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ClinicalTrials.gov public records Last synced Nov 5, 2026, 4:45 AM EST

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Showing 1225–1248 of 10,355 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: Congenital, Hereditary, and Neonatal Diseases and Abnormalities Clear all
Terminated Phase 3 Interventional Results available

Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome

NCT00004500
View directory record Official record
Conditions
Meconium Aspiration
Interventions
Lucinactant, Standard Care
Drug · Other
Lead sponsor
Windtree Therapeutics
Industry
Eligibility
Up to 48 Hours
Enrollment
69 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2000 – 2004
U.S. locations
1
States / cities
Warrington, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 3, 2012 · Synced Nov 5, 2026, 4:45 AM EST
Active, not recruiting No phase listed Observational

Longitudinal Assessment of Atypical Tripeptidyl Peptidase 1 Enzyme Deficiency Patients

NCT04098211
View directory record Official record
Conditions
Neuronal Ceroid-Lipofuscinoses, Neuronal Ceroid Lipofuscinosis CLN2, Spinocerebellar Ataxia, Autosomal Recessive 7
Interventions
Not listed
Lead sponsor
Children's Hospital of Orange County
Other
Eligibility
4 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
1
States / cities
Orange, California
Source: ClinicalTrials.gov public record
Updated Apr 8, 2026 · Synced Nov 5, 2026, 4:45 AM EST
Recruiting Phase 2 Interventional

A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy

NCT07047144
View directory record Official record
Conditions
Spinal Muscular Atrophy, SMA, Spinal Muscular Atrophy Type 2, Spinal Muscular Atrophy Type 3, Neuromuscular Manifestations, Anti-myostatin
Interventions
Apitegromab, Nusinersen, Risdiplam
Drug
Lead sponsor
Scholar Rock, Inc.
Industry
Eligibility
Up to 2 Years
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
12
States / cities
Phoenix, Arizona • Orange, California • Palo Alto, California + 9 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2026 · Synced Nov 5, 2026, 4:45 AM EST
Completed Phase 2 Interventional Results available

Risperidone for the Treatment of Huntington's Disease Involuntary Movements

NCT04201834
View directory record Official record
Conditions
Huntington Disease, Chorea
Interventions
Risperidone, BioStamp nPoint device
Drug · Device
Lead sponsor
University of Rochester
Other
Eligibility
18 Years to 65 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Mar 21, 2025 · Synced Nov 5, 2026, 4:45 AM EST
Recruiting Phase 1 Interventional

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria

NCT07241234
View directory record Official record
Conditions
Phenylketonuria
Interventions
AG-181
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 69 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
3
States / cities
Indianapolis, Indiana • Pittsburgh, Pennsylvania • Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Oct 28, 2026 · Synced Nov 5, 2026, 4:45 AM EST
Completed Phase 1 Interventional

Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery

NCT03009201
View directory record Official record
Conditions
Advanced Soft Tissue Sarcoma, Locally Advanced Angiosarcoma, Locally Advanced Leiomyosarcoma, Locally Advanced Liposarcoma, Locally Advanced Malignant Peripheral Nerve Sheath Tumor, Locally Advanced Myxofibrosarcoma, Locally Advanced Undifferentiated Pleomorphic Sarcoma, Metastatic Angiosarcoma, Metastatic Epithelioid Sarcoma, Metastatic Fibrosarcoma, Metastatic Liposarcoma, Metastatic Malignant Peripheral Nerve Sheath Tumor, Metastatic Myxofibrosarcoma, Metastatic Soft Tissue Sarcoma, Metastatic Synovial Sarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma, Pleomorphic Rhabdomyosarcoma, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Undifferentiated (Embryonal) Sarcoma, Unresectable Leiomyosarcoma, Unresectable Liposarcoma, Unresectable Malignant Peripheral Nerve Sheath Tumor, Unresectable Soft Tissue Sarcoma, Unresectable Synovial Sarcoma, Unresectable Undifferentiated Pleomorphic Sarcoma
Interventions
Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Ribociclib
Drug · Other
Lead sponsor
OHSU Knight Cancer Institute
Other
Eligibility
12 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
1
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Aug 16, 2023 · Synced Nov 5, 2026, 4:45 AM EST
Terminated Phase 1 Interventional Results available

Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency Department: Phase I

NCT01256281
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
Femoral Nerve Block
Procedure
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 23, 2015 · Synced Nov 5, 2026, 4:45 AM EST
Completed Phase 1 Interventional Accepts healthy volunteers

ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers

NCT04236219
View directory record Official record
Conditions
Hyperuricemia
Interventions
ALLN-346, Placebo
Drug
Lead sponsor
Allena Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 23, 2021 · Synced Nov 5, 2026, 4:45 AM EST
Active, not recruiting No phase listed Observational Accepts healthy volunteers

COVID-19 Vaccine Responses in PIDD Subjects

NCT05321407
View directory record Official record
Conditions
X-linked Agammaglobulinemia, XLA, Primary Immune Deficiency, CVID, Common Variable Immunodeficiency, Primary Antibody Deficiencies, Secondary Hypogammaglobulinemia
Interventions
Not listed
Lead sponsor
Duke University
Other
Eligibility
6 Months and older
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2026
U.S. locations
3
States / cities
St. Petersburg, Florida • Chapel Hill, North Carolina • Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Jun 3, 2025 · Synced Nov 5, 2026, 4:45 AM EST
Completed Phase 1Phase 2 Interventional

Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency

NCT00161707
View directory record Official record
Conditions
Alpha1-antitrypsin Deficiency
Interventions
Aerosolized, Recombinant Alpha 1-Antitrypsin
Drug
Lead sponsor
Baxalta now part of Shire
Industry
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003
U.S. locations
4
States / cities
Denver, Colorado • Gainesville, Florida • Cleveland, Ohio + 1 more
Source: ClinicalTrials.gov public record
Updated May 5, 2021 · Synced Nov 5, 2026, 4:45 AM EST
Recruiting Phase 4 Interventional

Hemlibra in Mild Hemophilia A

NCT04567511
View directory record Official record
Conditions
Factor VIII Deficiency, Congenital
Interventions
Emicizumab
Drug
Lead sponsor
Indiana Hemophilia &Thrombosis Center, Inc.
Other
Eligibility
5 Years to 45 Years · Male only
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Mar 15, 2024 · Synced Nov 5, 2026, 4:45 AM EST
Recruiting Not applicable Interventional

Well-Formulated Ketogenic Diet Polycystic Kidney Disease

NCT06325644
View directory record Official record
Conditions
Polycystic Kidney Disease
Interventions
Ketogenic Diet, Ketone/Glucose Monitoring, CGM/CKM, Blood Draw, Body Composition, Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .
Other · Biological
Lead sponsor
Ohio State University
Other
Eligibility
18 Years to 65 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Nov 3, 2026 · Synced Nov 5, 2026, 4:45 AM EST
Completed No phase listed Observational

At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill

NCT06150534
View directory record Official record
Conditions
Primary Immunodeficiency Diseases (PID)
Interventions
No Intervention
Other
Lead sponsor
Takeda
Industry
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Raleigh, North Carolina
Source: ClinicalTrials.gov public record
Updated Jun 13, 2025 · Synced Nov 5, 2026, 4:45 AM EST
Recruiting Phase 1Phase 2 Interventional

FOG-001 in Locally Advanced or Metastatic Solid Tumors

NCT05919264
View directory record Official record
Conditions
Cancer, Colorectal Cancer, Solid Tumor, Locally Advanced Solid Tumor, Metastatic Cancer, WNT Pathway, HCC, Desmoid, Microsatellite Stable Colorectal Cancer, Metastatic Castration-resistant Prostate Cancer, Familial Adenomatous Polyposis (FAP), Endometrial Carcinoma, Prostate Cancer, Microsatellite Instability-High Colorectal Cancer, Adamantinomatous Craniopharyngioma
Interventions
FOG-001, mFOLFOX-6, Nivolumab, Trifluridine/tipiracil, Bevacizumab
Drug
Lead sponsor
Parabilis Medicines, Inc.
Industry
Eligibility
18 Years and older
Enrollment
619 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
31
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Tucson, Arizona + 25 more
Source: ClinicalTrials.gov public record
Updated Oct 7, 2026 · Synced Nov 5, 2026, 4:45 AM EST
Completed No phase listed Observational Results available

Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment

NCT04053699
View directory record Official record
Conditions
Von Willebrand Diseases
Interventions
Von Willebrand Factor-Containing Product
Drug
Lead sponsor
Octapharma
Industry
Eligibility
66 Months and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Dec 7, 2023 · Synced Nov 5, 2026, 4:45 AM EST
Completed Phase 1 Interventional

A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies

NCT00343798
View directory record Official record
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Burkitt Lymphoma, Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Contiguous Stage II Adult Lymphoblastic Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Burkitt Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Noncontiguous Stage II Adult Lymphoblastic Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Previously Treated Myelodysplastic Syndromes, Prolymphocytic Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Refractory Chronic Lymphocytic Leukemia, Refractory Multiple Myeloma, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Splenic Marginal Zone Lymphoma, Stage I Adult Burkitt Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Mixed Cell Lymphoma, Stage I Adult Immunoblastic Large Cell Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Childhood Lymphoblastic Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Childhood Lymphoblastic Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma
Interventions
cyclophosphamide, fludarabine phosphate, cyclosporine, mycophenolate mofetil, ex-vivo umbilical cord blood expansion, double-unit umbilical cord blood transplantation, biopsy, immunologic technique, diagnostic laboratory biomarker analysis
Drug · Other · Procedure
Lead sponsor
Fred Hutchinson Cancer Center
Other
Eligibility
6 Months to 45 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2006
U.S. locations
4
States / cities
Duarte, California • Aurora, Colorado • Denver, Colorado + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 11, 2015 · Synced Nov 5, 2026, 4:45 AM EST
Completed Not applicable Interventional Results available

BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease

NCT02655887
View directory record Official record
Conditions
May-Thurner Syndrome, Peripheral Vascular Disease, Venous Disease, Iliofemoral Occlusive Disease
Interventions
VENOVO™ Venous Stent
Device
Lead sponsor
C. R. Bard
Industry
Eligibility
18 Years and older
Enrollment
170 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
12
States / cities
Darien, Connecticut • New Haven, Connecticut • Davenport, Iowa + 9 more
Source: ClinicalTrials.gov public record
Updated Feb 4, 2021 · Synced Nov 5, 2026, 4:45 AM EST
Recruiting No phase listed Observational Accepts healthy volunteers

Functional Evaluation in Patients With Urea Cycle Disorders (UCD) During a Driving Task

NCT07701694
View directory record Official record
Conditions
Urea Cycle Disorder
Interventions
Not listed
Lead sponsor
St. Jude Children's Research Hospital
Other
Eligibility
16 Years to 40 Years
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2032
U.S. locations
1
States / cities
Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated Jul 31, 2026 · Synced Nov 5, 2026, 4:45 AM EST
Completed Phase 2Phase 3 Interventional

Phase 2/3 Oxabact Study

NCT01037231
View directory record Official record
Conditions
Primary Hyperoxaluria
Interventions
Oxalobacter formigenes, Placebo
Biological · Drug
Lead sponsor
OxThera
Industry
Eligibility
2 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated May 15, 2013 · Synced Nov 5, 2026, 4:45 AM EST
Recruiting Phase 2 Interventional

Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease

NCT03121001
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
ATG, fludarabine, cyclophosphamide, Total body irradiation, Stem cell infusion, Sirolimus, mycophenolate mofetil
Drug · Radiation · Procedure
Lead sponsor
University of Illinois Chicago
Other
Eligibility
16 Years to 60 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2029
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jul 8, 2026 · Synced Nov 5, 2026, 4:45 AM EST
Completed Phase 1 Interventional Accepts healthy volunteers

Flaxseed Modulates Inflammation and Oxidative Stress in CF

NCT02014181
View directory record Official record
Conditions
Cystic Fibrosis, Oxidative Stress, Inflammation
Interventions
finely ground flaxseed powder
Dietary Supplement
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 64 Years
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2013
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 7, 2014 · Synced Nov 5, 2026, 4:45 AM EST
Completed Phase 3 Interventional

Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants

NCT00006401
View directory record Official record
Conditions
Lung Diseases, Bronchopulmonary Dysplasia
Interventions
iNO, Placebo
Drug · Other
Lead sponsor
University of Colorado, Denver
Other
Eligibility
Up to 1 Year
Enrollment
793 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2000 – 2007
U.S. locations
14
States / cities
Phoenix, Arizona • Loma Linda, California • Los Angeles, California + 11 more
Source: ClinicalTrials.gov public record
Updated Oct 6, 2015 · Synced Nov 5, 2026, 4:45 AM EST
Completed Phase 3 Interventional Results available

High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)

NCT01313507
View directory record Official record
Conditions
Primary Immunodeficiency Disease
Interventions
NewGam
Biological
Lead sponsor
Octapharma
Industry
Eligibility
2 Years to 75 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
6
States / cities
Irvine, California • Centennial, Colorado • Chicago, Illinois + 3 more
Source: ClinicalTrials.gov public record
Updated Mar 29, 2017 · Synced Nov 5, 2026, 4:45 AM EST
Recruiting Not applicable Interventional

Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease

NCT06555939
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
Collaborative Care Model, Promoting Resilience in Stress Management
Behavioral
Lead sponsor
Boston Children's Hospital
Other
Eligibility
8 Years to 25 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 5, 2026 · Synced Nov 5, 2026, 4:45 AM EST