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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Durvalumab and Tremelimumab in Combination With Chemotherapy in Virus-infected Patients With Non-small...
Georgetown University
Carcinoma, Non-Small Cell Lung
This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based
chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human
immunodeficiency virus (HIV) infection (cohort 1) or hepatitis B virus (HBV), or hepatitis C
virus (HCV)... expand
This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human immunodeficiency virus (HIV) infection (cohort 1) or hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (cohort 2) will be eligible. Patients will receive standard platinum-based chemotherapy plus durvalumab for 4 cycles (every 3 weeks), followed by durvalumab (with or without pemetrexed for non-squamous NSCLC) maintenance therapy. It is hypothesized that Durvalumab and tremelimumab in combination with standard chemotherapy is safe and effective for the treatment of stage IV NSCLC in patients with HIV, HBV, or HCV infection. Type: Interventional Start Date: Dec 2020 |
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
VA Office of Research and Development
Lung Neoplasm
Patients with stage I non-small cell lung cancer have been historically treated with surgery
whenever they are fit for an operation. However, an alternative treatment known as
stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors
believe... expand
Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other. Type: Interventional Start Date: Apr 2017 |
PICO- Single-use Negative Pressure Wound Therapy System
Walter C Hembree
Total Ankle Arthroplasty
To compare the rate of wound complications with the PICO dressing versus a standard nonstick
gauze dressing in patients undergoing anterior total ankle arthroplasty.
expand
To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty. Type: Interventional Start Date: Aug 2021 |
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
National Cancer Institute (NCI)
Stage III Cutaneous Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
This phase II/III trial studies the side effects of nivolumab and ipilimumab when given
together with or without sargramostim and to see how well they work in treating patients with
stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have
spread... expand
This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma. Type: Interventional Start Date: Nov 2015 |
Local Anesthesia Before Bulkamid Injection
Medstar Health Research Institute
Stress Urinary Incontinence
Intrinsic Sphincter Deficiency
While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for
stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral
anesthetic gel with or without periurethral block, there is no existing literature to guide... expand
While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection. Type: Interventional Start Date: Sep 2023 |
AltaValve Early Feasibility Study Protocol
4C Medical Technologies, Inc.
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve Incompetence
Mitral Valve Regurgitation
Mitral Incompetence
Prospective, single-arm, multicenter study to evaluate the safety and performance of the
AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in
subjects who are considered high risk for mortality and morbidity from conventional
open-heart... expand
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery. Type: Interventional Start Date: Dec 2019 |
Vaginal Injection of Platelet Rich Plasma for Sexual Function
Medstar Health Research Institute
Sexual Behavior
Sexual Activity
The goal of this clinical trial is to learn about an injection of platelet rich plasma into
the vaginal wall and around the clitoris. The main questions it aims to answer are:
- To see if a PRP injection improves sexual satisfaction
- To learn the effect of PRP injections... expand
The goal of this clinical trial is to learn about an injection of platelet rich plasma into the vaginal wall and around the clitoris. The main questions it aims to answer are: - To see if a PRP injection improves sexual satisfaction - To learn the effect of PRP injections on sexual function Participants will get assigned to getting a one time PRP injection or a placebo injection. They will answer questionnaires about their sexual function at their first visit and their followup visit. The investigators will then compare the two groups. Type: Interventional Start Date: Aug 2023 |
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and...
Theratechnologies
HIV Infections
Multi-Antiviral Resistance
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical
trials. This study will expand ibalizumab's clinical data set and allow a better
understanding of the virologic response durability on ARV regimens with or without ibalizumab
in a heterogeneous... expand
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end. Primary Objective: To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab. Secondary Objective: To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment. To assess the long-term safety and tolerability of ibalizumab. Other Objectives: To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll. Type: Observational Start Date: Mar 2022 |
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
ULURU Inc.
Diabetic Foot Ulcer
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming
powder dressing to standard of care dressing for healing diabetic foot ulcers.
expand
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers. Type: Interventional Start Date: Aug 2021 |
CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted...
ECOG-ACRIN Cancer Research Group
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Invasive Breast Carcinoma
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating
further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer
who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after... expand
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, 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. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment. Type: Interventional Start Date: Mar 2020 |
Comparing Two Methods to Follow Patients With Pancreatic Cysts
ECOG-ACRIN Cancer Research Group
Pancreatic Carcinoma
The purpose of this study is to compare the two approaches for monitoring pancreatic cysts.
The study doctors want to compare more frequent monitoring vs less frequent monitoring in
order to learn which monitoring method leads to better outcome for patients with pancreatic... expand
The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts. Type: Interventional Start Date: Jun 2020 |
Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes
VA Office of Research and Development
Diabetes Mellitus, Type 2
Hypoglycemia
More than 25% of the patients admitted in the general wards have a history of Diabetes
Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose
values); a condition that is associated with seizures, cardiac arrhythmias, and even death.
In Veterans,... expand
More than 25% of the patients admitted in the general wards have a history of Diabetes Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In Veterans, the prevalence is disproportionally higher. It is estimated that 40-50% of hospitalized Veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System (GTS), with which glucose values can be wirelessly transmitted from the patient's bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes. Type: Interventional Start Date: Jul 2018 |
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by...
ECOG-ACRIN Cancer Research Group
ALK Gene Rearrangement
ALK Gene Translocation
ALK Positive
Stage IB Non-Small Cell Lung Carcinoma AJCC v7
Stage II Non-Small Cell Lung Cancer AJCC v7
This randomized phase III trial studies how well crizotinib works in treating patients with
stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation
in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make... expand
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation. Type: Interventional Start Date: Mar 2015 |
A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK 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-655, determine the recommended phase 2 dose (RP2D), and evaluate the
antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid
tumors.... expand
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 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-655 in patients with advanced ALK-positive NSCLC and other solid tumors. Type: Interventional Start Date: Jun 2022 |
A Pragmatic Trial to Determine the Benefit of Behaviorally Enhanced Exercise Incentives and Corticosteroid...
VA Office of Research and Development
Osteoarthritis of the Knee
Knee osteoarthritis (KOA) is one of the most common and disabling conditions among Veterans.
Management of KOA is challenging as there are few effective treatments other than joint
replacement. Importantly, low levels of physical activity in patients with knee problems
might... expand
Knee osteoarthritis (KOA) is one of the most common and disabling conditions among Veterans. Management of KOA is challenging as there are few effective treatments other than joint replacement. Importantly, low levels of physical activity in patients with knee problems might worsen pain and disability. This study aims to determine the feasibility of using methods to change behavior that use social incentives and promote physical activity through playing games and interacting with a web-based platform. The study will also evaluate an important and widely used treatment, namely corticosteroid injections. Participants will be randomized into one of 4 arms and will receive a different combination of social incentives and injections. The study will evaluate which approach is most effective at promoting physical activity and reducing pain and disability. Type: Interventional Start Date: Mar 2022 |
Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
Children's Oncology Group
Acute Lymphoblastic Leukemia
Brain Neoplasm
Hematopoietic Cell Transplantation Recipient
Hodgkin Lymphoma
Osteosarcoma
This clinical trial keeps track of and collects follow-up information from patients who are
currently enrolled on or have participated in a Children's Oncology Group study. Developing a
way to keep track of patients who have participated in Children's Oncology Group studies may... expand
This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life. Type: Observational Start Date: May 2008 |
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
AtriCure, Inc.
Ischemic Stroke
Systemic Embolism
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority
trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage
exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in
subjects... expand
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke. Type: Interventional Start Date: Jan 2023 |
Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)
Virginia Commonwealth University
Breast Cancer
The purpose of this study is to test an evidence-based intervention designed to increase
adherence to systemic therapy in Black women compared to enhanced usual care.
expand
The purpose of this study is to test an evidence-based intervention designed to increase adherence to systemic therapy in Black women compared to enhanced usual care. Type: Interventional Start Date: Mar 2021 |
Older Breast Cancer Patients: Risk for Cognitive Decline
Georgetown University
Cancer, Breast
Age-related Cognitive Decline
Cognitive Decline
The goal of this study is to evaluate the impact of systemic therapy on cognition in older
breast cancer patients, explore change in APE, LM and Cognition domains, measure associations
between cognitive decline and QOL, and describe how genetic polymorphisms, inflammatory... expand
The goal of this study is to evaluate the impact of systemic therapy on cognition in older breast cancer patients, explore change in APE, LM and Cognition domains, measure associations between cognitive decline and QOL, and describe how genetic polymorphisms, inflammatory biomarkers, sleep and physical measures moderate cognitive outcomes. This study is being done nationally, with recruiting sites at Georgetown University, Montgomery General Hospital, Virginia Cancer Specialists, Washington Hospital Center, Reston Breast Care Specialists, Memorial Sloan-Kettering, Moffitt Cancer Center, City of Hope National Medical Center, Hackensack University Medical Center, Indiana University and University of California, Los Angeles. Type: Observational Start Date: Aug 2010 |
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
QuantumLeap Healthcare Collaborative
Breast Neoplasms
Breast Cancer
Breast Tumors
Angiosarcoma
TNBC - Triple-Negative Breast Cancer
The purpose of this study is to further advance the ability to practice personalized medicine
by learning which new drug agents are most effective with which types of breast cancer tumors
and by learning more about which early indicators of response (tumor analysis prior to... expand
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success. Type: Interventional Start Date: Mar 2010 |
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
University of Florida
Coronary Artery Disease
The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with
Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive
CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation
(PROBE design)... expand
The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) evaluating intensive statin/ACE-I (or ARB)/aspirin treatment (IMT) vs. usual care (UC) in 4,422 symptomatic women patients with symptoms and/or signs of ischemia but no obstructive CAD. The hypothesis is that IMT will reduce major adverse coronary events (MACE) 20% vs. UC. The primary outcome is first occurrence of MACE as death, nonfatal MI, nonfatal stroke/transient ischemic attack (TIA) or hospitalization for heart failure or angina. Secondary outcomes include quality of life, time to "return to duty"/work, health resource consumption, angina, cardiovascular (CV) death and primary outcome components. Events will be adjudicated by an experienced Clinical Events Committee (CEC). Follow-up will be 3-years using 50 sites: primarily VA and Active Duty Military Hospitals/Clinics and a National Patient-Centered Clinical Research Network (PCORnet) clinical data research network (CDRN)(OneFlorida Consortium). This study is being conducted to determine whether intensive medication treatment to modify risk factors and vascular function in women patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms (i.e., chest pain, shortness of breath) will reduce the patient's likelihood of dying, having a heart attack, stroke/TIA or being hospitalized for cardiac reasons. The results will provide evidence data necessary to inform future guidelines regarding how best to treat this growing population of patients, and ultimately improve the patient's cardiac health and quality of life and reduce health-care costs. Type: Interventional Start Date: Feb 2018 |
CO2 Laser Revision for Burn Related Donor Site Scars
Medstar Health Research Institute
Burn Scar
Scar
Skin Graft Scar
Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn
wounds may be left to heal by secondary intention or treated with surgical skin grafting; in
both circumstances, significant scars likely result. When surgical skin grafting is employed,... expand
Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR). Type: Interventional Start Date: Jan 2020 |
Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr...
Atara Biotherapeutics
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
Solid Organ Transplant Complications
Lymphoproliferative Disorders
Allogeneic Hematopoietic Cell Transplant
Stem Cell Transplant Complications
The purpose of this study is to determine the clinical benefit and characterize the safety
profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant
lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT)... expand
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab. Type: Interventional Start Date: Dec 2017 |
Cerebrovascular Reactivity and Oxygen Metabolism as Markers of Neurodegeneration After Traumatic Brain...
Washington D.C. Veterans Affairs Medical Center
Neurodegenerative Diseases
This grant award entitled, "Cerebrovascular Reactivity and Oxygen Metabolism as Markers for
Neurodegeneration after Traumatic Brain Injury" (hereafter, "Neurovascular Study"), aims to
determine if neurovascular contributors to neurodegeneration can serve as markers of the... expand
This grant award entitled, "Cerebrovascular Reactivity and Oxygen Metabolism as Markers for Neurodegeneration after Traumatic Brain Injury" (hereafter, "Neurovascular Study"), aims to determine if neurovascular contributors to neurodegeneration can serve as markers of the emergence or progression of degenerative processes after traumatic brain injury in middle-aged and older adults. Type: Observational Start Date: Oct 2021 |
Pediatric Boot Camp Program
Georgetown University
Type 1 Diabetes
Children, Only
An intensive 13 weeks program that aims to improve glucose control in children with type 1
diabetes.
expand
An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes. Type: Interventional Start Date: Nov 2020 |
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