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A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Prog1
Progressive Supranuclear Palsy
PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression
in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks and to
assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP. expand
PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks and to assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP. Type: Interventional Start Date: Jul 2024 |
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (B1
Alzheimer Disease, Early Onset
The purpose of this study is to assess the effectiveness, safety, and tolerability of
BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's
Disease. expand
The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease. Type: Interventional Start Date: Mar 2024 |
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
Orthopaedic Polytrauma
Chronic Opioid Use
The goal of this randomized clinical trial is to learn if the use of a low-dose
nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic
opioid use in orthopaedic polytrauma patients. The main questions this study aims to
answer are:
1. Are patients who are given sched1 expand
The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic polytrauma patients. The main questions this study aims to answer are: 1. Are patients who are given scheduled ketorolac during the first five hospital days less likely to develop chronic opioid use at 6 months after injury compared to patients who receive placebo? 2. Does scheduled ketorolac during the first five hospital days improve functional responses to pain at discharge, 3 months, and 6 months after injury? 3. Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both? Participants will be enrolled and randomized to either the ketorolac (treatment) group or placebo group to be given every 6 hours during the first five hospital days. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury. Researchers will compare ketorolac (treatment) versus saline (placebo) to see if ketorolac reduces chronic opioid use and improves the functional response to pain. Type: Interventional Start Date: Feb 2025 |
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 t1
Wheezing
Asthma
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of
dupilumab treatment in children 2 to <6 years of age with uncontrolled asthma and/or
recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be
a 52-week, randomized, double-blin1 expand
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to <6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A [4-week Screening and a 52-week treatment period] plus additional 52-week treatment period and a 12-week post-treatment follow-up period). Type: Interventional Start Date: Jan 2024 |
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately t1
Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants
with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are
that at least 1 tulisokibart dose level is superior to Placebo in the proportion of
participants achieving clinical remiss1 expand
The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12. Type: Interventional Start Date: Oct 2023 |
LEVosimendan to Improve Exercise Limitation in Patients with PH-HFpEF
Pulmonary Hypertension
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with
placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6
MWD; Day 1 to Week 12). expand
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12). Type: Interventional Start Date: Jan 2024 |
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Single Ventricle Heart Disease
This study will evaluate the clinical efficacy and safety of udenafil, an orally
administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of
adolescent who have had the Fontan procedure. expand
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure. Type: Interventional Start Date: Oct 2023 |
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Part1
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus
on participants who have either active subacute CLE or chronic CLE, or both. They may
also have systemic lupus erythematosus (SLE1 expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). The main questions researchers want to answer are: - How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? - How many participants have their skin disease activity go down by at least 70%? Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: - After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine. - Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. - The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin. - During the 2nd treatment period, all participants will receive litifilimab for 28 weeks. - After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks. - The total study duration for participants will be up to 80 weeks Type: Interventional Start Date: Sep 2022 |
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
The study is intended to assess the safety and efficacy of perioperative treatment with
Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet
chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or
Datopotamab deruxtecan (Dato-DXd) in combina1 expand
The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer. Type: Interventional Start Date: Apr 2022 |
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Endometrial Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
The purpose of this study is to find out whether the study drug, LY3537982, is safe and
effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients
must have already received or were not able to tolerate the standard of care, except for
specific groups who have not had c1 expand
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years. Type: Interventional Start Date: Jul 2021 |
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence1
Stage I Breast Cancer
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy
results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor
recurrence (IBTR) compared to breast conservation with breast radiation and endocrine
therapy. expand
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Type: Interventional Start Date: Jun 2021 |
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Hemorrhagic Shock
Traumatic Injury
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma
centers designed to determine the efficacy and safety of low titer whole blood
resuscitation as compared to standard of care resuscitation in patients at risk of
hemorrhagic shock and to appropriately characterize t1 expand
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age. Type: Interventional Start Date: Apr 2022 |
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Hemophilia A With Inhibitor
Hemophilia B With Inhibitor
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with
Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term
prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding
event (BE), or who are not on p1 expand
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE. Type: Interventional Start Date: Jun 2021 |
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Ne1
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
This phase III trial compares the effect of usual treatment of chemotherapy and steroids
and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab.
Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability
of cancer cells to grow and spread. The i1 expand
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care. Type: Interventional Start Date: Jan 2021 |
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Childr1
Coronavirus Infection (COVID-19)
Pulmonary Arterial Hypertension
Urinary Tract Infections in Children
Hypertension
Pain
The study investigators are interested in learning more about how drugs, that are given
to children by their health care provider, act in the bodies of children and young adults
in hopes to find the most safe and effective dose for children. The primary objective of
this study is to evaluate the PK1 expand
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider. Type: Observational Start Date: Mar 2020 |
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in P1
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
In this observational study researcher want to learn more about the effectiveness of drug
VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine
use in patients with TRK fusion cancer which is locally advanced or spread from the place
where it started to other plac1 expand
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months. Type: Observational Start Date: Apr 2020 |
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Meta1
Metastatic Breast Cancer
This is an umbrella study evaluating the efficacy and safety of multiple treatment
combinations in participants with metastatic or inoperable locally advanced breast
cancer.
The study will be performed in two stages. During Stage 1, four cohorts will be enrolled
in parallel in this study:
Cohort1 expand
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment. Type: Interventional Start Date: Mar 2018 |
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
Cystic Fibrosis
CFTR Gene Mutation
ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of
ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not
taking CFTR modulators due to drug intolerance, poor response, or lack of access to
modulators. expand
ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators. Type: Interventional Start Date: Dec 2024 |
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Part1
Focal Onset Seizure
Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and
several other countries around the world for the treatment of Partial-Onset (focal)
seizures in adult subjects (≥18 years of age). In the US it is approved for use as
monotherapy, however, there is little clinic1 expand
Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy. Type: Interventional Start Date: Oct 2024 |
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
The goal of this study is to learn if GS-1427 is effective in treating participants with
moderate to severe ulcerative colitis. The study will compare participants in different
treatment groups treated with GS-1427 with participants treated with placebo.
The primary objective of this study is to a1 expand
The goal of this study is to learn if GS-1427 is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo. The primary objective of this study is to assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12. Type: Interventional Start Date: Mar 2024 |
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Bilia1
Primary Biliary Cholangitis
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in
subjects with PBC. expand
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC. Type: Interventional Start Date: Feb 2024 |
A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejec1
Heart Failure
Heart Failure With Reduced Ejection Fraction
Cardiovascular Diseases
Heart Diseases
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine
compared to placebo to lower NT-proBNP in patients with chronic heart failure with
reduced ejection fraction. expand
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with reduced ejection fraction. Type: Interventional Start Date: Feb 2024 |
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cance1
Breast Cancer, Early Breast Cancer
This is a Phase III open-label study to assess if camizestrant improves outcomes compared
to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer
with intermediate-high or high risk for disease recurrence who completed definitive
locoregional therapy (with or without1 expand
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years. Type: Interventional Start Date: Oct 2023 |
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism
Deep Venous Thrombosis
Post-Thrombotic Syndrome
This study is a prospective, multicenter, randomized controlled trial of an
interventional strategy using the ClotTriever System to achieve and maintain vessel
patency (ClotTriever Intervention Arm) versus conservative medical management using
anticoagulation therapy alone (Conservative Medical Man1 expand
This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit. Type: Interventional Start Date: Jan 2023 |
Study of CHS-114 in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Head and Neck Squamous Cell Carcinoma
This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of
SRF114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid
tumors. expand
This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of SRF114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors. Type: Interventional Start Date: Dec 2022 |
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