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.


427 matching studies

Condition of Interest
Tamoxifen Therapy to Treat Pulmonary Arterial Hypertension
Hypertension Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Primary Pulmonary Hypertension Lung Diseases
The main purpose of this clinical trial is to examine the feasibility and effects of tamoxifen in subjects with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated, and its impact on functional condition and selected biomarkers. Changes... expand

The main purpose of this clinical trial is to examine the feasibility and effects of tamoxifen in subjects with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated, and its impact on functional condition and selected biomarkers. Changes in tricuspid annular plane systolic excursion (TAPSE) and other parameters determined by transthoracic echocardiography will be evaluated as well as changes in additional metrics such as six minute walk test distance, quality of life assessments, and hormone levels.

Type: Interventional

Start Date: Oct 2018

open study

Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants
Head and Neck Cancer
RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with cancer and from healthy participants to study in the laboratory may help the study of cancer in the future. PURPOSE: This research study is collecting and storing tissue samples from patients... expand

RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with cancer and from healthy participants to study in the laboratory may help the study of cancer in the future. PURPOSE: This research study is collecting and storing tissue samples from patients with head and neck cancer and from healthy participants.

Type: Observational [Patient Registry]

Start Date: Feb 2003

open study

Natural History Study of Synucleinopathies
Patients With Synucleinopathies Neurogenic Orthostatic Hypotension Pure Autonomic Failure REM Sleep Behavior Disorder Parkinson Disease
Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically... expand

Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically with slowness of movement, coordination difficulties or mild cognitive impairment. Development of these features indicates that abnormal alpha-synuclein deposits have destroyed key areas of the brain involved in the control of movement or cognition. Patients with synucleinopathies and signs of CNS-deficits are frequently diagnosed with Parkinson disease (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA). However, accumulation of alpha-synuclein and death of nerve cells can also begin outside the brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms of autonomic impairment (unexplained constipation, urinary difficulties, and sexual dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic hypotension) may be the only clinical finding. This "pre-motor" autonomic stage suggests that the disease process may not yet have spread to the brain. After a variable period of time, but usually within 5-years, most patients with abnormally low blood pressure on standing develop cognitive or motor abnormalities. This stepwise evolution indicates that the disease spreads from the body to the brain. Another indication of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem that occurs when the lower part of the brain is affected, may also be the first noticeable sign of Parkinson disease. The purpose of this study is to document the clinical features and biological markers of patients with synucleinopathies and better understand how these disorders evolve over time. The study will involve following patients diagnosed with a synucleinopathy (PD/DLB and MSA) and those believed to be in the "pre-motor" stage (with isolated autonomic impairment and/or RBD). Through a careful series of follow-up visits to participating Centers, we will focus on finding biological clues that predict which patients will develop motor/cognitive problems and which ones have the resilience to keep the disease at bay preventing spread to the brain. We will also define the natural history of MSA - the most aggressive of the synucleinopathies.

Type: Observational

Start Date: Jun 2011

open study

A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) Follicular Lymphoma (FL) Marginal Zone B Cell Lymphoma Diffuse Large B-cell Lymphoma (DLBCL)
A Three-Arm Study of ME-401 in Subjects with Relapsed/Refractory CLL/SLL or FL, of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell... expand

A Three-Arm Study of ME-401 in Subjects with Relapsed/Refractory CLL/SLL or FL, of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL

Type: Interventional

Start Date: Oct 2016

open study

Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
Type 1 Diabetes
Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia... expand

Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.

Type: Interventional

Start Date: Nov 2019

open study

Continuation of Antiarrhythmics Following Ventricular Tachycardia Catheter Ablation
Tachycardia, Ventricular Catheter Ablation
We aim to study if patients that undergo catheter ablation for ventricular tachycardia benefit from continuation of Vaughan-Williams class III antiarrhythmic drugs for 3 months after their ablation. expand

We aim to study if patients that undergo catheter ablation for ventricular tachycardia benefit from continuation of Vaughan-Williams class III antiarrhythmic drugs for 3 months after their ablation.

Type: Interventional

Start Date: Dec 2019

open study

Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer...
Biliary Tract Cancer
Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients. expand

Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients.

Type: Interventional

Start Date: Mar 2019

open study

Utility of PCD Diagnostics to Improve Clinical Care
Primary Ciliary Dyskinesia
This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing. expand

This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.

Type: Interventional

Start Date: Jun 2017

open study

Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase...
Myelodysplastic Syndromes Myeloproliferative Neoplasm
This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm. expand

This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.

Type: Interventional

Start Date: Aug 2017

open study

Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease
Parkinson's Disease and Parkinsonism Glymphatic System
This study is designed to measure the change in patients diagnosed with Parkinson's disease (PD) before, during and after a 12 week exercise program.The focus of this study is the glymphatic system. The glymphatic system is a recentlydiscovered novel waste clearance pathway,... expand

This study is designed to measure the change in patients diagnosed with Parkinson's disease (PD) before, during and after a 12 week exercise program.The focus of this study is the glymphatic system. The glymphatic system is a recentlydiscovered novel waste clearance pathway, in patients with Parkinson's Disease (PD).The glymphatic system acts as a waste-clearance system in the brain of vertebrate animals.The glymphatic system has been proposed in which new clearance pathways involving communication between paravascular spaces, interstitial fluid, and ultimately meningeal and dural lymphatic vessels exists, and we have provided evidence that this system may be dysfunctional in patients with Parkinson's disease with cognitive disorders. Early research suggest glymphatic function increases following exercise, this response is believed to clear beta-amyloid in the brain and may mediate the neurobehavioral response to exercise in PD. This study will use cognitive exams, neurological exams as well as specialized imaging to record data points and evaluate the glymphatic function after exercise.

Type: Interventional

Start Date: Nov 2019

open study

Executive Function in Early Childhood
Reading Disability
Despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (EF), have not been unpacked. This... expand

Despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (EF), have not been unpacked. This project will use a longitudinal design, following children from Kindergarten through 1st grade, to understand how the brain networks associated with reading, math, and EF interact to predict academic outcomes and, in those who struggle academically, intervention response.

Type: Interventional

Start Date: Aug 2019

open study

ME-401 in Subjects With Follicular Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Follicular Lymphoma (FL) Non Hodgkin Lymphoma
This is the study of the PI3Kδ inhibitor ME-401 in subjects with relapsed/refractory follicular lymphoma after failure of at least 2 prior lines of systemic therapy expand

This is the study of the PI3Kδ inhibitor ME-401 in subjects with relapsed/refractory follicular lymphoma after failure of at least 2 prior lines of systemic therapy

Type: Interventional

Start Date: Dec 2018

open study

Conditioning SCID Infants Diagnosed Early
SCID
The investigators want to study if lower doses of chemotherapy will help babies with SCID to achieve good immunity with less short and long-term risks of complications after transplantation. This trial identifies babies with types of immune deficiencies that are most likely to... expand

The investigators want to study if lower doses of chemotherapy will help babies with SCID to achieve good immunity with less short and long-term risks of complications after transplantation. This trial identifies babies with types of immune deficiencies that are most likely to succeed with this approach and offers them transplant early in life before they get severe infections or later if their infections are under control. It includes only patients receiving unrelated or mismatched related donor transplants. The study will test if patients receiving transplant using either a low dose busulfan or a medium dose busulfan will have immune recovery of both T and B cells, measured by the ability to respond to immunizations after transplant. The exact regimen depends on the subtype of SCID the patient has. Donors used for transplant must be unrelated or half-matched related (haploidentical) donors, and peripheral blood stem cells must be used. To minimize the chance of graft-versus-host disease (GVHD), the stem cells will have most, but not all, of the T cells removed, using a newer, experimental approach of a well-established technology. Once the stem cell transplant is completed, patients will be followed for 3 years. Approximately 9-18 months after the transplant, vaccinations will be administered, and a blood test measuring whether your child's body has responded to the vaccine will be collected.

Type: Interventional

Start Date: Oct 2018

open study

Central Pain Syndrome in Survivors of Head and Neck Cancer
Head and Neck Cancer
This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes. expand

This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.

Type: Interventional

Start Date: Oct 2019

open study

Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention
Behavior, Health Child Obesity
A randomized controlled trial enrolling 900 parent-infant dyads (English and Spanish speaking) comparing Greenlight (control), a behavioral intervention focusing on nutrition, physical activity, media use, and sleep as compared to Greenlight Plus (intervention) which includes... expand

A randomized controlled trial enrolling 900 parent-infant dyads (English and Spanish speaking) comparing Greenlight (control), a behavioral intervention focusing on nutrition, physical activity, media use, and sleep as compared to Greenlight Plus (intervention) which includes the above materials plus a health information technology (HIT) intervention aimed at supporting family goal‐setting and behavior change during well-child checks throughout the first 2 years of life.

Type: Interventional

Start Date: Oct 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

Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
Numerous studies show that remote monitoring and/or telenursing improves outcomes for patients especially those with chronic diseases. It is proposed that structured telenursing with non-invasive home monitoring of forced vital capacity and oxygen saturation in newly diagnosed... expand

Numerous studies show that remote monitoring and/or telenursing improves outcomes for patients especially those with chronic diseases. It is proposed that structured telenursing with non-invasive home monitoring of forced vital capacity and oxygen saturation in newly diagnosed patients with IPF will decrease hospitalizations for respiratory illness, increase compliance with therapies, and ultimately increase quality of life.

Type: Interventional

Start Date: Aug 2018

open study

Itacitinib for Low Risk GVHD
Low Risk Acute Graft-versus-host Disease Graft-versus-host-disease GVHD
Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). This study will test whether patients with... expand

Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). This study will test whether patients with low risk GVHD can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment.

Type: Interventional

Start Date: Mar 2019

open study

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With...
Acute Myeloid Leukemia Acute Myelogenous Leukemia Myelodysplastic Syndrome
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label... expand

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.

Type: Interventional

Start Date: Apr 2016

open study

Biomarkers to Predict Time to Plasma HIV RNA Rebound
HIV-1 Infection
The purpose of this study is to collect information about what happens when people pause, or temporarily stop taking, ART, and to collect blood samples from these people at frequent intervals. We will also study the safety of pausing ART under close observation. expand

The purpose of this study is to collect information about what happens when people pause, or temporarily stop taking, ART, and to collect blood samples from these people at frequent intervals. We will also study the safety of pausing ART under close observation.

Type: Observational

Start Date: Feb 2017

open study

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
Anaplastic Astrocytoma Recurrent Anaplastic Astrocytoma
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy. expand

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Type: Interventional

Start Date: Jul 2016

open study

A Study to Test the Efficacy and Safety of Inhaled TD139 in Subjects With Idiopathic Pulmonary Fibrosis...
Idiopathic Pulmonary Fibrosis (IPF)
This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of TD139. expand

This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of TD139.

Type: Interventional

Start Date: Feb 2019

open study

Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer
Castration-Resistant Prostatic Cancer Metastatic Prostate Carcinoma Recurrent Prostate Carcinoma Stage IV Prostate Cancer Hormone-Refractory Prostate Cancer
This clinical trial studies cognitive function in men with prostate cancer treated with androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes in brain... expand

This clinical trial studies cognitive function in men with prostate cancer treated with androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes in brain structure or activity related to treatment that may be related to changes in cognitive function. The investigators are also looking for genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer.

Type: Interventional

Start Date: Mar 2017

open study

Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
Childhood Malignant Neoplasm
This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure,... expand

This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Type: Observational

Start Date: Mar 2004

open study

KRT-232 in Subjects With PMF, Post-PV MF, or Post-ET MF Who Have Failed a JAK Inhibitor
Primary Myelofibrosis (PMF) Post-Polycythemia Vera MF (Post-PV-MF) Post-Essential Thrombocythemia MF (Post-ET-MF)
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study is a global, open-label... expand

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study is a global, open-label Phase 2 study to determine the efficacy and safety of KRT-232 in patients with primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF who have failed previous treatment with JAK inhibitor (Part A), or Ruxolitinib (Part B). In Part A of the study, patients will be randomly assigned to 2 different doses and 3 different dosing schedules of KRT-232. In Part B of the study, patients will be treated at the recommended dose and schedule from Part A.

Type: Interventional

Start Date: Jan 2019

open study