Clinical trials: sponsored by Children's National Research Institute
Solid Tumors
Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors
Patients with high-risk solid tumors, those that are refractory to standard up front therapy or relapse after completion of therapy, have a very poor prognosis despite attempts to induce remission with salvage regimen.
- Trial name
- REST (NCT02789228)
- Testing
- Tumor associated antigen lymphocytes (TAA-CTL)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Children's National Research Institute
Solid Tumor
Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors
This is an open-label phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning…
- Trial name
- ATTACK (NCT05238792)
- Testing
- Tumor-associated antigen-specific T cell (TAA-T)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Children's National Research Institute
Cleft Lip, Cleft Palate +/- Lip
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
This study will evaluate whether adding a suprazygomatic maxillary nerve block to the standard palatal nerve block improves pain control after cleft palate repair surgery in children.
- Conditions
- Cleft Lip, Cleft Palate +/- Lip, Pain Management, Wound Dehiscence, Surgical
- Trial name
- NCT07892963
- Testing
- Palatal Nerve Block, Suprazygomatic Maxillary Nerve Block
- Volunteers
- 144 people
- Sponsor
- Children's National Research Institute
Type 1 Diabetes, Continuous Glucose Monitoring
Research on Optimizing the Use of Technology With Education
Consistent use of continuous glucose monitors (CGM) has the potential to improve glycemic control and related type 1 diabetes (T1D) health outcomes, however young adolescents with T1D are the least likely age group to begin and…
- Conditions
- Type 1 Diabetes, Continuous Glucose Monitoring, Behavioral Intervention, Parent-Child Relations
- Trial name
- ROUTE-T1D (NCT05564481)
- Testing
- diabetes education and parent coaching support
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Children's National Research Institute
Sexually Transmitted Diseases
Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents
We will conduct a randomized trial to compare differences in sexually transmitted infection (STI) treatment adherence between patients receiving text messages versus those receiving usual care (e.g. no text messages).
- Trial name
- NCT04372485
- Testing
- mHealth Intervention
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- Children's National Research Institute
End Stage Renal Disease
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
An observational cohort study will be conducted to non-invasively investigate central blood pressure and pulse wave velocity in children with kidney disease and controls.
- Trial name
- NCT04212143
- Testing
- there is no intervention
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Children's National Research Institute
Pain, Appendicitis
PAINED: Project Addressing INequities in the Emergency Department
Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes.
- Conditions
- Pain, Appendicitis, Bias, Racial, Fractures, Bone
- Trial name
- PAINED (NCT05488080)
- Testing
- Department-level audit and feedback and electronic health record-embedded clinical decision support
- Where
- United States
- Volunteers
- 22,032 people
- Sponsor
- Children's National Research Institute
Cleft Lip, Cleft Lip Scar
Cleft Lip Scarring After Botox
This study is investigating whether botulinum toxin type A (Botox) can improve scar appearance after cleft lip repair surgery. Cleft lip repair is commonly performed during infancy, but visible scarring can occur as the incision…
- Trial name
- CLSAB (NCT07880860)
- Testing
- Botulinum Toxin Type A (BOTOX) Injection, Normal Saline
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Children's National Research Institute
DMG, DIPG
Blood-Brain Barrier Disruption Using Exablate Magnetic Resonance-Guided Low Intensity Focused Ultrasound With Microbubbles in Combination With T-Cell Infusion in Patients With Newly Diagnosed Diffuse Midline Glioma (LIFT)
This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for Diffuse Midline Glioma (DMG), an aggressive brain tumor with a very poor prognosis - an average one-year overall survival.
- Trial name
- LIFT (NCT07796061)
- Testing
- TAA-T Cell, BBB Disruption
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Children's National Research Institute
Medulloblastoma, Childhood, Atypical Teratoid/Rhabdoid Tumor of CNS
Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
This is an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA)…
- Conditions
- Medulloblastoma, Childhood, Atypical Teratoid/Rhabdoid Tumor of CNS, Embryonal Tumor With Multilayered Rosettes, Pineoblastoma
- Trial name
- IMPACT (NCT06193759)
- Testing
- Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA), Group A Standard-of-Care Backbone Therapy, Group B Salvage Backbone Therapy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Children's National Research Institute
Covid19, MIS-C Associated With COVID-19
Pediatric COVID Outcomes Study (PECOS)
This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including…
- Conditions
- Covid19, MIS-C Associated With COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children, SARS-CoV2 Infection
- Trial name
- NCT04830852
- Where
- 2 sites in United States
- Volunteers
- 1,097 people, healthy volunteers welcome
- Sponsor
- Children's National Research Institute
Executive Function Deficits (EFD)
Unstuck-Early Childhood Effectiveness & Implementation Trial
The goal of this clinical trial is to learn if a new school-based, Tier 2 (selective) cognitive-behavioral intervention called Unstuck and On Target for Early Childhood (Unstuck-EC) can treat executive function deficits in young…
- Trial name
- NCT07832344
- Testing
- Unstuck and On Target for Early Childhood
- Volunteers
- 90 people
- Sponsor
- Children's National Research Institute
Health Literacy, Comprehension
Impact of AI Care Summaries on Caregiver Comprehension
The primary objective is to assess if an AI-generated plain language summary of an inpatient progress note can improve caregiver understanding of their child's hospitalization by measuring differences in Hospital Course…
- Conditions
- Health Literacy, Comprehension, Patient Satisfaction
- Trial name
- NCT07831018
- Testing
- AI Care Summary
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Children's National Research Institute
Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma, High Grade Gliomas
NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors
This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for progressive and relapsed diffuse midline glioma (DMG) and other progressive and relapsed high-grade brain tumors.
- Conditions
- Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma, High Grade Gliomas, Medulloblastoma Recurrent, Ependymoma Recurrent
- Trial name
- NCT07664176
- Testing
- NeuroNavigation-Guided Focused Ultrasound (NgFUS), Lumason, Nivolumab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Children's National Research Institute
Turner Syndrome, Primary Ovarian Insufficiency
Pre-pubertal Low Dose Transdermal Estradiol in Turner Syndrome
This is a research study to find out if treatment with transdermal estradiol patches started between 8 to 11.5 years is safe in girls with Turner syndrome who have ovarian failure and to see whether it may improve performance on…
- Trial name
- NCT07784582
- Testing
- Estradiol transdermal patch 0.025mg/24 hours- 1/8th fractionated patch
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's National Research Institute
Rhabdomyosarcoma, Ewing Sarcoma
Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME Tumor Antigen-specific T cells) following lymphodepleting chemotherapy…
- Conditions
- Rhabdomyosarcoma, Ewing Sarcoma, Neuroblastoma, Wilms Tumor
- Trial name
- SABRE (NCT07172958)
- Testing
- Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Children's National Research Institute
Viral Infections, Bone Marrow Transplant Infection
T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation
This Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus, and human…
- Trial name
- NATS (NCT03180216)
- Testing
- Virus Specific T cells (VSTs)
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Children's National Research Institute
Astroblastoma, BCOR ITD Sarcoma
International Rare Brain Tumor Registry
The objective of the International Rare Brain Tumor Registry (IRBTR) is to better understand rare brain tumors through the collection of biospecimens and matched clinical data of children, adolescents, and young adult patients…
- Conditions
- Astroblastoma, BCOR ITD Sarcoma, CNS Sarcoma, Unclassified Tumor, Malignant
- Trial name
- IRBTR (NCT05697874)
- Where
- 13 sites in United States, Brazil and 2 more
- Volunteers
- 5,800 people
- Sponsor
- Children's National Research Institute
Healthy Participants
Pupillary Dilation Reflex in Healthy Volunteers
This a single site, observational study that will examine how the pupil responds to neurostimulation under different conditions in healthy adults.
- Trial name
- NCT07746167
- Testing
- No intervention (observational study)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Children's National Research Institute
Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus
Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations.
- Conditions
- Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, Fibromyalgia
- Trial name
- NCT04833465
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Children's National Research Institute