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Wearable Technology to Evaluate Hyperglycemia and HRV in DMD
Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is an X-linked disorder that causes muscle wasting,
cardiopulmonary failure, and premature death. Heart failure is a leading cause of death
in DMD, but substantial knowledge gaps exist regarding predisposing risk factors. In the
general population, hyperglycemia,... expand
Duchenne muscular dystrophy (DMD) is an X-linked disorder that causes muscle wasting, cardiopulmonary failure, and premature death. Heart failure is a leading cause of death in DMD, but substantial knowledge gaps exist regarding predisposing risk factors. In the general population, hyperglycemia, insulin resistance, and decreased heart rate variability (HRV; reflecting autonomic dysfunction) are associated with cardiomyopathy (CM). It is unclear whether these factors are associated with DMD-CM. Closing this knowledge gap may lead to novel screening and therapeutic strategies to delay progression of DMD-CM, now the leading cause of death in patients with DMD. Despite risk factors for hyperglycemia, including the use of glucocorticoids (GCs), sarcopenia, obesity, and reduced ambulation, little is known regarding glucose abnormalities in DMD. Some of these same risk factors, along with the distance needed to travel for specialty care, present significant barriers to research participation and clinical care for individuals with DMD. Remote wearable technology may improve research participation in this vulnerable population. Therefore, this study will leverage remote wearable technologies to overcome these barriers and define the relationship between dysglycemia and DMD-CM. The goal of this remote study is to evaluate rates of hyperglycemia in individuals with DMD compared to control participants using continuous glucose monitors, and to determine the relationship between hyperglycemia and heart rate variability. Participants will utilize continuous glucose monitors, cardiac monitors, and activity monitors to evaluate glucose levels, heart rate, activity, and sleep. Type: Observational Start Date: Mar 2024 |
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans...
Recurrent Langerhans Cell Histiocytosis
Refractory Langerhans Cell Histiocytosis
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib
(DAY101) in treating patients with Langerhans cell histiocytosis that is growing,
spreading, or getting worse (progressive), has come back (relapsed) after previous
treatment, or does not respond to therapy (refractory).... expand
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis. Type: Interventional Start Date: Mar 2024 |
Prospective Phenotyping for Genetic Subtypes of Early-onset Atrial Fibrillation
Atrial Fibrillation
This is a prospective, case-control study that seeks to learn about the role of genetics
in early onset atrial fibrillation (AF) and if genetic testing can be used to improve how
the investigators treat atrial fibrillation. The study will enroll 225 participants.
Eligible participants will have undergone... expand
This is a prospective, case-control study that seeks to learn about the role of genetics in early onset atrial fibrillation (AF) and if genetic testing can be used to improve how the investigators treat atrial fibrillation. The study will enroll 225 participants. Eligible participants will have undergone sequencing for arrhythmia and cardiomyopathy (CM) genes. Based on those results, participants will be recruited for an outpatient research visit with testing that includes cardiac MRI, rest/stress/signal-averaged ECGs, and cardiac monitoring. If an inherited arrhythmia/CM syndrome is diagnosed, guideline-directed changes to medical care will be recommended. Type: Observational [Patient Registry] Start Date: Apr 2022 |
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
Aortic Stenosis, Severe
The objective of this study is to establish the safety and effectiveness of the Edwards
SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific
aortic stenosis (AS). expand
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS). Type: Interventional Start Date: Jun 2022 |
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy...
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Hypopharyngeal Squamous Cell Carcinoma
Metastatic Laryngeal Squamous Cell Carcinoma
Metastatic Lip and Oral Cavity Carcinoma
This phase II/III compares the standard therapy (chemotherapy plus cetuximab) versus
adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and
atezolizumab in treating patients with head and neck cancer that has spread to other
places in the body (metastatic or advanced... expand
This phase II/III compares the standard therapy (chemotherapy plus cetuximab) versus adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and atezolizumab in treating patients with head and neck cancer that has spread to other places in the body (metastatic or advanced stage) or has come back after prior treatment (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. 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. Cisplatin and carboplatin are in a class of chemotherapy medications known as platinum-containing compounds. They work by killing, stopping, or slowing the growth of cancer cells. Docetaxel is in a class of chemotherapy medications called taxanes. It stops cancer cells from growing and dividing and may kill them. The addition of bevacizumab to standard chemotherapy or combination therapy with bevacizumab and atezolizumab may be better than standard chemotherapy plus cetuximab in treating patients with recurrent/metastatic head and neck cancers. Type: Interventional Start Date: Mar 2023 |
Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
Neurogenic Orthostatic Hypotension
Autonomic Failure
Pure Autonomic Failure
Multiple System Atrophy
Parkinson Disease
The purpose of this study is to learn more about the effects of abdominal compression and
the medication midodrine, two interventions used for the treatment of orthostatic
hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular
risk. The study will be conducted at the... expand
The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular risk. The study will be conducted at the Vanderbilt University Medical Center and consists of a screening and 2 testing days, one with abdominal compression and one with midodrine. The total length of the study will be about 5 days. Type: Interventional Start Date: Nov 2020 |
Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
Supine Hypertension
Autonomic Failure
Many persons with autonomic failure often have high blood pressure when lying down
(supine hypertension). This study is exploring the impact of decreased venous return to
the heart (achieved by raising the head of the bed) to lessen supine blood pressure. If
decreased venous return to the heart is... expand
Many persons with autonomic failure often have high blood pressure when lying down (supine hypertension). This study is exploring the impact of decreased venous return to the heart (achieved by raising the head of the bed) to lessen supine blood pressure. If decreased venous return to the heart is effective at lowering supine blood pressure, these approaches may be utilized to treat supine hypertension non-pharmacologically. Raising the head of the bed decreases the amount of blood returning to the heart due to the effects of gravity. In this case, the decreased blood return to the heart may decrease blood pressure. Type: Interventional Start Date: Aug 2020 |
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma
Low Grade Glioma
Metastatic Low Grade Astrocytoma
Metastatic Low Grade Glioma
This phase III trial compares the effect of selumetinib versus the standard of care
treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed
or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality
called BRAFV600E mutation and is not... expand
This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin and vincristine are chemotherapy drugs that work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it. Type: Interventional Start Date: Jan 2020 |
Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2
Heart Failure
LCZ696, a molecular complex of the angiotensin receptor blocker (ARB) valsartan with an
inhibitor of neprilysin (NEP, neutral endopeptidase-24.11) sacubitril improved mortality
compared to enalapril in patients with heart failure (HF), reduced ejection fraction
(EF), and increased brain natriuretic... expand
LCZ696, a molecular complex of the angiotensin receptor blocker (ARB) valsartan with an inhibitor of neprilysin (NEP, neutral endopeptidase-24.11) sacubitril improved mortality compared to enalapril in patients with heart failure (HF), reduced ejection fraction (EF), and increased brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) in the PARADIGM-HF trial.1 The PIONEER-HF study demonstrated the efficacy of LCZ696 in preventing rehospitalization in patients with acutely decompensated HF.2 LCZ696 has been underutilized in heart failure, in part due to concerns about hypotension. NEP degrades several vasodilator peptides including bradykinin, substance P and brain-type natriuretic peptide. Decreased degradation of endogenous bradykinin could contribute to hypotension at initiation of LCZ696 through vasodilation or through increased natriuresis and diuresis. Inhibition of the bradykinin B2 receptor using icatibant would be expected to prevent this effect. Objectives The main objectives of this mechanistic randomized, double-blind, crossover-design study are: - The primary objective is to test the hypothesis that endogenous bradykinin contributes to effects of ARB/NEP inhibition on blood pressure, natriuresis, and diuresis at initiation. - The secondary objective is to test the hypothesis endogenous bradykinin contributes to effects of ARB/NEP inhibition on blood pressure, natriuresis, and diuresis after up-titration. Eighty (80) subjects with stable heart failure who meet all inclusion/exclusion criteria will be enrolled. Subjects who qualify will collect their urine for 24 hours before each study day for measurement of volume, sodium and potassium. At the start of the study, they will stop their regular angiotensin-converting enzyme (ACE) inhibitor or ARB. After a 48-hour washout, they will undergo a study day in which they are given a single dose of 50 mg LCZ696. They will also receive either the bradykinin B2 receptor antagonist icatibant or placebo vehicle in random order (double-blind). After a 96-hour washout, they will repeat the study day and receive a single dose of 50 mg LCZ696 and the opposite study drug (icatibant or placebo). After completion of the two acute study days, subjects will take LCZ696 50 mg bid for two weeks, followed by LCZ696 100 mg bid for three weeks, and then LCZ696 200 mg bid, following the conservative up-titration protocol from the TITRATION study.3 Criteria for continuing up-titration appear in the full study protocol. On the 7th and 10th day of the 200 mg bid or highest tolerated dose, subjects will again undergo two more study days three days apart in which they are randomized to receive either icatibant or vehicle. Type: Interventional Start Date: Nov 2019 |
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
Advanced Malignant Neoplasm
Acute Myeloid Leukemia
Mixed Lineage Leukemia
Mixed Lineage Acute Leukemia
Acute Leukemia of Ambiguous Lineage
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess
ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute
myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will
continue in patients with NPM1-m AML. expand
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue in patients with NPM1-m AML. Type: Interventional Start Date: Sep 2019 |
A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and...
Low Grade Glioma
Neurofibromatosis Type 1
Visual Pathway Glioma
This phase III trial studies if selumetinib works just as well as the standard treatment
with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma
(LGG), and to see if selumetinib is better than CV in improving vision in subjects with
LGG of the optic pathway (vision nerves).... expand
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, 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 selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine. Type: Interventional Start Date: Jan 2020 |
Automated Abdominal Binder for Orthostatic Hypotension
Orthostatic Hypotension
Autonomic Failure
Pure Autonomic Failure
Multiple System Atrophy
The automated inflatable abdominal binder is an investigational device for the treatment
of orthostatic hypotension (low blood pressure on standing) in patients with autonomic
failure. The purpose of this study is to determine safety and effectiveness of the
automated abdominal binder in improving... expand
The automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in patients with autonomic failure. The purpose of this study is to determine safety and effectiveness of the automated abdominal binder in improving orthostatic tolerance in these patients. Type: Interventional Start Date: Mar 2018 |
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory...
Advanced Malignant Solid Neoplasm
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Histiocytic Sarcoma
Juvenile Xanthogranuloma
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well
treatment that is directed by genetic testing works in pediatric patients with solid
tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at
least one line of standard systemic therapy... expand
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas. Type: Interventional Start Date: Jul 2017 |
Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients
Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Precancerous Condition
RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids
from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy
may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at... expand
RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and biological fluid samples from patients and participants undergoing colonoscopy, endoscopy, or surgery. Type: Observational Start Date: Jun 2002 |
Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung...
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
This phase III trial compares the effect of the combination of ramucirumab and
pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell
lung cancer that is stage IV or that has come back after a period of improvement
(recurrent). Ramucirumab is a monoclonal antibody that... expand
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs 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. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy. Type: Interventional Start Date: Mar 2023 |
Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative...
Neurodegenerative Diseases
Parkinson Disease
Parkinson Disease Psychosis
It is hypothesize that patients with clinically diagnosed neurodegenerative diseases will
have significantly different receptor occupancy of 5HT2A receptors compared to a healthy
age/sex-matched control group. This will be tested by measuring 5HT2A receptor density
using the PET radioligand (R)-[18F]MH.MZ... expand
It is hypothesize that patients with clinically diagnosed neurodegenerative diseases will have significantly different receptor occupancy of 5HT2A receptors compared to a healthy age/sex-matched control group. This will be tested by measuring 5HT2A receptor density using the PET radioligand (R)-[18F]MH.MZ in both populations. Type: Interventional Start Date: Jan 2023 |
Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and...
Down Syndrome
Down Syndrome, Partial Trisomy 21
Alzheimer Disease
Progressive age-related cognitive deficits occurring in both AD and DS have been
connected to the degeneration of several neuronal populations, but mechanisms are not
fully elucidated. The most consistent neuronal losses throughout the progression of AD
are seen in cholinergic neurons where these... expand
Progressive age-related cognitive deficits occurring in both AD and DS have been connected to the degeneration of several neuronal populations, but mechanisms are not fully elucidated. The most consistent neuronal losses throughout the progression of AD are seen in cholinergic neurons where these losses negatively affect cognition, particularly in attention, learning, and memory formation. Evidence of reduced cholinergic integrity in DS is largely limited to animal models and post-mortem human data. The investigators propose to use molecular, functional, and structural biomarkers to assess the cholinergic integrity in adults with DS. The investigators anticipate using the data gathered in this pilot study to inform future study designs to determine AD risk stratification in DS by identifying individuals who show an accelerated decline in cholinergic integrity that correlates with cognitive and neurobehavioral changes. Also, our cholinergic biomarkers may identify whether individuals with DS are likely to respond to pro-cholinergic interventions, including the novel cholinergic modulators that are being developed to enhance cholinergic-sensitive cognitive functioning. The investigators anticipate using the data gathered here to inform future treatment studies in TRC-DS and beyond where novel cholinergic treatments may offer opportunities for early intervention in DS and be complementary to disease-modifying approaches such as anti-amyloid treatments. Type: Interventional Start Date: Aug 2021 |
Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Peripartum Cardiomyopathy, Postpartum
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5
months postpartum in a randomized placebo controlled trial of bromocriptine therapy to
evaluate its impact on myocardial recovery and clinical outcomes. Given that
bromocriptine prevents breastfeeding, an additional... expand
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort. Type: Interventional Start Date: Jul 2022 |
Improving Care After Inherited Cancer Testing
Inherited Cancer Syndrome
Prostate Cancer
Colorectal Cancer
Endometrial Cancer
Breast Cancer
The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on
improving guideline-adherent cancer risk management (CRM) and family communication (FC)
of genetic test results for individuals with a documented pathogenic/likely pathogenic
(P/LP) variant, and FC of family cancer... expand
The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results for individuals with a documented pathogenic/likely pathogenic (P/LP) variant, and FC of family cancer history for individuals with a variant of uncertain significance (VUS) in an inherited cancer gene. Type: Interventional Start Date: Aug 2022 |
Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and...
Acute Respiratory Failure
This is a phase 3 study designed to evaluate whether the administration of ganciclovir
increases ventilator-free days in immunocompetent patients with sepsis associated acute
respiratory failure. Our hypothesis is that IV ganciclovir administered early in critical
illness will effectively suppress... expand
This is a phase 3 study designed to evaluate whether the administration of ganciclovir increases ventilator-free days in immunocompetent patients with sepsis associated acute respiratory failure. Our hypothesis is that IV ganciclovir administered early in critical illness will effectively suppress CMV reactivation in CMV seropositive adults with sepsis-associated acute respiratory failure thereby leading to improved clinical outcomes Type: Interventional Start Date: Jun 2021 |
Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Synovial Sarcoma
Myxoid Liposarcoma
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible
and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma
(Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) . expand
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) . Type: Interventional Start Date: Aug 2019 |
Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
Multiple Sclerosis, Relapsing-Remitting
FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the
relapsing phase of MS but have minimal impact once the progressive phase has begun. It is
unclear if, in the relapsing phase, there is an advantage of early aggressive therapy
with respect to preventing long-term disability.... expand
FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability. Type: Interventional Start Date: May 2018 |
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment...
Peripheral Arterial Disease
Critical Limb Ischemia
This is a prospective, multicenter, single arm study designed to evaluate the safety and
efficacy of the Temporary Bare Spur Stent System (Spur Stent System). expand
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System). Type: Interventional Start Date: Oct 2022 |
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension...
NASH - Nonalcoholic Steatohepatitis
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver
fibrosis histological stage F2 or F3 expand
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3 Type: Interventional Start Date: Aug 2021 |
Autonomic Determinants of POTS - Pilot1
Postural Tachycardia Syndrome
Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly
otherwise healthy young women. It is the cause of significant disability and an
impairment in quality of life. These patients have high heart rate and symptoms during
standing. Many of these patients are disabled... expand
Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly otherwise healthy young women. It is the cause of significant disability and an impairment in quality of life. These patients have high heart rate and symptoms during standing. Many of these patients are disabled and have a poor quality of life. The sympathetic nerves are part of the nervous system that helps to maintain normal blood pressures and heart rates during activities of daily life. The purpose of this study is to determine the importance of sympathetic activation as a cause of orthostatic symptoms. The investigators will assess the effects of a blood pressure medication (Moxonidine) on the symptoms during standing. Moxonidine lowers sympathetic activity. The investigators believe patients with high resting sympathetic activity might benefit from Moxonidine. It might reduce high heart rate and improve symptoms during standing. This study should help clinicians and the growing population of patients with POTS gain a better understanding of this disorder and find more personalized treatment. Type: Interventional Start Date: Aug 2019 |
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