There are about 53 clinical studies being (or have been) conducted in Sierra Leone. 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.
War-related violence is a leading driver of mental disorders and illness affecting children in low- and middle-income countries (LMICs). Parents exposed early in life to war-related violence and loss are at risk for mental health problems and may pass risks to their offspring. The study posits that war-related trauma alters the stress-response circuitry in ways that endure into adulthood and affect the next generation. This will be the first investigation in a 20-year longitudinal study to examine mechanisms that link parental war-related trauma exposure and subsequent mental health problems to risk for mental disorders in offspring. This study will extend the first intergenerational study of war in Sub-Saharan Africa (R01HD073349) to focus on children (aged 7-24) born to war-affected parents. Assessments of behavioral and biological indicators of the Research Domain Criteria (RDoC)-linked constructs of self-regulation and stress reactivity will be collected, including autonomic nervous system reactivity, inflammation, and telomere length as well as sophisticated observations of parent-child interactions and synchrony. These measures will be utilized to identify potentially modifiable risk and protective processes both to inform the development of screening tools to identify families at risk for poor child mental health and to be deployed as active ingredients of interventions to reduce transmission of mental health problems to children of war-affected parents. This follow-up study involves the following activities: 1. Pilot to assess measure performance and field test study protocols. 1. Translation and adaptation of newly selected measures 2. Pilot study of new child and adult measures with 36 caregivers and 60 children in a district of Sierra Leone unlinked to participants to test the feasibility and validity of new tools. 2. Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24. 1. Household tracking and re-enrollment of 145 households that were formerly enrolled in the Longitudinal Study of War-Affected Youth (LSWAY; T1: 2002, T2: 2004, T3: 2008, T4: 2016). 2. Quantitative (full sample) and qualitative (subsample) data collection with 145 households who were enrolled in T4 LSWAY, including war-affected youth who are now parents, their intimate partners, and their children aged 7-24. Through these activities, the investigators will test three overarching hypotheses: 1. Childhood war-related trauma exposure will be associated with mental difficulties (anxiety, depression, post-traumatic stress, disruptions of emotion regulation). 2. Poor mental health in war-affected parents will be associated with emotional and behavioral disruptions in biological offspring. 3. Risk and protective factors across the social ecology may serve as intervention targets to mitigate the effects of parental war-related trauma on behavioral disruptions and stress physiology, both within and across generations.
Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC). Post-mortem pacemaker utilization could be safe, efficacious, and ethically responsible means of delivering the needed care. Reconditioned pacemakers can provide therapy for patients with symptomatic bradycardia and no means of receiving a new device. The objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in LMIC without resources. Consented patients in this multi-center trial will be randomized to undergo implantation of either a reconditioned device or a new device.