Clinical trials: sponsored by Duke University
Polyarticular Course Juvenile Idiopathic Arthritis (JIA)
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential…
- Trial name
- SMART-JIA (NCT06654882)
- Testing
- TNFi (Tumor Necrosis Factor inhibitor) medication, Abatacept, Tocilizumab
- Where
- 7 sites in United States, Germany and 2 more
- Volunteers
- 400 people
- Sponsor
- Duke University
Rheumatic Joint Disease
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies.
- Trial name
- NCT02418442
- Where
- 82 sites in United States, Canada and 3 more
- Volunteers
- 20,000 people
- Sponsor
- Duke University
Pediatric Abdominal Imaging, Pediatric Imaging
Pediatrics Mobile CT
A special kind of CT scanner that can move around (called a mobile CT) is already approved by the FDA to take pictures of adult and pediatric heads.
- Trial name
- NCT07166926
- Testing
- Mobile CT
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- 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
Retinopathy of Prematurity
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed…
- Trial name
- NCT05558059
- Testing
- Handheld Optical Coherence Tomography with OCT Angiography
- Where
- 2 sites in United States
- Volunteers
- 16 people
- 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
Pediatric Obesity, Pediatric Asthma
Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked,8-week interventional study among children aged 8-17 years (not yet 18 years old) of age with obesity and asthma.
- Trial name
- iPro (NCT05608668)
- Testing
- Pro2 - 60% of participant's MIP, Pro2 - 15% of participant's MIP
- Where
- United States
- Volunteers
- 22 people
- 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
Cardiac Disease, Critically Ill
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
OPTIC is a prospective, open-label, non-randomized study of multiple medications administered to approximately 2000 children in the pediatric cardiac intensive care unit (PCICU) per routine clinical car by their treating…
- Conditions
- Cardiac Disease, Critically Ill, Children, Adult
- Trial name
- OPTIC (NCT05055830)
- Testing
- The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Duke University
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
Combating Related Epidemics in HCV
This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm).
- Conditions
- HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV), HEPATITIS C (HCV)
- Trial name
- CREST (NCT07560046)
- Testing
- Cepheid GeneXpert HCV Test, Abbott Determine HIV - 1/2 Ag/Ab, Abbott Determine HbsAg 2
- Volunteers
- 1,280 people
- Sponsor
- Duke University
Early Onset Sepsis, Preterm Neonates
Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours).
- Conditions
- Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin
- Trial name
- OPTI-Amp (NCT07610486)
- Testing
- Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
- Where
- United States
- Volunteers
- 60 people
- 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
Eating Disorders, Body Image
FlexED: A Digital, Gamified Early Intervention for Eating Disorders
The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old.
- Trial name
- NCT05609409
- Testing
- FlexED
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Duke University
ADHD
Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD
The purpose of the study is to establish the feasibility of collecting estradiol (E2), Garmin-measured sleep, and ecological momentary assessments (EMA) of ADHD and related symptoms (mood, anxiety, executive functioning) across…
- Trial name
- DREAMS (NCT07805382)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Retinopathy of Prematurity (ROP)
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of prematurity (ROP) is a disorder of development of the retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime.
- Trial name
- (BabySTEPS3) (NCT07738874)
- Testing
- Ultra-widefield Optical Coherence Tomography (UWF-OCT), Wide-field ophthalmic imaging system
- Where
- 2 sites in United States
- Volunteers
- 175 people
- Sponsor
- Duke University
Epilepsy
Health Literacy Project
Evaluating changes in knowledge, attitude, and practices (KAP) related to epilepsy and its treatment as a result of an educational intervention among adolescents with epilepsy to determine if improved KAP about epilepsy results…
- Trial name
- NCT06634901
- Testing
- Health Literacy Educational Session- Comparator, Health Literacy Educational Session
- Where
- 2 sites in Uganda
- Volunteers
- 60 people
- Sponsor
- Duke University
Decision Making, Neonatal Critical Illness
Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE): An Intervention to Support Decision Making for Critically Ill Children
Parents of young children in the intensive care unit may be faced with decisions about their child's care. The Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE) intervention was designed to help support…
- Conditions
- Decision Making, Neonatal Critical Illness, Pediatric Critical Illness
- Trial name
- BRIDGE (NCT07390773)
- Testing
- BRIDGE intervention
- Where
- 3 sites in United States
- Volunteers
- 495 people
- Sponsor
- Duke University
Epilepsy Intractable
Sleep Disruption Pattern - Epilepsy Monitoring Unit
Epilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. Comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type…
- Trial name
- NCT06581133
- Testing
- Alarm system
- Volunteers
- 75 people
- Sponsor
- Duke University
Type 1 Diabetes, Eating Disorders
Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2)…
- Conditions
- Type 1 Diabetes, Eating Disorders, Disordered Eating Behaviors, Purging (Eating Disorders)
- Trial name
- NCT05540704
- Testing
- ACT, Supportive Diabetes Counseling
- Where
- 2 sites in United States
- Volunteers
- 235 people
- Sponsor
- Duke University
Pompe Disease, Pompe Disease (Late-onset)
Developing a Management Approach for Patients With "Late-Onset" Pompe Disease
This is an observational study with no study related treatment of interventions. The purpose of the study is to investigate and document disease specific clinical symptoms in newborns, infants and children with Pompe disease…
- Conditions
- Pompe Disease, Pompe Disease (Late-onset), GAA Deficiency
- Trial name
- NCT03694561
- Testing
- Observational
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Duke University