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583 matching studies

Condition of Interest
Strategies for Anticoagulation During Venovenous ECMO
Acute Hypoxemic Respiratory Failure Anticoagulant-induced Bleeding Thromboembolism
Moderate intensity titrated dose anticoagulation has been used in patients receiving extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic mechanical complications. As technology has improved, however, the incidence of thromboembolic events has... expand

Moderate intensity titrated dose anticoagulation has been used in patients receiving extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic mechanical complications. As technology has improved, however, the incidence of thromboembolic events has decreased, leading to re-evaluation of the risks of anticoagulation, particularly during venovenous (V-V) ECMO. Recent data suggest that bleeding complications during V-V ECMO may be more strongly associated with mortality than thromboembolic complications, and case series have suggested that V-V ECMO can be safely performed without moderate or high intensity anticoagulation. At present, there is significant variability between institutions in the approach to anticoagulation during V-V ECMO. A definitive randomized controlled trial is needed to compare the effects of a low intensity fixed dose anticoagulation (low intensity) versus moderate intensity titrated dose anticoagulation (moderate intensity) on clinical outcomes during V-V ECMO. Before such a trial can be conducted, however, additional data are needed to inform the feasibility of the future trial.

Type: Interventional

Start Date: Oct 2021

open study

Longitudinal Impact of Stressors in Adults With Tourette Syndrome
Tourette Syndrome
The Investigators propose a two-year, longitudinal pilot study of TS adults (>18) to determine impact of lifetime environmental stress exposure on tic severity, psychiatric comorbidity severity, and health-related quality of life (HRQOL). expand

The Investigators propose a two-year, longitudinal pilot study of TS adults (>18) to determine impact of lifetime environmental stress exposure on tic severity, psychiatric comorbidity severity, and health-related quality of life (HRQOL).

Type: Observational

Start Date: Sep 2021

open study

A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK-6482-018)
Carcinoma, Renal Cell
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating doses of belzutifan as second line positive (2L+) treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). expand

The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating doses of belzutifan as second line positive (2L+) treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).

Type: Interventional

Start Date: Jun 2021

open study

Translational Research to Inform Interventions for Challenging Behavior
Behavior and Behavior Mechanisms
This project is meant to identify relations between the reinforcement histories of 80 adults with intellectual and developmental disabilities (IDD) and the prevalence of extinction bursts. Extinction bursts, or temporary increases in rates and intensities of behavior during... expand

This project is meant to identify relations between the reinforcement histories of 80 adults with intellectual and developmental disabilities (IDD) and the prevalence of extinction bursts. Extinction bursts, or temporary increases in rates and intensities of behavior during extinction, often preclude the inclusion of extinction in intervention packages meant to suppress severe challenging behavior, despite the fact that extinction is often necessary to generate therapeutic outcomes. Study results will provide insight into how researchers can enhance interventions for the severe challenging behavior of individuals with IDD while mitigating the undesirable collateral effects (i.e., extinction bursts) of therapeutic action (i.e., extinction). Expanded access to study results will be made available to those who inquire after all data have been obtained and analyzed.

Type: Interventional

Start Date: Aug 2021

open study

A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for...
Essential Tremor of the Upper Limb
The purpose of this study is to determine whether a single treatment with administration of NT 201 (botulinum toxin) is superior to placebo (no medicine) for one-sided treatment of essential tremor in the arm (Unilateral Period). Participants will be assigned to the treatment... expand

The purpose of this study is to determine whether a single treatment with administration of NT 201 (botulinum toxin) is superior to placebo (no medicine) for one-sided treatment of essential tremor in the arm (Unilateral Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following treatment cycle will investigate the safety and tolerability of two-sided treatment with NT 201 (botulinum toxin) (Open Label Bliaterial Period). All participants will receive NT 201 treatment.

Type: Interventional

Start Date: Feb 2021

open study

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants...
Urinary Bladder Neoplasms
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant... expand

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease.

Type: Interventional

Start Date: Dec 2020

open study

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease
Parkinson Disease
The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease. expand

The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.

Type: Interventional

Start Date: Dec 2020

open study

Study of Atezolizumab and Bevacizumab With Y-90 TARE in Patients With Unresectable Hepatocellular Carcinoma...
Hepatocellular Carcinoma
This is an open-label, multi-center, randomized phase II study comparing the Y90 TARE followed by bevacizumab and atezolizumab treatment to the Y90 TARE treatment alone in unresectable intermediate stage HCC. expand

This is an open-label, multi-center, randomized phase II study comparing the Y90 TARE followed by bevacizumab and atezolizumab treatment to the Y90 TARE treatment alone in unresectable intermediate stage HCC.

Type: Interventional

Start Date: Nov 2020

open study

Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic...
Heart Failure With Reduced Ejection Fraction (HFrEF) Dilated Cardiomyopathy
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF). expand

Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

Type: Interventional

Start Date: Dec 2020

open study

HEALEY ALS Platform Trial - Master Protocol
Amyotrophic Lateral Sclerosis
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. expand

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Type: Interventional

Start Date: Jul 2020

open study

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted...
Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Invasive Breast Carcinoma
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after... expand

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

Type: Interventional

Start Date: Feb 2020

open study

Social Decision Making in Parkinson's Disease
Parkinson Disease
Impulsive and compulsive behaviors occur in up to 46% of Parkinson's Disease (PD) patients taking dopamine agonist (DAA) medications. While these abnormal social behaviors have been studied in other neurodegenerative disorders, the true incidence of social problems, and the... expand

Impulsive and compulsive behaviors occur in up to 46% of Parkinson's Disease (PD) patients taking dopamine agonist (DAA) medications. While these abnormal social behaviors have been studied in other neurodegenerative disorders, the true incidence of social problems, and the relationship to dopamine therapy, in PD patients remains unknown. This study is aiming to determine if dopamine agonists alter social decision-making and to determine if impaired social decision-making relates to dopamine-induced mesolimbic network dysfunction in PD patients. The protocol will include a screening visit, and on-DAA visit, and an off-DAA visit. For both the on and off DAA visits, participants will continue taking Carbidopa-Levodopa, but will withdrawal off of other PD related medications. Both visits will include an MRI, fMRI shock task, questionnaires to be filled out by other the participant and the caregiver, moral-decision making computer tasks, and the Unified Parkinsons Disease Rating Scale (UPDRS) part II and III. For the on-DAA visit, participants will take Pramipexole. For the off-DAA visit, participants will receive a placebo. Participants will remind blinded to which medication they are receiving that day and will be counterbalanced such that all participants will not take the Pramipexole or placebo on the same days.

Type: Interventional

Start Date: Dec 2019

open study

A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral...
Cerebral Palsy, Dyskinetic
Study TV50717-CNS-30081 is a 55-week study in which patients who have successfully completed the parent study (Study TV50717-CNS-30080) may be eligible to enroll in this study. The primary objective of this study is to evaluate the safety and tolerability of long-term therapy... expand

Study TV50717-CNS-30081 is a 55-week study in which patients who have successfully completed the parent study (Study TV50717-CNS-30080) may be eligible to enroll in this study. The primary objective of this study is to evaluate the safety and tolerability of long-term therapy with TEV-50717 in children and adolescents with DCP. The secondary objective of this study is to evaluate the efficacy of long-term therapy with TEV-50717 in reducing the severity of DCP.

Type: Interventional

Start Date: Feb 2020

open study

Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial...
Rehabilitation
The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar... expand

The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study.

Type: Interventional

Start Date: Jan 2020

open study

A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma or Non-Hodgkin Lymphoma
Relapsed and/or Refractory Multiple Myeloma Relapsed and/or Refractory Non Hodgkin Lymphoma
This will be a Phase 1 Open-Label, dose escalation and expansion study of MT-0169 (an Engineered toxin body (ETB) in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma. MT-0169 is an investigational drug that recognizes and binds to the CD38 receptor,... expand

This will be a Phase 1 Open-Label, dose escalation and expansion study of MT-0169 (an Engineered toxin body (ETB) in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma. MT-0169 is an investigational drug that recognizes and binds to the CD38 receptor, which may be found on the surface of multiple myeloma and non-Hodgkin lymphoma cancer cells. It delivers a dose of a modified toxin that kills these cells.

Type: Interventional

Start Date: Feb 2020

open study

MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform...
Plexiform Neurofibroma Neurofibromatosis Type 1 (NF1)
This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901). expand

This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901).

Type: Interventional

Start Date: Sep 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 and 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... expand

Bladder cancer is the most common urinary tract cancer and 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

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea
Obstructive Sleep Apnea
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects. expand

A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.

Type: Interventional

Start Date: Sep 2020

open study

Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced...
Carcinoma, Squamous Cell
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with... expand

This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).

Type: Interventional

Start Date: Apr 2019

open study

A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab...
Advanced Melanoma
This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma. expand

This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.

Type: Interventional

Start Date: Jan 2019

open study

A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children...
Cerebral Palsy, Dyskinetic
CP (cerebral palsy) refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. CP is caused by damage to or abnormalities inside the developing brain that disrupt the brain's ability to... expand

CP (cerebral palsy) refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. CP is caused by damage to or abnormalities inside the developing brain that disrupt the brain's ability to control movement and maintain posture and balance. The signs of CP usually appear in the early months of life, although specific diagnosis may be delayed until the age of 2 years or older. TEV-50717 (deutetrabenazine, also known as SD-809) has already provided evidence for safe and effective use in 2 other hyperkinetic movement disorders, namely chorea in Huntington's disease (HD) and tardive dyskinesia (TD). Currently, there is no approved treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options address some of the manifestations of DCP. The study population will include pediatric and adolescent participants (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had nonprogressive CP symptoms since infancy (≤2 years of age). Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria. This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered as oral tablets at a starting dose of 6 mg once daily in participants (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement disorder. The study will be conducted in multiple centers and will use 2 parallel treatment groups (ie, TEV-50717 and placebo) in which participants will be randomized in a 2:1 ratio. "Predominant" in this instance indicates that the choreiform movement disorder is the main cause of impairment or distress.

Type: Interventional

Start Date: Aug 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

Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid...
Acute Myeloid Leukemia
This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine,... expand

This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

Type: Interventional

Start Date: Jan 2019

open study

HD-Charge: Indirect and Out-of-Pocket Costs of Huntington's Disease in the United States
Huntington's Disease
Huntington's disease (HD) is a rare, inherited and progressive neurodegenerative disorder for which hallmark symptoms include movement disorders, loss of cognitive faculties and psychiatric disturbances. With the progression of the disease, patients require increasing level... expand

Huntington's disease (HD) is a rare, inherited and progressive neurodegenerative disorder for which hallmark symptoms include movement disorders, loss of cognitive faculties and psychiatric disturbances. With the progression of the disease, patients require increasing level of medical care, caregiver support, and long-term care, which lead to substantial burden of illness. Very little data are available on the direct or indirect costs for HD. The direct medical costs of HD in the US have been summarized from retrospective commercial and Medicaid claims data analysis. The indirect and out-of-pocket costs of HD in the US have not been quantified. This study will help to bridge these gaps. This study is a single-assessment, cross-sectional online survey administered to Huntington disease gene expansion carriers (HDGECs) and companions of HDGECs by HD stage to understand the indirect and out-of-pocket costs of Huntington's disease in the US.

Type: Observational

Start Date: May 2020

open study

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently...
Solid Tumors
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study. This study will consist of three phases: 1) First Course... expand

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

Type: Interventional

Start Date: Aug 2018

open study