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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Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Biohaven Therapeutics Ltd.
Focal Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of
refractory focal epilepsy.
expand
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. Type: Interventional Start Date: May 2024 |
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Puma Biotechnology, Inc.
Small Cell Lung Cancer
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with
pathologically-confirmed small cell lung cancer (SCLC) following progression on or after
treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one
additional... expand
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib. Type: Interventional Start Date: Feb 2024 |
An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin,...
Hoffmann-La Roche
Large B-Cell Lymphoma
The purpose of this study is to compare the efficacy and safety of glofitamab in combination
with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone
(Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large
B-cell... expand
The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL). Type: Interventional Start Date: Sep 2023 |
A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body...
AbbVie
Human Immuno-deficiency Virus (HIV) Disease
Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency
Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong
therapy. The purpose of this study is to assess change in disease activity, adverse events,
tolerability,... expand
Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body. Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. Participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness). Approximately 140 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide. Participants will receive 4 doses of IV budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 52 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 52 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Oct 2023 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic...
Bristol-Myers Squibb
Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278
in participants with Idiopathic Pulmonary Fibrosis.
expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Sep 2023 |
Nectero EAST System Clinical Study
Nectero Medical, Inc.
Abdominal Aortic Aneurysm
The purpose of this randomized clinical trial is to treat patients with small to mid-sized
abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally
delivered, single-dose endovascular treatment. The main question the study aims to answer is
to... expand
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years. Type: Interventional Start Date: Oct 2023 |
A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy
argenx
Multifocal Motor Neuropathy
This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy
over time and collect data on their clinical outcomes, quality of life, and use of health
care resources. Participants will follow their regular visit schedule with their treating... expand
This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy over time and collect data on their clinical outcomes, quality of life, and use of health care resources. Participants will follow their regular visit schedule with their treating physician, except for an optional second visit occurring 7 to 14 days after the start of the study to collect biomarker data. No IMP will be administered. Type: Observational Start Date: Nov 2023 |
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in...
Hoffmann-La Roche
Metastatic Breast Cancer
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo
(pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo
in combination with Phesgo, as maintenance therapy, after induction therapy in participants... expand
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC). Type: Interventional Start Date: Jul 2023 |
Proglumide and Chemotherapy for Metastatic Pancreatic Cancer
Georgetown University
Metastatic Pancreatic Cancer
This is a Phase 2 study with an open labelled lead-in study to approximately treat 30
patients [6 subjects for Lead-in and 24 for Phase 2] enrolled with metastatic pancreatic
cancer with combination therapy using standard of care first line therapy with GEM-NAB-P (GEM
1000mg/m2... expand
This is a Phase 2 study with an open labelled lead-in study to approximately treat 30 patients [6 subjects for Lead-in and 24 for Phase 2] enrolled with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with GEM-NAB-P (GEM 1000mg/m2 IV and NAB-P 125 mg/m2 given days 1, 8, and 15 every 28 days, and proglumide will be tested at the daily dose of 1200 mg orally given as 400 mg po TID. The lead-in study will determine the safety and tolerability of the 1200 mg daily dose of proglumide with standard of care GEM-NAB-P. If 0 or 1 of a total of 6 patients at 400mg experiences a DLT, then we will proceed to the Phase 2 randomized trial. Type: Interventional Start Date: Jan 2024 |
Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Synedgen, Inc.
Wound Heal
The purpose of this interventional study is to compare SynEx Wound Cleanser with the current
routine care (Saline) in traumatic wounds. Participants with gunshot, penetrating or burn
wounds who participate will be asked to attend up to four study visits, use the assigned
wound... expand
The purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds. Participants with gunshot, penetrating or burn wounds who participate will be asked to attend up to four study visits, use the assigned wound cleanser and complete brief surveys about their healing and well-being related to the wound healing. Type: Interventional Start Date: Apr 2023 |
STOP-HER2: Stopping Trastuzumab in HER2+ MBC
Dana-Farber Cancer Institute
Breast Cancer
Metastatic Breast Cancer
HER2-positive Breast Cancer
This study is being done to see if anti-HER2 treatment be safely stopped in patients with
HER2-positive metastatic breast cancer (MBC) that have had exceptional response to treatment.
Exceptional response" is considered as cancer progression being controlled for three years or... expand
This study is being done to see if anti-HER2 treatment be safely stopped in patients with HER2-positive metastatic breast cancer (MBC) that have had exceptional response to treatment. Exceptional response" is considered as cancer progression being controlled for three years or more since starting anti-HER2 treatment. Type: Interventional Start Date: Apr 2023 |
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Inari Medical
Venous Thromboembolism
Deep Venous Thrombosis
Post-Thrombotic Syndrome
This study is a prospective, multicenter, randomized controlled trial of an interventional
strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever
Intervention Arm) versus conservative medical management using anticoagulation therapy alone... expand
This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit. Type: Interventional Start Date: Jan 2023 |
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants...
Theravance Biopharma
Symptomatic Neurogenic Orthostatic Hypotension
MSA - Multiple System Atrophy
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and
durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of
treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and... expand
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE). Type: Interventional Start Date: Jun 2023 |
Life's End Benefits of Cannabidiol and Tetrahydrocannabinol
University of Southern California
Agitation
Dementia
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral
combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12
weeks. This study is designed to test the hypothesis that treatment with an oral combination... expand
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 24 week optional open-label extension will be offered to participants who complete the double-period. Type: Interventional Start Date: Dec 2023 |
Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body...
AbbVie
Advanced Solid Tumors
Cancer is a condition where cells in a specific part of body grow and reproduce
uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics
and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab,
carboplatin,... expand
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans. Type: Interventional Start Date: Dec 2022 |
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Chimerix
H3 K27M
Glioma
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase
3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether
treatment with ONC201 following frontline radiotherapy will extend overall survival and
progression-free... expand
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy. Type: Interventional Start Date: Jan 2023 |
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
Cognition Therapeutics
Early Alzheimer's Disease
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to
evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in
participants diagnosed with early Alzheimer's disease.
expand
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease. Type: Interventional Start Date: Jun 2023 |
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled...
Medtronic Vascular
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus
The purpose of this single-arm interventional study is to evaluate the long-term safety,
efficacy, and durability of the Symplicity Spyral system in subjects treated with renal
denervation.
Additionally, long-term follow-up data will also be collected from eligible subjects... expand
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies. Type: Interventional Start Date: Oct 2021 |
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Occlutech International AB
Stroke
Patent Foramen Ovale
The objective of this study is to investigate whether percutaneous PFO closure with the
Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore®
Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and
device/procedure... expand
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE). Type: Interventional Start Date: Apr 2022 |
SELUTION4BTK Trial
MedAlliance, LLC
Peripheral Arterial Disease
Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™
DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral
arterial disease (PAD) in the BTK arteries in CLTI patients.
expand
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients. Type: Interventional Start Date: May 2022 |
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Ono Pharmaceutical Co. Ltd
Refractory Primary Central Nervous System Lymphoma
Primary CNS Lymphoma
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib
monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in
combination with one of two different high dose methotrexate based regimens (methotrexate/
temozolomide/rituximab... expand
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B) Type: Interventional Start Date: Dec 2021 |
A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid...
Boehringer Ingelheim
Neoplasm Metastasis
Non-Small Cell Lung Cancer
The study has 2 parts. The first part is open to adults with different types of advanced
cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not
successful.
The second part is open to people with non-small cell lung cancer with a specific... expand
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib. Type: Interventional Start Date: Jun 2021 |
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score...
NRG Oncology
Stage I Breast Cancer
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy
results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor
recurrence (IBTR) compared to breast conservation with breast radiation and endocrine
therapy.... expand
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Type: Interventional Start Date: Jun 2021 |
A Peer-Led Intervention to Improve Postpartum Retention in HIV Care
University of Pennsylvania
HIV/AIDS
The purpose of this study is to test the efficacy of a theory-driven peer intervention for
pregnant and postpartum women living HIV. The peer intervention is designed to increase
self-efficacy, social support, self-regulatory behaviors, and outcome expectancy in order to
improve... expand
The purpose of this study is to test the efficacy of a theory-driven peer intervention for pregnant and postpartum women living HIV. The peer intervention is designed to increase self-efficacy, social support, self-regulatory behaviors, and outcome expectancy in order to improve retention in care and viral suppression postpartum. The intervention will consist of face-to-face prenatal educational sessions, starting in early third trimester, and postpartum sessions scheduled up to three months postpartum. Type: Interventional Start Date: Mar 2020 |
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple...
Hoffmann-La Roche
Multiple Sclerosis, Primary Progressive
This study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with
placebo in participants with primary progressive multiple sclerosis (PPMS), including
participants later in their disease course. This study focuses on upper limit disability
progression.... expand
This study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM). Type: Interventional Start Date: Aug 2019 |
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