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Pounce™ Thrombectomy System Retrospective Registry
Peripheral Arterial Disease
Acute Limb Ischemia
The PROWL registry is an open-label retrospective, multi-center, US study of the
Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi
in the peripheral arterial vasculature. expand
The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. Type: Observational Start Date: Apr 2023 |
Tennessee Alzheimer's Project
Aging
Alzheimer Disease
Biomarker
Cognitive Dysfunction
Mild Cognitive Impairment
The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to
provide local and national researchers with access to a well-characterized and diverse
clinical cohort, including participant referrals, biosamples, clinical data, and
neuroimaging data. The VADRC Clinical Core... expand
The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide local and national researchers with access to a well-characterized and diverse clinical cohort, including participant referrals, biosamples, clinical data, and neuroimaging data. The VADRC Clinical Core will create an infrastructure to support research efforts of both local and national investigator studies to develop early detection, prevention, and treatment strategies for Alzheimer's disease. The Clinical Core intends to enroll up to 1000 participants, including individuals who are cognitively unimpaired, have mild cognitive impairment, or have Alzheimer's disease. This cohort of about 1000 participants will be called the Tennessee Alzheimer's Project. Participants will be seen annually for comprehensive clinical characterization and then referred to other studies to enhance Alzheimer's disease research activities. Type: Observational Start Date: Oct 2021 |
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants...
Gastrointestinal Tract Malignancies
The purpose of this study is to evaluate the safety and preliminary clinical activity of
treatment combinations with and without chemotherapy in participants with locally
advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma.
Chemotherapy will consist of FOLFOX (oxaliplatin,... expand
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil). Type: Interventional Start Date: Jun 2022 |
Randomized Trial of Sedative Choice for Intubation
Acute Respiratory Failure
Among critically ill adults undergoing emergency tracheal intubation, one in five
experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce
anesthesia for emergency tracheal intubation have been hypothesized to effect
cardiovascular complications and patient outcomes,... expand
Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketamine and etomidate are the two most commonly used sedatives during intubation of critically ill adults. Data from a randomized clinical trial are urgently needed to determine the effect of ketamine versus etomidate on cardiovascular complications and clinical outcomes of emergency tracheal intubation. Type: Interventional Start Date: Apr 2022 |
Neural Correlates of Psychiatric Disorders
Psychiatric Disorder
Memory Disorders
This ClincialTrials.gov record originally corresponded to the protocol approved under IRB
# 202370. The study was expanded to include stimulation and recordings approved under new
IRB #211037. The participant data originally acquired from IRB# 202370 will be included
in this new record:
This study... expand
This ClincialTrials.gov record originally corresponded to the protocol approved under IRB # 202370. The study was expanded to include stimulation and recordings approved under new IRB #211037. The participant data originally acquired from IRB# 202370 will be included in this new record: This study seeks to better understand the neural activity underlying neuro cognitive disorders. Resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. Subjects will also participate in neuro cognitive tasks while neural recordings are performed, and/or receive neural stimulation through implanted depth electrodes. A better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases. Type: Observational Start Date: Mar 2021 |
Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
This phase II trial studies the side effects of enasidenib and sees how well it works in
treating pediatric patients with acute myeloid leukemia that has come back after
treatment (relapsed) or has been difficult to treat with chemotherapy (refractory).
Patients must also have a specific genetic change,... expand
This phase II trial studies the side effects of enasidenib and sees how well it works in treating pediatric patients with acute myeloid leukemia that has come back after treatment (relapsed) or has been difficult to treat with chemotherapy (refractory). Patients must also have a specific genetic change, also called a mutation, in a protein called IDH2. Enasidenib may stop the growth of cancer cells by blocking the mutated IDH2 protein, which is needed for leukemia cell growth. Type: Interventional Start Date: Aug 2023 |
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Heart Failure NYHA Class II
Heart Failure NYHA Class III
This is a prospective, multi-center, open label, randomized control clinical trial
evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in
NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).
The study contains of 5 arms:
Randomized Arm - To demonstrate... expand
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: Randomized Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients. - Treatment Arm (Cohort 1) - Active Control Arm (Cohort 2) - Crossover Arm (Cohort 3) Single Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in NYHA Class III HF patients. - Clinician-Directed Patient Self-Management Arm (Cohort 4) - Clinician Management Arm (Cohort 5) Type: Interventional Start Date: Nov 2023 |
XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
Heart Failure
Transplant; Failure, Heart
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of
extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe
and effective way to preserve and transport hearts for transplantation. expand
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation. Type: Interventional Start Date: Oct 2023 |
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult
Eosinophilic Esophagitis patients. expand
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients. Type: Interventional Start Date: Jun 2023 |
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
Allergy, Peanut
The primary purpose of this study is to assess the efficacy and safety of daily DBV712
250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7
years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period. expand
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period. Type: Interventional Start Date: Feb 2023 |
Vanderbilt Memory and Aging Project
Alzheimer Disease
Aging
Aged, 80 and Over
Biomarkers
Brain
This study will use an observational cohort to cross-sectionally and longitudinally
relate vascular health to clinical, imaging, and biological markers of early Alzheimer's
disease and cerebrovascular disease among aging adults. Adjusting for relevant clinical
covariates, we will test the hypothesis... expand
This study will use an observational cohort to cross-sectionally and longitudinally relate vascular health to clinical, imaging, and biological markers of early Alzheimer's disease and cerebrovascular disease among aging adults. Adjusting for relevant clinical covariates, we will test the hypothesis that vascular health is associated with clinical, brain magnetic resonance imaging (MRI), neuropsychological, and cerebrospinal fluid markers of early cerebrovascular and Alzheimer's disease changes (i.e., prior to the onset of significant cognitive decline or dementia). Secondarily, we will examine medical and genetic factors that might mediate associations between vascular health and brain aging, such as inflammatory processes, insulin resistance, and genetic factors (e.g., APOE, a susceptibility risk factor for dementia). Findings will advance knowledge regarding the role that vascular health plays in brain aging. Type: Observational Start Date: Sep 2012 |
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
Microtia
Dysbiosis
Alcohol Drinking
HIV Infections
Cardiovascular Diseases
Among people living with HIV, heavy drinking increases the risk of heart disease and
death. Studies suggest that alcohol changes the number and kind of bacteria in your gut
and these changes increase the risk of heart disease and death. This randomized
controlled trial will determine whether a pill... expand
Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death. Type: Interventional Start Date: Sep 2023 |
nCCR for Chemotherapy Related Cognitive Impairment Randomized Study
Chemo-brain
Chemotherapy-Related Cognitive Impairment
The investigators propose to apply neuroplasticity-based computerized cognitive
remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI). expand
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI). Type: Interventional Start Date: Aug 2022 |
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children...
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Acute Myeloid Leukemia Post Cytotoxic Therapy
Juvenile Myelomonocytic Leukemia
Mixed Phenotype Acute Leukemia
This study aims to use clinical and biological characteristics of acute leukemias to
screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone
marrow and blood from patients with leukemia that has come back after treatment or is
difficult to treat may provide information... expand
This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults. Type: Interventional Start Date: Apr 2022 |
RA-PRO PRAGMATIC TRIAL
Rheumatoid Arthritis
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality
evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose
among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab)
or a targeted synthetic DMARD arm... expand
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic. Type: Interventional Start Date: Sep 2021 |
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Central Nervous System Nongerminomatous Germ Cell Tumor
Choriocarcinoma
Embryonal Carcinoma
Immature Teratoma
Malignant Teratoma
This phase II trial studies the best approach to combine chemotherapy and radiation
therapy (RT) based on the patient's response to induction chemotherapy in patients with
non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the
brain or body (localized). This study has... expand
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, 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. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT. Type: Interventional Start Date: Jul 2021 |
Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory...
Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in
adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess
the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or
refractory large B-cell lymphoma and assess the... expand
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647. Type: Interventional Start Date: May 2020 |
The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease
HIV
Non-Alcoholic Fatty Liver Disease
Metabolic-Associated Steatotic Liver Disease
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty
liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are
not known. Changes in the intestinal microbiome may contribute to the development of
NAFLD in persons with HIV (PWH) through... expand
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH. Type: Interventional Start Date: Apr 2024 |
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Osteomyelitis Tibia
Tibial Fractures
Open Tibia Fracture
This prospective randomized clinical trial will compare outcomes between patients treated
primarily with a prophylactic antibiotic coated nail and those treated with traditional
standard of care intramedullary (IM) nailing. expand
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing. Type: Interventional Start Date: May 2023 |
Trial of Indication-Based Transfusion of Red Blood Cells in ECMO
Extracorporeal Membrane Oxygenation
Red Blood Cell Transfusion
Organ Failure, Multiple
TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a
multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to
determine whether restricting red blood cell (RBC) transfusion according to an
indication-based strategy for those with bleeding and/or... expand
TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether restricting red blood cell (RBC) transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving Extracorporeal Membrane Oxygenation (ECMO) support. Type: Interventional Start Date: Apr 2023 |
PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Type2Diabetes
ASCVD
PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare
rates of the total number of cardiovascular, kidney, and death events among two
alternative treatments for patients with type 2 diabetes (T2D) and either established
atherosclerotic cardiovascular disease (ASCVD)... expand
PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study. Type: Interventional Start Date: Sep 2022 |
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening...
Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Peripheral Arterial Disease
A prospective, single-arm, multi-center study designed to gather additional information
on the LimFlow System. expand
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. Type: Interventional Start Date: Dec 2022 |
Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable...
Metastatic Colon Adenocarcinoma
Metastatic Rectal Adenocarcinoma
Stage III Colon Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
Stage IV Colon Cancer AJCC v8
This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib
and cetuximab) works better than the usual treatment alone to shrink tumors in patients
with colorectal cancer that has spread to other places in the body (metastatic) or that
cannot be removed by surgery (unresectable)... expand
This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer. Type: Interventional Start Date: Jul 2022 |
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone
(fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of
children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who
are unable to receive additional anthracyclines, or... expand
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse. Type: Interventional Start Date: Oct 2022 |
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Mixed Phenotype Acute Leukemia
Acute Leukemia
Myelodysplastic Syndromes
This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation
(HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for
peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in
children. Post-transplant cyclophosphamide... expand
This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in children. Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well this treatment works in patients with hematologic malignancies. Type: Interventional Start Date: Sep 2021 |
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