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569 matching studies

Condition of Interest
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction...
Chronic Heart Failure With Reduced Ejection Fraction
The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or... expand

The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

Type: Interventional

Start Date: Nov 2021

open study

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With...
Cystic Fibrosis
The main objective of the study is to evaluate the pharmacokinetics of brensocatib in participants with cystic fibrosis following once daily oral administration of study drug and to evaluate the safety of brensocatib compared to placebo in participants with cystic fibrosis... expand

The main objective of the study is to evaluate the pharmacokinetics of brensocatib in participants with cystic fibrosis following once daily oral administration of study drug and to evaluate the safety of brensocatib compared to placebo in participants with cystic fibrosis (CF) over the 4-week treatment period.

Type: Interventional

Start Date: Nov 2021

open study

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine...
Pheochromocytoma/Paraganglioma Pancreatic Neuroendocrine Tumor Von Hippel-Lindau Disease
This is a study to evaluate the efficacy and safety of Belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET) or von Hippel-Lindau (VHL) Disease-Associated Tumors. The primary objective of the study is... 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) or von Hippel-Lindau (VHL) Disease-Associated Tumors. 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

open study

Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis Interstitial Lung Disease
Study RIN-PF-301 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) over a 52-week period. expand

Study RIN-PF-301 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) over a 52-week period.

Type: Interventional

Start Date: Jun 2021

open study

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated...
Neoplasms
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: - has spread to other parts of the body (metastatic); - has... expand

The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: - has spread to other parts of the body (metastatic); - has a certain type of abnormal gene called "BRAF"; and - has not received prior treatment. Participants in this study will receive one of the following study treatments: - Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. - Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. - Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. The study team will monitor how each participant responds to the study treatment for up to about 3 years.

Type: Interventional

Start Date: Dec 2020

open study

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor...
Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed... expand

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Type: Interventional

Start Date: Jul 2020

open study

Study of DF1001 in Patients With Advanced Solid Tumors
Solid Tumor, Adult
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of... expand

DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). Two combination therapy cohorts will be opened for enrollment, DF1001 + nivolumab and DF1001 + Nab paclitaxel. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either selected solid tumors, or solid tumors expressing high levels of HER2.

Type: Interventional

Start Date: Nov 2019

open study

Telehealth-Enhanced Patient-Oriented Recovery Trajectory After ICU
Critical Illness Acute Respiratory Distress Syndrome Septic Shock
Although more than 50% of survivors of critical illness experience one or more post-intensive care syndrome (PICS) problems, there are still no validated interventions for the management of PICS. The long-term goal of this study is to develop and refine in-person and telehealth... expand

Although more than 50% of survivors of critical illness experience one or more post-intensive care syndrome (PICS) problems, there are still no validated interventions for the management of PICS. The long-term goal of this study is to develop and refine in-person and telehealth strategies for the delivery of Intensive Care Unit (ICU) recovery care for the treatment of PICS.

Type: Interventional

Start Date: Nov 2019

open study

Mode Of Ventilation During Critical IllnEss Pilot Trial
Respiratory Failure
Landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. Limited evidence, however, informs the... expand

Landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. Limited evidence, however, informs the best method of mechanical ventilation to achieve these targets. To provide mechanical ventilation, clinicians must choose between modes of ventilation that directly control tidal volumes ("volume control"), modes that directly control the inspiratory airway pressure ("pressure control"), and modes that are hybrids ("adaptive pressure control"). Whether the choice of the mode used to target low tidal volumes and low inspiratory plateau pressures affects clinical outcomes for critically ill adults receiving mechanical ventilation is unknown. All three modes of mechanical ventilation are commonly used in clinical practice. A large, multicenter randomized trial comparing available modes of mechanical ventilation is needed to understand the effect of each mode on clinical outcomes. The investigators propose a 9-month cluster-randomized cluster-crossover pilot trial evaluating the feasibility of comparing three modes (volume control, pressure control, and adaptive pressure control) for mechanically ventilated ICU patients with regard to the outcome of days alive and free of invasive mechanical ventilation.

Type: Interventional

Start Date: Nov 2022

open study

Depuy Synthes Lower Extremity Shaft Nail Registry
Femoral Fractures Tibial Fractures
The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in... expand

The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in participants who have experienced femoral or tibial fractures, respectively, requiring fixation and stabilization or who require a revision due to a malunion or a nonunion.

Type: Observational [Patient Registry]

Start Date: May 2022

open study

RNS System NAUTILUS Study
Epilepsy Idiopathic Generalized Epilepsy Generalized Tonic Clonic Seizure
To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy. expand

To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.

Type: Interventional

Start Date: Aug 2022

open study

Study to Assess Dose, Efficacy and Safety of Setrusumab in Participants With Osteogenesis Imperfecta
Osteogenesis Imperfecta
The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate. expand

The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.

Type: Interventional

Start Date: Feb 2022

open study

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal...
Renal Cell Carcinoma
This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). expand

This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).

Type: Interventional

Start Date: Sep 2021

open study

Study of INBRX-109 in Conventional Chondrosarcoma
Conventional Chondrosarcoma
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. expand

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

Type: Interventional

Start Date: Sep 2021

open study

A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic...
Metastatic Colorectal Cancer
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific... expand

This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

Type: Interventional

Start Date: Oct 2021

open study

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism
Pulmonary Embolism
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1... expand

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

Type: Interventional

Start Date: Aug 2021

open study

A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
Renal Cell Carcinoma Ovarian Tumor
This clinical trial will evaluate DS-6000a in participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC). The main goals of this study will be to investigate the recommended dose of DS-6000a that can be given safely to participants, assess the side effects... expand

This clinical trial will evaluate DS-6000a in participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC). The main goals of this study will be to investigate the recommended dose of DS-6000a that can be given safely to participants, assess the side effects of DS-6000a, and evaluate the effectiveness of DS-6000a.

Type: Interventional

Start Date: Dec 2020

open study

A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151)...
Idiopathic Pulmonary Fibrosis
This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF). expand

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

Type: Interventional

Start Date: Aug 2021

open study

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... 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. 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 explosion of 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. 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) 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.

Type: Observational

Start Date: Sep 2020

open study

Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
Chronic Graft-versus-Host-Disease Leukemia Allogeneic Hematopoietic Stem Cell Transplantation Blood Cancer Non-Malignant Hematologic and Lymphocytic Disorder
This study will validate a previously developed pediatric prognostic biomarker algorithm aimed at improving prediction of risk for the later development of chronic graft-versus-host disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell... expand

This study will validate a previously developed pediatric prognostic biomarker algorithm aimed at improving prediction of risk for the later development of chronic graft-versus-host disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell transplant. By developing an early risk stratification of patients into low-, intermediate-, and high-risk for future cGvHD development (based upon their biomarker profile, before the onset of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed based upon an individual's biological risk profile. This study will also continue research into diagnostic biomarkers of cGvHD, and begin work into biomarker models that predict clinical response to cGvHD therapies.

Type: Observational

Start Date: Nov 2020

open study

Bringing to Light the Risk Factors And Incidence of Neuropsychological Dysfunction in ICU Survivors,...
Critical Illness Intensive Care Unit Delirium
This BRAIN-ICU-2 study [Bringing to light the Risk factors And Incidence of Neuropsychological dysfunction (dementia) in ICU Survivors, 2nd Study] is in direct response to PAR-17-038 and will determine ICU patients' main paths to decline, maintenance, or recovery of brain... expand

This BRAIN-ICU-2 study [Bringing to light the Risk factors And Incidence of Neuropsychological dysfunction (dementia) in ICU Survivors, 2nd Study] is in direct response to PAR-17-038 and will determine ICU patients' main paths to decline, maintenance, or recovery of brain function. We will answer gaps in knowledge about long-term outcome of post-ICU brain disease by following the remaining ICU survivors from the original BRAIN-ICU-1 study with complete cognitive testing for the first time ever to 12 years (AIM 1). We will consent and enroll 567 new ICU patients at Vanderbilt and Rush Universities (i.e., BRAIN-ICU-2 cohort) and determine how detailed neuroimaging and cerebrospinal fluid samples can help reveal locations and mechanisms of injury beyond what we learned from the clinical information collected in our original study (AIM 2). Importantly, we are mirroring the existing world-renowned Rush Alzheimer's Disease Research Center brain bank program so that all patients enrolled in Aims 1 and 2 will able to donate their brains to science for the first-ever in-depth pathological study of those who do and do not get post-ICU dementia to define this disease formally (AIM 3)

Type: Observational

Start Date: Oct 2020

open study

A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML
Myelodysplastic Syndromes Chronic Myelocytic Leukemia Acute Myeloid Leukemia Myelodysplastic Syndrome/Neoplasm
Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)... expand

Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months.

Type: Interventional

Start Date: May 2020

open study

Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
Lung Nodule
This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy: 1. a computed tomography... expand

This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy: 1. a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and 2. navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.

Type: Interventional

Start Date: May 2020

open study

Emergency Department-Initiated Buprenorphine Validation Network Trial
Opioid-use Disorder
This study will (1) recruit, train and provide resources to approximately 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to provide ED-initiated buprenorphine (BUP) for patients presenting with opioid use disorder (OUD)... expand

This study will (1) recruit, train and provide resources to approximately 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to provide ED-initiated buprenorphine (BUP) for patients presenting with opioid use disorder (OUD) who are not receiving medications for opioid use disorder (MOUD). Once implementation is adequately achieved, the sites will (2) conduct a randomized controlled trial (RCT) to compare the effectiveness of sublingual buprenorphine (SL-BUP) versus extended-release buprenorphine (XR-BUP) on ED patients' engagement in formal addiction treatment 7-days after their ED visit. In addition, in an ancillary component of the study, the investigators will (3) assess the use of XR-BUP in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores < 8 in a case series to potentially expand the eligibility of patients in the larger RCT to those presenting with little to no opioid withdrawal symptoms. Finally, the investigators will (4) develop and validate ED electronic health record (EHR) opioid-related phenotypes, both of which will inform the main RCT.

Type: Interventional

Start Date: Jul 2020

open study

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE)
The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies. expand

The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

Type: Interventional

Start Date: Feb 2020

open study