabled ECG (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria.
The overall goal of this feasibility study is to establish a standard of care stroke prevention program for children with sickle cell anemia in a community hospital by task shifting stroke detection and transcranial Doppler ultrasound screening to nurses. In Nigeria, approximately 150,000 children with sickle cell anemia (SCA) are born annually, accounting for more than half of the total births with SCA worldwide. In comparison, only 1,700 children with SCA are born in the United States annually. An estimated 11% of unscreened and untreated children at increase of strokes with SCA will have at least one stroke by 17 years of age. In high-income countries, evidence-based practices (EBP) for primary stroke prevention in children with SCA involves screening for abnormal transcranial Doppler ultrasound (TCD) velocity (>200cm/s) coupled with regular blood transfusion therapy for at least one year followed by treatment with hydroxyurea is considered standard care. This strategy decreases the risk of stroke by 92%. Due to safety and availability, regular blood transfusion is not a viable option for primary stroke prevention in most low-income settings, including Nigeria, where ~50% of the 300,000 children with SCA are born. Among each birth cohort, 15,000 children will have stroke annually in Nigeria. The American Society of Hematology (ASH) Central Nervous System Guidelines recommends moderate dose hydroxyurea (20mg/kg) to children with SCA with abnormal TCD measurements, living in resource-constrained settings where regular blood transfusions are not readily available. Our team has demonstrated in a previous trial the feasibility of primary stroke prevention with hydroxyurea in Kano, Nigeria. In 2016, as part of capacity building objective of Stroke Prevention Trial in Nigeria (1R01NS094041-SPRING) at Barau Dikko Teaching Hospital in Kaduna, TCD screening was adopted as standard of care. Before the trial, no TCD screening was done at our trial site in Kaduna. Now, as standard care, physicians at the teaching hospital do TCD screening, however, only 5.4% (1,101/20,040) of the eligible children with SCA living in Kaduna, Nigeria were reached. Clearly, for there to be an appreciable impact on decreasing the stroke rates in children with SCA living in Nigeria and elsewhere, applying the ASH guidelines and a better implementation strategy to increase the TCD reach (proportion of children eligible for TCD screening that are screened) is necessary. Therefore, objective of this physician-mentored application is to conduct an Effectiveness-Implementation Feasibility Trial is to test the test the hypothesis that the task-shifted site for primary stroke prevention team in a community hospital will have a non-inferior effectiveness in identifying children with abnormal TCD measurements when compared to primary stroke prevention team in a teaching hospital in Kaduna, Nigeria. the investigators will conduct i) a needs assessment at the community hospital to identify barriers and facilitators to the intervention, ii) Build capacity for stroke detection and TCD screening and iii) Compare the effectiveness of a physician-based stroke prevention program in a teaching hospital to a task-shifted stroke prevention in a community hospital.
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
This study is to be conducted in community pharmacies. It involves the use of trained mystery patients to evaluate community pharmacists at baseline and post intervention. The pharmacists will be divided into control and intervention groups using computer generated codes. Those in the intervention group will receive an online training by clinical pharmacists. The training will employ the use of didactic teaching and the use of case studies and simulations covering the diagnosis and management of acute uncomplicated urinary tract infections in adults. Post intervention, mystery patients will revisit the community pharmacists in the control and intervention groups for re-assessment.
BACKGROUND: Surgical site infection (SSI) is potentially catastrophic in neurosurgical procedures, causing poor in-hospital outcomes in more than half of those affected and significantly increased length of hospital stay. The appropriate and timely use of prophylactic antibiotics is found to reduce the prevalence of SSIs. At present, several regimen of antimicrobial agents are used in neurosurgical procedures since the choice of appropriate antibiotic agent is not fully established. Cephalosporins are among the frequently used antibiotics for prophylaxis in neurosurgical procedures, with studies comparing first and second generation Cephalosporins to third generation in neurosurgical prophylaxis, showing no superiority of the latter over the former. Clearly, comparing Cefuroxime (a second generation Cephalosporin) to Ceftriaxone (a third generation Cephalosporin) in neurosurgical procedures will provide more knowledge on the efficacy of Cefuroxime as antibiotics prophylaxis. OBJECTIVE: The study aimed to determine the comparative efficacy of cefuroxime versus ceftriaxone in the prevention of surgical site infection after neurosurgical procedures at the University College Hospital Ibadan, Nigeria. METHODS: The study will be a randomized controlled trial recruiting 92 participants. Participants would be patients undergoing neurosurgical procedures; they will be randomized to treatment arms (those receiving cefuroxime versus ceftriaxone for antibiotic prophylaxis). All the study articipants will be followed up for 30 days to assess for the development of surgical site infection. DATA ANALYSIS: Data will be collated, computed and analyzed using the Statistical Product and Service Solutions (SPSS) Version 21. Demographics will be presented using summary statistics; mean +/- standard deviation and figures (e.g pie chart, histogram). Study outcomes will yield categorical and continuous variables which will be analyzed using chi-squared test and Z-test and/or T-test for hypothesis testing.