University Hospital - UMMC
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Address:
2500 N. State St.
Jackson, MS 39216
Contact Us:
(601) 984-1000
Parking:
Directions:
From North State Street, turn onto campus from the stoplight at University Drive (across from Veterans Memorial Stadium). Turn left onto University Drive, and Garage A will be on your right.
Our Care Specialties at this location:
- Adult Psychiatry
- Cancer
- Children's Anesthesiology
- Children's Cancer and Blood Disorders
- Children's Hand Surgery
- Children's Hospital Medicine
- Children's Orthopaedics
- Children's Radiation Oncology
- Children's Radiology
- General Surgery
- Hand Surgery and Trauma
- Hospital Medicine
- Neurosurgery
- Orthopaedic
- Palliative Care
- Psychology
- Pulmonary and Critical Care
- Radiology
- Sleep Medicine
- Stroke
Our Providers who practice at this location:
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Derrick L. Burgess, MDSpecialties:
Orthopaedic, Cartilage Restoration, Sports Medicine, Arthroscopy and Minimally Invasive Surgery
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orthopedic, orthopedist, orthopaedist, concussion, knee, meniscal, ACL, joint | ||||||||||||||||
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pediatric, neuropsychology, neurologist, childrens neurosurgery, epilepsy, brain, children neurosurgery, pediatric neurosurgery, neurosurgeon | ||||||||||||||||
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ccu, neonatal icu, children critical care, pediatric icu, pediatric critical care, pediatric intensive care, childrens critical care, nicu | ||||||||||||||||
Luke C. Drake, MD, MSSpecialties:
Orthopaedic, Children's Orthopaedics, Orthopaedic Spine
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orthopedic, orthopedist, orthopaedist, pediatric orthopaedics, children's orthpedics, childrens orthopedics, children orthopaedics, pediatric orthopedics, childrens orthopaedics, childrens orthopedics, scoliosis, orthopedic, spinal, orthopedist, discectomy, disc, lumbar, cervical, back, laminectomy | ||||||||||||||||
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orthopedic, orthopedist, orthopaedist, pediatric orthopaedics, children's orthpedics, childrens orthopedics, children orthopaedics, pediatric orthopedics, childrens orthopaedics, childrens orthopedics | ||||||||||||||||
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Joaquin Hidalgo, MDSpecialties:
Children's Neurosurgery, Adult Cranial Neurosurgery, Neurosurgery, Spinal Neurosurgery
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pediatric, neuropsychology, neurologist, childrens neurosurgery, epilepsy, brain, children neurosurgery, pediatric neurosurgery, neurosurgeon, cranial, brain, neurosurgeon, skull, vascular, back, head, cervical, discectomy, lumbar, scoliosis, herniated disk, neurosurgeon, spondylolisthesis, back decompression, laminectomy, spine, slipped disc | ||||||||||||||||
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orthopedic, orthopedist, orthopaedist, pediatric orthopaedics, children's orthpedics, childrens orthopedics, children orthopaedics, pediatric orthopedics, childrens orthopaedics, childrens orthopedics | ||||||||||||||||
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childhood diseases, hiv, children infectious disease, pediatric diseases, infection, childrens infectious disease, pediatric infectious disease | ||||||||||||||||
Jonathan D. Princiotta, MSN, CPNP-ACSpecialties:
Children's Emergency Medicine, Orthopaedic, Children's Orthopaedics
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pediatric emergency medicine, emergency, pediatric, children emergency medicine, emergency room, childrens emergency medicine, er, urgent care, orthopedic, orthopedist, orthopaedist, pediatric orthopaedics, children's orthpedics, childrens orthopedics, children orthopaedics, pediatric orthopedics, childrens orthopaedics, childrens orthopedics | ||||||||||||||||
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dialysis, stones, nephrologist, renal | ||||||||||||||||
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psychiatry, cpap, snoring, apnea | ||||||||||||||||
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childrens palliative medicine, pediatric palliative medicine, end of life care, terminal care, hospice, children palliative medicine | ||||||||||||||||
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childhood diseases, hiv, children infectious disease, pediatric diseases, infection, childrens infectious disease, pediatric infectious disease | ||||||||||||||||
James M. Shiflett, MDSpecialties:
Children's Neurosurgery, Epilepsy, Neurosurgery
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pediatric, neuropsychology, neurologist, childrens neurosurgery, epilepsy, brain, children neurosurgery, pediatric neurosurgery, neurosurgeon, seizure, seizures, epileptic, vascular, back, head | ||||||||||||||||
Hamdi Sukkarieh, MDSpecialties:
Orthopaedic, Children's Orthopaedics, Orthopaedic Spine
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orthopedic, orthopedist, orthopaedist, pediatric orthopaedics, children's orthpedics, childrens orthopedics, children orthopaedics, pediatric orthopedics, childrens orthopaedics, childrens orthopedics, scoliosis, orthopedic, spinal, orthopedist, discectomy, disc, lumbar, cervical, back, laminectomy | ||||||||||||||||
Deandria M. Thompson, MPAS, PA-CSpecialties:
Orthopaedic, Children's Orthopaedics
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orthopedic, orthopedist, orthopaedist, pediatric orthopaedics, children's orthpedics, childrens orthopedics, children orthopaedics, pediatric orthopedics, childrens orthopaedics, childrens orthopedics | ||||||||||||||||
Laura J. Vaughan-Robinson, PhD, MS, CCC-SLPSpecialties:
Speech Language Pathology
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speech therapist, articulation disorder, speech language pathologist, therapy, language pathologist, voice disorder, speech, tep, pathologist, language therapy, pediatric speech therapy, delay disorder, ent speech language pathology, oral myofunctional disorder, voice, ent slp, language disorder, cognition, lymphadema, resonance disorder, language development, speech pathologist, speech, swallowing, language, oral motor | ||||||||||||||||
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Kristin J. Weaver, MDSpecialties:
Children's Neurosurgery, Adult Cranial Neurosurgery, Neurosurgery, Spinal Neurosurgery
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pediatric, neuropsychology, neurologist, childrens neurosurgery, epilepsy, brain, children neurosurgery, pediatric neurosurgery, neurosurgeon, cranial, brain, neurosurgeon, skull, vascular, back, head, cervical, discectomy, lumbar, scoliosis, herniated disk, neurosurgeon, spondylolisthesis, back decompression, laminectomy, spine, slipped disc | ||||||||||||||||
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Patrick B. Wright, MDSpecialties:
Children's Orthopaedics, Orthopaedic Spine, Orthopaedic Trauma, Orthopaedic Nonunions and Malunions
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pediatric orthopaedics, children's orthpedics, childrens orthopedics, children orthopaedics, pediatric orthopedics, childrens orthopaedics, childrens orthopedics, scoliosis, orthopedic, spinal, orthopedist, discectomy, disc, lumbar, cervical, back, laminectomy, orthopedist, orthopaedist, orthopedic, orthopedist, orthopaedist, orthopedic | ||||||||||||||||
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pediatric orthopaedics, children's orthpedics, childrens orthopedics, children orthopaedics, pediatric orthopedics, childrens orthopaedics, childrens orthopedics |
Our Clinical Trials offered at this location:
Researchers at UMMC are committed to discovering innovative ways to prevent and treat the diseases that affect our daily lives. Clinical research studies play a vital role in the advancement of medicine and can improve the well-being of our families, friends, communities, and future generations. In this way, participation in clinical research studies furthers our vision to create "a healthier Mississippi."
Partnering with UMMC’s researchers may have many advantages, including:
- Gaining access to investigational treatments
- Increasing knowledge about your own health
- Giving the gift of improved health to our communities and future generations
- Contributing to the advancement of science by helping researchers learn more about how the human body and mind work or by helping find a cure or better treatments for diseases
| Clinical Trials | Publish Date | Description | ||||||||||||
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21177: A randomized, double-blind, placebo controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney DiseaseIRB Number: 2022-48
Published: September 02, 2022
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20220902102021 |
The purpose of this study is to look at how well the new study drug, Finerenone, works in patients with non-diabetic chronic kidney disease. chronic kidney disease;finerenone;bay94-8862 21177 Delia Y. Owens tshafi Kidney/Renal Conditions |
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A Clinical Evaluation of the ATTUNE Revision System in Revision Total Knee ArthroplastyIRB Number: 2017-0103
Published: May 28, 2019
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20190528151335 |
This study will provide opportunities for active post-market surveillance of adverse effects in relation to use of the study device as well as providing both the patient's and clinician's perspectives of implant performance.<br> orthopedics;rehabilitation;surgery 15011 Leslie Johnson bstronach Orthopaedics Rehabilitation Services Surgery |
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A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn's DiseaseIRB Number: 2019-0309
Published: January 08, 2020
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20200108094703 |
<div>Crohn's disease (CD) is a relapsing and remitting form of inflammatory bowel disease (IBD) that causes gastrointestinal signs and symptoms of diarrhea, abdominal pain, weight loss, and the passage of blood or mucous per rectum. The inflammation of CD can involve the mucosal surface of the gastrointestinal tract and penetrate through the full thickness of the gastrointestinal</div><div>wall, including the serosal surface. A need for safer, better tolerated, durable efficacious therapies for patients with CD exists. Despite significant uptake in the use of anti-TNF agents, tolerability of anti-TNFs due to allergic and autoimmune reactions, lack of durable response, and significant increased risk of infection remain problematic. Filgotinib is a once daily, oral therapy that may prove efficacious without the risk of allergic and autoimmune phenomena observed with anti-TNF agents.This is a long-term extension study to provide treatment with filgotinib for subjects with moderately to severely active CD (who have completed or met protocol specified efficacy</div><div>discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for CD) for</div><div>144 weeks.</div> digestive conditions;digestion;pediatrics GS-US-419-3896 Olivia Henry scglover Digestive Conditions |
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A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-COV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with Covid-19IRB Number: 2020V0205
Published: August 17, 2020
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20200817091015 |
A study to evaluate
the effects of monoclonal antibodies in adult outpatients with COVID-19 and its
efficacy in preventing progression to moderate/severe COVID-19.<br> coronavirus;covid;covid-19;lungs;infectious diseases R10933-10987-COV-2067 Amy Wigglesworth gmarshall COVID-19 (Coronavirus) |
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A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)IRB Number: 2019-0027
Published: May 29, 2019
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20190529104313 |
The purpose of this study screening step is to test specific genes and proteins in your tumor sample cancer LUNGMAP Jennifer Barnes jruckdeschel Cancer |
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A Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee ArthroplastyIRB Number: 2017-0088
Published: May 28, 2019
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20190528152334 |
The primary outcome of this study is to evaluate the postoperative change that patients report for the ATTUNE Revision Total Knee Arthroplasty fixed bearing configuration and rotating platform component. <br> surgery;rehabilitation services;orthopedics DSJ-2016-03 Leslie Johnson bstronach Orthopaedics Rehabilitation Services Surgery |
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A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19IRB Number: 2020V0136
Published: October 22, 2020
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20201022124942 |
This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients coronavirus;covid;covid-19 NCT04505774 Dr. Matthew Kutcher mkutcher COVID-19 (Coronavirus) |
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A Multicenter, Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health RecordsIRB Number: 2020V0238
Published: August 11, 2020
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Clinical Trial Locations:
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20200811133248 |
<p>Researchers at UMMC are partnering with UMMC healthcare workers and patients to better understand the spread of COVID-19. Study participants are asked to complete short online questionnaires over several months about possible exposures, symptoms, and healthcare visits. Some volunteers may be asked to complete an in-home test kit for antibodies to COVID-19.</p><p><b>What is the purpose and goal of this study?</b></p><p>As you are aware, the COVID-19 pandemic is a global public health emergency. By studying who has been exposed and possibly infected, better identifying the timing and circumstances of exposure, and where infection patterns of the COVID-19 are advancing, researchers can help the medical community better understand the pandemic and develop strategies and treatments to contain and possibly eliminate it.</p><p><p>The goal of this study is to collect information about the community’s COVID-19 exposures, symptoms, and health care visits due to the disease. If you are a health care worker, the study will collect information on your use of personal protective equipment.</p><p>There is no cost for participating.</p><p>The information collected about you is for research purposes only. This information will not be used to guide your medical care. Your doctor or health care provider will not have access to this information. </p><p>For more information about clinical research study participation, visit <a href="https://umc.edu/Research/Research-Offices/Clinical-Trials/Participants/Home.html">https://umc.edu/Research/Research-Offices/Clinical-Trials/Participants/Home.html</a></p><p><p>For those interested in participating in this trial, please call <a href="tel:16018159522">601-815-9522</a> or email <a href="mailto:COVID19communitystudy@umc.edu">COVID19communitystudy@umc.edu</a></p><p>If you wish to be contacted about participating in the trial, you can also <a href="https://umc.edu/Research/Research-Offices/Clinical-Trials/Participants/Become.html">click here</a> to fill out our general interest form.</p><p>For the Informed
Consent and Enrollment Questionnaire <a href="https://redcap.umc.edu/surveys/?s=3DCAPXRRHT">click here</a><br></p> coronavirus;covid;covid-19 Pending Courtney Gomillia lmena COVID-19 (Coronavirus) |
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A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction ≥ 40% (LVEF ≥ 40%)IRB Number: 2020V0284
Published: January 14, 2022
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20220114161531 |
<div>The purpose of this study is to look at how well the study drug, Finerenone, works in patients <span style="font-size: 1rem; color: #0a0a0a;">with heart failure, to learn if the study drug is safe for the patients and how it </span><span style="font-size: 1rem;">affects the body</span></div> heart health 20103 Theresa Hutson rlong Heart Health |
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative ColitisIRB Number: 2020-0032
Published: February 21, 2020
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20200221155941 |
The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely active ulcerative colitis (UC). digestion;digestive conditions M14-675 Yilianys Pride scglover Digestive Conditions |
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis.IRB Number: 2020-0025
Published: February 21, 2020
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20200221154604 |
<div>This is a Phase 2b/3, multi center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and pharmacokinetics of upadacitinib as</div><div>induction and maintenance therapy in subjects with moderately to severely active Ulcerative Colitis.</div><div>The study comprises 3 sub studies: a Phase 2b dose-ranging induction sub study (Sub study 1), a Phase 3 dose-confirming induction sub study (Sub study 2), and a Phase 3 maintenance sub study (Sub study 3).</div> digestive conditions;digestion 2016-000641-31 Yilianys Pride scglover Digestive Conditions |
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A Multicenter, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients with Diabetic Cardiomyopathy / Stage B Heart Failure at High Risk of Progression to Overt Heart Failure (Stage C Heart Failure)IRB Number: 2020V0166
Published: October 20, 2021
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20211020154932 |
To evaluate the efficacy of AT-001 compared with placebo in preventing death or
hospitalization due to cardiac events. cardiac;heart;heart health AT-001-2001 Theresa Hickey lpapadimitriou Heart Health |
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A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (Anti-FRα Antibody-drug Conjugate) in Adult Patients With Recurrent Gynaecological CancersIRB Number: 2024-276
Published: June 25, 2025
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Clinical Trial Locations:
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20250625164130 |
<div style="box-sizing: border-box; margin-top: 0.5rem; font-weight: 700; font-size: 14px; color: #565c65; padding-bottom: 2px; border-bottom: 1px solid #dfe1e2; margin-bottom: 8px; text-transform: capitalize; font-family: Roboto, sans-serif; background-color: #ffffff;">rief Summary</div><div style="box-sizing: border-box; margin-bottom: 20px; color: #171716; line-height: 1.62; font-family: Roboto, sans-serif; background-color: #ffffff;">IIMGN151-1001 is a Phase 1, first in human, open-label dose-escalation, optimization, and expansion study designed to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of IMGN151 in adult participants with recurrent endometrial cancer; recurrent, high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers; or recurrent cervical cancers. All participants will be, in the opinion of the investigator, appropriate for nonplatinum single-agent therapy for their next line of therapy.</div><div style="box-sizing: border-box; position: relative; width: 743px; flex: 0 1 auto; font-weight: 700; font-size: 14px; color: #565c65; padding-bottom: 2px; border-bottom: 1px solid #dfe1e2; margin-bottom: 8px; text-transform: capitalize; font-family: Roboto, sans-serif; background-color: #ffffff;">Detailed Description</div><div style="box-sizing: border-box; margin-bottom: 20px; color: #171716; line-height: 1.62; font-family: Roboto, sans-serif; background-color: #ffffff;">Participants may continue on study drug based on clinical benefit until disease progression, adverse event (AE) requiring discontinuation, withdrawal of consent, physician decision, or other discontinuation criteria are met.</div> endometrial;ovarian;peritoneal;fallopian;fallopian tube IMGN151-1001 Winona Blount rocconi Cancer Women's Health |
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A Phase 1b/2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects with Severe Coronavirus Disease 2019 (COVID-19)IRB Number: 2020-0092
Published: April 16, 2020
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Clinical Trial Locations:
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20200416183528 |
Evaluation of the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines. covid;covid-19;coronavirus TJ003234COV201 Jamie Brown gmarshall COVID-19 (Coronavirus) |
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A Phase 2/3 Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of MK-4482 in Hospitalized Participants ≥18 Years of Age with COVID-19IRB Number: 2020V0307
Published: September 08, 2020
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Clinical Trial Locations:
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20200908152645 |
This study seeks to evaluate the efficacy, tolerability, and safety of MK-4482 (a novel ribonucleoside analog prodrug with broad-spectrum antiviral activity against a range of RNA viruses).. coronavirus;covid;covid-19 001-00 Jamie Brown unandi COVID-19 (Coronavirus) |
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A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative ColitisIRB Number: 2020-0031
Published: February 21, 2020
View Locations
Clinical Trial Locations:
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20200221155350 |
To evaluate the long-term safety and efficacy of upadacitinib in subjects with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have completed Study M14-234 Substudy 3. digestion;digestive conditions M14-533 Yilianys Pride scglover Digestive Conditions |
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A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of TherapyIRB Number: 2023-72
Published: November 20, 2023
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20231120093557 |
talquetamab, daratumumab, pomalidomide, multiple myeloma, cancer, elkins 64407564MMY3002 Jennifer Barnes Stephanie Elkins Cancer |
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A Phase 3 Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After TransplantIRB Number: 2023-111
Published: November 20, 2023
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20231120093859 |
<div>The purpose of the study is to evaluate whether elranatamab monotherapy can provide <span style="font-size: 1rem; color: #0a0a0a;">clinical benefit compared to lenalidomide monotherapy (control) in participants with newly </span><span style="font-size: 1rem;">diagnosed multiple myeloma who are MRD-positive after undergoing ASCT.</span></div> elkins, multiple myeloma, cancer, stem cell, elranatamab, lenalidomide C1071007 Jennifer Barnes Stephanie Elkins Cancer |
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A Phase 3, Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec Granules Containing 2 grams of Secnidazole for the Treatment of TrichomoniasisIRB Number: 2019-0217
Published: November 22, 2019
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20191122155345 |
This study will evaluate the efficacy and safety of a single, oral dose of Solosec compared to placebo for the treatment of trichomoniasis. women's health;pediatrics;infectious diseases SEC-WH-301 Courtney Sims Gomillia lmena Infectious Diseases Women's Health |
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A Phase 3, Open-Label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationIRB Number: 2018-0129
Published: June 27, 2019
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20190627111426 |
This study will evaluate the long-term effects of an experimental drug in Cystic Fibrosis patients who completed a previous Vertex study. lungs;pediatrics VX17-659-105 Sandra Tyler jspurzem Digestive Conditions Lungs/Breathing Pediatrics |
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A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 InfectionIRB Number: 2020V0356
Published: October 26, 2021
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20211026105654 |
To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the prevention of HIV-1 infection as assessed by the incidence rate per year of confirmed HIV-1 infections. infectious diseases;men's health MK-8591-022 Courtney Gomillia lmena Infectious Diseases |
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A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 InfectionIRB Number: 2020V0276
Published: October 26, 2021
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20211026131706 |
To evaluate the efficacy of oral ISL QM
compared to FTC/TDF QD for the
prevention of HIV-1 infection as assessed by
the incidence rate per year of confirmed
HIV-1 infections in women. infectious diseases MK-8591 Courtney Gomillia lmena Infectious Diseases |
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2IRB Number: 2020V0234
Published: August 17, 2020
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20200817091850 |
A study to evaluate
the effects of monoclonal antibodies in adult outpatients with COVID-19 and its
efficacy in preventing progression to moderate/severe COVID-19.<br> coronavirus;covid;covid-19 R10933-10987-COV-2069 Courtney Gomillia jlucarlloveras COVID-19 (Coronavirus) |
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A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of intravenous efzofitimod in patients with pulmonary sarcoidosisIRB Number: 2023-61
Published: September 13, 2023
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20230913123644 |
<p><span><span style="font-size:10.5pt;font-family:&quot;Helvetica Neue&quot;;
color:black;background:white">This study will assess the efficacy of
efzofitimod in patients with pulmonary sarcoidosis, assess the safety and
tolerability of efzofitimod in patients with pulmonary sarcoidosis, and explore
the utility of serum biomarkers in the evaluation of interventions to treat
pulmonary sarcoidosis.</span></span><span style="font-size: 12pt; font-family: &quot;Helvetica Neue&quot;;"></span></p> lung;breathing;wilhelm;efzofitimod;pulmonary sarcoidosis;sarcoidosis aTyr1923-C-001 Jennifer Lowery Andrew, Wilhelm, DO Lungs/Breathing |
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A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at SurgeryIRB Number: 2024-276
Published: June 25, 2025
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20250625165217 |
<span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.</span> 2870-012;tnbc;breast;breast cancer;triple negative breast neoplasms;triple negative breast cancer MK2870-012 Winona Blount bcraft Cancer Women's Health |
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A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Patient Optimization With ustEkinumab Re-induction POWER)IRB Number: 2019-0273
Published: December 04, 2019
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20191204160045 |
<div>This is a randomized, double-blind, placebo-controlled, multicenter, 24-week, Phase 3b study in adult patients with active moderate to severe Crohn's disease who initially responded to ustekinumab induction therapy per label followed, at any time, by secondary lost of response (LoR) to SC q8w ustekinumab maintenance therapy. The benefit of a single weight-tiered based IV re-induction dose of 6 mg/kg body weight ustekinumab versus continuous SC q8w maintenance treatment will be evaluated. <span style="font-size: 1rem; color: #0a0a0a;">This study is intending to evaluate the achievement of clinical response at Week 16 following a single IV re-induction dose of 6 mg/kg ustekinumab, compared with continuing regular SC q8w 90 mg ustekinumab administration, in participants with secondary loss of response (LoR) to SC q8w 90 mg ustekinumab maintenance therapy.</span></div> digestion;digestive conditions CNTO1275CRD3008 Yilianys Pride scglover Digestive Conditions |
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A Phase I, open-label, dose finding study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of OBT076, a CD205-directed antibody-drug conjugate, in recurrent and/or metastatic CD205-positive solid tumors and in women with CD205-positive HER2-negative metastatic breast cancerIRB Number: 2021-0541
Published: September 14, 2023
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20230914075648 |
The purpose of this study is to evaluate OBT076, a drug that combines an antibody with the anti-cancer drug. This study will look at several dose levels of the study drug to find out the highest does level that is safe and well-tolerated and to look at the side effects of the study drug in a small group of people. OBT076 is experimental.<div><br></div> tang;obto076-001;cancer;recurrent cancer;metastatic cancer OBT076-001 Jennifer Barnes John Henegan Cancer |
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A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk FeaturesIRB Number: 2021-0520
Published: March 27, 2025
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20250327124639 |
<span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.</span> head;head and neck;neck;cancer;morgan EA3191 Winona Blount dpmorgan Cancer Neurosciences |
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A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)IRB Number: 2022-459
Published: March 25, 2025
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20250325173703 |
This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Combination therapy with atezolizumab and cabozantinib may shrink the cancer and allow a longer survival time in patients with metastatic renal cell carcinoma. prcc;rcc;cancer;henegan;kidney cancer S2200 Winona Blount jhenegan Cancer Kidney/Renal Conditions |
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A Phase II Randomized Trial of Cabozantinib (NSC #761968) with or without Atezolizumab (NSC #783608) in Patients with Advanced Papillary Renal Cell Carcinoma (PAPMET2).IRB Number: 2022-459
Published: November 20, 2023
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20231120110550 |
<span style="color: #171716; font-family: Roboto, sans-serif; font-size: 16px; background-color: #ffffff;">This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Combination therapy with atezolizumab and cabozantinib may shrink the cancer and allow a longer survival time in patients with metastatic renal cell carcinoma.</span> henegan, cancer, cabozantinib, atezolizumab, advanced papillary renal cell carcinoma, papmet2 S2200 Jennifer Barnes John Henegan Cancer |
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A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)IRB Number: 2019-0132
Published: March 25, 2025
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20250325150150 |
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone. genitourinary;cancer;henegan A031702 Winona Blount jhenegan Cancer |
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A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 TherapyIRB Number: 2021-0584
Published: March 25, 2025
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20250325162803 |
This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer. bladder;urothelial cancer;henegan S1937 Winona Blount jhenegan Cancer |
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A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination with Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)IRB Number: 2022-0657
Published: November 20, 2023
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20231120091637 |
muscle, muscle invasive, bladder cancer, cancer, henegan, astrazeneca D910PC00001 Jennifer Barnes John Henegan Cancer |
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A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate CancerIRB Number: 2023-333
Published: June 25, 2025
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20250625162037 |
<span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other serious adverse reaction(s) in the long-term in adults with </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.</span> henegan;prostate;prostate cancer;cancer CAAA617A12402 Winona Blount jhenegan Cancer Men's Health |
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A Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast CancerIRB Number: 2018-0183
Published: May 28, 2019
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20190528151931 |
The purpose of this study is to test whether Carvedilol (Coreg) can reduce the occurrence of heart problems during cancer treatment. <br> cancer S1501 Jennifer Barnes bcraft Cancer |
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A qualitative hybrid III implementation study to identify and evaluate strategies for successful implementation of the cabotegravir + rilpivirine long-acting injectable regimen in the USIRB Number: 2019-0161
Published: August 26, 2019
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20190826145213 |
This study will test the efficacy of two long acting HIV antiretroviral medications administered as injections every month. This study will help us to understand the barriers and facilitators using this method of treatment and what training and support clinics need to deliver this injectable medication to patients. infectious diseases 209493 Courtney Sims Gomillia lmena Infectious Diseases |
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A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular DiseaseIRB Number: 2024-316
Published: June 25, 2025
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20250625101247 |
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk. elevated lp(a);cardiovascular disease;pelacarsen;tqj230;cardiovascular diseases;arteriosclerosis;heart disease CTQJ230A12303 Kimberly McGuire vgarla Heart Health |
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A Randomized Phase II Study of INC280 (Capmatinib) Plus Osimertinib With or Without Ramucirumab in Participants With EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)IRB Number: 2023-413
Published: June 25, 2025
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20250625162940 |
<div style="position: relative; color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"><div style="overflow-y: hidden;">This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has EGFR and MET gene changes. Capmatinib and osimertinib are in a class of medications called kinase inhibitors. They work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving capmatinib, osimertinib, and/or ramucirumab and targeting abnormal gene changes in tumor cells may be effective in shrinking or stabilizing advanced non-small cell lung cancer.</div><div><br></div></div><a href="https://clinicaltrials.gov/#"></a> morgan;nsclc;non-small cell lung cancer;cancer;lung;non small cell lung cancer S1900G Winona Blount dpmorgan Cancer Lungs/Breathing |
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A RANDOMIZED PHASE III TRIAL COMPARING ACTIVE SYMPTOM MONITORING PLUS PATIENT EDUCATION VERSUS PATIENT EDUCATION ALONE TO IMPROVE PERSISTENCE WITH ENDOCRINE THERAPY IN YOUNG WOMEN WITH STAGE I-III BREAST CANCER (ASPEN)IRB Number: 2022-69
Published: November 20, 2023
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20231120105244 |
<div>To compare persistence with the initially prescribed oral endocrine therapy (ET) <span style="font-size: 1rem; color: #0a0a0a;">through 72 weeks for young women being treated for hormone-receptor positive </span><span style="font-size: 1rem;">stage I-III breast cancer randomized to Active Symptom Monitoring (ASM) + </span><span style="font-size: 1rem;">patient education or patient education alone.</span></div> breast cancer, cancer, craft, endocrine, endocrine therapy S2010 Jennifer Barnes Barbara Craft Cancer |
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A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell TransplantIRB Number: 2019-0212
Published: September 24, 2019
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20190924092657 |
The purpose of this study is to find out whether treatment with daratumumab and lenalidomide improves disease response in Multiple Myeloma. cancer;bone marrow transplant l 54767414MMY3021 Jennifer Barnes selkins Cancer |
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A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATIONIRB Number: 2023-111
Published: March 27, 2025
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20250327135600 |
<span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years</span> myeloma;multiple myeloma;elkins C1071007 Winona Blount selkins Cancer |
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A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome - RECONNECTIRB Number: 2021-0614
Published: January 24, 2022
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20220124233647 |
<div><span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">The purpose of this study is to investigate of effective and safe ZYN002 transdermal gel is in patients with Fragile X Syndrom (FXS). </span><span style="font-family: Arial, sans-serif; font-size: 11pt;">The Drug Product
ZYN002 is a pharmaceutically manufactured </span><span style="font-family: Arial, sans-serif; font-size: 11pt;">Cannabidiol (CBD)</span><span style="font-family: Arial, sans-serif; font-size: 11pt;">. It is being developed as a clear
gel</span><i style="font-family: Arial, sans-serif; font-size: 11pt;"> </i><span style="font-family: Arial, sans-serif; font-size: 11pt;">that can be applied to the skin
(called transdermal delivery), to provide consistent, controlled levels of CBD
in the blood when it is given twice a day</span></div> zyn002;fragile x syndrome;cannabidiol (cbd);zynerba ZYN2-CL-033 Shelby Lee jingram Developmental Disorders Genetics Pediatrics |
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A Randomized, Double-Blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and OlderIRB Number: 2020V0285
Published: October 23, 2020
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20201023131954 |
The study will enroll up to 60,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.<div><br></div> coronavirus;covid;covid-19;vaccine CovPN3003 Joshua Agee lmena COVID-19 (Coronavirus) |
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19IRB Number: 2020V0180
Published: September 08, 2020
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20200908151006 |
The objective of the study is to evaluate the efficacy and safety of intramuscular administration of PLX-PAD (mesenchymal stem cells) for the treatment of severe COVID-19 (hospitalized, mechanicaly ventilated, adult patients diagnosed with severe COVID-19 and ARDS). coronavirus;covid;covid-19 PLX-COV-01 Luis Shimose lshimoseciudad COVID-19 (Coronavirus) |
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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of SOtagLiflozin on Clinical Outcomes in HemodynamIcally STable Patients with Type 2 Diabetes POST Worsening Heart FailureIRB Number: 2019-0149
Published: June 24, 2019
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20190624162939 |
We are doing this study to learn more about heart failure and diabetes and to see if an FDA approved diabetes medication called sotagliflozin improves cardiovascular outcomes in people with heart failure and diabetes. cardiac;heart;heart health;heart failure EFC15156 Theresa Hickey Hutson cmoore Heart Health |
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A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as first line therapy for locally advanced or metastatic non-squamous and squamous non-small cell lung cancer subjects (CANOPY-1)IRB Number: 2019-0119
Published: June 24, 2019
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20190624133128 |
<div><div>-To determine the RP3R of Canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy.</div><div>-To compare patient free survival by local investigator assessment and overall survival between the two treatment arms. </div><div>-To assess the preliminary clinical anti-tumor activity of canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy. </div><div>-To characterize the safety and tolerability of canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy. </div><div>-To characterize the pharmacokinetics of canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy. </div></div> cancer;lungs CACZ885U2301 Jennifer Barnes jruckdeschel Cancer Lungs/Breathing |
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A Randomized, Open-label, Phase 1b Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Signals of DUR-928 in Patients with Non-Alcoholic Steatohepatitis (NASH)IRB Number: 2019-0154
Published: August 22, 2019
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20190822153814 |
Nonalcoholic fatty liver disease (NAFLD) is a condition in which excess fat is deposited in the liver. Two types of NAFLD are simple fatty liver (NAFL – nonalcoholic fatty liver), and nonalcoholic steatohepatitis (NASH). NASH is a form of NAFLD in which one will have inflammation of the liver and liver cell damage, in addition to and related to excess fat within the liver. It is the hope that DUR-928 can treat participants with NASH by reducing liver inflammation and liver cell damage, and so prevent development of scar tissue within the liver. preventive medicine C928-012 Amy Wigglesworth scglover Liver Diseases Preventive Medicine |
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A Study Comparing Perioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)IRB Number: 2019-0009
Published: May 28, 2019
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20190528133424 |
The purpose of this study is to compare any good and bad effects of using nivolumab before and after the kidney cancer surgery to using the usual approach of surgically removing the kidney cancer followed by standard post-operative follow-up and monitoring.<br> cancer;surgery EA8143 Jennifer Barnes jhenegan Cancer Surgery |
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A Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk MelanomaIRB Number: 2019-0023
Published: May 28, 2019
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20190528133618 |
The purpose of this study is to determine if receiving the study drug pembrolizumab before and after surgery or only at surgery is better, the same or worse than usual treatment after surgery. <br> cancer S1801 Jennifer Barnes kjeanes Cancer |
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A Study of Atezolizumab Versus Placebo Administered in Combination with Paclitaxel, Carboplatin, and Bevacizumab to Patients with Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal CancerIRB Number: 2017-0109
Published: May 28, 2019
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20190528152643 |
The purpose of this study is to research the effects, good or bad of Ateozolizumab on ovarian, fallopian tube, or primary peritoneal cancer. <br> women's health;cancer GOG 3015/YO39523 Jennifer Barnes mridgway Cancer Women's Health |
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A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancerIRB Number: 2020-0197
Published: December 21, 2020
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20201221153205 |
<div>To assess the safety of ASG-22CE for the treatment of urothelial cancer</div> cancer SGN22E-002 Jennifer Barnes jhenegan Cancer |
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A Study of Erlotinib vs Observation in patients with completely resected epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer(NSCLC)IRB Number: 2015-0238
Published: May 28, 2019
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20190528153155 |
The purpose of this research study is to examine lung cancer patients' surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes. <br> cancer A081105 Jennifer Barnes jruckdeschel Cancer |
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A Study of Intravenous PI3K Inhibitor Copanlisib in Combination with Standard Immunochemotherapy versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-4IRB Number: 2017-0313
Published: May 28, 2019
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20190528145644 |
The purpose of this study is to evaluate the efficacy and safety of the study drug Copanlisib in combination with standard chemotherapy.<br> cancer BAY 80-6946 / 17833 Lisa Freeman selkins Cancer |
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A Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung CancersIRB Number: 2016-0250
Published: May 28, 2019
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20190528152727 |
The purpose of this study is to find if adding the study drug, Nivolumab will limit lung cancer from growing back in patients with early stage non-small cell lung cancer.<br> cancer EA5142 Jennifer Barnes JRuckdeschel Cancer |
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A Study of Radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases from Non-Small Cell Lung Cancer (NSCLC)IRB Number: 2017-0301
Published: May 28, 2019
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20190528145159 |
The purpose of this study is to obtain information on the safety and effectiveness of NovoTTF-100M (study device) in subjects with brain metastases (tumors) as a result of non-small cell lung cancer. <br> cancer;lungs;breathing EF-25 Jennifer Barnes manderson4 Cancer Lungs/Breathing |
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A Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)IRB Number: 2016-0179
Published: May 28, 2019
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20190528152905 |
The purpose of the Phase II part of the study is to compare any good and bad effects of using a combination of the experimental drugs cediranib and olaparib, to using the standard chemotherapy, or cediranib alone, or olaparib alone. The Phase III study will follow the Phase II to confirm the effectiveness of a combination of cediranib and olaparib to the standard chemotherapy. <br> cancer NRG-GY005 Jennifer Barnes kjeanes Cancer |
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A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed By Tislelizumab Monotherapy in Newly Diagnosed, State III Subjects with Locally Advanced, Unresectable Non-Small Cell Lung CancerIRB Number: 2019-0064
Published: May 28, 2019
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20190528113857 |
The purpose of this study is to see whether combining the study drug with chemotherapy and radiation is more effective in treating Non Small Cell Lung Cancer compared to chemotherapy and radiation alone.<br> cancer;lungs BGB-A317-NSCL-001 Jennifer Barnes jruckdeschel Cancer Lungs/Breathing |
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A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects with Acute Spinal Cord InjuryIRB Number: 2019-0331
Published: February 21, 2020
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20200221161127 |
<div>This study aims to investigate the safety, tolerability, pharmacokinetics of single ascending dose of</div><div>MT-3921 in subjects with acute spinal cord injury.</div> spine MT-3921-G01 Jennifer Lowery cwashington4 |
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A Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast CancerIRB Number: 2017-0144
Published: May 28, 2019
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20190528152542 |
The purpose of this study is to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost.<br> cancer;women's health A011401 Jennifer Barnes bcraft Cancer Women's Health |
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A Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion ProteinIRB Number: 2015-0239
Published: May 28, 2019
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20190528153122 |
The purpose of this research study is to examine lung cancer patients' surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.<br> cancer E4512 Jennifer Barnes jruckdeschel Cancer |
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A Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy with or Without Adjuvant DocetaxelIRB Number: 2018-0146
Published: May 28, 2019
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20190528151728 |
The purpose of this research study is to learn about the effects of the study drug Docetaxel, when given in combination with radiation therapy and hormone suppression therapy versus when using radiation and hormone suppression therapy alone in men with a high chance of prostate cancer recurrence after surgically removing the prostate.<br> cancer NRG-GU002 Jennifer Barnes jhenegan Cancer |
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A Trial of Carboplatin-Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic CarcinomaIRB Number: 2018-0173
Published: May 28, 2019
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20190528151834 |
The purpose this study is to compare any good and bad effects of using Ramucirumab along with the usual chemotherapy combination (Carboplatin and Paclitaxel) to the usual chemotherapy combination alone. <br> cancer S1701 Jennifer Barnes jruckdeschel Cancer |
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A Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer with or without Brain MetastasesIRB Number: 2017-0114
Published: May 28, 2019
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20190528152622 |
The study is to compare the good or bad effects of using the experimental drug ABT-888 (Veliparib) along with cisplatin to using cisplatin alone. The combination of the 2 drugs could shrink your cancer but could also cause side effects. This study will allow researchers to know whether this different approach is better, the same, or worse than the usual approach of chemotherapy.<br> cancer S1416 Jennifer Barnes bcraft Cancer |
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A Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal CancerIRB Number: 2019-0063
Published: May 28, 2019
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20190528133402 |
The purpose of this study is to compare any good or bad effects of adding triapine to the usual cisplatin chemotherapy and radiation therapy, compared to using cisplatin chemotherapy and radiation therapy alone.<br> cancer NRG-GY006 Jennifer Barnes mridgway Cancer |
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A Trial of SMO/ AKT/ NF2 Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2 MutationsIRB Number: 2016-0059
Published: May 28, 2019
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20190528153052 |
The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered genes and also to see if tumor genetic testing would be helpful at guiding treatment in patients .<br> cancer A071401 Takila Keys rlong Cancer |
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A Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate CancerIRB Number: 2018-0200
Published: May 28, 2019
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20190528133737 |
The purpose of this study is to research the effects, good or bad of adding either radiation therapy or adding surgery to the standard systemic therapy. <br> cancer S1802 Jennifer Barnes JHENEGAN Cancer |
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A Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and NeckIRB Number: 2014-0215
Published: May 29, 2019
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20190529082618 |
The purpose of the Phase II part of this study is to find out what effects, good and/or bad, one of the following treatments has on participants and their cancer: (Standard treatment) radiation therapy and cisplatin; (Experimental treatment) radiation therapy and docetaxel; or (Experimental treatment) radiation therapy, docetaxel, and cetuximab. The Phase III part of the study will compare the effects, good or bad, of the standard treatment (radiation and cisplatin) to one of the experimental arms (to be determined after completion of the Phase II part of the study) to find out which works best.<br> cancer RTOG 1216 Jennifer Barnes mkanakamedala Cancer |
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A Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung DiseaseIRB Number: 2017-0167
Published: May 28, 2019
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20190528150045 |
This study will evaluate the safety and effectiveness of inhaled treprostinil in participants with Pulmonary Hypertension (PH) due to Parenchymal Lung Disease.<br> lungs;breathing RIN-PH-201 Cathy Hudgins jspurzem Lungs/Breathing |
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A031702 (ICONIC): A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary CancersIRB Number: 2019-0132
Published: June 30, 2022
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20220630093035 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">The purpose of this study is to see how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread to other places in the body.</span> cabozantinib;nivolumab;ipilimumab;iconic;genitourinary (gu) A031702 Eulisa Goins-Freeman jhenegan Cancer |
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A031704: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]IRB Number: 2019-0147
Published: June 30, 2022
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20220630095647 |
The purpose of this study is to compare the usual treatment (Ipilimumab and Nivolumab followed by Nivolumab alone) to treatment with Ipilimumab and Nivolumab with Cabozantinib in patient with untreated renal cell carcinoma that has spread to other parts of the body. pdigree;kidney cancer;nivolumab;cabozantinib A031704 Eulisa Goins-Freeman jhenegan Cancer Kidney/Renal Conditions |
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A031901: Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority TrialIRB Number: 2020-0365
Published: June 30, 2022
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20220630101514 |
The purpose of this study is compare survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment wtih immune checkpoint inhibitors. urothelial carcinoma A031901 Eulisa Goins-Freeman jhenegan Cancer |
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Adjuvant study of MK-3475 (Pembrolizumab) in muScle invaSive and locAlly aDvanced urOthelial caRcinoma (AMBASSADOR) Versus ObservationIRB Number: 2018-0191
Published: May 28, 2019
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20190528144231 |
The purpose of this study is to compare the good or bad effects of using MK-3475 after the removal of muscle invasive bladder cancer.<br> cancer A031501 Jennifer Barnes jhenegan Cancer |
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ALCHEMIST - A081105: Randomized Study of Erlotinib vs Observation in patients with completely resected epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer(NSCLC)IRB Number: 2015-0238
Published: July 30, 2019
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20190730161507 |
The purpose of this research study is to examine lung cancer patients' surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes. cancer;lungs A081105 Jennifer Barnes jruckdeschel Cancer Lungs/Breathing |
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ALCHEMIST - A151216: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) A screening trial for A081105 and E4512IRB Number: 2015-0219
Published: July 30, 2019
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20190730155844 |
The purpose of this research study is to examine lung cancer patients' surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes. cancer;lungs A151216 Jennifer Barnes jruckdeschel Cancer Lungs/Breathing |
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ALgorithm using LINQ Sensors for EValuatIon And TreatmEnt of Heart Failure (ALLEVIATE-HF)IRB Number: 2020V0235
Published: December 21, 2020
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20201221154446 |
The purpose of the study is to gain experience with implementation of a
patient management pathway including protocolized PRN medication
interventions in subjects with a “high” heart failure risk status, which is
derived from an integrated device diagnostic-based risk stratification
algorithm based on data collected by the Reveal LINQ device. Additionally,
data collected in observational subjects will be utilized to estimate the
sensitivity and false detection rate of the heart failure risk status algorithm
for prediction of heart failure events cardiac;heart failure;heart health MDT19005 Connie Watson rlong Heart Health |
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All of Us Research ProgramIRB Number: 2018-0109
Published: November 08, 2019
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20191108150347 |
Precision medicine is a revolutionary approach for disease prevention and treatment that takes into account individual differences in lifestyle, environment, and biology. The All of Us Research Program seeks to extend precision medicine to all diseases by building a national research group of one million or more U.S. participants reflecting the rich diversity of the United States. Participants will have access to their results and will work as partners in the research process by maintaining involvement over time and receiving all of their study results. preventive medicine;disease prevention 2017-05 Christina Jordan, PhD cdjordan Preventive Medicine |
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An Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)IRB Number: 2017-0130
Published: May 28, 2019
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20190528152559 |
The study will compare three experimental drugs, crizotinib, cabozantinib and savolitinib to the standard treatment of sunitinib in the treatment of advanced kidney cancer. <br> cancer S1500 Jennifer Barnes jhenegan Cancer |
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An intermediate access protocol for selumetinib for treatment of neurofibromatosis type 1 with inoperable, progressive/symptomatic plexiform neurofibromasIRB Number: 2019-0185
Published: June 17, 2020
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20200617112859 |
The purpose of this protocol is to provide potential treatment of neurofibromatosis type 1 (NF1) with progressive/symptomatic plexiform neurofibromas (PN), by using the study drug, Selumetinib. pediatrics;neuroscience;cancer D1346R00002 Jennifer Barnes manderson4 Cancer Neurosciences Pediatrics |
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An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study Evaluating the Efficacy and Safety of Dapagliflozin in Respiratory Failure in Relation to COVID 19 (DARE 19)IRB Number: 2020-0115
Published: April 16, 2020
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20200416183412 |
To evaluate the effects of dapagliflozin, as compared with placebo, on the risk of death or disease progression in patients hospitalized with COVID-19. covid;covid-19;coronavirus D1690C00081 Savannah Vann vgarla COVID-19 (Coronavirus) |
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An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBMIRB Number: 2019-0171
Published: June 17, 2020
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20200617135035 |
The purpose of this research is to evaluate multiple investigational treatments for either newly diagnosed or recurrent brain tumors to determine if any of these study treatments improve overall survival as compared to standard treatments. brain;cancer;neuroscience GCAR-7213 Bridgett Sessions manderson4 Cancer Neurosciences |
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An Open Label Trial of Transfusion of COVID-19 Convalescent Plasma (CCP) to Patients with Moderate to Severe COVID-19IRB Number: 2020-0137
Published: April 20, 2020
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20200420092210 |
<p>To evaluate the safety and
clinical effectiveness of transfusing a unit of banked plasma obtained from
patients who have recovered from the novel coronavirus SARS-C0V-2 infection (CCP)
with high titers of IgG antibody to this virus transfused into patients with
severe or at high risk of progressing to severe coronavirus-induced disease
(COVID-19)<b>.</b></p> covid-19;coronavirus 2020-0137 Amy Wigglesworth gmarshall COVID-19 (Coronavirus) |
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An-Open Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications.IRB Number: 2019-0268
Published: January 08, 2020
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20200108101514 |
<div>The proposed study will determine the effect of triple combination therapy with an anti-integrin (vedolizumab IV), a tumor necrosis factor (TNF), antagonist (adalimumab SC), and an immunomodulator (oral methotrexate) on endoscopic <span style="font-size: 1rem; color: #0a0a0a;">remission at Week 26 in Crohn's Disease (CD) subjects at higher risk for CD complications.</span></div> digestive conditions;digestion 009125 Yilianys Pride scglover Digestive Conditions |
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ANNEXA-I: A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa InhibitorIRB Number: 2021-1011
Published: November 18, 2022
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20221118094059 |
<font color="#0a0a0a">The purpose of this study is to determine whether andexanet is better or worse than usual standard of care treatments (“usual care”) at treating the bleeding in the brain. </font> annexa-i;andexanet alfa;intracranial hemorrhage 18-513 Stephanie Moore unandi Stroke/Traumatic Brain Injury |
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Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery (ASPIRE)IRB Number: 2019-0338
Published: January 27, 2020
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20200127124541 |
A Phase III clinical trial designed to test the efficacy and safety of anticoagulation,compared with aspirin, in patients with a recent intracerebral hemorrhage (ICH) and high-risk non-valvular atrial fibrillation/flutter (AF). stroke NCT03907046 Sandra Powe cwashington4 Stroke/Traumatic Brain Injury |
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APOL1 Long-term Kidney Transplantation Outcomes NetworkIRB Number: 2019-0333
Published: January 27, 2020
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20200127123701 |
This study aims to prospectively assess the effects of genetic variants on outcomes for kidneys from donors with recent African ancestry and the recipients of such kidneys after deceased- and living-donor renal transplantation. kidney conditions;kidney disease 2019-0333 Amy Wigglesworth jjwynn Kidney/Renal Conditions |
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AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic strokeIRB Number: 2019-0111
Published: May 28, 2019
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20190528133315 |
This study intends to compare the effectiveness of aspirin vs. apixiban (two FDA approved medications that have anti-platelet effects) in preventing the recurrence of cryptogenic (without a known cause) stroke. <br> stroke;traumatic brain injury;neuroscience NCT03192215 Andrew Majeste sshekhar Neurosciences Stroke/Traumatic Brain Injury |
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AtRial Cardiopathy and Antithrombotic Drugs In prevention After crytogenic stroke Cognition and Silent Infarcts (Cognition and Silent Infarcts)IRB Number: 2019-0280
Published: January 27, 2020
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20200127131950 |
This is an ancillary study to the ARCADIA trial. It will assess cognitive function and silent infarcts in a subset of the ARCADIA population. Patients randomized in ARCADIA will be eligible for ARCADIA-CSI if they can undergo cognitive testing and have no MRI contraindications.The purpose of the study is to determine the effect of apixaban vs. aspirin on these two additional outcomes in patients with stroke of unknown cause and atrial cardiopathy. stroke 2019-0280 LaTronseya Berry sshekhar Stroke/Traumatic Brain Injury |
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ATrial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) who have Positive Sentinel Lymph Node Disease After Neoadjuvant ChemotherapyIRB Number: 2016-0069
Published: May 28, 2019
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20190528153021 |
The purpose of the study is to determine if radiation treatment to axillary (armpit) lymph nodes (undissected) and regional lymph nodes is as good as axillary lymph node dissection and only regional lymph node radiation therapy in invasive breast cancer patients with positive sentinel lymph nodes after completion of neoadjuvant chemotherapy. <br> cancer A011202 Jennifer Barnes bcraft Cancer |
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AUR-VCS-2021-03: A Prospective Observational Registry of Patients Treated with LUPKYNIS (voclosporin) in the USIRB Number: 2022-259
Published: August 15, 2022
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20220815160414 |
The purpose of this registry is to assess the use and effectiveness of LUPKYNIS in patients with lupus nephritis. lupus nephritis;lupkynis;voclosporin AUR-VCS-2021-03 Sherrina Dixon cleeching Arthritis/Rheumatology |
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Autonomic Retulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction (ANTHEM-HFrEF)IRB Number: 2018-0176
Published: May 28, 2019
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20190528151856 |
The purpose of this study is to see if a new investigational device called the VITARIA system is safe and effective in treating heart failure.<br> heart ANTHEM-HFrEF Theresa Hickey Hutson rlong Heart Health |
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AV001-004: Phase 2a multiple-dose escalating study in hospitalized patients with COVID-19 diseaseIRB Number: 2021V0784
Published: May 03, 2022
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20220503140352 |
The purpose of this study is to assess the safety and tolerability of multiple IV administrations of AV-001 shots compared with placebo in COVID-19 patients. vasomune;av001-004;covid-19;infectious diseases;lungs/breathing AV001-004 Jamie Brown gmarshall COVID-19 (Coronavirus) Infectious Diseases Lungs/Breathing |
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Avastin plus Chemotherapy versus Avastin plus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Platinum-Resistant or –Sensitive Epithelial Ovarian, Fallopian tube, or Primary Peritoneal Cancer (ACSCO trial)IRB Number: 2018-0147
Published: May 28, 2019
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20190528151746 |
The purpose of this study is to screen chemotherapy drugs currently used for the care of recurrent ovarian cancer and to determine the most effective treatment based on results from a chemosensitivity assay.<br> cancer ChemoID Jennifer Barnes kjeanes Cancer |
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Bio surveillance to determine Prevalence of SARS-CoV-2 Specific Antibodies in UMMC Employees with Varying Exposure to COVID-19 PatientsIRB Number: 2020-0172
Published: June 30, 2020
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20200630104005 |
<p>UMMC leadership has initiated
a biosurveillance study to estimate the prevalence of CoV-2 antibodies among
the UMMC community, both for those involved in the direct care of COVID-19
patients and for those not directly involved.</p>
<p>We are compiling a list of
volunteers who will consent to having a blood draw to determine antibody
presence. From this list, we will randomly select roughly 800
participants to be included in the study.</p><p>*This study is for UMMC Employees Only.</p> coronavirus;covid;covid-19 2020-0172 Denise Montgomery gmarshall COVID-19 (Coronavirus) |
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Biobank MississippiIRB Number: 2016-0333
Published: September 14, 2023
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20230914081138 |
This proposal defines the plans for creation of a new resource for future research that will be available to all investigators at University of Mississippi Medical Center (UMMC) and Mayo Clinic (Mayo) through this joint project. We propose to recruit and enroll 10,000 participants. Participants will provide a blood sample for DNA, cells, and serum/plasma, complete a health questionnaire, and allow access to historical and future medical record data. assessment;biospecimens;healthy volunteer BIOBANK MISSISSIPPI Gouri J Mahajan, PhD gmahajan Genetics |
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Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)IRB Number: 2015-0234
Published: May 29, 2019
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20190529083048 |
The purpose of this study screening step is to perform tests on genes and proteins produced by genes in tumor samples for certain features that investigational targeted agents used in this study are specifically designed to work against. Then the purpose is to assign a treatment sub-study that is chosen based on the results (genes and proteins called "biomarkers") of this genetic testing on your tumor sample. The purpose of the treatment part of this study is to compare the effects, good and bad, of these investigational agents to the usual approach to treating your type of cancer.<br> cancer S1400 Jennifer Barnes kjeanes Cancer |
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C16-170 (IRONMAN): International Registry for Men with Advanced Prostate CancerIRB Number: 2020-0161
Published: June 30, 2022
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20220630095849 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 15px; background-color: #ffffff;">The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Brazil, Canada, Ireland, Sweden, Switzerland, the United Kingdom (UK), and the US. </span><span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 15px; background-color: #ffffff;">Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of three years. Patients will be followed for overall survival, clinically significant adverse events, comorbidities, and changes in cancer treatments.</span> prostate cancer;patient registry;ironman C16-170 Eulisa Goins-Freeman jhenegan Cancer |
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Cabazitaxel with Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 TrialIRB Number: 2018-0192
Published: May 28, 2019
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20190528144214 |
The purpose of this study is compare the good and bad effects of using Cabazitaxel with the usual approach of the hormone based therapy Abiraterone Acteate in combination with Prednisone on patients with advance prostate cancer that have already undergone treatment with hormone therapy and docetaxel. <br> cancer EA8153 Jennifer Barnes jhenegan Cancer |
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CIBI322A102: A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumorsIRB Number: 2020-0283
Published: June 30, 2022
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20220630101603 |
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of IBI322 in cancer patients who failed standard treatment. CIBI322A102 Jessie Solise stang Cancer |
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Classification of Axial SpondyloarthritiS Inception Cohort (CLASSIC)IRB Number: 2020-0012
Published: March 04, 2020
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20200304162152 |
<div>This study is being done to find out how criteria for diagnosing patients with an early form of axial spondyloarthritis (axSpA) developed by an international group of experts in the field of spondyloarthritis are working and to find out if there are any other ways patients with axSpA can be diagnosed as early as possible. Participants will attend 5 visits which will include answering questions, physical examinations, lab test, x-ray and Magnetic Resonance Imaging (MRI).</div><div><br></div> spine;arthritis 2020-0012 Sherrin Dixon vmajithia Arthritis/Rheumatology |
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Clinical and Pre-Clinical Predictors of Response to Gattex in Short Bowel SyndromeIRB Number: 2019-0325
Published: February 11, 2020
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20200211154947 |
Gattex is one FDA approved medication to treat short bowel syndrome. Gattex is known to promote mucosal growth and increase enterocyte mass. In this observational study, we will examine the innate lymphoid cells (ILCs) in blood and intestinal biopsies of subjects treated with Gattex. The study will collect historical medical records and biological samples. digestive conditions 2019-0325 Yilanys Pride sglover Digestive Conditions |
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Clinical Evaluation Hemodialysis System for Home Nocturnal HemodialysisIRB Number: 2021V0444
Published: October 22, 2021
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20211022103141 |
This study is designed to compare HemoCare dialysis system to current dialysis treatment. kidney disease DKPL-00057-001 Sherrin Dixon tshafi Kidney/Renal Conditions |
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Clinical Evaluation of the ID NOW™ CT/NG TestIRB Number: UMMC-IRB-2024-111
Published: June 25, 2025
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20250625102949 |
<div style="box-sizing: border-box; margin-top: 0.5rem; font-weight: 700; font-size: 14px; color: #565c65; padding-bottom: 2px; border-bottom: 1px solid #dfe1e2; margin-bottom: 8px; text-transform: capitalize; font-family: Roboto, sans-serif; background-color: #ffffff;">Brief Summary</div><div style="box-sizing: border-box; margin-bottom: 20px; color: #171716; line-height: 1.62; font-family: Roboto, sans-serif; background-color: #ffffff;">The objective of this study is to determine the performance of the ™ CT/NG test in male urine, female urine, and self-collected vaginal swabs when tested by intended users (i.e., untrained operators). ™ CT/NG test results will be compared to results from up to three (3) FDA cleared CT/NG nucleic acid amplification tests (NAATs) for each sample type.</div><div style="box-sizing: border-box; position: relative; width: 743px; flex: 0 1 auto; font-weight: 700; font-size: 14px; color: #565c65; padding-bottom: 2px; border-bottom: 1px solid #dfe1e2; margin-bottom: 8px; text-transform: capitalize; font-family: Roboto, sans-serif; background-color: #ffffff;">Detailed Description</div><div style="box-sizing: border-box; margin-bottom: 20px; color: #171716; line-height: 1.62; font-family: Roboto, sans-serif; background-color: #ffffff;"><p>This is a global study and will be conducted at approximately thirty (30) US clinical study sites and up to five (5) study sites OUS in Europe, UK and Africa. The participating sites in the US will be in different geographical areas. Up to 30% of NG positive female participants (by composite Comparative Result (CCR)) may participate from OUS sites. ID NOW™ testing will be conducted by untrained operators (i.e., site staff with limited or no training or hands-on experience in conducting laboratory testing).</p><p>Approximately 7,100 participants will be enrolled. Consented participants will provide samples for ID NOW™ CT/NG and comparator assay testing. Each female participant will provide a 20-50 mL first-catch urine (FCU) sample, one (1) self-collected vaginal swab sample (SVS) and three (3) clinician-collected vaginal swabs (CVS). Each male participant will provide a 20-50 mL first-catch urine sample. Standard of care (SOC) samples should be collected first prior to clinical trial specimen collection. SOC vaginal swab should be collected before vaginal swabs (self- and clinician-collected) are collected as part of the study. If sites use urine as SOC, then SOC urine sample can be taken from the untreated sterile urine cup provided to collect first catch urine for this study.</p><p>Samples will be collected, handled, stored, shipped, and tested according to the applicable Package Insert(s), as appropriate. The site will record the order of sample collection for each participant. ID NOW™ CT/NG testing will be conducted on fresh samples. The sites will ship samples to a central laboratory for testing with up to three (3) FDA cleared CT/NG nucleic acid amplification tests (NAATs) according to the appropriate package insert(s). The central laboratory may be located outside of the clinical site(s) country for OUS sites and thus require shipping of samples outside of the clinical sites(s) country as per compliance.</p><p>Each urine sample will be collected in an untreated sterile urine cup provided by Sponsor. The site staff will ensure the urine cup is capped and then invert the urine cup five (5) times to mix. Once inverted five (5) times, site staff will test 1.5 ml of urine directly from the specimen cup with ID NOW™ CT/NG within two (2) hours of collection. The remaining urine will be aliquoted into applicable transport tubes for each comparator method (3 tubes) and one (1) retained urine sample (5mL). One (1) self-collected vaginal swab will be collected and placed in Sample Elution buffer by the participant in a private clinical setting. The participant will be provided with instructions on appropriate collection. Three (3) additional vaginal swabs will be collected by a clinician for each of the three (3) comparator tests per Product Inserts. The order in which SVS and CVS are collected will be randomized by Participant ID number. For participants with an odd-numbered Participant ID, the SVS will be collected first, followed by the three (3) CVS. For participants with an even-numbered Participant ID, the three (3) CVS will be collected first, followed by the SVS. For comparator tests, the order of CVS sample collection will be randomized (Appendix B). A portion (1.5 ml) of SVS in buffer will be tested with the ID NOW™ CT/NG test within 2 hours of sample collection. ID NOW™ CT/NG test results are investigational and will not be used for patient diagnosis or to guide treatment. After ID NOW™ CT/NG testing, leftover vaginal swab eluate and urine samples will be stored at the site according to Sponsor instructions and in the case that further testing is needed, shipped to an Abbott location/central laboratory at the Sponsor's request. No personally identifiable testing for human DNA will be performed on any samples obtained from this study. The Abbott location or central laboratory may be located outside of the clinical site(s) country for OUS sites and thus require shipping of samples outside of the clinical sites(s) country.</p><p>The Sponsor will perform data analysis. The results of the ID NOW™ CT/NG test will be presented separately for CT and NG. ID NOW™ CT/NG test results will be presented by sample type, by sex, and by symptomatic and asymptomatic status. POC Link functionality may be established with each ID NOW™ Instrument for remote connectivity.</p></div> disease attributes;pathologic processes;gram-negative bacterial infections;bacterial infections;bacterial infections and mycoses;sexually transmitted diseases;genital diseases;urogenital diseases;neisseriaceae infections;infections;communicable diseases;gonorrhea;asymptomatic diseases;std;sti 2308801 Tamera Brocks jgalbraith Emergency Medicine Urology |
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Colon Adjuvant Chemotherapy Based on Evaluation of Residual DiseaseIRB Number: 2023-265
Published: June 25, 2025
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20250625161533 |
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. cancer;colon;colon cancer;wilkinson NRG-GI008 Winona Blount kjeanes Cancer Digestive Conditions |
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Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn's DiseaseIRB Number: 2019-0308
Published: January 08, 2020
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20200108095603 |
<div>Crohn's disease (CD) is a relapsing and remitting form of inflammatory bowel disease (IBD) that causes gastrointestinal signs and symptoms of diarrhea, abdominal pain, weight loss, and the passage of blood or mucous per rectum. The inflammation of CD can involve the mucosal surface of the gastrointestinal tract and penetrate through the full thickness of the gastrointestinal</div><div><br></div> digestion;digestive conditions GS-US-419-3895 Olivia Henry scglover Digestive Conditions |
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COVID-19 Biobank (Adult and Pediatric)IRB Number: 2010-0036
Published: September 14, 2023
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20230914081158 |
<span style="line-height: 107%; font-family: &quot;Times New Roman&quot;,serif; font-size: 12pt; msofont-family: Calibri; msotheme-font: minor-latin; msolanguage: AR-SA; msofont-style: italic;"><font color="#000000">Collection of blood samples from adult and pediatric patients
with diagnosis of COVID-19<span style="line-height: 107%; font-family: &quot;Times New Roman&quot;,serif; font-size: 12pt; msofont-family: Calibri; msotheme-font: minor-latin; msolanguage: AR-SA; msofont-style: italic; msoproof: yes;"><font color="#000000"> for future research including
studies on the pathophysiology of COVID-19 in the adult population.</font></span></font></span><br> covid;covid-19;coronavirus N/A Gouri Mahajan, PhD gmahajan COVID-19 (Coronavirus) |
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CRA-US-001: Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management (PLATINUMIRB Number: UMMC-IRB-2022-244
Published: October 11, 2022
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20221011160528 |
The purpose of this research is to see if a drug, called patiromer, already approved by the U.S Food and Drug Administration (FDA), can help lower potassium while patients are in the emergency department. platinum;patiromer;hyperkalemia;2022v0861 CRA-US-001 Tamara Brock unandi Emergency Medicine |
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Creation of a Registry of Pediatric Respiratory Samples and Plasma/Sera to Define Viral Profiles and SARS-CoV2 Seroprevalence in Mississippi Children During the Global SARS-CoV2 (COVID19) PandemicIRB Number: 2020-0099
Published: June 08, 2020
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20200608155416 |
<p><span style="font-family:&quot;Calibri&quot;,sans-serif;color:black">SARS-CoV2
is a novel coronavirus causing a pandemic and which has recently been
spreading/diagnosed in MS with dramatically increasing frequency. There is
limited data regarding co-infection with other respiratory viruses in children
and increasing data supports SARS-CoV2-infected children are in fact,
asymptomatic or pauci-symptomatic.
Children may present with non-specific symptoms that are attributed to
other viruses. Understanding the presence of other viruses and the
seroprevalence of antibodies to SARS-CoV2 and other coronaviruses at this time
will allow clearer classification of disease within MS both prior to and during
the first anticipated peak of SARS-CoV2.</span></p><p><span style="font-size:12.0pt;font-family:&quot;Calibri&quot;,sans-serif;
msofont-family:&quot;Times New Roman&quot;;color:black;msolanguage:EN-US;
msolanguage:EN-US;msolanguage:AR-SA">Our goal is to create a
registry of specimens for the main objective of this study, which is to
understand better the viral co-infection profiles and SARS-CoV2 antibody
profiles in asymptomatic and/or pauci-symptomatic children in various health
care settings over time in MS.</span><span style="font-family:&quot;Calibri&quot;,sans-serif;color:black"><br></span></p><p><span style="font-family:&quot;Calibri&quot;,sans-serif;color:black"><br></span></p><p><span style="font-family:&quot;Calibri&quot;,sans-serif;color:black"><br></span></p> coronavirus;covid;covid-19 N/A Charlotte Hobbs chobbs COVID-19 (Coronavirus) |
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CSP-00006: A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPDIRB Number: 2021V0781
Published: October 04, 2022
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20221004231712 |
<div>The purpose of this study is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms <span style="font-size: 1rem; color: #0a0a0a;">of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis.</span></div> rhesolve;bronchitis;rheox bronchial rheoplasty CSP-00006 Thomas Hudson msenitko Allergy/Asthma/Immunology Lungs/Breathing Men's Health Women's Health |
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D18-11141: Phase III Randomized Trial of DFP-10917 vs. Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, Third, or Fourth SalvageIRB Number: 2021-0596
Published: June 30, 2022
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20220630102144 |
The purpose of this study is to compare the rate of complete response (CR) and duration of CR, in patients with relapsed or refractory AML to two, three, and four prior inductions regimens that my have included intensive chemotherapy, who will receive DFP-10917 versus non-intensive reinduction or intensive re-induction as a second, third, and fourth salvage treatment. aml;leukemia D18-11141 Eulisa Goins-Freeman selkins Cancer |
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Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)IRB Number: 2020-0163
Published: January 12, 2022
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20220112141836 |
This study will test whether the drug dapagliflozin is safe and has beneficial effects when added
to conventional heart failure therapy in patients who have been admitted to the hospital for acute
heart failure and whose heart is not pumping enough blood with each heartbeat. D1699C00004 Theresa Hutson rlong Heart Health |
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DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare TumorsIRB Number: 2017-0152
Published: May 28, 2019
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20190528150138 |
This is a study for rare cancers for which there is no standard of care or that has become worse with treatment. The purpose of this study is to determine what good and/or bad effects the combination of the study drugs, ipilimumab and nivolumab, have in the treatment of rare cancers and cancers of unknown primary origin.<br> women's health;cancer S1609 Jennifer Barnes kjeanes Cancer Women's Health |
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Dilated Cardiomyopathy Precision Medicine StudyIRB Number: 2014-0087
Published: May 29, 2019
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20190529082233 |
This study is aimed at enrolling individuals of European or African
ancestry, and Hispanic or non-Hispanic ethnicity, and identifying the genes
responsible for idiopathic DCM.<br> heart health 2014-0087 Teresa Witcher cmoore Heart Health |
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EA1181: (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete responseIRB Number: 2020-0136
Published: June 30, 2022
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20220630102517 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">The purpose of this study is to see how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy.</span> her2 positive, compasserher2-pcr, breast cancer EA1181 Jessie Solise stang Cancer |
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EA3132: Phase II Randomized Trial of Radiotherapy with or without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 SequencingIRB Number: 2020-0086
Published: June 30, 2022
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20220630105541 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">The purpose of this study is to see how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery.</span> head and neck;squamous cell carcinoma;imrt EA3132 Eulisa Goins-Freeman rhamilton Cancer |
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EA3191: A Phase II Randomized Trial of Adjuvant Therapy with Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma with High Risk FeaturesIRB Number: 2021-0520
Published: July 12, 2022
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20220712220204 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">Study the effect of pembrolizumab in combination with radiation therapy or pembrolizumab alone compared to the usual approach (chemotherapy plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary).</span> head and neck cancer;pembrolizumab;cancer EA3191 Eulisa Goins-Freeman rhamilton Cancer |
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EA8191 (INDICATE): Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical RecurrenceIRB Number: 2020-0336
Published: July 12, 2022
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20220712215956 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">This study compares the addition of apalutamide, with or without targeted radiation therapy, to standard of care treatment versus standard of care treatment alone in patients with prostate cancer biochemical recurrence (a rise in the blood level of prostate-specific antigen [PSA] after treatment with surgery or radiation). </span> indicate;prostate cancer EA8191 Eulisa Goins-Freeman jhenegan Cancer |
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EAY131 (MATCH): Molecular Analysis for Therapy Choice (MATCH)IRB Number: 2019-0241
Published: July 12, 2022
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20220712215700 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">The purpose of this study is to see how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists.</span> eay131;match EAY131 Eulisa Goins-Freeman jhenegan Cancer |
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ECHO: Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical StudyIRB Number: 2023-353
Published: June 25, 2025
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20250625162309 |
<p>The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma.</p><p>This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in tampon-collected vaginal fluid and 2) ovarian cancer (OC) in plasma and tampon-collected vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.</p> cancer;ovarian;endometrial;cervical;rocconi ECHO Winona Blount rocconi Cancer Women's Health |
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EMPERIAL STUDY: EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF)IRB Number: 2019-0006
Published: May 28, 2019
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20190528133434 |
The purpose of this study is to learn more about heart failure with preserved ejection fraction which is a type of heart failure and means the heart is not working as well as it should. We also want to see if an experimental medication called empagliflozin helps improve heart failure symptoms and patients' quality of life. <br> heart 1245-0167 Theresa Hickey Hutson rlong Heart Health |
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Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast ReconstructionIRB Number: UMMC-IRB-2024-329
Published: June 25, 2025
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20250625105700 |
<div style="box-sizing: border-box; margin-bottom: 20px; color: #171716; line-height: 1.62; font-family: Roboto, sans-serif; background-color: #ffffff;">The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Treatment Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Control Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Control Arm.</div><div><br></div><div style="box-sizing: border-box; color: #1b1b1b; font-family: Roboto, sans-serif; background-color: #ffffff;"></div> breast reconstruction;post-mastectomy;tissue expander;implant based breast reconstruction;two-stage;breast cancer TBR 22-07 Eldrin Bhanat bmcintyre Cancer Women's Health |
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Expanded Access Treatment Protocol: Remdesivir (RDV) for the Treatment of SARS-CoV2 (CoV) InfectionIRB Number: 2020-0128
Published: April 16, 2020
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20200416182845 |
Expanded access treatment protocol for use of RDV for the treatment of a participant with coronavirus disease-2019 (COVID-19) resulting from infection of SARS-CoV-2.<div><br></div><div>*UMMC is currently prescribing RDV for COVID-19 patients under the emergency use authorization as opposed to the expanded access treatment protocol.*</div> covid;covid-19;coronavirus GS-5734 David Cretella jparham COVID-19 (Coronavirus) |
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Genomically-Guided Treatment Trial in Brain MetastasesIRB Number: 2019-0259
Published: March 24, 2025
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20250324134539 |
<div>This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, PI3K, or KRAS G12C. Medications that target these genes such as abemaciclib, paxalisib, entrectinib and adagrasib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.</div><div><br></div> brain;cancer;matastases;anderson A071701 Winona Blount manderson4 Cancer Neurosciences |
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GOG 0263 A Randomized phase III Clinical Trial of Adjuvant Radiation versus Chemoradiation in Intermediate Risk, Stage I/II A Cervical cancer Treated With Initial Radical Hysterectomy and Pelvic LymphadenectomyIRB Number: 2010-0249
Published: July 30, 2019
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20190730154229 |
The purpose of this study is to find out if weekly cisplatin and concurrent radiation therapy increases the time participant's time without disease compared to radiation therapy alone. cancer GOG 0263 Jennifer Barnes kjeanes Cancer |
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Impact of Oral Immulina Supplementation on Natural Killer Cell Activities and Other Biomarkers Associated with Increasing Host Immune Resilience to Upper Respiratory Viruses in Normal Human VolunteersIRB Number: 2020-0020
Published: November 28, 2022
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20221128102945 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">This study aims to establish the impact of the oral supplement, Immulina TM, on enhancing host resiliience to the effects of viral influenza infections in humans.</span> spirulina;immulina 000000 Joy Walker gmarshall Allergy/Asthma/Immunology |
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Improving the Quality of Care for Adults with Inflammatory Bowel DiseaseIRB Number: 2019-0203
Published: July 07, 2020
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20200707134050 |
Demonstrate the impact of an Adult Inflammatory Bowel Disease (IBD) Learning Health System approach that enables patients and their care teams to co produce optimal health and high value care. digestion;digestive conditions 2019-0203 Yilanys Pride scglover Digestive Conditions |
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INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO (ACCIO)IRB Number: 2021-0643
Published: November 20, 2023
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20231120105857 |
non-small cell lung cancer, cancer, lung cancer, A081801 Jennifer Barnes Dennis Morgan Cancer |
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International Registry for Men With Advanced Prostate Cancer (IRONMAN)IRB Number: 2020-0161
Published: March 25, 2025
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20250325160016 |
<div>Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices.</div><div><br></div><div>Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs.</div><div><br></div><div>PROMs questionnaires will be collected at enrollment and every three months thereafter.</div><div><br></div><div>Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment.</div><div><br></div><div>As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.</div> ironman;prostate;prostate cancer c16-170 Winona Blount jhenegan Cancer Men's Health |
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LAE205INT3101: A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients with Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care TherapiesIRB Number: UMMC-IRB-2022-87
Published: July 13, 2022
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20220713120151 |
This purpose of this study is to find out if a new investigational drug Afuresertib in combination with Fulvestrant helps you better than Fulvestrant alone. breast cancer;her2 negative;afuresertib;theradex LAE205INT3101 Jessie Solise stang Cancer |
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LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)IRB Number: 2019-0027
Published: March 27, 2025
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20250327142640 |
<span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.</span> nsclc;morgan;non-small cell lung cancer;non small cell lung cancer;cancer LUNGMAP Winona Blount dpmorgan Cancer Lungs/Breathing |
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MIND: A prospective, multicenter study of artemis a minimally invasive neuro evacuation device, in the removal of intracerebral hemorrhage.IRB Number: 2019-0091
Published: June 24, 2019
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20190624135050 |
The primary objective of this multicenter randomized controlled study is to
compare the safety and efficacy of minimally invasive hematoma evacuation
with the Artemis Neuro Evacuation Device to best medical management for the
treatment of intracerebral hemorrhage (ICH). brain;neuroscience;surgery CLP 11899.A Jennifer Lowery cwashington4 Neurosciences Surgery |
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MK-1242-035: A Pivotal Phase 3 Randomized, Placebo-controlled Vericiguat Outcomes Study in HFrEF (VICTOR)IRB Number: 2021V0793
Published: March 02, 2022
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20220302112702 |
This study is testing MK-1242 (vericiguat) in people with a certain type of heart failure. It will compare MK-1242 to placebo (inactive substance) when added to your existing heart failure treatment. You, your study doctor and the study staff won't know what study drug you are getting. MK-1242 is experimental. heart health;victor;mk-1242 MK-1242-035 Will Pierce lpapadimitriou Heart Health |
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MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcerIRB Number: 2024-60
Published: June 25, 2025
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20250625162102 |
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, but require an additional treatment called immunotherapy to help prevent their bladder cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of bladder cancer patients who have undergone surgical removal of their bladder. urothelial carcinoma;cancer;urothelial cancer;henegan;bladder;genitourinary A032103 Winona Blount jhenegan Cancer |
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MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)IRB Number: 2022-0460
Published: June 25, 2025
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20250625163122 |
<span style="color: #171716; font-family: Roboto, sans-serif; font-size: 14px; background-color: #ffffff;">This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.</span> small-cell lung cancer, cancer, mundra, lung cancer;small cell lung cancer S1827 Winona Blount EMundra Cancer Lungs/Breathing |
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MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)IRB Number: 2019-0020
Published: June 28, 2023
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20230628135022 |
A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours. stroke B01-04 Margaret Smith Sameer Sharma Stroke/Traumatic Brain Injury |
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Muscular Dystrophy Association (MDA) / Muscular Dystrophy Association Neuromuscular Observational Research (MOVR) Data Hub ProtocolIRB Number: 2021V0650
Published: July 01, 2021
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20210701143936 |
<div>The MOVR Protocol is the first and only study that aggregates clinical, genetic and patient reported data for multiple neuromuscular diseases. The combination of data collected through the Protocol will provide a comprehensive understanding of health and patient experiences in a single data repository. Protocol has the</div><div>power to transform health outcomes, accelerate drug development and drive clinical research across multiple neuromuscular diseases, helping to ensure that the next generation of individuals living with neuromuscular disease are afforded every opportunity to thrive. </div> muscular dystrophy;neuromuscular 1273344 Amanda Witt awitt Neurosciences |
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NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in AdultsIRB Number: 2021-1094
Published: April 18, 2022
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20220418092752 |
This purpose of this study is to understand how COVID affects the body, and why some people who got COVID are still sick many months after being infected. recover;covid-19 S21-01226 Amy Wigglesworth gmarshall COVID-19 (Coronavirus) |
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NRG GU007: Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer (NADIR)IRB Number: 2019-0199
Published: June 15, 2022
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20220615120054 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">The purpose of this study is to study the side effects and determine the best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of coming back (high risk). </span> prostate cancer;nadir;niraparib NRG GU007 Eulisa Goins-Freeman JHENEGAN Cancer |
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NRG-BN009: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS with Brain Metastasis Velocity >/= 4 Brain Metastases/YearIRB Number: 2021-0613
Published: July 12, 2022
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20220712221545 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery.</span> non-small cell lung cancer;melanoma;breast cancer NRG-BN009 Jennifer Barnes Mark Anderson Cancer |
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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 CancerIRB Number: 2019-0227
Published: June 15, 2022
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20220615123907 |
<div>The purpose of this study is to see how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent).</div> gy018;endometrial cancer;pembrolizumab NRG GY0018 Cameronne Dodd kjeanes Cancer |
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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor TherapyIRB Number: 2023-267
Published: June 25, 2025
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20250625155946 |
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab. breast cancer;tnbc;craft A012103 Winona Blount bcraft Cancer |
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PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)IRB Number: 2023-67
Published: November 20, 2023
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20231120110906 |
<span style="color: #171716; font-family: Roboto, sans-serif; font-size: 16px; background-color: #ffffff;">This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.</span> cancer, prostate cancer, radiation, predict-rt, henegan NRG-GU009 Jennifer Barnes John Henegan Cancer |
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Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)IRB Number: 2023-67
Published: March 27, 2025
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20250327092650 |
This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score. henegan;prostate;prostate cancer;cancer NRG-GU009 Winona Blount jhenegan Cancer Men's Health |
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Patient attitudes about lung cancer screening at University of Mississippi Medical CenterIRB Number: 2020V0188
Published: October 26, 2021
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20211026145611 |
To evaluate and compare attitudes and knowledge about lung cancer screening in populations in both the outpatient internal medicine clinic and a lung nodule/lung cancer screening clinic. lungs LTI-01-2001 Kia Holly msenitko Lungs/Breathing |
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Pharmacokinetics of Understudied Drugs Administered to Children per Standard of CareIRB Number: 2018-0115
Published: June 28, 2019
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20190628101637 |
This study will collect information about how various drugs affect children/young adults. The information collected will help develop a standard of care for prescribing drugs in this age group. pediatrics NICHD-2011-POP01 Lacy Malloch jmajure Pediatrics |
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Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POPS)IRB Number: 2020-0101
Published: April 16, 2020
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20200416182756 |
A prospective, multicenter study to evaluate the pharmokinetics of understudied drugs currently being administered to children per standard of care, to include participants on treatment with COVID-19 drugs. covid;covid-19;coronavirus NICHD-2019-POP02 Lacy Malloch jmajure COVID-19 (Coronavirus) |
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Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway MutationsIRB Number: 2016-0059
Published: March 24, 2025
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20250324134408 |
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. intracranial meningioma;recurrent meningioma;nf2 gene mutation;meningioma;cancer;anderson A071401 Winona Blount MAnderson4 Cancer Neurosciences |
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Phase III Randomized Trial of DFP-10917 vs. Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, Third, or Fourth SalvageIRB Number: 2022-115
Published: November 20, 2023
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20231120092609 |
<p>This study will investigate
whether a new experimental treatment, DFP‑10917, will be an effective and safe
treatment option for patients with relapsed/refractory acute myelogenous
leukemia (AML). This is a “randomized” study. If
it is determined during screening that you are eligible for the study, you will
be “randomized” by a computer to receive either DFP-10917 (the experimental
group) or standard treatment (control group) by chance. Neither you nor your
study doctor can choose the group you will be in.</p> cancer, acute myelogenous leukemia, aml, cancer D18-11141 Jennifer Barnes Stephanie Elkins Cancer |
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Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate CancerIRB Number: 2018-0200
Published: March 25, 2025
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20250325130622 |
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. prostate;prostate cancer;cancer;henegan S1802 Winona Blount jhenegan Cancer Men's Health |
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Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)IRB Number: 2021-1029
Published: April 28, 2022
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20220428161745 |
The purpose of this study is to see if investigational drug trastuzumab deruxtecan, either alone or in combination with another medication, pertuzumab, is effective in treating patients with Human epidermal growth factor receptor 2 (HER2) positive breast cancer as a first line of treatment. Study will also allow us to better understand the studies disease and associated health problems. destiny;tang;breast09 D967UC00001 Jessie Solise Barbara Craft Cancer |
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Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)IRB Number: 2023-261
Published: June 25, 2025
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20250625161806 |
<span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.</span> rcc;kidney;kidney cancer;cancer;henegan S1931 Winona Blount jhenegan Cancer Kidney/Renal Conditions |
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PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMAIRB Number: 2018-0179
Published: June 17, 2020
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20200617140036 |
The purpose of this study is to compare any good and bad effects of using radiation to treat a meningioma that has been completely removed compared to just observing the tumor and treating it with radiation if it returns. brain;cancer;neuroscience NRG-BN003 Jennifer Barnes manderson4 Cancer Neurosciences |
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Photobiomodulation Therapy Using the MuReva Phototherapy System to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Patients with Head and Neck Cancer Receiving Radiation Therapy with or without Concurrent ChemotherapyIRB Number: 2022-389
Published: November 20, 2023
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20231120084943 |
<div>The overall purpose of this clinical study is to evaluate safety and</div><div>efficacy of the MuReva Phototherapy System with a light delivery</div><div>mouthpiece to reduce the severity of oral mucositis (OM) in adult</div><div>patients with squamous cell carcinoma of the oral cavity, oropharynx,</div><div>tonsils and base of tongue receiving radiation therapy with or without</div><div>concurrent chemotherapy.</div> oral mucositis, phototherapy, mureva, kane, cancer LLD-001 Jennifer Barnes Anne Kane Cancer |
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Pragmatic Evaluation of Events And Benefits of Lipid-lowering in older Adults (PREVENTABLE)IRB Number: 2020V0312
Published: January 15, 2021
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20210115100959 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.</span><div><span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;"><br></span></div> cardiac;heart;men's health;women's health;obesity;nutrition PREVENTABLE Theresa Hutson mehall Heart Health Women's Health |
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Program for Collection of BioSpecimensIRB Number: 2020V0329
Published: October 09, 2020
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20201009143952 |
<p align="left">The objective of the
protocol is to conduct biospecimen collection while protectingthe rights,
privacy, and safety of those subjects who provide biospecimens to assist in, but not
limited to, the evaluation of current products, products in development and/or competitive
products, for device assessment studies, marketing purposes,design control
testing, quality control, product incident reports, post-marketrequirements, training, and clinical trial testing for
product performance testing.</p> coronavirus;covid;covid-19 pending Tamara Brocks jgalbraith Emergency Medicine |
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Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF (PARAGLIDE-HF)IRB Number: 2020-2778
Published: January 12, 2022
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20220112135215 |
The purpose of this research study is to find out if the study drug, sacubitril/valsartan, is safe and has beneficial effects when added to conventional heart failure therapy in patients with heart failure with preserved ejection fraction who have been stabilized after being admitted to the hospital for new or worsening heart failure. CLCZ696DUS01 Theresa Hutson rlong Heart Health |
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Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase IIIIRB Number: 2018-0183
Published: March 25, 2025
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20250325114442 |
This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy. breast cancer;craft;tnbc S1501 Winona Blount bcraft Cancer |
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Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (Preamble)IRB Number: 2017-0212
Published: May 28, 2019
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20190528150015 |
The purpose of this study is to examine how multiple myeloma is treated by doctors all over the world, how people respond to these treatments, and the economic impact of these treatments.<br> cancer CA204-008 Lisa Freeman capayne Cancer |
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Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial FibrillationIRB Number: 2024-403
Published: June 25, 2025
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20250625104225 |
<div style="box-sizing: border-box; margin-top: 0.5rem; font-weight: 700; font-size: 14px; color: #565c65; padding-bottom: 2px; border-bottom: 1px solid #dfe1e2; margin-bottom: 8px; text-transform: capitalize; font-family: Roboto, sans-serif; background-color: #ffffff;">Brief Summary</div><div style="box-sizing: border-box; margin-bottom: 20px; color: #171716; line-height: 1.62; font-family: Roboto, sans-serif; background-color: #ffffff;">The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.</div><div style="box-sizing: border-box; position: relative; width: 743px; flex: 0 1 auto; font-weight: 700; font-size: 14px; color: #565c65; padding-bottom: 2px; border-bottom: 1px solid #dfe1e2; margin-bottom: 8px; text-transform: capitalize; font-family: Roboto, sans-serif; background-color: #ffffff;">Detailed Description</div><div style="box-sizing: border-box; margin-bottom: 20px; color: #171716; line-height: 1.62; font-family: Roboto, sans-serif; background-color: #ffffff;">The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).</div> pulsed field ablation;pfa;pulmonary vein isolation;pvi;ablation;atrial fibrillation;af;heart ADVENT PAS Memrie Cochran jhamilton Heart Health |
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Randomized Controlled Trial of Losartan for inpatients with COVID-19IRB Number: 2020-0135
Published: April 16, 2020
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20200416183005 |
Evaluation of the impact of early losartan compared to placebo on the change in respiratory failure in inpatients diagnosed with COVID19 requiring hospital admission. covid;covid-19;coronavirus HRP-590 Rebekah Peacock aejones COVID-19 (Coronavirus) |
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Randomized Master Protocol for Immune Modulators for Treating COVID-19IRB Number: pending
Published: October 23, 2020
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20201023134127 |
<div>ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of</div><div>moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).</div><div>The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and</div><div>hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at</div><div>the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on</div><div>other research findings. Comparisons of the agents among themselves is not a research objective.</div> coronavirus;covid;covid-19 ACTIV-1 IM Amy Wigglesworth gmarshall COVID-19 (Coronavirus) |
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Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients With Unresectable Stage III or Stage IV MelanomaIRB Number: 2024-5
Published: June 25, 2025
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20250625163036 |
<span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.</span> melanoma;wilkinson;cancer EA6141 Winona Blount kjeanes Cancer |
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Randomized Phase II/III Trial of Radiation With Cisplatin at 100 mg/m2 Every Three Weeks Versus Radiation With Weekly Cisplatin at 40 mg/m2 for Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)IRB Number: 2023-408
Published: June 25, 2025
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20250625162914 |
This phase II/III trial compares whether cisplatin given weekly with radiation therapy is better tolerated than cisplatin given every three weeks with radiation therapy for the treatment of head and neck cancer that has spread to other places in the body (advanced). The second part of this study will also help to find out if the cisplatin given weekly approach will extend patients' life by at least the same amount of time as the cisplatin given every three weeks approach. Cisplatin is in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Radiation with low-dose cisplatin given weekly may be effective in shrinking or stabilizing head and neck cancer or preventing its recurrence. head;neck;cancer;head and neck;morgan NRG HN009 Winona Blount dpmorgan Cancer Neurosciences |
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Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway InhibitionIRB Number: 2023-402
Published: March 27, 2025
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20250327093829 |
<div style="margin-top: 0.5rem; font-weight: 700; font-size: 14px; color: var(-colordark); padding-bottom: 2px; border-bottom: 1px solid var(-colorlighter); margin-bottom: 8px; text-transform: capitalize; font-family: Roboto, sans-serif; background-color: #ffffff;">Brief Summary</div><div style="box-sizing: border-box; position: relative; width: 743px; flex: 0 1 auto; font-weight: 700; font-size: 14px; color: var(-colordark); padding-bottom: 2px; border-bottom: 1px solid var(-colorlighter); margin-bottom: 8px; text-transform: capitalize; font-family: Roboto, sans-serif; background-color: #ffffff;">Detailed Description</div> prostate;prostate cancer;cancer;henegan PRESERVE-006 Winona Blount jhenegan Cancer Men's Health |
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Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of a Multi-Dose Regimen of Oral Varespladib-Methyl in Subjects Bitten by Venomous Snakes (BRAVO study – Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite)IRB Number: 2021-1045
Published: January 24, 2022
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20220124232533 |
The purpose of this clinical research study is to learn more about the use of the study medicine, varespladib, for the treatment of snakebite. You or your child will receive a medication called Varespladib or placebo. Varespladib is an experimental treatment, meaning that it has not yet been approved by the Food and Drug Administration (FDA) for the treatment of snakebite. In this study, varespladib will be compared to a placebo. A placebo is a pill that looks exactly like the study medicine but does not contain any active ingredient, and has no therapeutic effect by itself. bravo;snakebite;varespladib-methyl (ly333013) OPX-PR-01 Simon Barinas dvearrier Emergency Medicine |
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RARE Study: Clinical Specimen Collection Protocol for the Rheonix STI Tri-Plex Assay and Rheonix EncompassMDx(TM) WorkstationIRB Number: 2015-0031
Published: May 29, 2019
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20190529085117 |
This study will test the safety and efficacy of a new workstation that will automatically analyze clinical specimens for the presence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and/or Trichomonas vaginalis (TN) as an aid in the diagnosis of chlamydial, gonococcal, and/or trichomoniasis urogenital disease in symptomatic and asymptomatic individuals.<br> infectious diseases 2015-0031 Angelena Sharp lmena Infectious Diseases |
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Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke CigarettesIRB Number: 2019-0046
Published: May 28, 2019
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20190528133606 |
<p>The purpose of this study is to see if post-operative complications can be reduced by helping participants stop smoking with a drug called Varenicline and using the NCI Tabacco Quitline for counseling. <br></p> cancer A211401 Jennifer Barnes jmoremen Cancer Lungs/Breathing |
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Registry to Evaluate Effectiveness and Safety of the Nanoknife System for the Ablation of Stage 3 Pancreatic AdenocarcinomaIRB Number: 2020-0169
Published: July 17, 2020
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20200717135332 |
<div>This multicenter, observational study will evaluate the</div><div>effectiveness and safety of the NanoKnife System when used</div><div>for the ablation of Stage 3 pancreatic adenocarcinoma (Stage</div><div>3 PC). Eligible patients will be recruited over a 36-month</div><div>period and participating institutions will enroll and provide</div><div>data on consecutive patients that meet inclusion and</div><div>exclusion criteria. Each patient will be followed up for the</div><div>duration of the study or until death. The study will include</div><div>two (2) cohorts: patients who received standard of care (SOC)</div><div>and received irreversible electroporation (IRE) [IRE cohort],</div><div>and patients who were treated with SOC and did not receive</div><div>IRE [SOC cohort].</div> cancer 2019-ONC-02 Sandra Powe tearl Cancer |
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Role of Pseudomonas aeruginosa Serine Proteases and Staphylococcus aureus Toxins in Exacerbations of Cystic FibrosisIRB Number: 2016-0153
Published: June 27, 2019
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20190627132447 |
This is an observational study in cystic fibrosis patients looking at the influence of bacteria in causing infections in cystic fibrosis. Blood and sputum samples will be collected during a well visit and sick visits. Clinical data will be collected. lungs;pediatrics 2016-0153 Sandra Tyler jspurzem Digestive Conditions Lungs/Breathing |
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RRx-001-33: REPLATINUM: A Phase 3, Controlled, Open-label, Randomized Study of RRx-001 Administered Sequentially with a platinum doublet or a platinum doublet in third-line or beyond small cell carcinomaIRB Number: 2018-0228
Published: July 31, 2019
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20190731093956 |
The purpose of this study is to look at an experimental drug that boosts the body's natural defenses to fight cancer to see if it has the potential to reduce or prevent tumors. cancer RRx001-33 Jennifer Barnes jruckdeschel Cancer |
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S1614: A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid TumorsIRB Number: 2019-0277
Published: July 12, 2022
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20220712223109 |
The purpose of this study is to study the effect of tenofovir alafenamide in preventing liver complications in patients with current or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid tumors. s1416;solid tumor;entecavir;tenofovir alafenamide;tenofovir disoproxil fumarate;hepatitis b (hbv) S1416 Eulisa Goins-Freeman jhenegan Cancer |
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S1823: A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell TumorsIRB Number: 2021-0581
Published: July 12, 2022
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20220712224250 |
Studies whether the blood marker micro ribonucleic acid (miRNA) 371 can predict the chance of cancer returning in patients with germ cell cancers. germ cell tumor S1823 Eulisa Goins-Freeman jhenegan Cancer |
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S1826: A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin LymphomaIRB Number: 2019-0206
Published: July 12, 2022
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20220712225540 |
This study compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma, hodgkin disease;lymphoma S1826 Eulisa Goins-Freeman selkins Cancer |
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S1900E: A Phase II Study of AMG 510 in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY)IRB Number: 2021-0600
Published: July 19, 2022
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20220719114113 |
Lung MAP treatment trial studies the effect of AMG 510 in treating non-squamous non-small cell lung cancer (NSCLC) that is stage IV or has come back (recurrent) and has a specific mutation in the KRAA gene, known as KRAS G12C. non-squamous non-small cell lung cancer;lung map;lung cancer S1900E Eulisa Goins-Freeman dpmorgan Cancer |
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S1914: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLCIRB Number: 2021-0641
Published: July 19, 2022
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20220719112925 |
The purpose of the study is to how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. non-small cell lung cancer;lung cancer S1914 Eulisa Goins-Freeman dpmorgan Cancer |
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S1937: A Phase III Randomized Trial of Eribulin with or Without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 TherapyIRB Number: 2021-0584
Published: July 12, 2022
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20220712233458 |
Study compares the usual chemotherapy treatment to eribulin alone to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread to other places in the body (metastatic). urothelial carcinoma S1937 Eulisa Goins-Freeman jhenegan Cancer |
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Shared and Distinct Antispastic Effects of Electrical and Pharmacological NeuromodulationIRB Number: UMMC-IRB-2023-125
Published: March 24, 2025
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20250324172906 |
<div>People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.</div><div><br></div><div>The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.</div> krenn;spine;spinal cord;spinal cord injury;neuromodulation;electrical stimulation;spinal cord stimulation;paralysis 1001784 Deandra Andrade mkrenn Neurosciences Surgery |
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Shared Decision Making for Stroke Prevention in Atrial FibrillationIRB Number: 2018-0104
Published: May 28, 2019
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20190528151617 |
This study is to see if a conversation tool called the "Anticoagulation Choice Conversation Tool" will help participants and their doctors with discussing treatment choices and adherence to therapy in patients with atrial fibrillation (AF) who are at risk for stroke.<br> stroke;brain;atrial fibrillation SDM4Afib Theresa Hickey Hutson tsuzuki Stroke/Traumatic Brain Injury |
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Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III StudyIRB Number: 2024-9
Published: June 25, 2025
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20250625160416 |
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer. craft;breast cancer;tnbc;cancer S2212 Winona Blount bcraft Cancer |
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Sleep for Stroke Management And Recovery Trial (SleepSMART)IRB Number: 2019-0145
Published: August 26, 2019
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20190826142949 |
Investigator-initiated,
phase 3 multicenter, prospective randomized open-, blinded-endpoint (PROBE)
controlled trial to test whether treatment of obstructive sleep apnea (OSA)
with continuous positive airway pressure is effective for secondary prevention
and recovery after stroke. stroke Pending Susan Hetzel dchoufani Sleep Medicine Stroke/Traumatic Brain Injury |
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SPR001-203: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal HyperplasiaIRB Number: 2021-1092
Published: June 16, 2022
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20220616150837 |
<p>The purpose of this study is to determine the safety and effects of tildacerfont (SPR001), an investigational drug that may be used for congenital adrenal hyperplasia (CAH).</p> spr001-203;tildacerfont;congenital adrenal hyperplasia SPR001-203 Shelby Lee vgarla Endocrinology/Diabetes |
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Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM)IRB Number: 2018-0139
Published: May 28, 2019
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20190528151701 |
The purpose of this study is to screen chemotherapy drugs currently used for the care of recurrent glioblastoma (a form of brain cancer) and to determine the most effective treatment based on results from a chemosensitivity assay which is a lab test that measures the number of tumor cells that are killed by a cancer drug. <br> cancer CSCRGBM Jennifer Barnes manderson4 Cancer |
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STAR-T: Safe and Timely Antithrombotic Removal - Ticagrelor: Prospective, Multi-center, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor with the Intraoperative use of the DrugSorb-ATR Device in Patients Undergoing on-pump Cardiothoracic Surgery within Two Days of Ticagrelor DiscontinuationIRB Number: 2022V0857
Published: November 16, 2022
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20221116131246 |
<span style="color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px; background-color: #ffffff;">This study will evaluate the safety and effectiveness of the DrugSorb-ATR system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).</span><br> star-t;ticagrelor STAR-T Stephanie Moore aprotos Heart Health Surgery |
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Strategic MAnagement to Improve CRT Using Multi-Site Pacing (SMART-MSP)IRB Number: 2018-0066
Published: May 28, 2019
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20190528145708 |
We are doing this study to learn more about the safety and effectiveness of pacing features in the Boston Scientific Resonate pacemakers in patients with heart failure according to the device's approved labeling and after Food and Drug Administration approval of the device.<br> heart C1918 Theresa Hickey Hutson tsuzuki Heart Health |
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Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitorIRB Number: 2021V0540
Published: March 31, 2022
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20220331163046 |
The purpose of this study is to demonstrate how well OCTAPLEX works at different doses in people who have acute major bleeding and are currently taking medication which make their blood thinner. octaplex;bleeding LEX-210 Tamara Brocks unandi Stroke/Traumatic Brain Injury |
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Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)IRB Number: 2019-0049
Published: May 28, 2019
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20190528133527 |
The purpose of this study is to test the good and bad effects of the study drug Rucaparib. Another purpose of this study is to learn if a biomarker test for LOH or BRCA1 or BRCA2 genes is helpful in assigning treatment.<br> cancer;preventive medicine S1900A Jennifer Barnes jruckdeschel Cancer Preventive Medicine |
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Study Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate CancerIRB Number: 2019-0078
Published: May 28, 2019
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20190528113828 |
The purpose of this study is to compare any good and bad effects of using the study drug Apalutamide along with usual radiation therapy to using usual radiation therapy alone.<br> cancer;men's health NRG-GU006 Jennifer Barnes jhenegan Cancer Men's Health |
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SWIFT-2: Placebo-controlled efficacy and safety study of GSK3511294 (depemokimab) in participants with severe asthma with an eosinophilic phenotypeIRB Number: 0000000
Published: November 10, 2022
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20221110160603 |
<div><span style="background-color: #ffffff; color: #000000; font-family: &quot;Source Sans Pro&quot;, &quot;Helvetica Neue&quot;, Helvetica, Roboto, Arial, sans-serif; font-size: 14px;">The purpose of this study to assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy in patients with severe uncontrolled asthma with an eosinophilic phenotype.</span><br></div> swift-2;asthma 213744 Jamie Brown gmarshall Allergy/Asthma/Immunology |
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Tamibarotene in Combination with Venetoclax and Azacitidine in Previously Untreated Adult Patients Selected for RARA-positive AML Who Are Ineligible for Standard Induction TherapyIRB Number: 2022-126
Published: November 20, 2023
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20231120093105 |
<span style="font-size:12.0pt;msofont-size:11.0pt;
font-family:&quot;Arial&quot;,sans-serif;msofont-family:&quot;Times New Roman&quot;;
msofont-family:&quot;Times New Roman&quot;;color:black;msolanguage:EN-US;
msolanguage:EN-US;msolanguage:AR-SA">This research study is
being done to determine if an investigational drug, called tamibarotene
(formerly SY-1425), adds any benefit in treating Newly Diagnosed Acute Myeloid
Leukemia (ND-AML) in combination with drugs called azacitidine (also known as
VIDAZA) and venetoclax (also known as VENCLEXTA) when compared to treatment
with only azacitidine and venetoclax. Only patients that are RARA-positive will
be able to be in this study.<i> </i>RARA-positive patients express high levels
of a gene called<i> RARA.</i> Tamibarotene is a targeted medication for RARA‑positive
patients. Previous studies with tamibarotene in combination with azacitidine
have shown beneficial effects in RARA-positive patients diagnosed with Acute
Myeloid Leukemia (AML). </span> tamibarotene, sy-1425, nd-aml, aml, acute myeloid leukemia, elkins, azacitidine, vidaza, venetoclax, cancer SY-1425-202 Jennifer Barnes Stephanie Elkins Cancer |
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Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-Small Cell Lung Cancer, ALCHEMIST TrialIRB Number: 2021-0643
Published: March 27, 2025
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20250327143700 |
<span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.</span> nsclc;morgan;non small cell lung cancer;non-small cell lung cancer A081801 Winona Blount dpmorgan Cancer Lungs/Breathing |
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The Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) in WomenIRB Number: 2019-0074
Published: May 28, 2019
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20190528113911 |
This study will use vaginal swabs to assess the performance of the Click Diagnostics point-of-care, single-use device for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). <br> infectious diseases;pediatrics;women's health 18-0024 Jennifer Brumfield lmena Infectious Diseases Pediatrics Women's Health |
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The Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung CancerIRB Number: 2018-0103
Published: May 28, 2019
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20190528151603 |
The purpose of this research study is to see if taking Naloxegol will help relieve pain related to Advanced Non-Small Cell Lung Cancer and will help stop the cancer from getting bigger.<br> cancer;lungs A221504 Jennifer Barnes jruckdeschel Cancer Lungs/Breathing |
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The Study of MOR00208 with Bendamustine versus Rituximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT) – B-MINDIRB Number: 2018-0111
Published: May 28, 2019
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20190528151632 |
The purpose of this research study is to compare the effects and safety of the study drug, MOR00208, given with bendamustine (BEN) to another treatment combination, rituximab (RTX) in combination with BEN to find out which combination is better for treating DLBCL.<br> cancer MOR208C204 Lisa Goins-Freeman selkins Cancer |
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TMB-301: The ASCEND Study: Evaluating TMB-001 in the treatment of RXLI or ARCI- IchthyosisIRB Number: 2022-293
Published: November 15, 2022
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20221115225412 |
<font face="Times New Roman, serif">The purpose of this study is to find out if Topical TMB=001 ointment is safe and effective for the treatment of moderate to severe congenital ichthyosis (CI) in subjects 6 years of age and older</font> ascend;ichthyosis;dermatology TMB01-301 Thy Huynh tnhuynh Dermatology/Skin Care |
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TO-TAS3681-101: A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability, and Pharmacokinetic Study of TAS3681 in Patients with Metastatic Castration-Resistant Prostate CancerIRB Number: 2021-0699
Published: July 12, 2022
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20220712235036 |
The purpose of the study is to investigate the safety and tolerability of TAS3681, to find the maximum tolerated dose (MTD)/recommended dose of TAS3681 (Escalation Phase). prostate cancer;tas3681 TO-TAS3681-101 Jessie Solise stang Cancer |
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ToRsemide compArisoN with furoSemide FOR Management of Heart FailureIRB Number: 2018-0117
Published: May 28, 2019
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20190528151645 |
We are doing this study to learn more about loop diuretic pills (water pills), and to see which one works better in people who have heart failure. <br> heart;heart health;heart failure NCT03296813 Connie Watson mehall Heart Health |
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Trial of Early Antiviral Therapies during Non hospitalized Outpatient Window (TREAT NOW) for COVID-19IRB Number: 2020V0192
Published: July 21, 2020
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20200721140155 |
A study to evalute the efficacy of Lopinavir/Ritonavir (Kaletra) for treatment of COVID-19. coronavirus;covid-19 pending Jenna Davis aejones COVID-19 (Coronavirus) |
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UAB 2031: Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy with Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Are Folate Receptor Α PositiveIRB Number: 2024-20
Published: June 25, 2025
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20250625162400 |
<span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">The proposed study design is a single arm Phase II trial to document the feasibility of </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">-</span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> identified as appropriate for study participation if IHC staining is PS2+ in >75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">, followed by </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> + </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> + </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> the patient will be declared a screen failure. Patients with BRCA mutations are not excluded from this trial </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;"> are allowed to receive standard of care maintenance therapy including bevacizumab </span><span style="color: #171716; font-family: Roboto, sans-serif; background-color: #ffffff;">/or PARP inhibitors.</span> ovarian;fallopian tube;primary peritoneal;cancer UAB 2031 Winona Blount rocconi Cancer Women's Health |
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VX20-121-103: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationIRB Number: 2021-1102
Published: August 15, 2022
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20220815143410 |
The purpose of this study is to learn more about the safety and effects of taking VX-121/TEZ/D-IVA in patients with cystic fibrosis. cystic fibrosis;vx-121/tez/d-iva;f508del VX20-121-103 Stephanie Moore jspurzem Genetics Lungs/Breathing |