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Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modul1
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed
to determine whether intensification of immune modulation early in the course of the
disease (while patients are on low f1 expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 2023 |
Metastatic Leiomyosarcoma Biomarker Protocol
Leiomyosarcoma
Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can
occur in various sites including soft tissue, uterus and retroperitoneal large vessels.
Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma
and prognosis is poor in setting of m1 expand
Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and chemotherapy, and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing. Type: Observational Start Date: Dec 2022 |
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Tr1
Refractory IPA
To assess the safety and efficacy of nebulized PC945 in combination with systemic
antifungal therapy for the treatment of refractory IPA expand
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA Type: Interventional Start Date: Jun 2022 |
Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
Acute Myeloid Leukemia in Remission
Prospective determination of the clinical utility of measurable residual disease (MRD)
testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing
allogeneic hematopoietic cell transplantation (alloHCT). expand
Prospective determination of the clinical utility of measurable residual disease (MRD) testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (alloHCT). Type: Observational Start Date: Aug 2022 |
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With1
DLBCL
Diffuse Large B-Cell Lymphoma
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and
expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in
combination with standard of care options for the treatment of rrDLBCL. This study will
be divided into 2 parts: Dose Conf1 expand
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab [BR] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B. Type: Interventional Start Date: Jan 2022 |
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Hematologic Disorder
Bleeding Disorder
Connective Tissue Disorder
Hemophilia
Thrombosis
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN)
clinical studies, the number of new therapies for all congenital and acquired hematologic
conditions, not just those for bleeding and clotting disorders, is increasing
significantly. Some of the recently FDA-approved1 expand
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Type: Observational Start Date: Sep 2020 |
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
Anaplastic Kidney Wilms Tumor
Recurrent Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
This phase II trial studies how well combination chemotherapy works in treating patients
with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable
histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy
regimens such as UH-3 (vincristine,1 expand
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) 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 may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT). Type: Interventional Start Date: Oct 2020 |
The ADAPT Trial: Adapting Evidence-Based Obesity Interventions in Community Settings
Childhood Obesity
Evidence-based obesity treatment is inaccessible to most children in the United States.
This lack of access is a source of health inequity, whereby children from rural and
minority communities, who have the highest rates of childhood obesity, are also the least
likely to receive an evidence-based i1 expand
Evidence-based obesity treatment is inaccessible to most children in the United States. This lack of access is a source of health inequity, whereby children from rural and minority communities, who have the highest rates of childhood obesity, are also the least likely to receive an evidence-based intervention. Developing strategies to improve access to evidence-based obesity interventions could reduce health disparities by improving reach to these underserved communities. The premise of this study is that using a systematic framework to adapt a community-based behavioral intervention for childhood obesity that accounts for individual, family, and community factors will increase reach and effectiveness among low-income, minority, and rural populations. COACH is a multi-level obesity intervention that supports 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by directly addressing parent weight loss and engaging parents as agents of change for their children, and 3) the community by building the capacity of local community centers to offer parent-child programming. The investigators propose testing the process of adapting COACH in a cluster-randomized trial. Type: Interventional Start Date: Oct 2024 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in1
Thyroid Eye Disease
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and
pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized
anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye
disease (TED). expand
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED). Type: Interventional Start Date: Nov 2023 |
Pulsed Field Ablation (PFA) Vs Anti-Arrhythmic Drug (AAD) Therapy As a First Line Treatment for Per1
Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field
ablation as a first-line ablation treatment for subjects with persistent atrial
fibrillation as compared to subjects who received an initial treatment with
anti-arrhythmic drugs. expand
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs. Type: Interventional Start Date: Dec 2023 |
Prevention of Anhedonia in Children
Anhedonia
Depression
This trial will test the effects of a positive emotion-focused preventive intervention on
reward responsiveness in children of mothers with histories of depression and anhedonia. expand
This trial will test the effects of a positive emotion-focused preventive intervention on reward responsiveness in children of mothers with histories of depression and anhedonia. Type: Interventional Start Date: Nov 2023 |
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capeci1
Metastatic Colorectal Carcinoma
Metastatic Malignant Solid Neoplasm
Stage IV Colorectal Cancer AJCC v8
Unresectable Colorectal Carcinoma
Unresectable Malignant Solid Neoplasm
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in
combination with the usual treatment with capecitabine in treating patients with cancer
that has spread from where it first started (primary site) to other places in the body
(metastatic) or cannot be removed by surger1 expand
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Giving ZEN003694 in combination with capecitabine may be safe in treating patients with metastatic or unresectable solid tumors. Type: Interventional Start Date: Nov 2023 |
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma
Metastatic Breast Cancer
This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate
the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with
non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC) expand
This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC) Type: Interventional Start Date: Sep 2023 |
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated1
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
The purpose of this study is to evaluate the safety and tolerability of extended dosing
with eplontersen in participants with ATTR-CM. expand
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM. Type: Interventional Start Date: Nov 2022 |
Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat1
Angelman Syndrome
This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56
participants with deletion Angelman Syndrome (AS) aged 5-17 years (inclusive) will be
enrolled in the study. expand
This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56 participants with deletion Angelman Syndrome (AS) aged 5-17 years (inclusive) will be enrolled in the study. Type: Interventional Start Date: Jul 2023 |
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-1
Pulmonary Arterial Hypertension
The primary objectives of the study are to evaluate the safety and tolerability, and
pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18
years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC).
There is no formal hypothesis. expand
The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis. Type: Interventional Start Date: Jan 2023 |
Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors
Advanced Cancer
RBS2418 (investigational product) is a specific immune modulator, working through
ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to
anti-tumor immunity by increasing endogenous 2'-3'-cyclic guanosine
monophosphate-adenosine monophosphate (cGAMP) and adenosine triphosph1 expand
RBS2418 (investigational product) is a specific immune modulator, working through ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine production in the tumors. RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with checkpoint blockade. This study is an open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in combination with pembrolizumab or as a monotherapy in subjects with advanced unresectable, recurrent or metastatic tumors. Type: Interventional Start Date: Jul 2022 |
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Ind1
SSM
Mastocytosis, Indolent
Mastocytosis, Systemic
Mastocytosis
ISM
This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study
comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care
(BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis
(NonAdvSM), including indolent systemic mas1 expand
This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib. Type: Interventional Start Date: Jun 2022 |
A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
Type 2 Diabetes Mellitus
Chronic Kidney Diseases
The purpose of this study is to assess the safety and efficacy (including durability) of
up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously
into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD. expand
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD. Type: Interventional Start Date: Jan 2022 |
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
Obesity
Genetic Obesity
The protocol describes a randomized, double-blind, placebo-controlled trial with
independent sub-studies of setmelanotide in patients with obesity and at least one of the
specific gene variants in the Melanocortin-4 Receptor pathway:
- POMC or PCSK1 (Sub-study 035a)
- LEPR (Sub-study 035b)1 expand
The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway: - POMC or PCSK1 (Sub-study 035a) - LEPR (Sub-study 035b) - SRC1 (Sub-study 035c) - SH2B1 (Sub-study 035d) The objectives and endpoints are identical for these sub-studies. Type: Interventional Start Date: Dec 2021 |
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Ag1
Stereotypical Prolonged Seizures
The purpose of the study is to assess the success of a single administration of Staccato
alprazolam compared with placebo both in rapidly terminating a seizure episode within 90
seconds and with no recurrence of seizure(s) up to 2 hours after investigational
medicinal product (IMP) administration. expand
The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration. Type: Interventional Start Date: Dec 2021 |
A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder
CDKL5 Deficiency Disorder
Generalized Tonic Clonic Seizure
Epileptic Spasm
Refractory Seizures
This is a multicenter, double-blind, parallel-group, placebo controlled, 2-part study to
evaluate the efficacy and safety of ZX008 when used as adjunctive therapy for the
treatment of uncontrolled seizures in children and adults with cyclin-dependent kinase
like-5 (CDKL5) deficiency disorder (CDD). expand
This is a multicenter, double-blind, parallel-group, placebo controlled, 2-part study to evaluate the efficacy and safety of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD). Type: Interventional Start Date: Mar 2022 |
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic1
Pheochromocytoma/Paraganglioma
Pancreatic Neuroendocrine Tumor
Von Hippel-Lindau Disease
Advanced Gastrointestinal Stromal Tumor
HIF-2α Mutated Cancers
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in
participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic
neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced
Gastrointestinal Stromal Tumor (wt GIST), or Advance1 expand
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Type: Interventional Start Date: Aug 2021 |
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants1
Cervical Cancer
Gastric/Gastroesophageal Junction Adenocarcinoma
Microsatellite Stable Colorectal Cancer
Non-Small-Cell Lung Cancer
Squamous Cell Carcinoma of Head and Neck
The purpose of this study is to assess the safety, tolerability, and recommended dose(s)
of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in
participants with advanced solid tumors. This study is a first-in-human (FIH) study of
BMS-986340 in participants with advanced sol1 expand
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors. Type: Interventional Start Date: May 2021 |
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