Vanderbilt Clinical Trials

Numerous studies show that remote monitoring and/or telenursing improves outcomes for patients especially those with chronic diseases. It is proposed that structured telenursing with non-invasive home monitoring of forced vital capacity and oxygen saturation in newly diagnosed patients with IPF will decrease hospitalizations for respiratory illness, increase compliance with therapies, and ultimately increase quality of life.

Type: Interventional

Start Date: Aug 2018

open study

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.

Type: Interventional

Start Date: Apr 2016

open study

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

open study

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Type: Interventional

Start Date: Jul 2016

open study

The purpose of this study is to collect information about what happens when people pause, or temporarily stop taking, ART, and to collect blood samples from these people at frequent intervals. We will also study the safety of pausing ART under close observation.

Type: Observational

Start Date: Feb 2017

open study

This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of TD139.

Type: Interventional

Start Date: Feb 2019

open study

This clinical trial studies cognitive function in men with prostate cancer treated with androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes in brain structure or activity related to treatment that may be related to changes in cognitive function. The investigators are also looking for genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer.

Type: Interventional

Start Date: Mar 2017

open study

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study is a global, open-label Phase 2 study to determine the efficacy and safety of KRT-232 in patients with primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF who have failed previous treatment with JAK inhibitor (Part A), or Ruxolitinib (Part B). In Part A of the study, patients will be randomly assigned to 2 different doses and 3 different dosing schedules of KRT-232. In Part B of the study, patients will be treated at the recommended dose and schedule from Part A.

Type: Interventional

Start Date: Jan 2019

open study

This is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12 weeks.

Type: Observational

Start Date: Oct 2019

open study

This phase III trial studies iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or crizotinib and standard therapy may work better compared to crizotinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Type: Interventional

Start Date: May 2018

open study

This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-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. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.

Type: Interventional

Start Date: Dec 2018

open study

The overall goals are to change the paradigm for development of mechanism targeted pharmacotherapy in neurodevelopmental disorders and provide a definitive test of the mGluR theory in humans by determining whether AFQ056, an mGluR5 negative modulator, can enhance neural plasticity in the form of language learning during an intensive language intervention in very young children with fragile X syndrome. This trial therefore will use an innovative but exploratory new trial design to develop a different way to examine efficacy of an agent with substantial support as a drug targeting CNS plasticity in preclinical models of a developmental disorder. If the design is successful, this trial can serve as a model for future trials of mechanistically-targeted treatments operating on neural plasticity in other neurodevelopmental disorders.

Type: Interventional

Start Date: Aug 2017

open study

This clinical trial studies low- dose total skin electron therapy in treating patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). Radiation therapy uses high energy electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform. Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.

Type: Observational

Start Date: Apr 2016

open study

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase 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. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Type: Interventional

Start Date: Oct 2019

open study

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

The purpose of this study is to investigate the effectiveness of Low Molecular Weight Heparin (LMWH) compared to Aspirin in preventing death and clinically important pulmonary blood clots in patients who sustain trauma.

Type: Interventional

Start Date: Apr 2017

open study

The proposed study is intended to inform the hypotheses that (1) regular dosing of exoskeleton walking will provide health benefits to non-ambulatory and poorly-ambulatory individuals with SCI, including decreased pain and spasticity, improvements in bowel and bladder function, decreased body-mass index (BMI), enhanced well-being; (2) regular dosing of exoskeleton walking will facilitate neurological or functional recovery in some individuals with SCI, particularly those with incomplete injuries; and (3) the level of mobility enabled by a lower limb exoskeleton is commensurate with the walking speeds, distances, and surfaces required for community ambulation.

Type: Interventional

Start Date: Nov 2016

open study

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.

Type: Interventional

Start Date: Jun 2018

open study

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.

Type: Interventional

Start Date: Aug 2016

open study

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy 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. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

Type: Interventional

Start Date: Nov 2015

open study

The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System. The optional, interventional arm of this study will assess bone quality in the proximal humerus of a fracture patient population. Specific Aims: - Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs - Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions - Document revisions, complications, and adverse events The optional, interventional arm of this study will assess bone quality in the proximal humerus of a fracture patient population. DXA is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fragility fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies. Shifting from the current paradigm of using X-ray based modalities to assess fracture risk, the reference point indentation (RPI) method acquires direct measurements of 'materal quality' of the bone tissue. Specifically, the OsteoProbe-RPI engages the patient's bone, and upon applying an impact force, it measures the ability of the tissue to resist micro-indentation. Despite the encouraging results from aformentioned studies applying RPI to bone, there is no evidence that a local measurement of bone material quality are predictive of fracture resistance at sites that are prone to fragility fractures (e.g. the proximal humerus). By affirming the ability of RPI to discriminate a fragility fracture from a high-energy (trauma) fracture of otherwise normal bone, the data from this optional study arm may provide justification for large prospective studies that evaluate whether intra-operative RPI is useful for surgical guidance.

Type: Interventional

Start Date: Aug 2017

open study

The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

Type: Interventional

Start Date: Jan 2019

open study

Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ESS). It has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. The purpose of this study is to better understand the pain management requirements of patients who undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS). This prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ESS can be adequately controlled by non-opioid medications. It will also determine whether post-ESS narcotic use can be avoided entirely, or at least significantly limited. Patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and the Brief Pain Inventory (BPI). The results of this study will help to develop a standardized approach to pain management in the post-ESS setting and help to elucidate the role of non-opioid pain medications. The ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ESS in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain.

Type: Interventional

Start Date: Apr 2019

open study

It is recognized that patients with various forms of heart and lung disease exhibit varying degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not well understood. Rapid advances in high throughput omic methodology, combined with powerful bioinformatics and network biology capability, have created the opportunity to conduct studies that broadly search for homologies and differences across the spectrum of disease states associated with pulmonary hypertension, and determinants of the spectrum of right ventricular compensation that accompanies these conditions

Type: Observational

Start Date: Nov 2016

open study

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Type: Interventional

Start Date: Aug 2013

open study