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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COVID-19 Associated Lymphopenia Pathogenesis Study in Blood
National Institute of Allergy and Infectious Diseases (NIAID)
Coronavirus Disease 2019
Background:
COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the
number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood
cell that fights infections. With fewer lymphocytes, the body cannot effectively fight
back against SARS CoV-2,... expand
Background: COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. Researchers want to better understand how SARS-CoV-2 affects these blood cells. This information may give them ideas for new treatments. Objective: To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system. Eligibility: Adults age 18 and older who either currently have COVID-19 or have recently recovered from it Design: Participants will give a blood sample. For this, a needle is used to collect blood from an arm vein. For participants who have a central line, blood will be collected through that instead. Participants medical records related to COVID-19 will be reviewed. Participants who have recovered from COVID-19 will be asked to undergo leukapheresis to collect white blood cells. For this, blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned to the participant through a needle placed in the other arm. This takes about 2-3 hours. Recovered participants may have material collected from inside the nostrils and/or rectum. This is done by gently rubbing the area with a sterile cotton swab. Recovered participants may have an echocardiogram to look at their heart. For this, a small probe is held against the chest to get pictures of the heart from different angles. This takes less than 30 minutes. Participation lasts 1-2 days on most cases and may be split in a few visits for recovered patients if leukapheresis and echocardiogram are done. ... Type: Observational Start Date: May 2020 |
NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer
Georgetown University
Advanced Biliary Tract Cancer
This is a study to evaluate the clinical activity of the combination of fluorouracil,
leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with
advanced biliary tract cancers following gemcitabine and platinum chemotherapy. expand
This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy. Type: Interventional Start Date: Jul 2019 |
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
Ying Liu
Hysterectomy
Gynecologic Surgical Procedures
Narcotic Use
Pain, Postoperative
The study is a prospective, double-blinded, placebo-controlled multi-center trial to
measure if postoperative pain and the amount of narcotics used are reduced by a
clinically significant amount in women undergoing minimally invasive hysterectomy
receiving a continuous infusion of intraperitoneal... expand
The study is a prospective, double-blinded, placebo-controlled multi-center trial to measure if postoperative pain and the amount of narcotics used are reduced by a clinically significant amount in women undergoing minimally invasive hysterectomy receiving a continuous infusion of intraperitoneal (IP) local anesthetic (LA) or a continuous infusion of LA combined with an NSAID compared with a control group who receives only 0.9% normal saline. Type: Interventional Start Date: Sep 2019 |
Device Feasibility and Acceptability to Improve Insomnia in Cancer
Medstar Health Research Institute
Cancer
Insomnia Chronic
Sleep disruption is common among young adult cancer survivors for a variety of reasons.
Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve chronic sleep
disorders. This project will test the feasibility and acceptability of a new
voice-activated virtual assistant (VAVA) device... expand
Sleep disruption is common among young adult cancer survivors for a variety of reasons. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve chronic sleep disorders. This project will test the feasibility and acceptability of a new voice-activated virtual assistant (VAVA) device to deliver CBT-I to improve sleep among young adult cancer survivors with chronic sleep disorders. Type: Interventional Start Date: Jul 2023 |
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield...
Mercator MedSystems, Inc.
Iliofemoral; Thrombosis
This is a study of a medical procedure that utilizes a commercially available catheter
(the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available
anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins
after DVT recanalization, where DVT symptoms... expand
This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for at least 14 days and no more than 60 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure. Type: Interventional Start Date: Aug 2022 |
A Balanced Reach Training Platform to Address Balance Disorders in Older and Neurologically Disabled...
VA Office of Research and Development
Older Men and Women With High Fall Risk
Falls are by far the leading cause of accidental injury and death in older adults. The
Veteran population is more severely affected by falls since it is significantly older
than the overall population (45% over 65 years of age vs. 13%); and Veterans would
benefit substantially more from an accurate... expand
Falls are by far the leading cause of accidental injury and death in older adults. The Veteran population is more severely affected by falls since it is significantly older than the overall population (45% over 65 years of age vs. 13%); and Veterans would benefit substantially more from an accurate diagnosis and treatment of fall propensity. Despite its importance, much is still unknown about the manner in which balance control is compromised by age and disease. Therapeutic interventions for people who are at risk of falling have proven to be of limited utility. Engineering methods are well suited to study and evaluate balance; but have to date been applied to overly simplified scenarios that lack the complexity to probe the musculoskeletal and neurophysiological bases for balance and falls. The long term objective of this research, which began with a VA Rehabilitation Research & Development (RR&D) Career Development Award (CDA-2), is to develop improved directives and protocols for the diagnosis and treatment of balance-related posture and movement coordination problems. This proposal significantly advances engineering methods to address existing gaps in the diagnosis and treatment of balance impairments through the development of a Balanced Reach Training Protocol (BRTP). The BRTP continuously challenges subjects to perform reaching tasks at the limits of their balance for an extended period of time, and increases these limits as subjects demonstrate improved performance. The goal of this tool is to quantitatively assess and improve at-risk individuals' ability to maintain balance when disturbed by volitional movements of the body and its parts-an important class of balance disturbances integral to many activities of daily living that can precipitate falls. The BRTP focuses on performance at and just beyond the limits of balance, unlike most such tests and training protocols that do not challenge subjects in this way. The BRTP's most immediate and salient metric is the limiting boundary of standing reach; and we hypothesize that expanding this boundary, as the BRTP is designed to do, will improve balance and make individuals more resistant to falls (in the context of expected balance disturbances). Confirmation of this hypothesis could provide a new perspective on existing training protocols' modest success rates, and direction for the design of new protocols with the potential to significantly improve these rates. [Though the BRTP is a training platform, we also believe that the performance metrics and analytical results produced by it can form the basis for new diagnostic measures that more reliably and precisely quantify and explain balance performance problems; and track changes in them over time.] Such diagnostic and treatment protocols would be particularly beneficial to the VA Health Care System, as it would lead to improvements in: patient throughput, quality of care, and treatment costs. Though this proposal targets the aging Veteran population, the BRTP is a general tool that can aid in the diagnosis and treatment of balance disorders arising from conditions other than aging. These include obesity, diabetes (which often leads to lower extremity muscle degeneration and peripheral neuropathy), sarcopenia, vestibular disorders, and neurological disorders such as stroke. Veterans whose balance has been compromised by Traumatic Brain Injury (TBI) (whether combat-related or not) may also benefit from the BRTP. Type: Observational Start Date: Nov 2021 |
Carboplatin or Olaparib for BRcA Deficient Prostate Cancer
VA Office of Research and Development
Metastatic Castrate Resistant Prostate Cancer
BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2
RAD51B, RAD51C, RAD51D, or RAD54L Mutations
This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging
chemotherapy using carboplatin, to standard of care therapy for patients who have
metastatic castrate resistant prostate cancer. This trial will use olaparib or
carboplatin as initial therapy with crossover to the... expand
This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L inactivating mutations. Participants are randomized (1:1) and receive either carboplatin (AUC 5, IV) every 21 days, first or olaparib taken orally (300 mg), twice daily in 28 day cycles, until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria. Participants then crossover from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or olaparib. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen/pelvis, or MRI and PSA as per PCWG3 criteria. Type: Interventional Start Date: Oct 2019 |
Reshaping Postpartum Follow-up
Medstar Health Research Institute
Hypertension in Pregnancy
Gestational Diabetes
Cervical Dysplasia
The aim of this study is to evaluate the impact of personalized postpartum follow-up
cards on completion of postpartum health related tasks. The intervention will consist of
a card given to patients at time of discharge. One side of the card will list the
patient's name and a list of recommended postpartum... expand
The aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. Participants will be randomized to this intervention or the control group, which will consist of standard education routinely given at discharge. The primary endpoint will be the rate of completion of a postpartum blood pressure check or two hour glucose tolerance test, or both, depending on the patient's discharge diagnosis within the first year after discharge. The secondary endpoints will include establishing care with a primary care provider within the first year after delivery, or completion of postpartum pap smear or colposcopy, as indicated. Type: Interventional Start Date: May 2023 |
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Massachusetts General Hospital
Myocarditis Acute
Cancer
The primary aim is to test whether abatacept, as compared to placebo, is associated with
a reduction in major adverse cardiac events (MACE) among participants hospitalized with
myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE,
is a composite of first occurrence... expand
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Type: Interventional Start Date: Jun 2022 |
Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis
Adaptive Phage Therapeutics, Inc.
Osteomyelitis
Diabetic Foot Osteomyelitis
This is a phase IIa randomized trial designed to evaluate bacteriophage therapy in
patients with diabetic foot osteomyelitis. expand
This is a phase IIa randomized trial designed to evaluate bacteriophage therapy in patients with diabetic foot osteomyelitis. Type: Interventional Start Date: Nov 2021 |
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Vasomune Therapeutics, Inc.
Acute Respiratory Distress Syndrome
Viral or Bacterial Infections
Pneumonia
Pneumonia, Viral
Respiratory Infection
A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study
in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen
therapy. The purpose of this study is to examine the safety, tolerability and efficacy of
AV-001 Injection administration daily... expand
A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy. The purpose of this study is to examine the safety, tolerability and efficacy of AV-001 Injection administration daily to the earlier of day 28 or EOT (day prior to hospital discharge). A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) will be recruited from up to 25 participating institutions/hospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001 Injection or AV-001 placebo Injection, together with standard of care (SOC). Type: Interventional Start Date: Dec 2021 |
A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening
Georgetown University
Lung Cancer
To test the impact of a multilevel intervention on primary (provider-patient
communication, intentions, and knowledge) and secondary (screening referrals and
completion) outcomes. expand
To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes. Type: Interventional Start Date: Feb 2024 |
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 |
Consent for Use of Stored Patient Specimens for Future Testing
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infections
The purpose of this study is to obtain informed consent to use stored human biological
materials (HBM) (e.g., blood and other tissues) for future studies that may include
genetic testing. expand
The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing. Type: Observational Start Date: Feb 2002 |
Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant...
Silk Road Medical
Carotid Artery Diseases
The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent
when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard
risk for adverse events from carotid endarterectomy expand
The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy Type: Observational Start Date: Sep 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 |
K0706 for Patients Diagnosed With Dementia With Lewy Bodies
Georgetown University
Dementia With Lewy Bodies
This study evaluates the safety and tolerability of treatment with K0706 in Dementia with
Lewy Bodies (DLB).
The hypothesis is that K0706 will be safe and tolerable and that this drug will alter CSF
and plasma biomarkers in DLB. Clinical assessments of cognitive, behavioral and motor
functioning... expand
This study evaluates the safety and tolerability of treatment with K0706 in Dementia with Lewy Bodies (DLB). The hypothesis is that K0706 will be safe and tolerable and that this drug will alter CSF and plasma biomarkers in DLB. Clinical assessments of cognitive, behavioral and motor functioning will also be evaluated. A total of 45 participants will be randomized 1:1:1 into 3 groups (n=15/per group) to be treated with sachet of 192 mg powder of K0706 ( equivalent to 96 mg capsule of K0706) or sachet of 384 mg powder of K0706 (equivalent to 192 capsule of K0706) or sachet of matching placebo ( equivalent to a capsule of placebo) for 12 weeks, followed by 4-week wash-out period. Type: Interventional Start Date: Sep 2019 |
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 |
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