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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Qualitative Assessment of the Impact of TTNS on QOL and Participation
Medstar Health Research Institute
Neurogenic Bladder
Urinary Retention
Urinary Tract Infections
Spinal Cord Injuries
This study through the use of semi-structured interviews or focus groups will explore the
lived experience with Transcutaneous Tibial Nerve Stimulation (TTNS) with Neurogenic
Lower Urinary Tract Dysfunction to generate user-defined themes regarding bladder
function and catheter-related barriers and... expand
This study through the use of semi-structured interviews or focus groups will explore the lived experience with Transcutaneous Tibial Nerve Stimulation (TTNS) with Neurogenic Lower Urinary Tract Dysfunction to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life. Type: Observational Start Date: May 2022 |
HEAL-IST IDE Trial
AtriCure, Inc.
Inappropriate Sinus Tachycardia
Inappropriate Sinus Tachycardia (IST) is a prevalent and debilitating condition in
otherwise healthy younger patients, resulting in significant loss of quality of life,
lacking effective treatment options or systematic clinical evidence to support a therapy.
The primary objective of this clinical... expand
Inappropriate Sinus Tachycardia (IST) is a prevalent and debilitating condition in otherwise healthy younger patients, resulting in significant loss of quality of life, lacking effective treatment options or systematic clinical evidence to support a therapy. The primary objective of this clinical trial is to evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure for the treatment of symptomatic drug refractory or drug intolerant IST. Type: Interventional Start Date: May 2022 |
mHealth for Breast Cancer Survivors With Insomnia
Medstar Health Research Institute
Breast Cancer Survivor
Insomnia
The aim of this study is to determine the impact of the voice-activated smart speaker
CBT-I components on insomnia symptoms among breast cancer survivors using a randomized
clinical trial. expand
The aim of this study is to determine the impact of the voice-activated smart speaker CBT-I components on insomnia symptoms among breast cancer survivors using a randomized clinical trial. Type: Interventional Start Date: Apr 2022 |
Vibroacoustic Study of Lung Development in Newborn Infants
Level 42 AI, Inc.
Prematurity
Premature Birth
Premature Lungs
Prematurity; Extreme
Investigators hypothesize that premature newborns with poor cardiopulmonary performance
have higher morbidities and poorer physical and cognitive developmental outcomes.
Investigators further hypothesize that audible sounds combined with novel inaudible
vibrations above and below human perception... expand
Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes. Investigators further hypothesize that audible sounds combined with novel inaudible vibrations above and below human perception interpreted with transparent and auditable AI algorithms can detect and identify early gas and fluid movement anomalies not uncovered by conventional tools in an non-invasive, easy, fast, and low cost examination. Type: Observational Start Date: Feb 2023 |
Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation
Medstar Health Research Institute
Neuroma
This study is being done to demonstrate the effectiveness of Regenerative Peripheral
Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits
following amputation compared to standard of care using a Prospective, Observational
Trial expand
This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial Type: Observational Start Date: Oct 2021 |
Peer Support For Young Adult Women With High Breast Cancer Risk
Georgetown University
Breast Cancer Risk
This trial will recruit young adult female relatives (YARs) of male or female carriers of
BRCA1/2. YARs who consent to participate will be randomized to either a 3-session peer
coach-led telephone counseling intervention or usual care navigation to peer support
interventions provided by community... expand
This trial will recruit young adult female relatives (YARs) of male or female carriers of BRCA1/2. YARs who consent to participate will be randomized to either a 3-session peer coach-led telephone counseling intervention or usual care navigation to peer support interventions provided by community organizations that support the hereditary cancer community. Study aims are to 1) Assess intervention effects on distress and decision making outcomes, including uptake of counseling for untested YARs, 2) Identify YARs most likely to engage with and benefit from the intervention, 3) Understand intervention mechanisms. Participants will complete interviews at baseline, 1, 6, and 12 months. Type: Interventional Start Date: Jul 2020 |
TruGraf® Long-term Clinical Outcomes Study
Transplant Genomics, Inc.
Kidney Transplant Rejection
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™
(TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In
addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a
clinical suspicion of acute rejection.... expand
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period. Type: Observational Start Date: Sep 2020 |
Brain-based Understanding of Individual Language Differences After Stroke
Georgetown University
Aphasia
Stroke
Alexia
Strokes often cause a loss of communication ability, referred to as aphasia, as well as
cognitive difficulties. Each stroke survivor has a unique pattern of strengths and
weaknesses in communication and cognition, and a unique course of recovery. The BUILD
study aims to understand the brain basis... expand
Strokes often cause a loss of communication ability, referred to as aphasia, as well as cognitive difficulties. Each stroke survivor has a unique pattern of strengths and weaknesses in communication and cognition, and a unique course of recovery. The BUILD study aims to understand the brain basis of these individual differences in stroke outcome. Participants with stroke as well as controls matched in age, educational background, race, and sex are examined using a combination of standardized and in-house tests of language and cognition to provide a detailed profile of strengths and weaknesses. Each participant will have between three and six sessions, including an MRI to measure details of the structure, function, and connections in the brain. The data are analyzed to test how patterns in the stroke lesion explain the patterns of communication and cognitive difficulties, and how patterns in the uninjured parts of the brain explain resilience and recovery from the stroke. Ultimately, we hope that BUILD will guide us toward new targets for brain stimulation treatments or other biologically based treatments that improve language and cognitive abilities after stroke. Type: Observational Start Date: Nov 2018 |
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
University of South Florida
Urinary Bladder, Overactive
Incontinence, Urge
Incontinence, Urinary
Urinary Urge Incontinence
Urinary Frequency More Than Once at Night
Currently, in clinical practice there has been no standardization in the number of
injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given
the increasing use of this treatment modality, the aim of this study is to compare
outcomes for patients given a 100 unit dose... expand
Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment. Type: Interventional Start Date: Oct 2019 |
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
NeoChord
Mitral Valve Insufficiency
The objective of this trial is to assess the safety and effectiveness of the study device
in subjects with degenerative mitral valve disease receiving a mitral valve repair
without cardiopulmonary bypass (treatment group) when compared to subjects receiving
mitral valve repair using standard surgical... expand
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group). Type: Interventional Start Date: Nov 2016 |
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Sanofi
Multiple Sclerosis
The purpose of each study is to independently measure the annualized relapse rate (ARR)
with administration of frexalimab compared to a daily oral dose of teriflunomide in male
and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years
at the time of enrollment). People... expand
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. - The study intervention duration will vary ranging from approximately 12 to 40 months. - The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
Merck Sharp & Dohme LLC
HIV-1 Infection
This is a randomized, active-controlled, double-blind clinical study designed to evaluate
the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL
[MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1
(HIV-1) infection. It is hypothesized... expand
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48. Type: Interventional Start Date: Mar 2023 |
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With...
Hoffmann-La Roche
Huntington Disease
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with
placebo in participants with prodromal and early manifest Huntington's Disease expand
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease Type: Interventional Start Date: Feb 2023 |
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients...
Gilead Sciences
Triple Negative Breast Cancer
The goal of this study is to find out if the experimental product, sacituzumab
govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective
and safe compared to the treatment of physician's choice (TPC) which includes either
pembrolizumab or pembrolizumab plus capecitabine... expand
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment. Type: Interventional Start Date: Dec 2022 |
A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
Pfizer
Pneumonia
The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate
vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia
(RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae
that cause pneumonia) included in... expand
The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia (RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae that cause pneumonia) included in 20vPnC vaccine. This study is seeking participants who: - are male or female ≥65 years of age. - are hospitalized with physician suspicion of community acquired pneumonia (CAP). - have pneumonia confirmed with imaging like a chest x-ray Participants will be asked to provide demographic and medical history information, and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae. We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC. Participants will actively take part in the study for about 1-2 days. Information on participant's illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review. Type: Observational Start Date: Oct 2022 |
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants...
Merck Sharp & Dohme LLC
Metastatic Esophageal Squamous Cell Carcinoma
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus
lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line
intervention in participants with metastatic esophageal carcinoma.
The primary hypotheses are that pembrolizumab plus lenvatinib... expand
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma. The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Type: Interventional Start Date: Jul 2021 |
MILD® Percutaneous Image-Guided Lumbar Decompression: a Medicare Claims Study
Vertos Medical, Inc.
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against
a control group of similar patients... expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
Biospecimen Procurement for Head and Neck Disorders
National Cancer Institute (NCI)
Hearing Disorder
Oral Mucosal Disease
Pharyngeal Neoplasm
Head and Neck Neoplasms
Laryngeal Disease
Background:
Researchers want to learn more about head and neck disorders. Understanding these
disorders could help them find better treatments. To do this, they are collecting tissue
samples for research.
Objective:
To create a repository of tissue samples and data to better study conditions... expand
Background: Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research. Objective: To create a repository of tissue samples and data to better study conditions of the head and neck. Eligibility: People who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2. Design: Participants will be screened with a questionnaire, medical history, and physical exam. Part 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used. If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2. Part 2: Participants will have additional samples collected. These could be: - Blood: Blood is drawn through a needle in the arm. - Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek. - Saliva: They rinse their mouth with water and spit into a tube or cup. - Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin. - Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed. Participants samples will be used for future research, including genetic testing. Type: Observational Start Date: May 2018 |
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy...
Biohaven Therapeutics Ltd.
Generalized Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment
of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an
additional open-label extension (OLE) phase. expand
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase. Type: Interventional Start Date: Jun 2024 |
RECOVER-AUTONOMIC Platform Protocol
Kanecia Obie Zimmerman
Long COVID
Long Covid19
Long Covid-19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems and in community settings where it can
be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-arm,... expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate...
Eli Lilly and Company
Diabetes Mellitus, Type 2
The purpose of this study is to investigate the efficacy and safety of retatrutide
compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic
control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i).
The study will last about 26 months and... expand
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits. Type: Interventional Start Date: Feb 2024 |
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the...
Ipsen
Spasticity as Sequela of Stroke
This study will monitor patients during the first year following their stroke.
Stroke is a very serious condition where there is a sudden interruption of blood flow in
the brain.
The main aim of the study will be to find out how many of those who experience their
first-ever stroke then go on... expand
This study will monitor patients during the first year following their stroke. Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain. The main aim of the study will be to find out how many of those who experience their first-ever stroke then go on to develop spasticity that would benefit from treatment with medication. Spasticity is a common post-stroke condition that causes stiff or ridged muscles. The results of this study will provide a standard guideline on the best way to monitor the development of post-stroke spasticity. Type: Observational Start Date: Nov 2023 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive...
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in Participants with Progressive Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma
Georgetown University
Borderline Resectable Carcinoma
Biliary Tract Cancer
The goal of this clinical trial is to test feasibility and safety of the combination of
tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment
bridge patients to a curative resection in treatment naïve borderline resectable, or
resectable with high risk for recurrence... expand
The goal of this clinical trial is to test feasibility and safety of the combination of tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment bridge patients to a curative resection in treatment naïve borderline resectable, or resectable with high risk for recurrence intrahepatic cholangiocarcinoma patients. The main question[s] it aims to answer are: - What is the rate of conversion of unresectable tumor to resectable cancer? - What are the side effects of this treatment combination? Participants will undergo an initial tumor biopsy, imaging and laboratory studies prior to starting treatment with durvalumab, tremelimumab, gemcitabine and cisplatin. Participants will continue for 4 cycles and if the tumor is found to be resectable then they will undergo surgical resection. If the tumor is unresectable (can't be surgically removed) after 4 cycles, then participants will receive 4 more cycles and repeated imaging. If the tumor remains unresectable then the participant will be treated with capecitabine for up to 8 cycles and durvalumab for up to 12 months. Type: Interventional Start Date: Oct 2024 |
Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Michael B. Atkins, MD
Advanced Renal Cell Carcinoma
This study is a randomized, open label, multicenter Phase II trial to evaluate the
efficacy and safety of botensilimab (a novel Fc enhanced Tree depleting anti-CTLA4) and
balstilimab (a novel anti-PD1) relative to ipilimumab and nivolumab in treatment naïve
patients with metastatic ccRCC. The study... expand
This study is a randomized, open label, multicenter Phase II trial to evaluate the efficacy and safety of botensilimab (a novel Fc enhanced Tree depleting anti-CTLA4) and balstilimab (a novel anti-PD1) relative to ipilimumab and nivolumab in treatment naïve patients with metastatic ccRCC. The study will plan to enroll 120 eligible patients randomized in a 2:1 fashion to Arm A and Arm B. Patients in all IMDC Risk Groups are included. This study utilizes a Simon's two stage design which is described in the protocol. Patients randomized to Arm A will receive botensilimab in combination with balstilimab. Patients randomized to Arm B will receive ipilimumab in combination with nivolumab. Study treatment on both arms will continue until toxicity, disease progression or a maximum of 96 total weeks (12 weeks induction, 84 weeks maintenance). Type: Interventional Start Date: Sep 2023 |
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