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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Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
NRG Oncology
Breast Cancer
Cognitive Impairments
This Phase III trial will examine the efficacy of computerized cognitive training methods
on perceived cognitive impairment in breast cancer survivors. expand
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors. Type: Interventional Start Date: Apr 2024 |
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack-...
Janssen Research & Development, LLC
Ischemic Stroke; Ischemic Attack, Transient
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke. expand
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke. Type: Interventional Start Date: Feb 2023 |
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease...
University of Minnesota
COVID-19
Treatments are needed to improve outcomes among patients hospitalized for COVID-19,
including direct-acting antiviral (DAA) agents to mitigate the pathology driven by
ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an
anti-SARS-CoV2 3C-like protease inhibitor (PI) developed... expand
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization. Type: Interventional Start Date: Dec 2022 |
RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms
Kanecia Obie Zimmerman
Long COVID
Long Covid19
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, double-blind, randomized, controlled platform trial with different interventions organized as appendices to the protocol. Each appendix (or sub-study) evaluates potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection, viral reactivation, and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms. Type: Interventional Start Date: Jul 2023 |
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and...
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC)
in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in
combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination
with pomalidomide and dexamethasone... expand
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). Type: Interventional Start Date: Oct 2022 |
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed...
Merck Sharp & Dohme LLC
Carcinoma, Non-Small-Cell Lung
Researchers are looking for new ways to treat people with locally advanced non-small cell
lung cancer (NSCLC). The goal of this study is to learn if people who receive the
combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer
getting worse and live longer overall... expand
Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab. Type: Interventional Start Date: May 2022 |
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic...
Edwards Lifesciences
Aortic Valve Insufficiency
Aortic Valve Stenosis
The objective of this study is to establish the safety and effectiveness of the Edwards
SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk
with a failing aortic bioprosthetic valve. expand
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve. Type: Interventional Start Date: Nov 2023 |
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
Takeda
Coagulation Disorder
The aim of this study is to find out the effects of TAK-330 compared with four-factor
prothrombin complex concentrate (4F-PCC) as part of standard treatment other than
Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa
inhibitors who require urgent surgery/invasive... expand
The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasive procedure. The participant will be assigned by chance to either TAK-330 or SOC 4F-PCC as part of standard treatment before surgery. Patients participating in this study will need to be hospitalized. They will also be contacted (via telehealth/phone call) 30 days after the surgery. Type: Interventional Start Date: Aug 2022 |
SELUTION4SFA Trial
MedAlliance, LLC
Peripheral Arterial Disease
Superficial Femoral Artery Stenosis
This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB
compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial
disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery
(PPA). expand
This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Type: Interventional Start Date: Dec 2022 |
A Study of NDI 1150-101 in Patients With Solid Tumors
Nimbus Saturn, Inc.
Solid Tumor
This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2
dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and
preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with
pembrolizumab in adult patients with... expand
This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adult patients with advanced solid tumors. Type: Interventional Start Date: Nov 2021 |
TheraSphere With Durvalumab and Tremelimumab for HCC
Boston Scientific Corporation
Hepatocellular Carcinoma
The objective of the ROWAN clinical study is to assess the efficacy of local tumor
control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab. expand
The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab. Type: Interventional Start Date: Nov 2023 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
Prothena Biosciences Ltd.
Light Chain (AL) Amyloidosis
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care
compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis. expand
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis. Type: Interventional Start Date: Aug 2021 |
Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
Alliance for Clinical Trials in Oncology
Advanced Malignant Solid Neoplasm
Anorexia
Hematopoietic and Lymphoid Cell Neoplasm
This phase III trial compares the effects of olanzapine versus megestrol acetate in
treating loss of appetite in patients with cancer that has spread to other places in the
body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find
out if olanzapine is better than the... expand
This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss. Type: Interventional Start Date: Jan 2022 |
A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.
Ipsen
Upper Limb Spasticity
This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A)
versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority
of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary
efficacy endpoint when used at optimal... expand
This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product. Type: Interventional Start Date: Jun 2021 |
Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
Octapharma
Congenital Antithrombin Deficiency
Assess the incidence of the composite of thrombotic events (TEs) and thromboembolic
events (TEEs) in patients with congenital antithrombin deficiency under cover of Atenativ
for surgical procedures or parturition. expand
Assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition. Type: Interventional Start Date: Jul 2022 |
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms...
Biogen
Lupus Erythematosus, Systemic
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus
on participants who have active disease and are already taking standard of care
medications. These may include antimalarials, steroids,... expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks. Type: Interventional Start Date: May 2021 |
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular...
Abiomed Inc.
Left Ventricular Dysfunction
Coronary Artery Disease
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device
during high-risk PCI in patients with reduced left-sided heart function will result in an
improvement in symptoms, heart function and health after a heart procedure compared to
the current standard of care. expand
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care. Type: Interventional Start Date: Apr 2021 |
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Wake Forest University Health Sciences
Colorectal Cancer
Sarcopenia
This study will examine the association between low muscle mass (myopenia) at diagnosis
and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal
cancer. expand
This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer. Type: Observational Start Date: Sep 2019 |
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Yale University
Intracerebral Hemorrhage
Atrial Fibrillation
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the
composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in
patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in... expand
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. Type: Interventional Start Date: Jan 2020 |
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently...
Merck Sharp & Dohme LLC
Solid Tumors
Hematologic Malignancies
The purpose of this study is to evaluate the long-term safety and efficacy of
pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent
studies who transition into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up
Phase... expand
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. Type: Interventional Start Date: Aug 2018 |
Focused Ultrasound for the Complex Patient
Washington D.C. Veterans Affairs Medical Center
Opioid Use Disorder
Chronic Back Pain
Anxiety
The goal of this clinical trial is to to inhibit the anterior insula (AI) with low
intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain
processing, anxiety, and opiate cue-induced craving. The main question[s] it aims to
answer are:
- the safety and tolerability... expand
The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question[s] it aims to answer are: - the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain - the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham. Type: Interventional Start Date: Jan 2024 |
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive...
Sanofi
Multiple Sclerosis
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is
to determine the efficacy of frexalimab in delaying the disability progression and the
safety up to approximately 51 months administration of study intervention compared to
placebo in male and female participants... expand
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 ranging from approximately 27 to 51 months. - The study intervention duration will vary ranging from approximately 12 to 51 months. - The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
A Phase 2 Study of VLX-1005 Versus Placebo in Suspected Heparin Induced Thrombocytopenia
Veralox Therapeutics
Thrombocytopenia, Immune
Heparin Induced Thrombocytopenia
The purpose of this study is to evaluate the efficacy and safety of VLX-1005, a
12-lipoxygenase (12-LOX) enzyme inhibitor in treating heparin induced thrombocytopenia
(HIT). Participants with suspected HIT will receive the usual standard of care, and will
be assigned randomly to either VLX-1005 or... expand
The purpose of this study is to evaluate the efficacy and safety of VLX-1005, a 12-lipoxygenase (12-LOX) enzyme inhibitor in treating heparin induced thrombocytopenia (HIT). Participants with suspected HIT will receive the usual standard of care, and will be assigned randomly to either VLX-1005 or placebo treatment. The study will measure important outcomes including platelet count, stroke, pulmonary embolus (clot to the lungs) and bleeding. Type: Interventional Start Date: Sep 2023 |
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 undergoing cardiac... 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 |
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