Search Clinical Trials
Below please find a list of studies actively recruiting volunteers at one of the following GHUCCTS institutions: Georgetown University, Howard University, MedStar Health Research Institute, or Washington DC VA Medical Center. Please enter your search criteria below to help find a study for you. If you have any questions, please email us or call us at 301-560-2963.
Sponsor Condition of Interest |
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Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention
VA Office of Research and Development
Asymptomatic Carotid Stenosis (50-69%)
Mobility Impairment
Moderate (50-69%) asymptomatic carotid artery stenosis (ACAS) is an important and
under-appreciated contributor to balance and mobility dysfunction. This is significant
because declines in balance and mobility are a significant predictor of falls,
disability, loss of independence, and death in older... expand
Moderate (50-69%) asymptomatic carotid artery stenosis (ACAS) is an important and under-appreciated contributor to balance and mobility dysfunction. This is significant because declines in balance and mobility are a significant predictor of falls, disability, loss of independence, and death in older adults. Further, falls and fall-related injuries in older adults cost approximately 50 billion dollars annually in the United States, and are the leading cause of adverse events reported by the Veterans Health Administration. This proposal seeks to: 1) investigate the impact of a supervised aerobic and challenging balance exercise program on balance and mobility function in patients with moderate ACAS; and 2) elucidate whether these changes are related to changes in cerebral perfusion. With 830,000 Veterans estimated to have moderate ACAS and at risk for balance and mobility dysfunction and increased falls, the findings from this study could have significant impacts on the clinical management, quality of life, and functional independence of Veterans with moderate ACAS. Type: Interventional Start Date: Oct 2022 |
A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy...
Biogen
Spinal Muscular Atrophy
The primary objective of this study is to evaluate motor function following treatment
with HD nusinersen in participants with spinal muscular atrophy (SMA) previously treated
with risdiplam.
The secondary objective of this study is to evaluate the safety and tolerability of HD
nusinersen in participants... expand
The primary objective of this study is to evaluate motor function following treatment with HD nusinersen in participants with spinal muscular atrophy (SMA) previously treated with risdiplam. The secondary objective of this study is to evaluate the safety and tolerability of HD nusinersen in participants with SMA previously treated with risdiplam. Type: Interventional Start Date: Jan 2022 |
PositiveLinks: mHealth for DC Cohort
George Washington University
HIV/AIDS
To achieve the end of the HIV epidemic, concerted efforts will be needed to address the
HIV care continuum, including improving retention in care (RIC) and viral suppression
(VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even
fewer are VS. Studies have shown that... expand
To achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care (RIC) and viral suppression (VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even fewer are VS. Studies have shown that these PWH have poorer clinical outcomes and are at risk of transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at-risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self-monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study in poorly retained PWH found that PL increased RIC and VS, with app use related to benefit as well as improved social support and stigma. PL is a promising existing mHealth tool for PWH, yet its efficacy has not been tested in a randomized trial, nor in urban populations. The investigators will test the efficacy of PositiveLinks to improve RIC and VS among a cohort of PWH in a high HIV prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal prospective cohort of PWH receiving HIV care at 15 clinics in DC. First, the investigators will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this urban cohort and conduct subsequent adaptations based on these findings. The investigators will then conduct an efficacy study through a cluster randomized controlled trial at 12 DC Cohort sites among 482 PWH. Clinics will be randomized to PL or usual care. Primary outcomes will include VS, RIC, and visit constancy at 12 months. Finally, the investigators will conduct mixed methods implementation science research guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that characterize best practices in program implementation. If successful, this research will lead to the development of a novel and efficacious approach to improving RIC and VS among PWH which could lead to dissemination research that will contribute to HIV epidemic control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve sustained viral suppression in a geographic hotspot for HIV. Type: Interventional Start Date: Dec 2022 |
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
Skingenix, Inc.
Burns
To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to
healing" (≥95% re-epithelialization) of a partial thickness target thermal burn. expand
To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn. Type: Interventional Start Date: Mar 2022 |
Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials
University of Cincinnati
Stroke
Stroke, Acute
Stroke, Ischemic
Stroke Hemorrhagic
VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute
ischemic stroke window for immediate use in clinical trials, and explore these biomarkers
in acute intracerebral hemorrhage. VERIFY will create the first multicenter, large-scale,
prospective dataset of clinical, transmagnetic... expand
VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, transmagnetic stimulation (TMS), and MRI measures in the acute stroke time window. Type: Observational Start Date: Jun 2022 |
Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide...
NRG Oncology
Glioblastoma
Gliosarcoma
This phase III trial compares the effect of adding lomustine to temozolomide and
radiation therapy versus temozolomide and radiation therapy alone in shrinking or
stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as
lomustine and temozolomide, work in different ways... expand
This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, 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. Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma. Type: Interventional Start Date: Nov 2021 |
PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
VA Office of Research and Development
Stress Disorders, Post-Traumatic; Mental Disorders
PTSD is common among Veterans with serious mental illness (SMI). Co-occurring PTSD and
SMI lead to poorer mental health and physical functioning than either diagnosis alone.
Despite known high prevalence rates of PTSD in SMI populations as well as disparities in
prevalence and treatment use for Black,... expand
PTSD is common among Veterans with serious mental illness (SMI). Co-occurring PTSD and SMI lead to poorer mental health and physical functioning than either diagnosis alone. Despite known high prevalence rates of PTSD in SMI populations as well as disparities in prevalence and treatment use for Black, Indigenous, and other people of color (BIPOC), little research has been done to: a) evaluate leading treatments for PTSD in individuals with SMI, and b) develop culturally responsive methods to integrate with PTSD treatments for SMI Veterans. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Written Exposure Therapy (WET), a VA evidence-based psychotherapy for PTSD in Veterans with SMI, and b) incorporating culturally responsive assessment methods. Results from this study will inform whether WET and culturally responsive assessment are feasible to implement, acceptable to Veterans with SMI, and worth examining in standard or optimized form in a larger clinical trial. Type: Interventional Start Date: Dec 2023 |
Intravesical BCG vs GEMDOCE in NMIBC
ECOG-ACRIN Cancer Research Group
Non-muscle-invasive Bladder Cancer
The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC)
patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a
non-inferior event-free survival (EFS) compared to standard treatment with intravesical
BCG. The purpose of this study is to test... expand
The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE. Type: Interventional Start Date: Feb 2023 |
Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
Johns Hopkins University
HIV Infection
HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant
from an HIV+ deceased donor will be followed to determine the safety and efficacy of this
practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected
(HIV-) donors will also be followed. expand
HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected (HIV-) donors will also be followed. Type: Observational Start Date: Nov 2015 |
ExoLuminate Study for Early Detection of Pancreatic Cancer
Biological Dynamics
Pancreas Cancer
Exosomes
Extracellular Vesicles
Pancreatic Neoplasms
ExoLuminate is a nationally-enrolling registry study designed for earlier detection of
cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal
adenocarcinoma (PDAC).
Those with elevated risk for PDAC can include individuals with intraductal papillary
mucinous neoplasms,... expand
ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC). Those with elevated risk for PDAC can include individuals with intraductal papillary mucinous neoplasms, family history of pancreatic cancer, germline mutations in genes known to be associated with cancer, and a personal or family history of pancreatitis. The goal of the study is to compare the performance of ExoVerita™ assay in early detection of PDAC to current standard-of-care methods of surveillance. Type: Observational [Patient Registry] Start Date: Dec 2022 |
CONVERGE Post-Approval Study (PAS)
AtriCure, Inc.
Chronic Atrial Fibrillation
The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural
and long-term) in a cohort of patients treated during commercial use of the EPi-Sense®
Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic
long-standing persistent atrial fibrillation... expand
The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD. Type: Interventional Start Date: Apr 2022 |
Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures
Target ALS Foundation, Inc.
Amyotrophic Lateral Sclerosis
Movement Disorders
Degenerative Disorder
Motor Neuron Disease
Brief Summary: The goal of the study is to generate a biorepository of longitudinal blood
(plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and
longitudinal clinical information that are made available to the research community. To
accomplish these goals, we will enroll... expand
Brief Summary: The goal of the study is to generate a biorepository of longitudinal blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 200 Amyotrophic Lateral Sclerosis (ALS) patients and 80 healthy controls from multiple sites, over a 5 year time frame. Additionally, speech measures will be collected on weekly basis at home for all participants. The measurements are performed using a speech recording application installed on their personal device. For a subset of both ALS and healthy participants, we will also collect at-home vital capacity on a weekly basis. It is expected that increased frequency data sampling of these outcome measures will help in better tracking of disease progression. Biofluids and clinical information are collected over a 20-month time frame for each individual enrolled in the research study. ALS participants will be coming to clinic for 5 study visits with a 4-month interval between visits. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies. Type: Observational [Patient Registry] Start Date: Jan 2021 |
Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical...
SpineX Inc.
Neurogenic Bladder
Spinal Cord Injuries (Complete and Incomplete)
Stroke
Multiple Sclerosis
The purpose of this study is to evaluate the effectiveness and safety of SCONE
neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control
in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction expand
The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction Type: Interventional Start Date: May 2022 |
Social Risk Factors and Discrimination in Cancer Survivorship
Medstar Health Research Institute
Social Determinants of Health
Breast Cancer
Prostate Cancer
Health Equity
Disparities
The objective of the proposed study is to scale social risk factor screening and referral
for cancer survivors and to solidify information exchange between clinical and community
settings in order to improve survivor health and well-being. This will be completed
through three primary aims: 1) To ascertain... expand
The objective of the proposed study is to scale social risk factor screening and referral for cancer survivors and to solidify information exchange between clinical and community settings in order to improve survivor health and well-being. This will be completed through three primary aims: 1) To ascertain workflow and map community resources needed to facilitate social risk factor screening and referral for breast and prostate cancer survivors in Washington, District of Columbia. 2) To determine impact of Community Health Worker (CHW) support on Black breast and prostate cancer survivor health and wellbeing as measured through quality of life (QOL) and social connection. 3) To determine impact of anti-racism training for staff and clinicians at three cancer centers on patient-reported discrimination. Type: Interventional Start Date: May 2022 |
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies
Georgetown University
Dementia With Lewy Bodies
Dementia with Lewy Bodies (DLB) is an alphasynucleinopathy and the second most common
form of dementia in the elderly. DLB shares striking neuropathological and clinical
similarities with both Parkinson's disease (PD) and Alzheimer's disease (AD). Nilotinib
(Tasigna®, AMN107, Novartis, Switzerland)... expand
Dementia with Lewy Bodies (DLB) is an alphasynucleinopathy and the second most common form of dementia in the elderly. DLB shares striking neuropathological and clinical similarities with both Parkinson's disease (PD) and Alzheimer's disease (AD). Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) is approved by the FDA and is well tolerated for CML treatment at oral doses of 600-800mg daily. The Investigators propose to perform a phase II randomized, double blinded, placebo controlled study to evaluate the impact of Nilotinib in patients with DLB. Type: Interventional Start Date: Jul 2019 |
Exercise and Brain Health
Baltimore VA Medical Center
Stroke
Cardiovascular Risk Factors
Transient Ischemic Attack (TIA)
The risk of stroke and vascular dementia is high in individuals who have had a prior
stroke or TIA, and in those who have vascular disease risk factors, such as high blood
pressure, abnormal cholesterol, diabetes or pre-diabetes. These vascular risk factors can
improve with exercise. This study will... expand
The risk of stroke and vascular dementia is high in individuals who have had a prior stroke or TIA, and in those who have vascular disease risk factors, such as high blood pressure, abnormal cholesterol, diabetes or pre-diabetes. These vascular risk factors can improve with exercise. This study will examine the impact of a 6 month, low intensity group exercise class on fitness, walking, balance, and brain health. This study will also collect fitness, walking, balance, and brain health outcome measures at baseline and post all other MERCE exercise and robotics interventions. Type: Interventional Start Date: Jul 2013 |
Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer...
NRG Oncology
Anatomic Stage IV Breast Cancer AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Breast Carcinoma
Metastatic Digestive System Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery
(FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer
that has spread from where it first started to the brain. Radiation therapy uses high
energy x-rays to kill tumor cells and... expand
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain. Type: Interventional Start Date: Aug 2024 |
RECOVER-SLEEP: Platform Protocol
Duke University
Long COVID
Long COVID-19
Hypersomnia
Sleep Disturbance
The platform protocol is designed to be flexible so that it is suitable for a range of
study settings and intervention types. Therefore, the platform protocol provides a
general protocol structure that can be shared by multiple interventions and allows
comparative analysis across the interventions.... expand
The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance). Type: Interventional Start Date: Jul 2024 |
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 |
Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial
Wake Forest University Health Sciences
Breast Cancer Female
The goal of this clinical trial is to develop an effective internet-delivered program to
help breast cancer survivors manage cancer-related sexual concerns.
This study is being done to find out if the study approach is better or worse than the
usual approach to helping breast cancer survivors manage... expand
The goal of this clinical trial is to develop an effective internet-delivered program to help breast cancer survivors manage cancer-related sexual concerns. This study is being done to find out if the study approach is better or worse than the usual approach to helping breast cancer survivors manage cancer-related sexual concerns. The usual approach is defined as care most cancer survivors get for their cancer-related sexual concerns. Participants will complete a questionnaire and if they qualify, they will be assigned to one of sixteen groups of participants. Groups will get access to various kinds of help through an Internet-delivered program called SHINE, which was designed and is run by researchers at the University of Virginia Center for Behavioral Health and Technology. All groups will get access to education about sexual health after cancer: either a standard education website or an enhanced education web program. Groups may also receive up to three additional web programs on: talking to your clinicians about sexual concerns, and/or talking to your partner about sexual concerns, and/or increasing intimacy. Participants are asked to complete the SHINE program within 12 weeks. After participants finish this 12-week period, the study team will ask them to complete a questionnaire to check in with the participant. The participant will be asked one additional time 12 weeks later to complete another questionnaire to see how the participant is doing. A participant will be in the study for 24 weeks. Type: Interventional Start Date: Mar 2024 |
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following...
CG Oncology, Inc.
Non Muscle Invasive Bladder Cancer
Urologic Cancer
Bladder Cancer
Urothelial Carcinoma
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT
followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the
treatment of participants with IR-NMIBC. expand
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the treatment of participants with IR-NMIBC. Type: Interventional Start Date: Dec 2023 |
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 systemic anti-cancer therapy... 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 |
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic...
Cytokinetics
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
This clinical trial will study the effects of aficamten (versus placebo) on the quality
of life, exercise capacity, and clinical outcomes of patients with non-obstructive
hypertrophic cardiomyopathy. expand
This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy. Type: Interventional Start Date: Aug 2023 |
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 lymphoma (LBCL). 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, and how the drug moves... 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. In Part 1, 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). In Part 2, eligible participants will be placed in an open-label arm to receive Budigalimab. Approximately 160 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. In Part 1, participants will receive 4 doses of intravenous (IV) budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. In Part 2, participants will receive 4 doses of open-label subcutaneous (SC) Budigalimab for a 6 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 112 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 112 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 |
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