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UMC Clinical Trials

Principal Investigator
Stephen Lim, MD

Category
Infectious Disease

Title of Protocol
ACTIV-6: COVID-19 Outpatient randomized Trial to Evaluate Efficacy of Repurposed Medications.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Dahlene Fusco, MD, PhD

Category
Infectious Disease

Title of Protocol
ADMIRE-CD II: A Phase III, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, International, Multicenter study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-Derived Stem Cells (eASC), for the Treatment of Complex Perianal Fistula(s) in Patients with Crohn’s Disease over a Period of 24 Weeks and a Follow-Up Period up to 52.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Guy Orangio, MD

Category
Colorectal Surgery

Title of Protocol
ADMIRE-CD II: A Phase III, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, International, Multicenter Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-Derived Stem Cells (eASC), for the Treatment of Complex Perianal Fistula(s) in Patients with Crohn’s Disease over a Period of 24 Weeks and a Follow-Up Period up to 52.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Agustin Garcia, MD

Category
Oncology

Title of Protocol
A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects with Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Jyotsna Fuloria, MD

Category
Oncology - Multiple

Title of Protocol
RECITE: A Phase 3 Randomized Placebo-Controlled Double-Blind Study of Romiplostim for the Treatment of Chemotherapy-Induced Thrombocytopenia in Patients Receiving Oxaliplatin-Based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Jyotsna Fuloria, MD

Category
Oncology - Multiple

Title of Protocol
A Phase 3 Randomized Placebo-Controlled Double-Blind Study of Romiplostim for the Treatment of Chemotherapy-Induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Elizabeth Ellent, MD

Category
Oncology - Lung

Title of Protocol
BGB-A317-A1217-302: A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination with Tislelizumab Compared to Pembrolizumab in Patients with Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Augustin Garcia, MD

Category
Oncology - Cervical

Title of Protocol
A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Jyotsna Fuloria, MD

Category
Oncology - Esophageal

Title of Protocol
KEYNOTE 975: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Pembrolizumab (MK-3475) vs. Placebo in Participants with Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Jyotsna Fuloria, MD

Category
Oncology - Colorectal

Title of Protocol
LYNK 003: A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab with a Fluoropyrimidine in Participants with Unresectable or Metastatic Colorectal Cancer who Have Not Progressed Following First-line Induction.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Jyotsna Fuloria, MD

Category
Oncology - Liver

Title of Protocol
LEAP 012: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Jyotsna Fuloria, MD

Category
Oncology - Breast

Title of Protocol
A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Jyotsna Fuloria, MD

Category
Hematology - Breast

Title of Protocol
An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected with a Test Measuring Live Cell HER2 Signaling Transduction.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Jyotsna Fuloria, MD

Category
Oncology - Breast

Title of Protocol
The PROOF Trial: A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib vs. Gemcitabine with Cisplatin in Subjects with Advanced/Metastatic or Inoperable Cholangiocarcinoma with FGFR2 Gene Fusions/Translocations.

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Augustin Garcia, MD

Category
Oncology - Breast

Title of Protocol
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients with Metastatic Breast Cancer

Brief Description
Additional Information

Research Contact
# 504.702.2440


Principal Investigator
Brian Boulmay, MD

Category
Oncology - Head and neck

Title of Protocol
NRG-HN009: Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin Every Three Weeks vs. Radiation with Low-Dose Weekly Cisplatin for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck.

Brief Description
Additional Information

Recruitment Contact
# 504.210-2671


Principal Investigator
Brian Boulmay, MD

Category
Oncology - Anal

Title of Protocol
EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients.

Brief Description
Additional Information

Recruitment Contact
# # 504.210-2671


Principal Investigator
Agustin Garcia, MD

Category
Pulmonology

Title of Protocol
(CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response.

Brief Description
Additional Information

Recruitment Contact
# 504.210.2671


Principal Investigator
Amelia Jernigan, MD

Category
Oncology - Ovarian

Title of Protocol
A Randomized, Phase III, Two Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Monotherapy in Patients with State II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum.

Brief Description
Additional Information

Recruitment Contact
# 504.210.2671


Principal Investigator
Brian Boulmay, MD

Category
Oncology

Title of Protocol
A081801: Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO).

Brief Description
Additional Information

Recruitment Contact
# 504.210.2671


Principal Investigator
Brian Boulmay, MD

Category
Oncology - Skin

Title of Protocol
EA6174; Testing Pembrolizumab versus Observation in Patients with Merkel Cell Carcinoma after Surgery.

Brief Description
Additional Information

Recruitment Contact
# 504.210.2671


Principal Investigator
Agustin Garcia, MD

Category
Oncology - Breast

Title of Protocol
DRAGONFLY: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications.

Brief Description
Additional Information

Recruitment Contact
# 504.210.2671


Principal Investigator
Agustin Garcia, MD

Category
Oncology - Breast

Title of Protocol
A011801; The CompassHER2 trials (COMprehensive use of Pathologic Response ASSessment to optimize therapy in HER2-positive breast cancer): CompassHER2 Residual Disease (RD), a double-blinded, phase III randomized trial of T-DM1 and placebo compared with T-DM1 and tucatinib

Brief Description
Additional Information

Recruitment Contact
# 504.210.2671


Principal Investigator
Michelle Loch, MD

Category
Oncology - Endometrial

Title of Protocol
DARE: A Randomized, Phase II Trial of circulating Tumor DNA guided 2nd Line Adjuvant Therapy for High Residual Risk, Stage II-III, estrogen Receptor Positive, HER2 Negative Breast Cancer

Brief Description
Additional Information

Recruitment Contact
# 504.210.1847


Principal Investigator
Navya Nair, MD

Category
Oncology - Endometrial

Title of Protocol
NRG-GY018: A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

Brief Description
Additional Information

Recruitment Contact
# 504.210.1847


Principal Investigator
Juzar Ali, MD

Category
Pulmonology

Title of Protocol
ARISE: Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Brief Description
Additional Information

Recruitment Contact
# 504.568.4634


Principal Investigator
Juzar Ali, MD

Category
Pulmonology

Title of Protocol
ENCORE: A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

Brief Description
Additional Information

Recruitment Contact
# 504.568.4634


Principal Investigator
Juzar Ali, MD

Category
Pulmonology

Title of Protocol
ASPEN: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis

Brief Description
Additional Information

Recruitment Contact
# 504.568.4634


Principal Investigator
Juzar Ali, MD

Category
Pulmonology

Title of Protocol
Clofazimine in the treatment of pulmonary Mycobacterium avium complex (MAC) disease (MAC-CLOFAZ-001)

Brief Description
Additional Information

Recruitment Contact
# 504.568.4634


Principal Investigator
Bennett deBoisblanc, MD

Category
Pulmonology

Title of Protocol
ASTER: Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery.

Brief Description
Additional Information

Recruitment Contact
# 504.568.3451


Principal Investigator
Matthew Lammi, MD

Category
Pulmonology

Title of Protocol
COVID-19 Post-Hospital Thrombosis Prevention Study: A Multicenter, Adaptive, Prospective, Randomized Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients with COVID-19 Following Hospital Discharge

Brief Description
Additional Information

Recruitment Contact
# 504.568.3452


Principal Investigator
Matthew Lammi, MD

Category
Pulmonology

Title of Protocol
A Phase 3, Prospective, Multicenter, Double-Blind, Double-Dummy, Randomized, Active-Controlled, Parallel Group, Group-Sequential, Adaptive, Event-Driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75mg vs. Macitentan 10mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-Label Treatment Period with Macitentan 75mg

Brief Description
Additional Information

Recruitment Contact
# 504.568.3451


Principal Investigator
Matthew Lammi, MD

Category
Pulmonology

Title of Protocol
A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults with COVID-19

Brief Description
Additional Information

Recruitment Contact
# 504.568.3451


Principal Investigator
Herbert Phelan, MD

Category
Burn

Title of Protocol
DeepView SnapShot Portable (DV-SSP): Device Training Study

Brief Description
Additional Information

Recruitment Contact
# 504.702.5171


Principal Investigator
Jeffrey Carter, MD

Category
Burn

Title of Protocol
A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb® Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries

Brief Description
Additional Information

Recruitment Contact
# 504.702.5171


Principal Investigator
Charles Tuggle, MD

Category
Surgery

Title of Protocol
A Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring below the Distal Border of the Brachial Plexus Requiring Surgical Repair

Brief Description
Additional Information

Recruitment Contact
# 504.702.5171


Principal Investigator
Aaron Mammoser, MD

Category
Neurosurgery

Title of Protocol
GBM AGILE: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma.

Brief Description
Additional Information

Recruitment Contact
# 504.568.2507


Principal Investigator
Nassir Marrouche, MD

Category
Cardiology

Title of Protocol
EDORA: Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence Post-Ablation.

Brief Description
Additional Information

Recruitment Contact
# 504.988.6443


Principal Investigator
Maissaa Janbain, MD

Category
Hematology - Hemophilia

Title of Protocol
TRM-HA-301: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study with a Long-Term, Open-Label Extension to Evaluate the Efficacy and Safety of TRM-201 (Rofecoxib) in Patients with Hemophilic Arthropathy

Brief Description
Additional Information

Recruitment Contact
# 504.988.3596


Principal Investigator
Cindy Leissinger, MD

Category
Hematology - Hemophilia

Title of Protocol
The Inhibitor ERAdication Trial (ERADICATE): The Phase III Multicenter, Randomized Controlled Inhibitor Eradication Trial Comparing Eloctate Immune Tolerance Induction (ITI) plus Emicizumab vs. Eloctate ITI alone to Eradicate Inhibitor Formation in Severe Hemophilia A

Brief Description
Additional Information

Recruitment Contact
# 504.988.3596


Principal Investigator
Maissaa Janbain, MD

Category
Hematology - Hemophilia

Title of Protocol
Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth.

Brief Description
Additional Information

Recruitment Contact
# 504.988.3596

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