Vanderbilt conducts research studies and clinical trials in various divisions throughout the Medical Center. We know that figuring out where to start can be one of the biggest obstacles a volunteer faces when searching for research study opportunities.


417 matching studies

Condition of Interest
Family-Centered Songwriting in Pediatric Palliative Care
Cognitive Impairment
This study evaluates the feasibility and efficacy of a family-centered songwriting intervention for cognitively-impaired children referred to a palliative care service. expand

This study evaluates the feasibility and efficacy of a family-centered songwriting intervention for cognitively-impaired children referred to a palliative care service.

Type: Interventional

Start Date: Mar 2020

open study

Study of BHV-3241 in Subjects With Multiple System Atrophy
Multiple System Atrophy
The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with Multiple System Atrophy expand

The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with Multiple System Atrophy

Type: Interventional

Start Date: Jul 2019

open study

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients...
CMV Disease
The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated,... expand

The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.

Type: Interventional

Start Date: May 2018

open study

PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)
NHL Solid Tumors
This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL). expand

This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).

Type: Interventional

Start Date: Jun 2016

open study

Breast Cancer WEight Loss Study (BWEL Study)
Breast Carcinoma
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk... expand

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

Type: Interventional

Start Date: Aug 2016

open study

Mechanism(s) Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 1
Hypertension
The purpose of this study is to test the hypothesis that combined angiotensin receptor blockade (ARB)/neprilysin (NEP) inhibition potentiates the effects of exogenous bradykinin, substance P, and brain natriuretic peptide (BNP) on forearm blood flow or endothelial tissue-type... expand

The purpose of this study is to test the hypothesis that combined angiotensin receptor blockade (ARB)/neprilysin (NEP) inhibition potentiates the effects of exogenous bradykinin, substance P, and brain natriuretic peptide (BNP) on forearm blood flow or endothelial tissue-type plasminogen activator (t-PA) release compared to ARB alone. A secondary goal is to determine if there is an interactive effect of ARB/NEP inhibition and dipeptidyl peptidase 4 (DPP4) inhibition on responses to these peptides.

Type: Interventional

Start Date: Nov 2018

open study

Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
Coronavirus Acute Respiratory Infection SARS-CoV Infection
ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment. expand

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

Type: Interventional

Start Date: Apr 2020

open study

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Hypercholesterolaemia
Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in patients with heterozygous familial hypercholesterolemia... expand

Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in patients with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins. Secondary Objective: - To evaluate the efficacy of alirocumab versus placebo on low-density lipoprotein cholesterol (LDL-C) levels. - To evaluate the effects of alirocumab versus placebo on other lipid parameters. - To evaluate the safety and tolerability of alirocumab in comparison with placebo. - To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment. - To evaluate the development of anti-alirocumab antibodies.

Type: Interventional

Start Date: May 2018

open study

Zoster Eye Disease Study
Herpes Zoster Ophthalmicus
This is a multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due... expand

This is a multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment.

Type: Interventional

Start Date: Aug 2017

open study

Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive...
EBV-Related Post-Transplant Lymphoproliferative Disorder Monomorphic Post-Transplant Lymphoproliferative Disorder Polymorphic Post-Transplant Lymphoproliferative Disorder Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder
This pilot phase II trial studies how well rituximab and latent membrane protein (LMP)-specific T-cells work in treating pediatric solid organ recipients with Epstein-Barr virus-positive, cluster of differentiation (CD)20-positive post-transplant lymphoproliferative disorder.... expand

This pilot phase II trial studies how well rituximab and latent membrane protein (LMP)-specific T-cells work in treating pediatric solid organ recipients with Epstein-Barr virus-positive, cluster of differentiation (CD)20-positive post-transplant lymphoproliferative disorder. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. LMP-specific T-cells are special immune system cells trained to recognize proteins found on post-transplant lymphoproliferative disorder tumor cells if they are infected with Epstein-Barr virus. Giving rituximab and LMP-specific T-cells may work better in treating pediatric organ recipients with post-transplant lymphoproliferative disorder than rituximab alone.

Type: Interventional

Start Date: Mar 2017

open study

Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active...
Inflammatory Bowel Disease
The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease. Results of this study may be pooled with the results of a separate study being conducted in participants with... expand

The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease. Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the same objective. The total planned number of participants in both studies combined will be up to approximately 250 participants.

Type: Interventional

Start Date: Jul 2017

open study

Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors...
Neoplasms
GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary... expand

GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab, chemotherapy or other immune therapies. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

Type: Interventional

Start Date: Jun 2016

open study

Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung...
Non-small Cell Lung Cancer
This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate... expand

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2).

Type: Interventional

Start Date: Oct 2018

open study

Adaptive COVID-19 Treatment Trial (ACTT)
COVID-19
This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites... expand

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

Type: Interventional

Start Date: Feb 2020

open study

Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed Diseases...
Genetic Disease
Background: - Without an explanation for severe and sometimes life-threatening symptoms, patients and their families are left in a state of unknown. The NIH helped create a network of medical research centers, called the Undiagnosed Diseases Network (UDN), to provide care and... expand

Background: - Without an explanation for severe and sometimes life-threatening symptoms, patients and their families are left in a state of unknown. The NIH helped create a network of medical research centers, called the Undiagnosed Diseases Network (UDN), to provide care and answers for these individuals. Objectives: - To improve diagnosis and care for people with undiagnosed diseases. Eligibility: - People with undiagnosed diseases, and their relatives. Design: - Participants will travel to one of the UDN medical centers for a 5-day clinical and research visit. - As part of the visit, UDN healthcare providers may ask participants to have: - Clinically indicated tests and procedures performed including: - A physical exam - Blood and urine tests - A review of health and family history - X-rays and body scans - Surveys - Photographs of the face and body - A special diet to see if the body can handle the food without having a reaction, like vomiting - Video or voice recordings - Other tests and procedures to help reach a diagnosis - Research tests and procedures performed including: - A skin biopsy. For this, a small piece of skin will be taken. - Surveys - Other tests and procedures for research that may not be related to a diagnosis or treatment. - Most participants will be asked to give samples for genetic testing. - Participants may be contacted after their visit to discuss test results. They may also be contacted in the future for interviews and surveys. - Relatives of participants may be asked to give samples for genetic testing. They may be asked to have parts of their visit recorded and to have additional tests. They may also be contacted in the future for interviews and surveys. - Clinical and research information collected will be stored in a database. - Information and samples collected will be shared with others for research purposes.

Type: Observational

Start Date: Jul 2015

open study

COVID-19 and Cancer Consortium Registry
COVID-19 Invasive Malignancy (Any Type)
In this study we will collect granular information on cancer patients infected with COVID-19, as rapidly as possible. The mechanism for collection of this information is a de-identified centralized registry housed at Vanderbilt University Medical Center, with data donations from... expand

In this study we will collect granular information on cancer patients infected with COVID-19, as rapidly as possible. The mechanism for collection of this information is a de-identified centralized registry housed at Vanderbilt University Medical Center, with data donations from internal and external health care professionals.

Type: Observational [Patient Registry]

Start Date: Mar 2020

open study

Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Rheumatic Joint Disease
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer... expand

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.

Type: Observational [Patient Registry]

Start Date: Jul 2015

open study

Mechanisms of Familial Pulmonary Fibrosis
Familial Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Familial Interstitial Pneumonia
This a prospective, longitudinal study of first-degree family members of patients diagnosed with familial interstitial pneumonia (FIP). FIP is the familial form of idiopathic pulmonary fibrosis (IPF), which is defined as 2 or more bloodline relatives which have a diagnosis of... expand

This a prospective, longitudinal study of first-degree family members of patients diagnosed with familial interstitial pneumonia (FIP). FIP is the familial form of idiopathic pulmonary fibrosis (IPF), which is defined as 2 or more bloodline relatives which have a diagnosis of idiopathic interstitial pneumonia (IIP). The most common form of idiopathic interstitial pneumonia in FIP families is IPF (approximately 70%). The inheritance pattern in FIP is consistent with autosomal dominant inheritance with incomplete penetrance. Therefore, individuals in this study have approximately 50% risk of carrying a disease-associated allele. The causative gene is currently only known approximately 20% of families. The main goal of this longitudinal study is to better establish the natural history of FIP and to identify risk factors for later development of symptomatic disease. The investigators' plan is to follow these at-risk individuals with yearly questionnaires and planned in person 5 year follow-ups through age 70 or until they develop symptomatic FIP.

Type: Observational

Start Date: Jan 2009

open study

Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia
Ventricular Tachycardia
The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This... expand

The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This approach is desirable because some people have ventricular arrhythmias that originate deep within the heart muscle where it is not abolished by ablation with standard catheters. The investigators seek to determine whether the INA catheter can potentially help people who have ventricular arrhythmias that have failed standard radiofrequency ablation. The investigators also want to determine if it is likely to be safe, without excessive side effects.

Type: Interventional

Start Date: Sep 2016

open study

Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal...
Penicillin Allergy
Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden... expand

Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. The investigators objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a randomized controlled trial.

Type: Interventional

Start Date: Mar 2019

open study

CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer
Bladder Cancer Cancer of the Bladder, Recurrent Non-muscle Invasive Bladder Cancer
Bladder cancer is the most common urinary tract cancer, affecting men and women, and is the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce... expand

Bladder cancer is the most common urinary tract cancer, affecting men and women, and is the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Type: Observational

Start Date: Jul 2019

open study

Advocating for Supports to Improve Service Transitions
Autism Spectrum Disorder Autism
This is a randomized intervention study to test and develop the national curriculum of a parent intervention training targeting parent's ability for advocate for services to improve the transition to adulthood for their youth with autism spectrum disorder (ASD). UPDATE regarding... expand

This is a randomized intervention study to test and develop the national curriculum of a parent intervention training targeting parent's ability for advocate for services to improve the transition to adulthood for their youth with autism spectrum disorder (ASD). UPDATE regarding COVID-19: The current intervention has been paused until it is safe to meet as a group again. We are still recruiting participants for cohort 2 (in TN and IL) and Cohort 1 and 2 (in WI), as the plan is to resume the intervention as soon as the situation allows and to keep the future scheduled interventions happening in the Fall of 2020, Fall of 2021 and Winter of 2022. For the baseline data collection visit, we have moved to remote data collection for all measures except the psychological testing with the youth - meaning that families will be able to partially complete baseline data via teleconference and/or phone calls and online surveys. In-person visits to complete the psychological testing with the youth will be scheduled in the future when it is safe to meet face to face.

Type: Interventional

Start Date: Dec 2019

open study

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive...
Depressive Disorder, Major
The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD)... expand

The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.

Type: Interventional

Start Date: Oct 2017

open study

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
Anal Canal Squamous Cell Carcinoma Metastatic Anal Canal Carcinoma Stage IV Anal Canal Cancer AJCC v6 and v7
This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies,... expand

This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). 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.

Type: Interventional

Start Date: May 2015

open study

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active...
Crohn Disease
This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease. expand

This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.

Type: Interventional

Start Date: Jun 2018

open study