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.
Sponsor Condition of Interest |
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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 |
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 |
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People...
Pfizer
Advanced or Metastatic Breast Cancer
The purpose of this study is to learn about the safety and how effective the study
medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of
treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one
that is unlikely to be cured or taken care... expand
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: - are 18 years of age or older; - are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; - have advanced or metastatic breast cancer after taking other treatments before this study; - have not taken or need to take medications that are not allowed by the study protocol; - do not have any medical or mental conditions that may increase the risk of study participation. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be: - Fulvestrant alone taken as shot into the muscle. - Everolimus along with exemestane taken once daily by mouth. This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: - imaging scans (such as an MRI and/or CT) show that their cancer is getting worse. - the study doctor thinks the participant is no longer benefitting from the study medicine. - has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. - the participant chooses to stop taking part. Type: Interventional Start Date: Jan 2024 |
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 |
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 |
A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With...
Hoffmann-La Roche
Carcinoma, Hepatocellular
This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate
neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is
designed with the flexibility to open new treatment arms as new agents become available,
close existing treatment arms that... expand
This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population. 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 Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor...
Hoffmann-La Roche
Small Cell Lung Cancer
Neuroendocrine Carcinoma
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will
have 3 parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants
with advanced stage small cell lung... expand
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3 parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with advanced stage small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC) will be enrolled in the study. Type: Interventional Start Date: Jan 2023 |
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 |
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in...
Hoffmann-La Roche
Advanced Liver Cancers
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants
with advanced liver cancers. The study is designed with the flexibility to open new
treatment arms as new treatments become available, close existing treatment arms that
demonstrate minimal clinical activity... expand
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol. Type: Interventional Start Date: Nov 2020 |
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 |
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