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Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Migraine
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo
as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years
with episodic migraine. expand
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine. Type: Interventional Start Date: Feb 2022 |
P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
Multiple Myeloma
Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1
allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory
Multiple Myeloma (RRMM). expand
Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM). Type: Interventional Start Date: May 2022 |
Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic...
Heart Failure With Reduced Ejection Fraction (HFrEF)
Dilated Cardiomyopathy
Prospective, randomized, open-label, international, multi-center clinical study to
evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in
patients with heart failure and reduced ejection fraction (HFrEF). expand
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF). Type: Interventional Start Date: Dec 2020 |
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently...
Solid Tumors
Hematologic Malignancies
The purpose of this study is to evaluate the long-term safety and efficacy of
pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent
studies who transition into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up
Phase... expand
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. Type: Interventional Start Date: Aug 2018 |
Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants with Epstein-Barr...
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
Solid Organ Transplant Complications
Lymphoproliferative Disorders
Allogeneic Hematopoietic Cell Transplant
Stem Cell Transplant Complications
The purpose of this study is to determine the clinical benefit and characterize the
safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated
post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ
transplant (SOT) after failure of rituximab... expand
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab. Type: Interventional Start Date: Dec 2017 |
RESET-Myositis: an Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with...
Idiopathic Inflammatory Myopathy
Dermatomyositis
Anti-Synthetase Syndrome
Immune-Mediated Necrotizing Myopathy
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
Subjects with Active Idiopathic Inflammatory Myopathy expand
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy Type: Interventional Start Date: Dec 2023 |
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight...
Obesity
Overweight
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in
adolescents that have obesity or overweight with at least one weight-related comorbidity.
The study will last approximately 90 weeks and may include up to 25 visits. expand
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits. Type: Interventional Start Date: Oct 2023 |
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
Analgesia
Abuse Opioids
Pain
The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal
buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly
controlled experimental setting. This is a translational study in which healthy
participants are phenotyped for psychosocial... expand
The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly controlled experimental setting. This is a translational study in which healthy participants are phenotyped for psychosocial and Opioid-Use-Disorder-risk-related metrics. In a within-subjects crossover design, 60 participants will receive a standard postoperative oral oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5 separate sessions. Quantitative Sensory Testing (QST) will be used to evaluate alterations in pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will compare abuse potential (indexed by the standard FDA drug liking metric) following equianalgesic doses of the two drugs. Type: Interventional Start Date: Oct 2023 |
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Focal Onset Seizures
The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled
study that will evaluate the clinical efficacy, safety and tolerability of XEN1101
administered as adjunctive therapy in focal-onset seizures. expand
The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures. Type: Interventional Start Date: May 2023 |
A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
R/R CD19-Positive B-Cell Malignancies
Indolent Non-Hodgkin Lymphoma
Aggressive Non-Hodgkin Lymphoma
ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety,
pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or
refractory cluster of differentiation (CD)19-positive B-cell malignancies. expand
ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or refractory cluster of differentiation (CD)19-positive B-cell malignancies. Type: Interventional Start Date: Jan 2023 |
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative...
Embryonal Rhabdomyosarcoma
Fusion-Negative Alveolar Rhabdomyosarcoma
Spindle Cell/Sclerosing Rhabdomyosarcoma
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This
phase III trial aims to maintain excellent outcomes in patients with very low risk
rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24
weeks of vincristine and dactinomycin... expand
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved. Type: Interventional Start Date: Aug 2022 |
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for...
Advanced Extrapulmonary Neuroendocrine Carcinoma
Metastatic Extrapulmonary Neuroendocrine Carcinoma
Recurrent Extrapulmonary Neuroendocrine Carcinoma
Unresectable Extrapulmonary Neuroendocrine Carcinoma
This phase II/III trial compares the effect of immunotherapy with atezolizumab in
combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin)
and etoposide versus standard therapy alone for the treatment of poorly differentiated
extrapulmonary (originated outside the lung)... expand
This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone. Type: Interventional Start Date: Jun 2022 |
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms...
Lupus Erythematosus, Systemic
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus
on participants who have active disease and are already taking standard of care
medications. These may include antimalarials, steroids,... expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks. Type: Interventional Start Date: May 2021 |
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures At High Risk of...
Post Operative Surgical Site Infection
The overall objective is to compare the effect of Vancomycin and Tobramycin powder
combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation
infections of tibial plateau and tibial pilon fractures at high risk of infection
(collectively considered the "study injuries"). expand
The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries"). Type: Interventional Start Date: May 2021 |
Niraparib + Dostarlimab in BRCA Mutated Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Breast Cancer
HER2-negative Breast Cancer
This research study involves pre-operative therapy that is specifically targeted for
breast cancer in individuals with BRCA and PALB2 mutations.
The names of the study drugs involved in this study are:
- Niraparib (Zejula)
- Dostarlimab expand
This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA and PALB2 mutations. The names of the study drugs involved in this study are: - Niraparib (Zejula) - Dostarlimab Type: Interventional Start Date: Dec 2020 |
Neuroblastoma Maintenance Therapy Trial
Neuroblastoma
Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter,
study for patients with neuroblastoma in remission. In this study subjects will receive
730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID
(strata 1, 2, 3, and 4) OR 2500 mg/m2... expand
Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence. Type: Interventional Start Date: Feb 2016 |
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return...
Peripheral Nerve Injury
Current strategies for peripheral nerve repair are severely limited. Even with current
techniques, it can take months for regenerating axons to reach denervated target tissues
when injuries are proximally located. This inability to rapidly restore the loss of
function after axonal injury continues... expand
Current strategies for peripheral nerve repair are severely limited. Even with current techniques, it can take months for regenerating axons to reach denervated target tissues when injuries are proximally located. This inability to rapidly restore the loss of function after axonal injury continues to produce poor clinical outcomes. The investigators propose testing the efficacy and safety of a combination therapy: polyethylene glycol (PEG) assisted axonal fusion technique to repair peripheral nerve injuries in humans. Type: Interventional Start Date: Sep 2019 |
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
Stage III Cutaneous Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
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... expand
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. Type: Interventional Start Date: Nov 2015 |
Hormonal, Metabolic, and Signaling Interactions in PAH
Idiopathic Pulmonary Arterial Hypertension
Heritable Pulmonary Arterial Hypertension
Scleroderma Associated Pulmonary Arterial Hypertension
Appetite Suppressant Associate PAH
Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which
underlie PAH will improve pulmonary vascular function and consequences of the disease. expand
Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which underlie PAH will improve pulmonary vascular function and consequences of the disease. Type: Observational Start Date: Sep 2012 |
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for...
Opioid Use Disorder
Pregnancy Related
Substance Use
Drug Abuse
Drug Abuse in Pregnancy
The primary objective of this study is to evaluate the ability of TOME to increase
Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and
postpartum persons. expand
The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons. Type: Interventional Start Date: Jun 2024 |
P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
High-grade B-cell Lymphoma
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Transformed Follicular Lymphoma (tFL)
Follicular Lymphoma Grade 3B
Phase 1 study comprised of open-label, dose escalation and expansion cohort study of
P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with
relapsed/refractory B cell malignancies expand
Phase 1 study comprised of open-label, dose escalation and expansion cohort study of P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory B cell malignancies Type: Interventional Start Date: Apr 2024 |
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer
Esophageal Adenocarcinoma
Esophageal Squamous Cell Cancer
Siewert Type 1 GEJ Cancer
Pancreatic Cancer
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate
the efficacy, safety, and tolerability of futibatinib in combination with PD-1
antibody-based SoC therapy in adult patients with solid tumors. expand
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors. Type: Interventional Start Date: Jul 2023 |
(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell...
Head and Neck Squamous Cell Carcinoma
Metastatic Head and Neck Squamous Cell Carcinoma
Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test
(zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography
(PET)/computed tomography (CT) for diagnosing the spread of disease from where it first
started (primary site) to other places... expand
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT). Type: Interventional Start Date: May 2023 |
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
Tourette Disorder
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and
tolerability of ecopipam tablets in children, adolescents and adults in the treatment of
Tourette's Disorder (TD). The study includes an open-label period followed by
double-blind, placebo-controlled, randomized withdrawal... expand
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period. Type: Interventional Start Date: Jan 2023 |
A Diagnostic Test for Dementia With Lewy Bodies
MCI-AD, Early Stage Alzheimer's Disease
MCI-DLB, Early Stage Dementia With Lewy Bodies
The Syn-D Study will be evaluating α-synuclein in patients with suspected MCI-AD and
MCI-DLB. Using a simple diagnostic test will improve clinical accuracy in diagnosing,
earlier diagnosis, and distinguish between neurodegenerative diseases. expand
The Syn-D Study will be evaluating α-synuclein in patients with suspected MCI-AD and MCI-DLB. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases. Type: Observational Start Date: Aug 2022 |
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