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Condition of Interest |
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Cholinergic Mechanisms of Attention in Aging
Subjective Cognitive Decline
This study will use an anticholinergic pharmacological probe to examine attention network
function in SCD using EEG. The overall hypothesis is that in older adults with SCD,
normal cognitive performance is maintained by compensatory attention network activity,
supported by enhanced cholinergic function.... expand
This study will use an anticholinergic pharmacological probe to examine attention network function in SCD using EEG. The overall hypothesis is that in older adults with SCD, normal cognitive performance is maintained by compensatory attention network activity, supported by enhanced cholinergic function. The investigators anticipate that SCD will be associated with greater compensatory attention network activity and that disrupting this compensatory process through anticholinergic challenge will result in a greater negative effect on attentional performance (Attention Network Test, ANT) and attention network functioning (EEG) in older adults with SCD compared to those without SCD. Type: Interventional Start Date: Apr 2022 |
Fenofibrate for Prevention of DR Worsening
Diabetic Retinopathy
This randomized trial will evaluate the effect of fenofibrate compared with placebo for
prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes
with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
In addition to evaluating efficacy,... expand
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort. Type: Interventional Start Date: Mar 2021 |
Academic-Community EPINET (AC-EPINET)
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Major Depression with Psychotic Features
Bipolar Disorder with Psychotic Features
The investigators propose to examine the effects of CSC services delivered via TH
(CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes
in a 12-month, randomized trial. expand
The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial. Type: Interventional Start Date: Mar 2022 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive...
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Trastuzumab... expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal...
Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
Clinical Stage IV Gastric Cancer AJCC v8
Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IVA Gastric Cancer AJCC v8
Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
This phase III trial studies how well the addition of radiotherapy to the usual treatment
(chemotherapy) works compared to the usual treatment alone in treating patients with
esophageal and gastric cancer that has spread to a limited number of other places in the
body (oligometastatic disease). Radiotherapy... expand
This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine, 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. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer. Type: Interventional Start Date: May 2020 |
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation
(chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating
patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin,
fluorouracil, and capecitabine, work in different... expand
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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 to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Type: Interventional Start Date: Jan 2020 |
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic...
Castration Levels of Testosterone
Metastatic Prostatic Adenocarcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
This phase III trial studies how well standard systemic therapy with or without
definitive treatment (prostate removal surgery or radiation therapy) works in treating
participants with prostate cancer that has spread to other places in the body. Addition
of prostate removal surgery or radiation therapy... expand
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Type: Interventional Start Date: Sep 2018 |
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Eosinophilic Gastrointestinal Disorders (EGIDs)
Eosinophilic Esophagitis
Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophilic Colitis
The purpose of this observational study is to find the best measures to define how well a
person with eosinophilic disorder is doing. People with EoE, EoG, EoN and EoC normally
undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis.
Treatments are then decided based... expand
The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EoG, EoN and EoC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing. Type: Observational Start Date: Jul 2015 |
The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization,...
Respiratory Syncytial Virus Infection
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract
infections (LRTIs) in infants and young children. It is also a leading cause of mortality
in children <5 years of age worldwide. Until recently, no Food and Drug Administration
(FDA)-approved vaccines were available... expand
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children <5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined. Type: Interventional Start Date: Sep 2024 |
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic...
Digestive System Neuroendocrine Tumor G1
Digestive System Neuroendocrine Tumor G2
Metastatic Digestive System Neuroendocrine Neoplasm
Metastatic Malignant Neoplasm in the Liver
Pancreatic Neuroendocrine Tumor G1
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor
radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible
(debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor
(SSTR) positive, gastroenteropancreatic... expand
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs Type: Interventional Start Date: May 2024 |
Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG...
Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
The purpose of the study is to prospectively assess longitudinal changes in biomarkers
(MECP2, potential biomarkers of target engagement and disease activity) in cerebrospinal
fluid (CSF) and blood; characterize longitudinal changes in performance on clinical
scales (clinician-reported measures of... expand
The purpose of the study is to prospectively assess longitudinal changes in biomarkers (MECP2, potential biomarkers of target engagement and disease activity) in cerebrospinal fluid (CSF) and blood; characterize longitudinal changes in performance on clinical scales (clinician-reported measures of neurodevelopment and functioning) and caregiver-reported outcome assessments (communication, gastrointestinal, social-emotional-adaptive behavioral measures); evaluate longitudinal changes in caregiver-reported health-related quality-of-life measures; and assess the frequency, type, and severity of seizures over time. Type: Observational Start Date: Oct 2023 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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