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.


463 matching studies

Sponsor Condition of Interest
Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis,...
CTI BioPharma Primary Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis
This is a Bayesian adaptive dose-finding study in patients with primary or secondary myelofibrosis: 1. who have failed therapy with ruxolitinib on the basis of intolerance or loss of efficacy, 2. highly symptomatic (DIPSS risk score of Intermediate-1, Intermediate-2... expand

This is a Bayesian adaptive dose-finding study in patients with primary or secondary myelofibrosis: 1. who have failed therapy with ruxolitinib on the basis of intolerance or loss of efficacy, 2. highly symptomatic (DIPSS risk score of Intermediate-1, Intermediate-2 or High Risk, and MPN-SAF TSS 2.0 of ≥10), 3. and have splenomegaly (assessed by physical examination). Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib Phase: Phase 2

Type: Interventional

Start Date: Jun 2017

open study

Blood Pressure Lowering Effects of Angiotensin-(1-7) in Primary Autonomic Failure
Vanderbilt University Autonomic Nervous System Disorders Pure Autonomic Failure Shy-Drager Syndrome Orthostatic Hypotension, Dysautonomic
Pharmacologic approaches to increase levels or actions of the vasodilatory peptide angiotensin-(1-7) are currently in development for the treatment of hypertension based on findings from animal models. There are limited and contradictory clinical studies, however, and it is not... expand

Pharmacologic approaches to increase levels or actions of the vasodilatory peptide angiotensin-(1-7) are currently in development for the treatment of hypertension based on findings from animal models. There are limited and contradictory clinical studies, however, and it is not clear if this peptide regulates blood pressure in humans. The purpose of this study is to better understand the cardiovascular effects angiotensin-(1-7) in human hypertension, and to examine interactions of this peptide with the autonomic nervous system. The investigators propose that the difficulties in showing angiotensin-(1-7) cardiovascular effects in previous clinical studies relates to the buffering capacity of the baroreceptor reflex to prevent changes in blood pressure. Autonomic failure provides the ideal patient population to test this hypothesis. These patients have loss of baroreflex buffering and have low levels of angiotensin-(1-7) in blood. The investigators will test if angiotensin-(1-7) infusion can lower blood pressure in patients with autonomic failure, and will determine the hemodynamic and hormonal mechanisms involved in this effect.

Type: Interventional

Start Date: Feb 2016

open study

Serial, Non-invasive Analysis of Exhaled Breath Condensate in Ventilated Trauma Patients
Vanderbilt University Ventilator Associated Pneumonia (VAP)
To determine if the analysis of exhaled breath condensate correlates with the development & resolution of pneumonia. expand

To determine if the analysis of exhaled breath condensate correlates with the development & resolution of pneumonia.

Type: Interventional

Start Date: Jan 2016

open study

Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
Cumberland Pharmaceuticals Asthma, Aspirin-Induced
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal... expand

The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.

Type: Interventional

Start Date: Jul 2017

open study

STOP Persistent AF
Medtronic Atrial Fibrillation Solutions Atrial Fibrillation
To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation. expand

To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation.

Type: Interventional

Start Date: Mar 2017

open study

A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced...
Bristol-Myers Squibb Renal Cell Carcinoma
To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer. expand

To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.

Type: Interventional

Start Date: Dec 2016

open study

Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
Vanderbilt University Medical Center Knee Arthroplasty, Total Osteoarthritis Radiologic Tibiofemoral Osteoarthritis
Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine... expand

Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).

Type: Interventional

Start Date: Jan 2018

open study

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed...
National Cancer Institute (NCI) Anaplastic Large Cell Lymphoma, ALK-Positive Ann Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell Lymphoma Ann Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell Lymphoma Ann Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell Lymphoma CD30-Positive Neoplastic Cells Present
This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin,... expand

This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. It is not yet known whether brentuximab vedotin and combination chemotherapy is more effective than crizotinib and combination chemotherapy in treating anaplastic large cell lymphoma.

Type: Interventional

Start Date: Nov 2013

open study

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
Novo Nordisk A/S Congenital Bleeding Disorder Haemophilia B
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B. expand

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

Type: Interventional

Start Date: Jul 2014

open study

Safety and Tolerability of Atezolizumab (ATZ) in Combination With Radium-223 Dichloride (R-223-D) in...
Hoffmann-La Roche Castrate-Resistant Prostate Cancer
This study is designed to assess the safety and tolerability of atezolizumab when given in combination with radium-223 dichloride in participants with metastatic CRPC who have progressed after treatment with an androgen pathway inhibitor. This adaptive design study includes a... expand

This study is designed to assess the safety and tolerability of atezolizumab when given in combination with radium-223 dichloride in participants with metastatic CRPC who have progressed after treatment with an androgen pathway inhibitor. This adaptive design study includes a cohort phase and a potential randomization phase. An initial concurrent dosing evaluation will evaluate the safety and tolerability of a treatment regimen that employs a concurrent start time for atezolizumab and radium-223 dichloride (Cohort 1). If concurrent dosing is found to be safe and tolerable in Cohort 1, additional participants will be enrolled and eligible participants will be randomized in a 1:1:1 ratio to Arms A, B, and C. If concurrent dosing is not tolerated in Cohort 1, new participants will be enrolled in a staggered dosing evaluation: Cohort 2 (28-day radium-223 dichloride run-in, atezolizumab will begin on Day 1 of Cycle 2) and Cohort 3 (56-day radium-223 dichloride run-in, atezolizumab will begin on Day 1 of Cycle 3). If the Cohort 2 schedule is tolerable, then additional participants will be enrolled using this treatment schedule; If the Cohort 2 schedule is not tolerable, subsequent participants will be enrolled in Cohort 3. If the Cohort 3 schedule is tolerable, then additional participants will be enrolled using this treatment schedule. If Cohort 3 schedule is not tolerable, no additional participant will be enrolled in the study.

Type: Interventional

Start Date: Sep 2016

open study

Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic...
Jazz Pharmaceuticals Veno-occlusive Disease
This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant... expand

This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.

Type: Interventional

Start Date: Sep 2016

open study

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial...
Cumberland Pharmaceuticals Scleroderma, Diffuse Scleroderma, Systemic Scleroderma, Limited Sclerosis, Progressive Systemic Skin Diseases
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH). expand

The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).

Type: Interventional

Start Date: Jan 2017

open study

A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients
Intuitive Surgical Hernia Incisional Hernia Hernia, Inguinal, Indirect Hernia, Inguinal, Direct Inguinal Hernia
The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair. The outcomes that will be collected include various routine clinical parameters,... expand

The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair. The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.

Type: Observational [Patient Registry]

Start Date: Apr 2016

open study

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple...
Sanofi Plasma Cell Myeloma
Primary Objective: - Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). - Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM... expand

Primary Objective: - Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). - Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab. Secondary Objectives: - Part A: - To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM. - Part B: - To evaluate the safety of SAR650984 (isatuximab). - To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS). - To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline. - To evaluate the immunogenicity of SAR650984 (isatuximab).

Type: Interventional

Start Date: Sep 2015

open study

A Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary...
Pharmacyclics LLC. Renal Cell Carcinoma (RCC) Urothelial Carcinoma Gastric Adenocarcinoma Colorectal Adenocarcinoma (CRC)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors. expand

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.

Type: Interventional

Start Date: Nov 2015

open study

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic...
Vanderbilt University Orthostatic Hypotension Pure Autonomic Failure Multiple System Atrophy Autonomic Failure
Compression garments have been shown to be effective in the treatment of orthostatic hypotension in autonomic failure patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure... expand

Compression garments have been shown to be effective in the treatment of orthostatic hypotension in autonomic failure patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. The investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt.

Type: Interventional

Start Date: Apr 2015

open study

Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Duke University Rheumatic Joint Disease
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer... expand

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.

Type: Observational [Patient Registry]

Start Date: Jul 2015

open study

Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children...
Amgen Osteogenesis Imperfecta
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab. expand

This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.

Type: Interventional

Start Date: Jun 2015

open study

Selinexor Treatment of Refractory Myeloma
Karyopharm Therapeutics Inc Multiple Myeloma
This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only). expand

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

Type: Interventional

Start Date: May 2015

open study

Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic...
National Cancer Institute (NCI) Metastatic Ewing Sarcoma Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Bone Marrow Metastatic Malignant Neoplasm in the Lung Metastatic Peripheral Primitive Neuroectodermal Tumor of Bone
This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in different... expand

This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, 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 yet known whether combination chemotherapy is more effective with or without ganitumab in treating patients with newly diagnosed Ewing sarcoma.

Type: Interventional

Start Date: Dec 2014

open study

Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia
William G. Stevenson, MD Ventricular Tachycardia
The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This... expand

The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This approach is desirable because some people have ventricular arrhythmias that originate deep within the heart muscle where it is not abolished by ablation with standard catheters. The investigators seek to determine whether the INA catheter can potentially help people who have ventricular arrhythmias that have failed standard radiofrequency ablation. The investigators also want to determine if it is likely to be safe, without excessive side effects.

Type: Interventional

Start Date: Sep 2016

open study

Natural History Study of Synucleinopathies
New York University School of Medicine Patients With Synucleinopathies Neurogenic Orthostatic Hypotension Pure Autonomic Failure REM Sleep Behavior Disorder Parkinson Disease
Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically... expand

Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically with slowness of movement, coordination difficulties or mild cognitive impairment. Development of these features indicates that abnormal alpha-synuclein deposits have destroyed key areas of the brain involved in the control of movement or cognition. Patients with synucleinopathies and signs of CNS-deficits are frequently diagnosed with Parkinson disease (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA). However, accumulation of alpha-synuclein and death of nerve cells can also begin outside the brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms of autonomic impairment (unexplained constipation, urinary difficulties, and sexual dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic hypotension) may be the only clinical finding. This "pre-motor" autonomic stage suggests that the disease process may not yet have spread to the brain. After a variable period of time, but usually within 5-years, most patients with abnormally low blood pressure on standing develop cognitive or motor abnormalities. This stepwise evolution indicates that the disease spreads from the body to the brain. Another indication of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem that occurs when the lower part of the brain is affected, may also be the first noticeable sign of Parkinson disease. The purpose of this study is to document the clinical features and biological markers of patients with synucleinopathies and better understand how these disorders evolve over time. The study will involve following patients diagnosed with a synucleinopathy (PD/DLB and MSA) and those believed to be in the "pre-motor" stage (with isolated autonomic impairment and/or RBD). Through a careful series of follow-up visits to participating Centers, we will focus on finding biological clues that predict which patients will develop motor/cognitive problems and which ones have the resilience to keep the disease at bay preventing spread to the brain. We will also define the natural history of MSA - the most aggressive of the synucleinopathies.

Type: Observational

Start Date: Jun 2011

open study

Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
Asahi Kasei Pharma America Corporation Severe Sepsis Coagulopathy
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality. expand

The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

Type: Interventional

Start Date: Aug 2012

open study

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal...
Bristol-Myers Squibb Advanced Cancer
The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo. expand

The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo.

Type: Interventional

Start Date: May 2016

open study

Phase I Trial of BAY1251152 for Advanced Blood Cancers
Bayer Hematologic Neoplasms
The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness... expand

The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.

Type: Interventional

Start Date: Jun 2016

open study