Clinical trials: sponsored by Duke University
Macular Holes, Epiretinal Membrane
Intraoperative OCT Guidance of Intraocular Surgery II
The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes.
- Conditions
- Macular Holes, Epiretinal Membrane, Diabetic Retinopathy, Retinal Detachment
- Trial name
- MIOCT (NCT03713268)
- Testing
- Microscope integrated optical coherence tomography
- Where
- United States
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Duke University
ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI)
This randomized control trial comparing Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) among adolescents with a pre-existing ADHD diagnosis presenting to the Duke ADHD Program.
- Trial name
- NCT07089745
- Testing
- Mindfulness-Based Intervention, Organizational Skills Training
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Duke University
Substance Abuse, Intimate Partner Violence (IPV)
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
This study aims to prevent syndemic health conditions by decreasing acculturative stress and promoting resilience via SER Familia (Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience in Families), a…
- Conditions
- Substance Abuse, Intimate Partner Violence (IPV), HIV Infections, Depression
- Trial name
- SER Familia (NCT06627764)
- Testing
- SER Familia
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Duke University
Retinal Dystrophies
SS-HH-OCT as a Novel Diagnostic Modality for Early-Onset Retinal Dystrophies (EORDs)
The goal of this observational study is to utilize a novel imaging system designed for high-resolution retinal imaging of neonates, infants and children to identify the signs of photoreceptor development and degeneration in…
- Trial name
- SS-HH-OCT (NCT06177977)
- Testing
- SS-HH-OCT
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Duke University
Eye Diseases
Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging
The goal of this observational study is to test the use of a novel Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging in pediatric and adult subjects who are undergoing clinical…
- Trial name
- WiSLO (NCT06177639)
- Testing
- WiSLO, Volk Pictor Plus™
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Duke University
Atherosclerosis, Wounds and Injuries
Machine Learning for Handheld Vascular Studies
The use of handheld arterial 'stethoscopes' (continuous wave Doppler devices) are ubiquitous in clinical practice. However, most users have received no formal training in their use or the interpretation of the returned data.
- Trial name
- DopplerZAM (NCT02932176)
- Testing
- Non-invasive vascular testing, machine-learning algorithm
- Where
- United States
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Duke University
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose…
- Conditions
- Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension
- Trial name
- POPS or POP02 (NCT04278404)
- Testing
- The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
- Where
- 52 sites in United States, Canada
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Duke University
Retinal Disease, Glaucoma
Optimize Pediatric OCT Imaging
Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an…
- Conditions
- Retinal Disease, Glaucoma, Optic Nerve Diseases
- Trial name
- NCT06139523
- Testing
- Investigational contact OCT system, Investigational noncontact OCT system:
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Duke University
Sleep, Psychiatric Health
Sustainable Habits for Encouraging Even Teen Sleep
This study will examine the feasibility, acceptability, and effectiveness of two digital sleep interventions in improving sleep regularity and psychiatric health during a critical period of adolescence.
- Trial name
- SHEETS (NCT05378373)
- Testing
- Garmin, Pattern Health App
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Duke University
Pain, Injection Site Reaction
Safety of Pediatric COVID-19 Vaccination
This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to < 16) will be followed post administration of mRNA COVID-19 vaccines.
- Conditions
- Pain, Injection Site Reaction, Adverse Drug Event
- Trial name
- NCT05157191
- Testing
- Observational
- Where
- 5 sites in United States
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Duke University
Visual Field Defect, Peripheral
Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease
The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at.
- Trial name
- NCT05150197
- Testing
- VisuALL, Humphrey Visual Field
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Duke University
Retinopathy of Prematurity
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime.
- Trial name
- BabySTEPS2 (NCT04995341)
- Testing
- Investigational ultracompact OCT and OCTA system, retinal photographs
- Where
- 2 sites in United States
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Duke University
Fever After Vaccination, Fever
Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19…
- Conditions
- Fever After Vaccination, Fever, Seizures Fever
- Trial name
- NCT06038617
- Testing
- mRNA COVID-19 Vaccine, Routine Childhood Vaccinations
- Where
- 5 sites in United States
- Volunteers
- 347 people, healthy volunteers welcome
- Sponsor
- Duke University
Liver Diseases
DILIN - Prospective Study
The purpose of this study is to identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine.
- Trial name
- NCT00345930
- Where
- 6 sites in United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Duke University
Eye Diseases, Retinal Disease
Advancing Pediatric Retinal Imaging With Auto-aligned OCT
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
- Conditions
- Eye Diseases, Retinal Disease, Glaucoma, Optic Nerve Diseases
- Trial name
- NCT06841575
- Testing
- Auto-aligned OCT
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Duke University
Fever, Adverse Event Following Immunisation
Safety of RSV Preventive Monoclonal Antibody
This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously…
- Trial name
- NCT07158814
- Testing
- Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
- Where
- 6 sites in United States
- Volunteers
- 524 people, healthy volunteers welcome
- Sponsor
- Duke University
Autism, Autism Spectrum Disorder
SenseToKnow Autism Screening Device Validation Study
This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow device for the detection of autism spectrum disorder in children 16-36 months of age.
- Trial name
- NCT05874466
- Where
- United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Duke University
Nutrition, Energy Requirement
Energy Needs and Nutritional Status of Adolescent Girls
The purpose of this study is to investigate the energy needs and nutritional status of adolescent girls in Abia State, Nigeria
- Trial name
- NARNia (NCT06601959)
- Where
- 2 sites in United States, Nigeria
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Duke University
Diet Habit
Project humAn dieTary daTa rEtuRN
This study is designed to test the effects of diet data return on human dietary patterns. The investigators' working hypothesis is that returning diet data, collected via an empirical biomarker-based assessment method, will…
- Trial name
- PATTERN (NCT06266689)
- Testing
- Personalized Diet Information
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Duke University
Pediatric Obesity, Food Insecurity
Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health
Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the…
- Conditions
- Pediatric Obesity, Food Insecurity, Nutrition, Healthy, Nutrition Poor
- Trial name
- NOURISH (NCT06116422)
- Testing
- Grocery intervention - unrestricted, Grocery intervention - restricted
- Where
- United States
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Duke University