Vanderbilt Clinical Trials

The goal of this clinical trial is to learn if a novel text-message-based intervention is a more effective method for providing food resource information to families of recently hospitalized children who are experiencing food insecurity compared to the current standard practice of a paper handout delivered at the time of hospital discharge. The hypotheses the investigators seek to prove are: 1. That the Text Connect intervention will have greater reach and engagement and be more effective in facilitating connection to food resources than receiving a paper handout alone. 2. That the Text Connect intervention will improve household food security to a greater degree than a paper handout alone.

Type: Interventional

Start Date: Mar 2025

open study

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

Type: Interventional

Start Date: Sep 2021

open study

Evidence-based obesity treatment is inaccessible to most children in the United States. This lack of access is a source of health inequity, whereby children from rural and minority communities, who have the highest rates of childhood obesity, are also the least likely to receive an evidence-based intervention. Developing strategies to improve access to evidence-based obesity interventions could reduce health disparities by improving reach to these underserved communities. The premise of this study is that using a systematic framework to adapt a community-based behavioral intervention for childhood obesity that accounts for individual, family, and community factors will increase reach and effectiveness among low-income, minority, and rural populations. COACH is a multi-level obesity intervention that supports 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by directly addressing parent weight loss and engaging parents as agents of change for their children, and 3) the community by building the capacity of local community centers to offer parent-child programming. The investigators propose testing the process of adapting COACH in a cluster-randomized trial.

Type: Interventional

Start Date: Oct 2024

open study

This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)

Type: Interventional

Start Date: Sep 2023

open study

This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.

Type: Interventional

Start Date: Jun 2024

open study

Part A of this trial will evaluate the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos Delivery Device to safely achieve the intended product performance.

Type: Interventional

Start Date: Sep 2023

open study

This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.

Type: Interventional

Start Date: Jan 2022

open study

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

open study

The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques. The main question it aims to answer are: • Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.

Type: Interventional

Start Date: Nov 2022

open study

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

open study

This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma

Type: Interventional

Start Date: Dec 2023

open study

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Type: Observational [Patient Registry]

Start Date: Jul 2012

open study

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

open study

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

open study

The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit. Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.

Type: Observational

Start Date: Sep 2025

open study

This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess safety, tolerability, pharmacokinetics, and efficacy of ONO-2020 in participants with mild to moderate Alzheimer's disease (AD). This study aims to determine whether administering ONO-2020, an epigenetic regulator, may improve cognitive functions like memory and cognition in individuals with Alzheimer's disease dementia.

Type: Interventional

Start Date: Apr 2025

open study

This is a Phase 3, randomized, double-blind, controlled, adaptive, 2-arm, multicenter study to demonstrate the efficacy and safety of DefenCath in adult participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.

Type: Interventional

Start Date: May 2025

open study

The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR.

Type: Interventional

Start Date: Dec 2024

open study

The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Type: Interventional

Start Date: Apr 2025

open study

The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to receive either iptacopan or matching placebo, for 6 months (180 days) while continuing on a stable SOC treatment. The randomization will be stratified based on region.

Type: Interventional

Start Date: Jul 2024

open study

This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria. One of them is bladder cancer. While bladder cancer is one of the biggest worries, it is only found in few of these patients. Most microhematuria patients will have a cystoscopy to look inside the bladder. During a cystoscopy, a small camera is inserted into the bladder. This is done through the urethra, the tube that passes urine from the bladder to the outside. In some patients it can cause pain or anxiety. Not all patients have a cystoscopy. Those that don't, usually return for a urine sample within 6 months. This is done to check if there is still blood in their urine. This study is conducted to find out if the use of "Cxbladder Triage Plus" changes the number of cystoscopies in microhematuria patients. Cxbladder Triage Plus is also called "Triage Plus". It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder. Urothelial carcinoma is by far the most common type of bladder cancer. For the test, the patient voids some urine into a cup. A laboratory then checks the urine of specific genetic material. Abnormalities can be a sign of urothelial carcinoma. The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients. The study is done to find out how Triage Plus changes the number of cystoscopies. Study participants first void urine into a cup. The urine is used for the Triage Plus test. The patients are then assigned to one of two groups. The assignment is random. This means the nobody can influence the assignment. The chance to be assigned to either group is the same. In the test group, the urologist will receive the Triage Plus result and discuss it with the patient. Together they decide whether to do a cystoscopy. In the control group, the urologist will not receive the Triage Plus result. The patient will also not get the result. The urologist and patient will follow standard of care to decide whether to do a cystoscopy. For test group patients, the study gives a recommendation whether to proceed with cystoscopy. It is based on the patient's Triage Plus result. The urologist and patient do not need to follow the recommendation. If the urologist does not follow it, they will complete a survey. The survey has only one question. It is asking for the reasons of the decision. After making their decision, patients will follow the chosen pathway. Data on the performed procedures are collected. The diagnosis will also be documented. Data will be collected for up to about 9 months. To see how Triage Plus changes the number of cystoscopies, these will be counted in each group and then compared.

Type: Interventional

Start Date: Apr 2025

open study

The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.

Type: Interventional

Start Date: May 2024

open study

Duchenne Muscular Dystrophy (DMD) is an X-linked disorder that causes muscle wasting, cardiopulmonary failure, and premature death. Heart failure is a leading cause of death in DMD, but substantial knowledge gaps exist regarding predisposing risk factors. In the general population, hyperglycemia, insulin resistance, and decreased heart rate variability (HRV; reflecting autonomic dysfunction) are associated with cardiomyopathy (CM). It is unclear whether these factors are associated with DMD-CM. Closing this knowledge gap may lead to novel screening and therapeutic strategies to delay progression of DMD related CM. Despite risk factors for hyperglycemia, including the use of glucocorticoids, low muscle mass, obesity, and reduced ambulation, little is known regarding glucose abnormalities in DMD. Some of these same risk factors, along with the distance needed to travel for specialty care, present significant barriers to research participation and clinical care for individuals with DMD. Remote wearable technology may improve research participation in this vulnerable population. Therefore, this study will leverage remote wearable technologies to overcome these barriers and define the relationship between dysglycemia and DMD-CM. In this Aim of the study, the investigators will assess the utility of remote wearable technology to predict changes in traditional metrics of metabolism and cardiac function. In this pilot study, 10 individuals with DMD will undergo cardiac magnetic resonance imaging (CMR) and oral glucose tolerance tests (OGTTs) at baseline and two years. The investigators will remotely assess glycemia (using continuous glucose monitors), HRV (using extended Holter monitors), and activity (using accelerometers) every 6 months over the 2 years and evaluate if changes in wearable metrics predict changes in CMR and OGTT.

Type: Observational

Start Date: Jul 2024

open study

The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease. Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.

Type: Interventional

Start Date: Feb 2024

open study

The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose.

Type: Interventional

Start Date: Dec 2022

open study