Search Clinical Trials
Below please find a list of studies actively recruiting volunteers at one of the following GHUCCTS institutions: Georgetown University, Howard University, MedStar Health Research Institute, or Washington DC VA Medical Center. Please enter your search criteria below to help find a study for you. If you have any questions, please email us or call us at 301-560-2963.
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Reducing Fall Risk With NMES
VA Office of Research and Development
Falls
Falls are dangerous leading to injuries, hospital admissions and even death. Fall
prevention is a priority but effective programs only reduce falls by 30%. Weak hip
muscles may be one reasons individuals experience a loss of balance. However individuals
who have weak hip muscles may be unable to exercise... expand
Falls are dangerous leading to injuries, hospital admissions and even death. Fall prevention is a priority but effective programs only reduce falls by 30%. Weak hip muscles may be one reasons individuals experience a loss of balance. However individuals who have weak hip muscles may be unable to exercise at sufficient intensities to improve their hip muscle strength. The purpose of this study is to utilize a common physical therapy method, neuromuscular electrical stimulation (NMES), on the hip muscles to improve hip muscle strength and improve balance. The new program focuses on using NMES during a resistance training program along with exercise to improve standing balance, walking and stepping over objects. This study will test the additive effect of NMES applied to the hip muscles during a balance and strengthening program to improve balance and mobility, and ultimately reduce the risk of falls in older Veterans at high risk for falls. Type: Interventional Start Date: Jan 2022 |
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
The University of Texas Health Science Center, Houston
Spinal Cord Injuries
The purpose of this study is to determine if electric stimulation to the leg, called
transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute
spinal cord injury. expand
The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury. Type: Interventional Start Date: Jun 2020 |
The ENCIRCLE Trial
Edwards Lifesciences
Mitral Regurgitation
Mitral Valve Insufficiency
This study will establish the safety and effectiveness of the SAPIEN M3 System in
subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially
available surgical or transcatheter treatment options are deemed unsuitable.
Following completion of enrollment, subjects will... expand
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial. Type: Interventional Start Date: Nov 2020 |
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Icahn School of Medicine at Mount Sinai
Atrial Fibrillation
Stroke
Bleeding
The primary objective of this study is to evaluate the effectiveness (prevention of
thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC)
to background antiplatelet therapy in patients who develop new-onset post-operative
atrial fibrillation (POAF) after isolated... expand
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey. Type: Interventional Start Date: Dec 2019 |
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple...
Hoffmann-La Roche
Multiple Sclerosis, Primary Progressive
This study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with
placebo in participants with primary progressive multiple sclerosis (PPMS), including
participants later in their disease course. This study focuses on upper limit disability
progression. This study will consist... expand
This study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM). Type: Interventional Start Date: Aug 2019 |
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of...
Merz Pharmaceuticals GmbH
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
The purpose of this study is to determine whether a single treatment with administration
of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the
treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main
Period). Participants will be assigned to... expand
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated. Type: Interventional Start Date: Sep 2019 |
SVC Occlusion in Subjects With Acute Decompensated Heart Failure
Abiomed Inc.
Acute Decompensated Heart Failure
Acute Heart Failure
Congestive Heart Failure
Heart Diseases
Safety and performance evaluation of the preCARDIA System for patients with ADHF. expand
Safety and performance evaluation of the preCARDIA System for patients with ADHF. Type: Interventional Start Date: Jul 2019 |
Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics
VA Office of Research and Development
Osteomyelitis
Diabetes
Amputation
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine
that treats infections), is effective in treating osteomyelitis (infection of the bone)
of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a
long period of time, many diabetic... expand
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many Veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA. Type: Interventional Start Date: Jan 2018 |
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
National Institute on Drug Abuse (NIDA)
Drug Abuse
Nicotine Dependence
Background:
- Functional and structural magnetic resonance imaging (MRI) techniques have allowed
researchers to map and study how the brain works when at rest and when engaged in
specific tasks. MRI scans have provided more information about how drugs affect the
brain, and about... expand
Background: - Functional and structural magnetic resonance imaging (MRI) techniques have allowed researchers to map and study how the brain works when at rest and when engaged in specific tasks. MRI scans have provided more information about how drugs affect the brain, and about how drug addiction changes the brain and influences behavior, mood, and thinking processes. To better understand the underlying mechanism of drug addiction and to develop strategies for more effective treatment, researchers are interested in developing new MRI techniques to study the effects of addiction on the brain. Objectives: - To develop new functional and structural MRI techniques, and to evaluate their potential use in brain imaging studies related to addiction. Eligibility: - Individuals between 18 and 80 years of age. - Participants may be smokers or nonsmokers, and may use drugs or not use drugs. Design: - During the initial screening, participants will complete questionnaires about family and personal history, drug use, and other information as required by the researchers. Participants who will be asked to complete tasks during the MRI scan will be shown how to perform these tasks before the scanning session. - Before each study session, participants may be asked to complete some or all of the following: questions about their drug use during the last week, a breathalyzer test, a urine drug-use assessment, a urine pregnancy test, or a measure of carbon monoxide. Participants will also provide blood samples before the start of the scan. - For each scanning session, participants will have an MRI scan that will last approximately 2 hours. - MRI scans may include specific tasks to be performed during the scan, or an experiment that studies the brain's response to carbon dioxide. Type: Interventional Start Date: Oct 2003 |
Gerofit and Cognition
VA Office of Research and Development
Aging
Cognitive Impairment
Physical Activity
Over 50% of the Veterans enrolled for VA health care are over the age of 65. Dementia
prevalence increases with age, and with the increase in the population of people ages 65
and older, the total number of people with dementia is also increasing. Older Veterans
often have comorbid PTSD, major depression... expand
Over 50% of the Veterans enrolled for VA health care are over the age of 65. Dementia prevalence increases with age, and with the increase in the population of people ages 65 and older, the total number of people with dementia is also increasing. Older Veterans often have comorbid PTSD, major depression and traumatic brain injury so that they are at 2 to 5 times the risk for cognitive impairment and dementia compared to the general population. There is evidence that exercise interventions in sedentary older adults could improve both physical and cognitive function. However, there have been very few studies on the effects of exercise on cognition in older Veterans and do not reflect the broader ethnic and health-status diversity of Veterans. Thus, improved knowledge of the role of exercise on cognition as well as the predictive power of biomarkers could have a major beneficial impact on Veterans' functional independence and quality of life. The investigators hypothesize that participation in the VA Gerofit exercise program will improve cognitive function in older Veterans and that blood and muscle biomarkers will predict these improvements. Type: Interventional Start Date: Apr 2024 |
Nectero EAST System Clinical Study
Nectero Medical, Inc.
Abdominal Aortic Aneurysm
The purpose of this randomized clinical trial is to treat patients with small to
mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a
locally delivered, single-dose endovascular treatment. The main question the study aims
to answer is to demonstrate efficacy of... expand
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years. Type: Interventional Start Date: Oct 2023 |
STOP-HER2: Stopping Trastuzumab in HER2+ MBC
Dana-Farber Cancer Institute
Breast Cancer
Metastatic Breast Cancer
HER2-positive Breast Cancer
This study is being done to see if anti-HER2 treatment be safely stopped in patients with
HER2-positive metastatic breast cancer (MBC) that have had exceptional response to
treatment. Exceptional response" is considered as cancer progression being controlled for
three years or more since starting... expand
This study is being done to see if anti-HER2 treatment be safely stopped in patients with HER2-positive metastatic breast cancer (MBC) that have had exceptional response to treatment. Exceptional response" is considered as cancer progression being controlled for three years or more since starting anti-HER2 treatment. Type: Interventional Start Date: Apr 2023 |
Life's End Benefits of Cannabidiol and Tetrahydrocannabinol
University of Southern California
Agitation
Dementia
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral
combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over
12 weeks. This study is designed to test the hypothesis that treatment with an oral
combination of THC/CBD will reduce... expand
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period. Type: Interventional Start Date: Dec 2023 |
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants...
Merck Sharp & Dohme LLC
Renal Cell Carcinoma
The purpose of this study is to evaluate the efficacy and safety of belzutifan
monotherapy and belzutifan plus palbociclib combination therapy in participants with
advanced clear-cell renal cell carcinoma (ccRCC) who experienced disease progression on
or after receiving prior therapy. Part 1 will... expand
The purpose of this study is to evaluate the efficacy and safety of belzutifan monotherapy and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced disease progression on or after receiving prior therapy. Part 1 will establish the safety of belzutifan plus palbociclib and determine a recommended dosage of palbociclib for the combination therapy by ascending dose escalation. Part 2 will evaluate the efficacy and safety of belzutifan plus palbociclib at the dosage level determined in Part 1. Type: Interventional Start Date: Aug 2022 |
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated...
Novartis Pharmaceuticals
Coronary Artery Disease
CKJX839D12303 is a research study to determine if the study treatment, called inclisiran,
in comparison to placebo taken in addition to statin medication can effectively reduce
the total amount of plaque formed in the heart's vessels as measured by coronary computed
tomography angiography (CCTA) from... expand
CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events. Type: Interventional Start Date: Jul 2022 |
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Ono Pharmaceutical Co. Ltd
Refractory Primary Central Nervous System Lymphoma
Primary CNS Lymphoma
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib
monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in
combination with one of two different high dose methotrexate based regimens
(methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/
vincristine)... expand
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B) Type: Interventional Start Date: Dec 2021 |
A Peer-Led Intervention to Improve Postpartum Retention in HIV Care
University of Pennsylvania
HIV/AIDS
The purpose of this study is to test the efficacy of a theory-driven peer intervention
for pregnant and postpartum women living HIV. The peer intervention is designed to
increase self-efficacy, social support, self-regulatory behaviors, and outcome expectancy
in order to improve retention in care... expand
The purpose of this study is to test the efficacy of a theory-driven peer intervention for pregnant and postpartum women living HIV. The peer intervention is designed to increase self-efficacy, social support, self-regulatory behaviors, and outcome expectancy in order to improve retention in care and viral suppression postpartum. The intervention will consist of face-to-face prenatal educational sessions, starting in early third trimester, and postpartum sessions scheduled up to three months postpartum. Type: Interventional Start Date: Mar 2020 |
Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory...
National Cancer Institute (NCI)
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Recurrent B Acute Lymphoblastic Leukemia
Refractory B Acute Lymphoblastic Leukemia
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in
treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly
diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal
antibodies, such as inotuzumab ozogamicin... expand
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: May 2019 |
Coronary Microvascular Disease (CMD) Registry
Medstar Health Research Institute
Coronary Microvascular Dysfunction
The purpose of this project is to provide appropriate administrative and technical
supports for the warehousing and use of a database of patients with coronary
microvascular disease (CMD). This protocol will outline the process for identification
and capture of data, storage, as well as data use and... expand
The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of a database of patients with coronary microvascular disease (CMD). This protocol will outline the process for identification and capture of data, storage, as well as data use and sharing internally and externally for research purposes. Type: Observational Start Date: Feb 2023 |
A Study of Mosunetuzumab in People With Follicular Lymphoma
Memorial Sloan Kettering Cancer Center
Follicular Lymphoma
Lymphoma
The purpose of this study is to find out if mosunetuzumab is an effective treatment in
people with follicular lymphoma that was recently diagnosed and have not yet received any
treatments for their disease. expand
The purpose of this study is to find out if mosunetuzumab is an effective treatment in people with follicular lymphoma that was recently diagnosed and have not yet received any treatments for their disease. Type: Interventional Start Date: May 2022 |
Emicizumab in Patients With Acquired Hemophilia A
University of Washington
Acquired Hemophilia A
This is a phase II multicenter open-label, single-arm prospective study to evaluate the
efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds
in patients with acquired hemophilia A (AHA). expand
This is a phase II multicenter open-label, single-arm prospective study to evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA). Type: Interventional Start Date: Aug 2022 |
A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement...
Nuvalent Inc.
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and
tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the
antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other
advanced ROS1-positive solid tumors.
Phase... expand
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. Type: Interventional Start Date: Jan 2022 |
VItamin C in Thermal injuRY: The VICToRY Trial
Clinical Evaluation Research Unit at Kingston General Hospital
Shock
Thermal Burn
This study aims to show that giving high dose, intravenous vitamin C in addition to
standard care to burned critically ill patients will be associated with less organ
dysfunction, improved survival and a quicker rate of recovery. In this study, all
patients will receive standard care and of the patients... expand
This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo. Type: Interventional Start Date: Jul 2020 |
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients...
Children's Oncology Group
Childhood Extracranial Germ Cell Tumor
Extragonadal Embryonal Carcinoma
Germ Cell Tumor
Malignant Germ Cell Tumor
Malignant Ovarian Teratoma
This phase III trial studies how well active surveillance help doctors to monitor
subjects with low risk germ cell tumors for recurrence after their tumor is removed. When
the germ cell tumor has spread outside of the organ in which it developed, it is
considered metastatic. Drugs used in chemotherapy,... expand
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, 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. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors. Type: Interventional Start Date: May 2017 |
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
Georgetown University
Thymoma
Thymic Carcinoma
The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in
adult patients with advanced thymoma and thymic carcinoma after progressing on at least
one prior line of therapy.
The main question it aims to answer is:
• What is the overall response rate (ORR) in patients... expand
The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy. The main question it aims to answer is: • What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma? Participants will: - receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity - have regular blood tests, scans, and examinations to monitor their health. - have blood and a biopsy of their tumor for research purposes. Type: Interventional Start Date: Apr 2024 |
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