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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 raludotatug deruxtecan (R-DXd; 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 R-DXd that can be given safely to
participants,... expand
This clinical trial will evaluate raludotatug deruxtecan (R-DXd; 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 R-DXd that can be given safely to participants, assess the side effects of R-DXd, and evaluate the effectiveness of R-DXd. Type: Interventional Start Date: Dec 2020 |
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 |
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 |
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... 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 |
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 |
A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease
Parkinson Disease
This study investigates the safety and tolerability of drug IkT-148009 in untreated
Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of
IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features
of... expand
This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features of the disease. This 12 week study is designed to be 3:1 randomized across 3 doses of IkT-148009 or placebo. Each participant will self-administer one of 3 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks. For more information, visit our website: www.the201trial.com Type: Interventional Start Date: May 2023 |
Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
Epilepsy
The purpose of this post-approval study is to further evaluate the long-term safety and
effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted
participants through 3 years of follow-up.
expand
The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up. Type: Interventional Start Date: Mar 2020 |
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke...
Stroke
PFO - Patent Foramen Ovale
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a
post approval setting and evaluate the quality of operator education and training and
transferability of trial experience to a post-market setting.
expand
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting. Type: Interventional Start Date: Jul 2019 |
CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
Cystic Fibrosis
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat
chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and
currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator... expand
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies. Type: Observational Start Date: Jan 2018 |
Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer
Lung Cancer
RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk
of cancer for laboratory studies may help doctors learn more about changes that may occur in
DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking... expand
RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer. Type: Observational Start Date: Dec 2003 |
Comparison Study of LMX4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine for In-Office...
Clubfoot
Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous
tendoachilles lengthening (TAL) after serial casting. This procedure is commonly performed in
the office with a local anesthetic to avoid exposure to general anesthesia in the operating... expand
Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous tendoachilles lengthening (TAL) after serial casting. This procedure is commonly performed in the office with a local anesthetic to avoid exposure to general anesthesia in the operating room. Topical anesthetic creams are commonly used to provide local analgesia for this procedure. The cream is applied to the infant's skin around the heel cord and requires 30-60 minutes to provide adequate analgesia, reaching a depth of up to 5 mm at maximum effect. Alternative to analgesic cream, the J-tip is a needle-free jet injection system that uses compressed CO2 instead of a needle to push 0.25 ml of lidocaine into the skin, providing local analgesia at the site of administration. This method likewise provides analgesia to the site of application at a depth of 5-8 mm, yet only takes approximately 1-2 minutes to achieve maximum effect. Aim 1: Determine which pain management method, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF Injection, provides the greatest pain relief to infants with clubfoot undergoing an in-office percutaneous TAL. Hypothesis: J-tip 1% Xylocaine MPF injection will provide equal or greater pain control when compared to L.M.X.4 cream in infants undergoing an in-office percutaneous TAL. Aim 2: Determine if there is a difference in the rate of adverse events between the two pain management methods, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF Injection. Hypothesis: J-tip 1% Xylocaine MPF injection will not be associated with an increased rate of adverse events in comparison to L.M.X.4 cream in infants undergoing an in-office percutaneous TAL. If J-tip Xylocaine MPF injection is shown to provide comparable or better pain control without an increase in adverse events, use of this needle-free injection system will decrease the overall length of visit and the cost of the procedure, thus increasing the quality, safety, and value. Type: Interventional Start Date: Jun 2021 |
Cooperative Assessment of Late Effects for SCD Curative Therapies
Sickle Cell Disease
Pulmonary Disease
Renal Disease
Heart Disease
Sickle Cell Disease is one of the most common genetic diseases in the United States,
occurring in approximately 1 in 400 births. Approximately 100,000 individuals are diagnosed
with SCD in the United States. Mortality for children with SCD has decreased substantially
over... expand
Sickle Cell Disease is one of the most common genetic diseases in the United States, occurring in approximately 1 in 400 births. Approximately 100,000 individuals are diagnosed with SCD in the United States. Mortality for children with SCD has decreased substantially over the past 4 decades, with >99% of those born in high resource settings, including the United States, France, and England, now surviving to 18 years of age. However, the life expectancy of adults with SCD is severely shortened. Dysfunction of the heart, lung, and kidney is directly associated with decreased life expectancy. With the variety of curative therapies that are now available for SCD, long-term health outcomes studies are time-sensitive. As of now, efforts to determine long-term health outcomes following curative therapies for SCD have been limited. Though curative therapies initially should provide a cure for symptoms of SCD, there is the risk of late health outcomes to consider. Defining health outcomes following curative therapy is essential to improve personalized decision-making when considering curative versus disease-modifying therapeutic options. The primary goal of this study is to determine whether curative therapies for individuals with SCD will result in improved or worsening heart, lung, and kidney damage when compared to individuals with SCD receiving standard therapy. The investigators will also explore whether certain genes are associated with a good or bad outcome after curative therapy for SCD. Type: Observational Start Date: Jul 2022 |
Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
Renal Cell Carcinoma
This study will assess whether DNA released by kidney cancer into the blood stream and urine
of patients can be used to monitor tumor burden and tumor response to treatment in patients
receiving immunotherapy
expand
This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy Type: Observational Start Date: Jan 2021 |
Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)
Heart Failure
Acute Heart Failure
This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared
to structured usual care in ED patients with AHF. Participants will be recruited following an
initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual... expand
This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ED patients with AHF. Participants will be recruited following an initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium. Type: Interventional Start Date: May 2022 |
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
Rotator Cuff Tear
Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the
United States and one of the fastest growing ambulatory surgery procedures. However, data on
comparison of operative versus non-operative treatment is lacking and urgently needed.
expand
Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed. Type: Interventional Start Date: Mar 2018 |
Consent for Use of Stored Patient Specimens for Future Testing
HIV Infections
The purpose of this study is to obtain informed consent to use stored human biological
materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic
testing.
expand
The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing. Type: Observational Start Date: Feb 2002 |
Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
AMD
nAMD
Wet Age-related Macular Degeneration
wAMD
WetAMD
RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular
(wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision
due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of... expand
RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. RGX-314 is being developed as a potential one-time treatment for wet AMD. Type: Interventional Start Date: Dec 2021 |
Effect of Donepezil on Speech Recognition in Cochlear Implant Users
Bilateral Sensorineural Hearing Loss
Hearing loss is a major cause of disability that affects over 48 million Americans. There are
currently no medications used to treat sensorineural hearing loss. Cochlear implants can
significantly restore hearing in adults with moderate to profound sensorineural hearing loss,... expand
Hearing loss is a major cause of disability that affects over 48 million Americans. There are currently no medications used to treat sensorineural hearing loss. Cochlear implants can significantly restore hearing in adults with moderate to profound sensorineural hearing loss, but their utility is limited by the wide variability in hearing outcomes. Differences in cochlear implant outcomes may be explained by neuroplasticity, as neural networks must reorganize to process the new auditory information provided by the implant. The investigators predict that cholinergic enhancement with donepezil (an acetylcholinesterase inhibitor) may facilitate cortical reorganization in cochlear implant users, leading to functional improvements in speech recognition and cognition. In addition to taking donepezil, study participants will be asked to increase their daily processor use. Studies suggest that increasing daily device use can improve speech recognition, and this study will explore whether this effect can be augmented further with donepezil. In this randomized, double-blind controlled trial, the investigators aim to assess the effects of donepezil on speech recognition, cortical plasticity, and cognition. Participants will start daily treatment with either donepezil 5 mg or placebo. Participants will be followed longitudinally at 1 month and 3 months after starting the study. The findings from this study will provide important insight into the mechanisms of hearing restoration and could potentially improve hearing and cognitive outcomes for future cochlear implant users. Type: Interventional Start Date: Mar 2023 |
Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment
Parkinson Disease
The goal of this study is to learn more about the brain activity underlying Parkinson's
disease cognitive impairment. The investigators will utilize neural recordings from
corticostriatal structures performed during deep brain stimulation surgery to measure neural
activity... expand
The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease. Type: Interventional Start Date: Jun 2021 |
Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
Kidney Calculi
The rationale for this study is to determine if there is a difference in complications among
patients undergoing ureteroscopy for renal stones who receive a stent compared to not
receiving a stent postoperatively.
expand
The rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively. Type: Interventional Start Date: Nov 2019 |
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
Pulmonary Invasive Fungal Infections
Pulmonary Invasive Aspergillosis
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes
for children at high-risk for pulmonary invasive fungal infection (PIFI).
expand
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI). Type: Observational Start Date: Oct 2018 |
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
Kidney Transplant Rejection
The ProActive registry is a longitudinal, multi-center study with a prospective arm observing
clinical care for patients receiving physician ordered Prospera, an allograft rejection test,
and a historical control arm collecting data on cases at the same sites whose kidney... expand
The ProActive registry is a longitudinal, multi-center study with a prospective arm observing clinical care for patients receiving physician ordered Prospera, an allograft rejection test, and a historical control arm collecting data on cases at the same sites whose kidney allograft rejection status was managed with Serum Creatinine SCr/estimated Glomerular Filtration Rate eGFR. This registry will compare patient management and outcomes in patients who receive Prospera (Prospera arm) to the outcomes of the historical control group (control arm) to determine Prospera's clinical utility. High-risk subjects defined as having a biopsy-demonstrated rejection event or at least one pre-existing Donor Specific Antibody DSA with total Mean Fluorescent Intensity MFI>3000 or a calculated Panel Reactive Antibodies cPRA>70% will be followed for an additional period up to 24 months in both the Prospera arm and historical control arm. Type: Observational [Patient Registry] Start Date: Nov 2019 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer screening
and may... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Sep 2017 |
Providing Access to the Visual Environment
Vision Impairment
Providing Access to the Visual Environment is a pediatric low vision grant which has the
ability to provide comprehensive, interdisciplinary low vision rehabilitation services to
every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected
vision... expand
Providing Access to the Visual Environment is a pediatric low vision grant which has the ability to provide comprehensive, interdisciplinary low vision rehabilitation services to every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected vision of 20/50 or worse in the better seeing eye are prescribed optical devices to improve their visual functioning and trained to use the devices. Type: Observational Start Date: Jul 2001 |
Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
Lung Cancer
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
help doctors learn more about changes that may occur in RNA and identify biomarkers related
to cancer.
PURPOSE: This research study is collecting and analyzing lung tissue samples... expand
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer. PURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer. Type: Observational Start Date: May 2001 |
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