
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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Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
Children's Oncology Group
Hematopoietic Cell Transplantation Recipient
Leukemia
Solid Tumor
This clinical trial keeps track of and collects follow-up information from patients who
are currently enrolled on or have participated in a Children's Oncology Group study.
Developing a way to keep track of patients who have participated in Children's Oncology
Group studies may allow doctors learn1 expand
This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life. Type: Observational Start Date: Jul 2008 |
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Mindful Self-compassion for Anxiety and Depression: Impact of Delivery Method
Georgetown University
Anxiety Disorders
Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Agoraphobia
The study will compare the delivery of an 8-week Mindful Self-Compassion training,
in-person against video-conference, on anxiety and depression symptom severity in
patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety
disorder, and panic disorder) or major depress1 expand
The study will compare the delivery of an 8-week Mindful Self-Compassion training, in-person against video-conference, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder or dysthymia. Type: Interventional Start Date: Jun 2025 |
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Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Medstar Health Research Institute
Fallopian Tube Patency Tests
Fibroid/Myoma (Uterus/Cervix)
Myomectomy
Fallopian Tube Disease
This study uses a procedure called chromopertubation to look at how fibroids and fibroid
surgery affect the fallopian tubes. Specifically, this study will test if the fallopian
tubes are occluded or patent (open) before and after surgically removing fibroids.
Chromopertubation is a commonly perfor1 expand
This study uses a procedure called chromopertubation to look at how fibroids and fibroid surgery affect the fallopian tubes. Specifically, this study will test if the fallopian tubes are occluded or patent (open) before and after surgically removing fibroids. Chromopertubation is a commonly performed and well-established procedure that is done during laparoscopic surgery to determine if the fallopian tubes are open or blocked. It includes inserting a dilute solution of saline with a small amount of medical-grade blue dye (called methylene blue) into the uterine cavity to see if it spills out of the fallopian tubes. Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare. The minimum amount of methylene blue dye will be used to further reduce risks of a reaction. Open fallopian tubes are necessary to become pregnant without the use of IVF. While it is known that some conditions can affect the functioning of the fallopian tubes, there is a lack of research about how fibroids affect the tubes. It is also not known how much about how the process of removing fibroids may affect the fallopian tubes. The investigators hypothesize that tubal occlusion will be observed in patients with fibroids and that the frequency of tubal occlusion will change after myomectomy compared to pre-myomectomy. This study will be conducted entirely during planned surgery for laparoscopic myomectomy. Chromopertubation will be performed at the beginning and again at the end of the surgery. This is expected to take less than 10 minutes in total. The results of the chromopertubation as well as background medical information will be recorded and the characteristics of the fibroids (size, number, and location) will be compared to the presence or abscence of tubal occlusion as determined by chromopertubation. Type: Interventional Start Date: Jun 2025 |
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POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse1
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 pelvi1 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 satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease/difficulty of pessary insertion/removal, importance of ability to self-manage pessary, and adverse events. Specific Aims Aim 1: To compare satisfaction with pessary use and management 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, number of self-management events 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 ease/difficulty of pessary use and importance of ability to self-manage, as well as 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: Nov 2024 |
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Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
Revolution Medicines, Inc.
Non-Small Cell Lung Cancer, NSCLC
KRAS, NRAS, HRAS-mutated NSCLC
KRAS G12C-mutated Solid Tumors, Lung Cancer
Lung Cancer Stage IV, Advanced Solid Tumor, Cancer
RAS G12D-mutated NSCLC
The purpose of this platform study is to evaluate the safety, tolerability,
pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as
a monotherapy or combined with Standard(s) of Care (SOC) or with each other.
The first four subprotocols include the following:
Subp1 expand
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other. The first four subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805 Type: Interventional Start Date: Jan 2024 |
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Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
NYU Langone Health
Pulmonary Embolism
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare
catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation
alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and
right ventricular dilation. expand
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation. Type: Interventional Start Date: Jul 2023 |
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Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alo1
Angiodynamics, Inc.
Peripheral Arterial Diseases
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon
angioplasty safe and effective in treating lower limb blockages. The main question it
aims to answer is: Is treatment with Auryon Atherectomy System more effective than
angioplasty alone in preventing death, a1 expand
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone. Type: Interventional Start Date: Apr 2025 |
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Esprit BTK Post-Approval Study
Abbott Medical Devices
Chronic Limb-Threatening Ischemia
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to
assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting
Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal
lesions causing CLTI (Chronic Limb-Threa1 expand
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation. Type: Interventional Start Date: Oct 2024 |
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ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aorti1
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 |
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Clinical Trial of Approaches to Prostate Cancer Surgery
Weill Medical College of Cornell University
Prostate Cancer
This is a prospective, randomized controlled trial to compare cancer control and
health-related quality of life following pelvic fascia-sparing radical prostatectomy
versus standard radical prostatectomy.
The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have
simi1 expand
This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy. The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy. Type: Interventional Start Date: May 2023 |
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Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-smal1
Georgetown University
Carcinoma, Non-Small Cell Lung
This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based
chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human
immunodeficiency virus (HIV) infection will be eligible. Patients will receive standard
platinum-based chemotherapy plus durval1 expand
This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human immunodeficiency virus (HIV) infection will be eligible. Patients will receive standard platinum-based chemotherapy plus durvalumab for 4 cycles (every 3 weeks), followed by durvalumab (with or without pemetrexed for non-squamous NSCLC) maintenance therapy. It is hypothesized that Durvalumab and tremelimumab in combination with standard chemotherapy is safe and effective for the treatment of stage IV NSCLC in patients with HIV infection. Type: Interventional Start Date: Dec 2020 |
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RevCore for In Stent Thrombosis
Inari Medical
In-stent Thrombosis
The purpose of this research is to collect information about how the RevCore Thrombectomy
Catheter works to treat stent blockages. expand
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages. Type: Observational Start Date: Sep 2024 |
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Hybrid Type I Effectiveness-Implementation Trial of a Social Network Support Intervention
University of Chicago
HIV Seropositivity
The goal of this Hybrid Type I effectiveness-implementation trial is to test an
evidence-based, flexible, and tailored intervention that leverages existing social
network members to promote retention in care and viral suppression among people living
with HIV aged 18-49. expand
The goal of this Hybrid Type I effectiveness-implementation trial is to test an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV aged 18-49. Type: Interventional Start Date: Feb 2023 |
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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 o1 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: Apr 2024 |
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Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for T1
Evon Medics LLC
Chronic Pain
Low Back Pain
The overarching goal of this study phase, Phase II component is to perform a randomized
clinical trial of the refined Computerized Chemosensory-Based Orbitofrontal Networks
Training for Treatment of Pain [CBOT-Pain (or CBOT-P)] from Phase I, compared to sham
Computerized Chemosensory-Based Orbitofr1 expand
The overarching goal of this study phase, Phase II component is to perform a randomized clinical trial of the refined Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain [CBOT-Pain (or CBOT-P)] from Phase I, compared to sham Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) in Chronic Low Back Pain (CLBP) to determine its short- and long-term effectiveness on Pain, Negative Affect (NA), Cognition and Cortical Brain Structure (PACS), long-term safety, and indications. The investigators will perform a randomized clinical trial of the refined CBOT-P from Phase I, compared to sham CBOT in CLBP. Aim 2.1: To determine if CBOT-P significantly influences: (1) acute and long-term reduction of pain severity, and (2) acute and long-term reduction of negative affect. The hypothesis is that optimized CBOT will produce faster, stronger, and longer-lasting improvements in pain severity, NA severity, cognitive impairments, and sleep and functional outcomes. Aim 2.2 To determine if CBOT-P significantly prevents or reduces progressive shrinkage in the orbitofrontal cortex (OFC), cingulate cortex, and hippocampus. MRI will be acquired at baseline and 6th month. An integrative analysis will be conducted to determine the link between changes in brain structure and cognitive trajectory. The hypothesis is that the CBOT optimized with BCP significantly attenuates shrinkage in OFC and other prefrontal cortex (PFC) regions, compared to the Sham intervention. Type: Interventional Start Date: Oct 2024 |
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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 w1 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 |
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A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Famil1
Kardigan, Inc.
Symptomatic Genetic Dilated Cardiomyopathy
The Sponsor is studying an investigational medication called danicamtiv to determine if
it can help people with genetic and familial dilated cardiomyopathy (DCM).
Investigational means that the safety and effectiveness of danicamtiv have not been
established. Currently, there are no approved drugs1 expand
The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). Investigational means that the safety and effectiveness of danicamtiv have not been established. Currently, there are no approved drugs that are designed specifically to treat genetic or familial DCM. The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does not contain any danicamtiv) and see how safe it is for people with genetic and familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood; this can happen for different reasons. Some people have DCM because of a change in a gene (called genetic DCM). Others may have DCM that runs in their family, even if no specific gene change is found (called familial DCM). The main goals of the study are: - To assess the effect of danicamtiv on cardiac function using echocardiogram. - To evaluate the impact of danicamtiv on exercise capacity - To evaluate the safety and tolerability of danicamtiv Participants will: - Take danicamtiv or placebo every day for approximately 6 months - Visit the clinic about 12 times for initial evaluation, checkups, tests and follow up Type: Interventional Start Date: Feb 2026 |
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A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Imm1
Pfizer
COVID-19 Infection
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy,
superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in
combination with remdesivir IV compared to remdesivir IV alone for the treatment of
symptomatic COVID-19 in severely immunocompromised1 expand
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19. Type: Interventional Start Date: Jul 2025 |
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A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Ve1
Merck Sharp & Dohme LLC
Endometrial Cancer
Researchers are looking for new ways to treat people with proficient mismatch repair
(pMMR) endometrial cancer (EC) that is advanced or recurrent.
- EC is a type of cancer that starts in the tissues inside the uterus (womb)
- pMMR indicates that certain normal proteins are present in the ca1 expand
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. - EC is a type of cancer that starts in the tissues inside the uterus (womb) - pMMR indicates that certain normal proteins are present in the cancer cells - Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery - Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone. Type: Interventional Start Date: May 2025 |
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Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalu1
Alliance for Clinical Trials in Oncology
Castration-Sensitive Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
This phase III trial compares the effect of adding docetaxel to hormonal therapy and
apalutamide versus hormonal therapy and apalutamide alone in treating patients with
prostate cancer that has spread from where it first started (primary site) to other
places in the body (metastatic). Docetaxel is1 expand
This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone. Type: Interventional Start Date: Dec 2025 |
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A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
argenx
Chronic Inflammatory Demyelinating Polyneuropathy
CIDP
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
The main purpose of this study is to compare empasiprubart and IVIg for treating people
with CIDP. This study consists of a Part A where participants will either receive
empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling
empasiprubart for 24 weeks (6 months). Following Pa1 expand
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months). More information can be found here: https://clinicaltrials.argenx.com/emvigorate Type: Interventional Start Date: Aug 2025 |
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A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects1
Vericel Corporation
Chondral Defect
Articular Cartilage Defect
The objective of this study is to demonstrate the superiority of MACI (autologous
cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the
treatment of patients aged 17 to 65 years with symptomatic articular chondral or
osteochondral defects of the talus. expand
The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with symptomatic articular chondral or osteochondral defects of the talus. Type: Interventional Start Date: Mar 2026 |
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A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubici1
Merck Sharp & Dohme LLC
Lymphoma, Large B-Cell, Diffuse
Researchers are looking for ways to treat germinal center B-cell-like diffuse large
B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells.
GCB is a type of DLBCL that affects young B-cells that are still maturing.
The goal of this study is to learn if more people w1 expand
Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP. Type: Interventional Start Date: Apr 2025 |
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The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
Boehringer Ingelheim
Bronchiectasis
This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis.
People can participate in this study if they produce sputum and have had flare-ups (also
called exacerbations).
The purpose of this study is to find out whether a medicine called BI 1291583 helps
people with bron1 expand
This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects. Type: Interventional Start Date: Jun 2025 |
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A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Takeda
Immune Thrombocytopenic Purpura (ITP)
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly
destroys platelets, which are cells that help stop bleeding. This leads to a low number
of platelets, making it easier to bruise or bleed. The main aim of this study is to learn
whether mezagitamab, when given j1 expand
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously [SC]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. The participants will be treated with mezagitamab for up to 6 months. During the study, participants will visit their study clinic several times. Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study). Type: Interventional Start Date: Feb 2025 |