Clinical trials: sponsored by Duke University
Pregnancy Related, Hypertension
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
The goal of this clinical trial is to test an approach to improve care for pregnant and post-partum patients with high blood pressure.
- Trial name
- ACHIEVE (NCT06002165)
- Testing
- Usual Care, ACHIEVE Multi-component Implementation Strategy
- Where
- 8 sites in United States
- Volunteers
- 5,677 people
- Sponsor
- University of North Carolina, Chapel Hill
Familial Mediterranean Fever (FMF), Autoinflammation
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases.
- Conditions
- Familial Mediterranean Fever (FMF), Autoinflammation, Periodic Fever, Fever
- Trial name
- NCT00001373
- Where
- 5 sites in United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- National Human Genome Research Institute (NHGRI)
Krabbe Disease
Long-term Follow-up Study to Evaluate Safety and Efficacy of FBX-101 in Krabbe Patients
This is an observational study that will enroll any patients with Krabbe disease that have participated in prior interventional clinical trials involving the administration of FBX-101.
- Trial name
- NCT06308718
- Testing
- FBX-101
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Duke University
Krabbe Disease
Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Treated Previously With HSCT
This is a non-blinded, non-randomized dose escalation study of intravenous FBX-101 in which subjects will receive a single infusion of an adeno-associated virus gene therapy product, after more than 21 days of the HSCT (UCBT…
- Trial name
- REKLAIM (NCT05739643)
- Testing
- FBX-101
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Duke University
Atopic Dermatitis
Dupilumab De-escalation in Pediatric Atopic Dermatitis
This is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (AD)…
- Trial name
- NCT06116526
- Testing
- Dupilumab - Discontinuation, Dupilumab - Dose Reduction, Dupilumab - Standard Dose
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Johns Hopkins University
Malaria,Falciparum, Malaria in Pregnancy
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL)…
- Conditions
- Malaria,Falciparum, Malaria in Pregnancy, Malaria in Childbirth, Pregnancy
- Trial name
- INTREPiD (NCT05757167)
- Testing
- Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT), Artemether-lumefantrine (AL)
- Where
- 2 sites in Democratic Republic of the Congo, Kenya
- Volunteers
- 2,174 people
- Sponsor
- Duke University
Cerebral Palsy, Hydrocephalus
Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries
This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders.
- Conditions
- Cerebral Palsy, Hydrocephalus, Apraxia of Speech, Hypoxia Ischemia, Cerebral
- Trial name
- NCT03327467
- Testing
- Cord Blood Infusion
- Where
- United States
- Sponsor
- Joanne Kurtzberg, MD
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
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
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
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
Anesthesia, Pain
Anesthetics and Analgesics in Children
The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
- Trial name
- ANA01 (NCT03427736)
- Testing
- Ketorolac Tromethamine, Hydromorphone, Ketamine
- Where
- 13 sites in United States, Canada
- Volunteers
- 551 people
- Sponsor
- Chi Dang Hornik
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
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
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
Behavior, Health, Child Obesity
Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention
A randomized controlled trial enrolling 900 parent-infant dyads (English and Spanish speaking) comparing Greenlight (control), a behavioral intervention focusing on nutrition, physical activity, media use, and sleep as compared…
- Trial name
- NCT04042467
- Testing
- Greenlight Plus, Greenlight
- Where
- 6 sites in United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center