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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POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
Medstar Health Research Institute
Pelvic Organ Prolapse
Prolapse
This multi-centered, randomized controlled trial will evaluate the safety and efficacy of
home use of the novel Reia System (RS), which includes the Reia pessary and applicator,
compared to standard pessary care (Gellhorn or ring with/without support without knob)
among women with stage II-IV pelvic... expand
This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 182 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be the number of successful self-managed pessary removal events completed over the six-month time frame. Secondary outcomes will include validated surveys to assess quality of life, adverse events and satisfaction with treatment. Specific Aims Aim 1: To compare number of self-management events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 2: To assess successful fitting, number of refitting visits, and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 3: To compare satisfaction with treatment and quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Type: Interventional Start Date: Oct 2024 |
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events...
Eli Lilly and Company
Atherosclerotic Cardiovascular Disease (ASCVD)
Elevated Lp(a)
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing
cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular
disease or are at risk of a heart attack or stroke. The study drug will be administered
subcutaneously (SC) (under the skin). expand
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin). Type: Interventional Start Date: Mar 2024 |
CLEANer Aspiration for Pulmonary Embolism
Argon Medical Devices
Pulmonary Embolism
Acute Pulmonary Embolism
Cardiovascular Diseases
Venous Thromboembolism
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for
aspiration thrombectomy in patients with acute pulmonary embolism (PE). expand
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE). Type: Interventional Start Date: Oct 2024 |
Obsidio™ Conformable Embolic Registry
Boston Scientific Corporation
Hypervascular Tumors
Bleeding
Hemorrhage
OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry
of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of
this Registry is to assess effectiveness and safety outcomes of subjects who undergo
embolization with Obsidio. expand
OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio. Type: Observational [Patient Registry] Start Date: Jun 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 |
Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
Merck Sharp & Dohme LLC
Endometrial Cancer
Researchers are looking for new ways to treat people with endometrial cancer (EC) who
have previously received treatment with platinum based therapy (a type of chemotherapy)
and immunotherapy. Immunotherapy is a treatment that helps the immune system fight
cancer. This clinical study will compare... expand
Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare MK-2870 sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive MK-2870 sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy. Type: Interventional Start Date: Dec 2023 |
MAGNITUDE: a Phase 3 Study of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy...
Intellia Therapeutics
Transthyretin Amyloidosis (ATTR) with Cardiomyopathy
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in
participants with ATTR-CM. expand
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM. Type: Interventional Start Date: Dec 2023 |
Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)
Shockwave Medical, Inc.
Coronary Artery Disease
Myocardial Infarction
This investigational device exemption (IDE) study is to assess the safety and
effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the
Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary
lesions prior to stenting. expand
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting. Type: Interventional Start Date: Dec 2023 |
SELUTION 4 De Novo Small Vessel IDE Trial
M.A. Med Alliance S.A.
Coronary Artery Disease
Prospective, randomized controlled, single-blind, multicenter, clinical trial to
demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de
novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of
2.00 mm to 2.75 mm, in support of a pre-market... expand
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US. Type: Interventional Start Date: Oct 2023 |
A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term...
Bayer
Chronic Kidney Disease
Type 1 Diabetes Mellitus
Researchers are looking for a better way to treat people with chronic kidney disease
(CKD), a progressive decrease in the kidneys' ability to work properly, and type 1
diabetes.
In people with type 1 diabetes, the body does not make enough of a hormone called
insulin, resulting in high blood sugar... expand
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes. The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes. In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured. Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with: - medical problems (also called treatment-emergent adverse events (TEAEs)) - serious TEAEs. An TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important - higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines. The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times. The study team will: - collect blood and urine samples - check the participants' vital signs such as blood pressure and heart rate - do a physical examination including height and weight - check the participants' heart health by using an electrocardiogram (ECG) - do pregnancy tests in women of childbearing potential Type: Interventional Start Date: Feb 2024 |
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 |
Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease
Afimmune
Sickle Cell Disease
To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in
adult SCD patients who are aged ≥18 years. expand
To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in adult SCD patients who are aged ≥18 years. Type: Interventional Start Date: Jan 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 |
Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
Massachusetts General Hospital
Thyroid Cancer
Thyroid Carcinoma
Metastatic Thyroid Cancer
Follicular Thyroid Cancer
Unresectable Thyroid Gland Carcinoma
This research is being done to determine the efficacy of selpercatinib to restore
radioactive iodine (I-131 NaI) uptake and allow for I-131 treatment in people with RET
fusion-positive radioiodine-refractory thyroid cancer.
This research study involves the study drug selpercatinib in combination... expand
This research is being done to determine the efficacy of selpercatinib to restore radioactive iodine (I-131 NaI) uptake and allow for I-131 treatment in people with RET fusion-positive radioiodine-refractory thyroid cancer. This research study involves the study drug selpercatinib in combination with standard of care treatments, I-131 and thyrotropin alfa (rhTSH). Type: Interventional Start Date: Mar 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 |
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 |
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 Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
SynOx Therapeutics Limited
TGCT
This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which
aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the
treatment of patients with localized or diffuse TGCT where surgical removal of the tumor
is not viewed as an option.
The... expand
This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the treatment of patients with localized or diffuse TGCT where surgical removal of the tumor is not viewed as an option. The study consists of two parts. In Part 1, eligible subjects will be assigned in a 2:1 ratio to receive either emactuzumab or matching placebo in a double-blind fashion, that will be administered in total 5 times as an intravenous (i.v.) infusion once every 2 weeks. This will be followed by an observation period of 3 months leading to a total duration of 24 weeks in Part 1. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. Part 2 is a long-term double-blind follow-up phase of the subjects on emactuzumab or placebo. Subjects assigned to placebo in Part 1 have the option, subject to eligibility, to crossover to receive open-label emactuzumab in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances. Type: Interventional Start Date: Apr 2024 |
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 real-world patient... 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 |
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 |
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
NRG Oncology
Stage III Colon Cancer
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to
patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery
for colon cancer. expand
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Type: Interventional Start Date: Mar 2022 |
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 |
Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
University of Washington
Endometrial Cancer
The SISTER study is a randomized trial, looking at various modalities of social support
for Black patients undergoing treatment for endometrial cancer. There are three study
arms: group support, 1:1 peer support, and enhanced usual care. The primary outcome is
treatment completion, and the secondary... expand
The SISTER study is a randomized trial, looking at various modalities of social support for Black patients undergoing treatment for endometrial cancer. There are three study arms: group support, 1:1 peer support, and enhanced usual care. The primary outcome is treatment completion, and the secondary outcome is social isolation. Type: Interventional Start Date: Sep 2021 |
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