Clinical trials: sponsored by University of Florida
Premature Infants, Bronchopulmonary Dysplasia
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
This study is designed to answer one of the fundamental gaps in knowledge in the resuscitation of preterm infants at birth: What is the optimal target oxygen saturation (SpO2) range that increases survival without long-term…
- Conditions
- Premature Infants, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Neurodevelopmental Outcomes
- Trial name
- OptiSTART (NCT05849077)
- Testing
- Sat75, Sat50
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- University of Texas Southwestern Medical Center
Immune Defects
Detection and Characterization of Host Defense Defects
This protocol is designed to evaluate selected patients with documented recurrent or unusual infections and their family members for clinical and laboratory correlates of immune abnormalities.
- Trial name
- NCT00001355
- Where
- United States
- Volunteers
- 3,600 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in…
- Trial name
- PEACH (NCT04837547)
- Testing
- Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- University of Florida
Recurrent Group 3 Medulloblastoma, Recurrent Group 4 (Non-SHH/Non-WNT) Medulloblastoma
Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma
This is a pilot study in a small number of children and young adults with suspected recurrent/progressive medulloblastoma (MB) looking at the feasibility and safety of adoptive cell therapy plus PD-1 blockade.
- Trial name
- MATCHPOINT (NCT06514898)
- Testing
- TTRNA-DC vaccines with GM-CSF, TTRNA-xALT, Td vaccine
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Florida
Recurrent Pulmonary Osteosarcoma, Recurrent High-grade Glioma
RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors
The Investigators have demonstrated in preclinical studies that RNA liposomes activate APCs, induce antigen-specific T cell immunity, and can supplant DCs in a cell therapy model for HGG and have shown feasibility and activity of…
- Trial name
- RNA PRIME (NCT05660408)
- Testing
- pp65 RNA LP (DP1), pp65/tumor mRNA RNA-LP (DP2), Surgical Biopsy/Resection
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Florida
High-grade Glioma, Diffuse Intrinsic Pontine Glioma
IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)
This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in newly diagnosed and recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse…
- Trial name
- Peds IMPACT (NCT06946680)
- Testing
- Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Florida
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
This is a first in children prospective study of allogeneic hematopoietic cell transplant using a centrally manufactured engineered donor graft (Orca-Q).
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Acute Undifferentiated Leukemia
- Trial name
- NCT05322850
- Testing
- Orca-Q
- Where
- 4 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Florida
Adult Glioblastoma, High Grade Glioma
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or…
- Conditions
- Adult Glioblastoma, High Grade Glioma, WHO Grade III or IV Malignant Glioma
- Trial name
- PNOC020 (NCT04573140)
- Testing
- Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- University of Florida
Duchenne Muscular Dystrophy
Tadalafil as Adjuvant Therapy for DMD
This project will assess the vascular responsiveness in leg muscles of boys with Duchenne muscular dystrophy (DMD) to one single dose of tadalafil, a common vasodilator drug, using non-invasive techniques (MRI or Doppler…
- Trial name
- NCT05195775
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Florida
HIV, PrEP
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC…
- Conditions
- HIV, PrEP, PrEP Adherence
- Trial name
- LYPS (NCT07438041)
- Testing
- LYPS, Enhanced Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Westat
Brain and Central Nervous System Tumors
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat brain tumors in young children. Using chemotherapy gives the brain more time to develop before radiation is given.
- Trial name
- NCT00602667
- Testing
- Induction Chemotherapy, Low-Risk Therapy, High-Risk Therapy
- Where
- 6 sites in United States, Australia
- Volunteers
- 293 people
- Sponsor
- St. Jude Children's Research Hospital
Obesity, Childhood, Metabolic Syndrome
FIT Families Multicomponent Obesity Intervention for African American Adolescents
Obesity is one of the most prevalent medical problems facing children and adolescents today, particularly among African American adolescents where the rate is alarmingly high.
- Trial name
- NCT04974554
- Testing
- FIT, Home-Based Family Support
- Where
- United States
- Volunteers
- 360 people
- Sponsor
- Medical University of South Carolina
Gonorrhea, Chlamydia
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also…
- Conditions
- Gonorrhea, Chlamydia, Syphilis, Sexually Transmitted Infections (STIs)
- Trial name
- NCT06738407
- Testing
- Doxycycline hyclate delayed released 200 mg, Doxycycline hyclate delayed released 200 mg weekly, Per standard of care with quarterly STI testing/treatment and sexual health counseling
- Where
- 13 sites in United States
- Volunteers
- 760 people
- Sponsor
- Westat
HIV, STIs
Combatting HIV Or Other STIs Early (CHOOSE)
The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people.
- Conditions
- HIV, STIs, STIs Prevention, HIV Prevention
- Trial name
- CHOOSE (NCT07510048)
- Testing
- Standard of care and PrEP Choice at Enrollment, Standard of care followed by PrEP Choice at Month 9
- Where
- 6 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Westat
Duchenne Muscular Dystrophy, Duchenne Disease
Evaluating VM100 Nutritional Supplement for Improving Quality of Life in Duchenne Muscular Dystrophy Patients
This pilot study will investigate the potential efficacy of VM100, a nutritional supplement specifically formulated for patients with DMD, on quality of life and physical symptoms.
- Conditions
- Duchenne Muscular Dystrophy, Duchenne Disease, Muscular Dystrophy in Children, DMD
- Trial name
- NCT07766980
- Testing
- VM100 Nutritional Supplement
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Papillomavirus Vaccines
ReMARK: Addressing Disparities in Rural HPV-related Cancer Prevention
There are three main objectives of the protocol. First, we will evaluate the added clinical- and cost- effectiveness of parent-targeted motivational aids (reminder/recall and phone-based MI) alone and when combined with…
- Trial name
- NCT06535139
- Testing
- Brief training, Parent-targeted motivational aids, Healthcare access
- Where
- United States
- Volunteers
- 4,630 people
- Sponsor
- University of Florida
Friedreich's Ataxia
Biomarkers in Friedreich's Ataxia
The purpose of this project is to characterize measures of cardiac performance and neuromuscular physiology in FA patients using novel techniques, including echocardiography and magnetic resonance imaging (MRI), metabolic…
- Trial name
- NCT02497534
- Where
- United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- University of Florida
Acanthamoeba Keratitis
Parasitic Ulcer Treatment Trial
The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis…
- Trial name
- PUTT (NCT06213649)
- Testing
- Polyhexamethylene biguanide (PHMB), Topical corticosteroid
- Where
- 22 sites in United States, Brazil and 2 more
- Volunteers
- 232 people
- Sponsor
- Jeremy Keenan, MD, MPH
Perceived Burdensomeness, Suicidal Ideation
Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth (Phase 2)
This project embeds the "Give to Others" (GO) talk therapy module in a standard, outpatient therapy protocol to demonstrate target engagement in the context of ongoing clinical care and testing the ability of the GO module to…
- Trial name
- NCT07847008
- Testing
- Safety Planning, Give to Others (GO) Module, MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Florida International University
Recurrent Medulloblastoma
RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB)
The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in pediatric patients with recurrent/progressive Medulloblastoma (MB)
- Trial name
- PNOC020 rMB (NCT07492316)
- Testing
- Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Florida