Vanderbilt Clinical Trials

This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of 2 parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2).

Type: Interventional

Start Date: Jun 2017

open study

The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug treatment. The primary hypothesis is that the area under the concentration-time curve from 0 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of adults with bezlotoxumab,

Type: Interventional

Start Date: Mar 2018

open study

To investigate the efficacy, safety and tolerability of BI 409306 once daily compared to placebo given for 52 weeks to subjects with attenuated psychosis syndrome.

Type: Interventional

Start Date: Sep 2017

open study

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Type: Interventional

Start Date: Aug 2016

open study

This study evaluates the effect of acute administration of oral prednisone in white blood cells counts and glucose tolerance and the relationship of these measures with changes in gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene expression will be study before and after prednisone administration.

Type: Interventional

Start Date: Feb 2017

open study

This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

Type: Interventional

Start Date: Mar 2017

open study

The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).

Type: Interventional

Start Date: Dec 2016

open study

This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients with symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.

Type: Interventional

Start Date: Apr 2016

open study

It can be difficult to achieve remission in individuals with late-life depression (LLD) and they often require aggressive treatment. This challenge is in part due to age-related vascular changes that are common in LLD. Successful antidepressant treatment involve changes across affective, cognitive, and default mode networks. We hypothesize that in LLD, vascular disease adversely affects response to antidepressants by disrupting connectivity of these networks. The primary goal of this project is to characterize how focal vascular damage affects regional connectivity and response to antidepressants. Based on past work and pilot data, we a priori focus on the cingulum bundle and uncinate fasciculus. These key fiber bundles connect frontal, temporal, and cingulate regions involved in cognition and affective responses. Our central hypothesis is that ischemic damage to the cingulum bundle and uncinate fasciculus contributes to structural and functional connectivity deficits of those tracts. This results in a disconnection effect that alters the function of connected regions. In turn, this increases the risk of a poor response to antidepressants. Our approach is to enroll up to 130 adults over age 60 years with a diagnosis of Major Depressive Disorder. Subjects will complete clinical evaluation, cognitive testing, and MRI/functional MRI (fMRI) sessions, including an fMRI emotional oddball task that includes attentional and affective components. Participants will be stratified by cerebral lesion severity and randomized in a 2:1 ratio to a double-blinded 8-week trial of escitalopram or matching placebo. Those who do not remit will transition to an 8-week trial of open-label bupropion, an antidepressant with a different mechanism of action. This will allow us to determine if different and distinct circuit deficits affect response to antidepressants with different mechanisms of action while also accounting for the placebo response.

Type: Interventional

Start Date: Apr 2015

open study

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

Type: Interventional

Start Date: Feb 2014

open study

The purpose of the study is to evaluate the safety, tolerability and time-course profile of FVIII activity levels with adaptive doses of SB-525.

Type: Interventional

Start Date: Jun 2017

open study

A study of a drug to be used in addition with another drug to treat adults with Uncontrolled Partial-onset Seizures

Type: Interventional

Start Date: Jul 2017

open study

The investigators will explore barriers to improving self-efficacy, or the ability to feel in control of their disease, and medication adherence with text messaging through surveys and interviews with adolescents and adults with SCD cared for at the Vanderbilt Meharry Center of Excellence (VMCE) in Sickle Cell Disease (SCD). The investigators will identify preferences to improve and sustain adherence to daily medication through selection of investigator-proposed or patient-generated text messaging strategies. Finally, the investigators will fill in the literature gaps by describing barriers to self-efficacy and medication adherence among adults with SCD as well as adolescents with SCD who are transitioning to adult care.

Type: Observational

Start Date: May 2016

open study

The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with MCI. Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine improving attention, learning, and memory function. The study will enroll 300 participants for a 2 year period. Participants will be randomized (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day, or placebo skin patch.

Type: Interventional

Start Date: Jan 2017

open study

The purpose of this study is to determine the safety and effectiveness of nivolumab plus ipilimumab or nivolumab plus chemotherapy compared to chemotherapy alone in the treatment of Early Stage Non-Small Cell Lung This study has multiple primary endpoints. The first primary completion date of Pathological Complete Response is anticipated to be reached September 2020. The completion date for all primary outcome measures is expected May 2023.

Type: Interventional

Start Date: Jan 2017

open study

To assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on independent central radiology review.

Type: Interventional

Start Date: Dec 2015

open study

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are - to prove the concept of clinical activity of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) - to confirm efficacy and safety of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) - To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Type: Interventional

Start Date: Mar 2018

open study

Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.

Type: Interventional

Start Date: Mar 2018

open study

This study is being performed in patients who have undergone transcatheter aortic valve replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a novel post-procedure rehabilitation strategy, including a daily activity goal using a fitness tracking device (Fitbit Alta HR) and in-home resistance training exercises targeting muscles related to activities of daily living. We will evaluate the effect of these interventions on physical performance and several quality of life domains.

Type: Interventional

Start Date: Nov 2017

open study

Patients with POTS experience significant gastrointestinal symptoms. Current evidence suggesting that abnormal post-ganglionic sympathetic function could play a role in the pathophysiology of these GI abnormalities. Sympathetic fiber regulate motor and the postprandial GI peptides secretion. The focus of the present proposal is to determine glucose homeostasis, GI motility, and their association with GI and cardiovascular symptoms in POTS patients versus healthy controls. Furthermore, we will determine differences in these outcomes in POTS patients with and without evidence of postganglionic sympathetic fiber neuropathy. As a long-term goal, this study can lead us to understand the pathophysiology of common co-morbidities in patients with POTS to provide new treatment approaches and prevention strategies.

Type: Observational

Start Date: Jun 2017

open study

The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset Still's disease).

Type: Interventional

Start Date: Sep 2017

open study

Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic hypotension are scarce and not effective. If left untreated, these patients have the highest risk of syncope, falls and fall-related injuries. The proposed study will determine the clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms associated with neurogenic orthostatic hypotension in patients with autonomic failure.

Type: Interventional

Start Date: Aug 2016

open study

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

Type: Interventional

Start Date: Nov 2016

open study

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission in participants with Crohn's disease involving the small bowel. Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

Type: Interventional

Start Date: Apr 2017

open study

4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.

Type: Interventional

Start Date: Jan 2016

open study