Search Clinical Trials
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.
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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 |
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation
System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial
fibrillation (AF).
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To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF). Type: Interventional Start Date: Jun 2020 |
Angelman Syndrome (AS) Biomarker Study
Angelman Syndrome
Chromosome 15q Duplication (dup15q) Syndrome
The primary objective of this study is to measure ubiquitin-protein ligase E3A (UBE3A)
protein levels in cerebrospinal fluid (CSF) and to evaluate its utility as a biomarker in
support of the development of therapies for AS.
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The primary objective of this study is to measure ubiquitin-protein ligase E3A (UBE3A) protein levels in cerebrospinal fluid (CSF) and to evaluate its utility as a biomarker in support of the development of therapies for AS. Type: Interventional Start Date: Dec 2019 |
A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia
Acute Myeloid Leukemia
JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to
determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination
with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia
(AML)... expand
JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia (AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to treatment arms based on results of AML mutation testing. Type: Interventional Start Date: Dec 2019 |
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 |
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Cystic Fibrosis
This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and
in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are
homozygous for the F508del mutation.
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This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation. Type: Interventional Start Date: Dec 2019 |
Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
The primary objective of this study is to evaluate whether cilofexor reduces the risk of
fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
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The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC). Type: Interventional Start Date: Mar 2019 |
An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in...
Huntington Disease
This study will evaluate the long-term safety and tolerability of RO7234292 (RG6042) in
participants who have completed other F. Hoffmann-La Roche, Ltd.-sponsored and/or
Genentech-sponsored studies in the Huntington's disease (HD) in the development program for
RG6042.... expand
This study will evaluate the long-term safety and tolerability of RO7234292 (RG6042) in participants who have completed other F. Hoffmann-La Roche, Ltd.-sponsored and/or Genentech-sponsored studies in the Huntington's disease (HD) in the development program for RG6042. Type: Interventional Start Date: Apr 2019 |
Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
Acute Myeloid Leukemia
Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and
65 will be randomized to receive gilteritinib or midostaurin during induction and
consolidation. Patients will also receive standard chemotherapy of daunorubicin and
cytarabine during... expand
Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 65 will be randomized to receive gilteritinib or midostaurin during induction and consolidation. Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation. Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective. Gilteritinib has been approved by the Food and Drug Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is considered investigational. Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML. The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for FLT3 AML. Type: Interventional Start Date: Dec 2019 |
Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic...
Symptomatic Neurogenic Orthostatic Hypotension
A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in
subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4
weeks of treatment.
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A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment. Type: Interventional Start Date: Jan 2019 |
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With...
KRAS p.G12C Mutant Advanced Solid Tumors
Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant
advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult
subjects with KRAS p.G12C mutant advanced solid tumors.
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Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors. Type: Interventional Start Date: Aug 2018 |
Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma,...
Advanced Malignant Solid Neoplasm
Recurrent Ependymoma
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Glioma
Recurrent Hepatoblastoma
This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have
spread to other places in the body and have come back or do not respond to treatment.... expand
This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Type: Interventional Start Date: Jul 2017 |
Dapagliflozin in PRESERVED Ejection Fraction Heart Failure
Chronic Heart Failure With Preserved Systolic Function
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared
with placebo, on heart failure, disease specific biomarkers, symptoms, health status and
quality of life in patients with chronic heart failure with preserved systolic function.
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The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure, disease specific biomarkers, symptoms, health status and quality of life in patients with chronic heart failure with preserved systolic function. Type: Interventional Start Date: Mar 2017 |
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination...
Bladder Cancer
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus
ALT-803 in patients with BCG unresponsive high grade non-muscle invasive bladder cancer
(NMIBC). All patients treated in the study will receive via a urinary catheter in the
bladder,... expand
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus ALT-803 in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus ALT-803 weekly for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. The study duration is 24 months. Type: Interventional Start Date: Jun 2017 |
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients...
High Grade Fallopian Tube Serous Adenocarcinoma
High Grade Ovarian Serous Adenocarcinoma
Ovarian Seromucinous Carcinoma
Primary Peritoneal High Grade Serous Adenocarcinoma
Recurrent Fallopian Tube Carcinoma
This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with
atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or
primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as
pegylated... expand
This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as pegylated liposomal doxorubicin hydrochloride, 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. Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer. Type: Interventional Start Date: May 2017 |
Biobanking of Rett Syndrome and Related Disorders
Rett Syndrome
MECP2 Duplication
CDKL5
FOXG1 Disorders
The overarching purpose of this study is to advance understanding of the natural history of
Rett syndrome (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders including
CDKL5, FOXG1, and individuals with MECP2 mutations who do not have RTT. Although all these... expand
The overarching purpose of this study is to advance understanding of the natural history of Rett syndrome (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders including CDKL5, FOXG1, and individuals with MECP2 mutations who do not have RTT. Although all these disorders are the result of specific genetic changes, there remains broad clinical variation that is not entirely accounted for by known biological factors. Additionally, clinical investigators currently do not have any biomarkers of disease status, clinical severity, or responsiveness to therapeutic intervention. To address these issues, biological materials (DNA, RNA, plasma, cell lines) will be collected from affected individuals and in some cases from unaffected family members, initial evaluation performed to identify additional biological factors contributing to disease severity, and these materials will be stored for future characterization. Type: Observational Start Date: Sep 2017 |
PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)
Solid Tumors
NHL
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).
Currently enrolling melanoma patients in combination with nivolumab, only.
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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). Currently enrolling melanoma patients in combination with nivolumab, only. Type: Interventional Start Date: Jun 2016 |
SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes
Liposarcoma
Osteogenic Sarcoma
Ewing/Ewing-like Sarcoma
Rhabdomyosarcoma
Mesenchymal Chondrosarcoma
Although regorafenib was approved for use in patients who had progressive GIST despite
imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been
examined in a systematic fashion in patients with other forms of sarcoma.
Given the activity of sorafenib,... expand
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents. Type: Interventional Start Date: Jul 2014 |
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 |
A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.
Ventricular Tachycardia
This is a randomized, placebo controlled trial of Dantrolene (N= 84 participants) to
demonstrate the feasibility of using I.V. dantrolene to study the effect of RyR2 inhibition
on cardiac electrophysiology, hemodynamics and ventricular arrhythmia inducibility in
patients with... expand
This is a randomized, placebo controlled trial of Dantrolene (N= 84 participants) to demonstrate the feasibility of using I.V. dantrolene to study the effect of RyR2 inhibition on cardiac electrophysiology, hemodynamics and ventricular arrhythmia inducibility in patients with structural heart disease referred for VT ablation. The investigators will also explore the pharmacokinetic/pharmacodynamic relationship of I.V. dantrolene and it short-term effect on specific cardiac electrophysiologic and hemodynamic parameters. Type: Interventional Start Date: Aug 2020 |
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic...
Symptomatic Neurogenic Orthostatic Hypotension
A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of
ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic
nOH over 182 weeks.
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A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks. Type: Interventional Start Date: Sep 2019 |
Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-angle Glaucoma or Ocular...
Glaucoma, Open-Angle
Ocular Hypertension
This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of
as needed administrations of Bimatoprost sustained release (SR) in participants with
open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with
topical... expand
This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy. Type: Interventional Start Date: Feb 2019 |
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... 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 |
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic...
Symptomatic Neurogenic Orthostatic Hypotension
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating
Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
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A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure Type: Interventional Start Date: Feb 2019 |
Interleukin 6 Blockade Modifying Antibody-Mediated Graft Injury and Estimated Glomerular Filtration Rate...
Antibody-mediated Rejection
This trial investigates whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody
(mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by
inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune... expand
This trial investigates whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody (mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune responses. Type: Interventional Start Date: Oct 2019 |