
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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A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine1
Ipsen
Episodic Migraine
Chronic Migraine
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on
one side of the head. It is often accompanied by feeling or being sick and a sensitivity
to bright lights and sound. Migraines are caused by a series of events when the brain
gets stimulated or activated, which1 expand
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. Corabotase (also known as IPN10200) is a medication that stops the release of these chemical messengers. Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics. This study aims to determine: - The safety and efficacy of injecting Corabotase directly into the muscles of the head and neck to prevent EM and CM, - The right amount (dose) of Corabotase to inject at each point, - The total amount (dose) of Corabotase that provides the best balance between safety and efficacy preventing migraines. Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks. Type: Interventional Start Date: Oct 2024 |
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Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Allogene Therapeutics
Large B-cell Lymphoma
This is a randomized, open-label study in adult patients who have completed standard
first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or
partial response suitable for observation, but who have minimal residual disease (MRD) as
detected by the Foresight CLARITY™ I1 expand
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen. Type: Interventional Start Date: Jun 2024 |
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A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Bre1
Stemline Therapeutics, Inc.
Breast Cancer
The primary goal of this study is to evaluate the effectiveness of elacestrant versus
standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive
(ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high
risk of recurrence. expand
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence. Type: Interventional Start Date: Sep 2024 |
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Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Seconda1
OSE Immunotherapeutics
Patients With Non-Small Cell Lung Cancer
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with
squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with
OSE2101 monotherapy or control Arm B SoC with doce1 expand
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1). Type: Interventional Start Date: Dec 2024 |
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Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic1
Merck Sharp & Dohme LLC
Non-small Cell Lung Cancer
NSCLC
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane
(paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance
sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous
non-small cell lung cancer. It is hypothesiz1 expand
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS). Type: Interventional Start Date: Jun 2024 |
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A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patien1
BioNTech SE
Endometrial Cancer
The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will
be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in
their tumor sample.
In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or
chemotherapy (doxor1 expand
The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample. In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel [or docetaxel, if participants cannot take paclitaxel]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs). In Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment. The safety of BNT323 will also be assessed by following the occurrence of unfavorable/adverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life. Type: Interventional Start Date: Jun 2025 |
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VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTL1
Replimune, Inc.
Advanced Melanoma
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study
comparing VO in combination with nivolumab versus Physician's Choice treatment for
patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on
an anti PD-1 and an anti-CTLA-4 containing regi1 expand
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy. Type: Interventional Start Date: Jul 2024 |
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A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metasta1
Merck Sharp & Dohme LLC
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Prostatic Neoplasms
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily
corticosteroids compared to alternative abiraterone acetate or enzalutamide in
participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously
treated with one next-generation hormonal agen1 expand
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants. Type: Interventional Start Date: Dec 2023 |
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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Gilead Sciences
Primary Biliary Cholangitis
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis. expand
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis. Type: Interventional Start Date: Sep 2023 |
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Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
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Mindful Self-Compassion for Anxiety Disorders and Depression
Georgetown University
Anxiety Disorders
Generalized Anxiety Disorder
Social Anxiety Disorder
Social Phobia
Panic Disorder
The study will compare 8-week Mindful Self-Compassion training, compared to a control
group that does not receive the intervention, on anxiety and depression symptom severity
in patients with diagnosed anxiety disorders (generalized anxiety disorder, social
anxiety disorder, and panic disorder) or1 expand
The study will compare 8-week Mindful Self-Compassion training, compared to a control group that does not receive the intervention, 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. Type: Interventional Start Date: Jan 2022 |
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A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Xenon Pharmaceuticals Inc.
Primary Generalized Tonic-Clonic Seizures
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as
adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). expand
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). Type: Interventional Start Date: Feb 2023 |
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Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Medtronic Cardiovascular
Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
The purpose of this trial is to generate clinical evidence related to key performance
outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder
Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are
randomized and imaging collected at all foll1 expand
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint. Type: Interventional Start Date: Jan 2023 |
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Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone C1
Elute, Inc.
Periprosthetic Joint Infections
This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and
assessor-blinded study with two arms: a treatment arm (where subjects will be treated
with the EP Granules + Tobramycin (EP G + T) investigational device, a combination device
+ antibiotic, in the 1st stage of1 expand
This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study with two arms: a treatment arm (where subjects will be treated with the EP Granules + Tobramycin (EP G + T) investigational device, a combination device + antibiotic, in the 1st stage of a staged revision for periprosthetic joint infection (PJIs), and a control arm (where subjects are treated with the standard-of-care revision for infected PJIs). Type: Interventional Start Date: Aug 2023 |
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MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up1
Kuros Biosurgery AG
Degenerative Disc Disease
Spine Fusion
Leg Pain and/or Back Pain
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is
a synthetic bone graft extender product that is routinely used by surgeons as a treatment
for patients with degenerative disc disease and undergoing spinal fusion surgery.
In this study, MagnetOs Flex Matrix1 expand
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery. In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine. Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects. Type: Interventional Start Date: Jun 2024 |
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A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-1
Genentech, Inc.
Non-small Cell Lung Cancer
This trial will evaluate the efficacy and safety of various therapies in participants
with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated NSCLC tumors
that meet protocol-specified biomarker criteria. expand
This trial will evaluate the efficacy and safety of various therapies in participants with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated NSCLC tumors that meet protocol-specified biomarker criteria. Type: Interventional Start Date: Nov 2020 |
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A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Merus B.V.
Advanced/Metastatic Solid Tumors
Colorectal Cancer
Gastric Cancer
Gastroesophageal-junction Cancer
NSCLC
This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose
escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single
agent in patients with mCRC.
The dose escalation part has been completed and the RP2D will be further evaluated in an
expansi1 expand
This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC). The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies. Type: Interventional Start Date: May 2018 |
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Kentucky - Quality Improvement Implementation Lung Cancer Screening (QUILS™) Health Services Resear1
Timothy Mullett
Lung Cancer Screening
This clinical trial studies statewide optimization of lung cancer screening (LCS) in
Kentucky using the Quality Implementation of Lung Screening (QUILS™) System. Data from
the Kentucky Cancer Registry shows that LCS implementation has contributed to a rapid
decline in late-stage lung cancer diagnos1 expand
This clinical trial studies statewide optimization of lung cancer screening (LCS) in Kentucky using the Quality Implementation of Lung Screening (QUILS™) System. Data from the Kentucky Cancer Registry shows that LCS implementation has contributed to a rapid decline in late-stage lung cancer diagnosis at twice the national average. Further, the declines are more than three times the national average decline in Kentucky's Central Appalachian region. Kentucky-based multilevel initiatives are needed to expand and accelerate this leading role and extend the LCS opportunity to more Kentuckians who are at increased risk of lung cancer. This trial may be able to accelerate optimal high-quality implementation of LCS utilizing the QUILS™ System and reduce the burden of lung cancer by assisting lung cancer screening programs located throughout Kentucky in implementing best practices in lung cancer screening by integrating the QUILS™ System domains and elements into their screening programs. Type: Interventional Start Date: Apr 2025 |
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A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intraven1
AbbVie
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease
characterized by B cell hyperactivity.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness,
swelling and loss of joint function. The purpose of this study is to assess the
pharmacokinetics,1 expand
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA. This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: May 2026 |
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A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migra1
Merz Therapeutics GmbH
Chronic Migraine
In this clinical trial, participants with chronic migraine will receive injections with
Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change
in monthly migraine days with Xeomin injections compared to Placebo injections.
Trial details include:
- Trial durat1 expand
In this clinical trial, participants with chronic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections. Trial details include: - Trial duration: 52 to 55 weeks; - Screening period: 4 to 5 weeks; - Treatment duration: 4 treatments, each about 12 weeks apart; and - Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call. Type: Interventional Start Date: Aug 2025 |
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A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migr1
Merz Therapeutics GmbH
Episodic Migraine
In this clinical trial, participants with episodic migraine will receive injections with
Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change
in monthly migraine days with Xeomin injections compared to Placebo injections.
Trial details include:
- Trial dura1 expand
In this clinical trial, participants with episodic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections. Trial details include: - Trial duration: 52 to 55 weeks; - Screening period: 4 to 5 weeks; - Treatment duration: 4 treatments, each about 12 weeks apart; and - Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call. Type: Interventional Start Date: Aug 2025 |
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BoxX-NoAF Clinical Trial
AtriCure, Inc.
Post Operative Atrial Fibrillation
Atrial Fibrillation, Postoperative
Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac
surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics
and surgery type. Patients with POAF tend to have worse acute and long-term clinical
outcomes. BoxX-NoAF is a randomized tria1 expand
Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type. Patients with POAF tend to have worse acute and long-term clinical outcomes. BoxX-NoAF is a randomized trial to evaluate if prophylactic ablation and exclusion of the Left Atrial Appendage at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk. Type: Interventional Start Date: Oct 2025 |
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A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheime1
Bristol-Myers Squibb
Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for
cognitive impairment in Alzheimer's Disease expand
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease Type: Interventional Start Date: Jul 2025 |
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Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
NRG Oncology
Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma
Stage II Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
This phase III trial compares the effect of dose-escalated radiation therapy to usual
care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who
have received an initial 4-6 months of chemotherapy. Usual care options include
additional chemotherapy, observation, or sta1 expand
This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival. Type: Interventional Start Date: Aug 2025 |
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A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Eli Lilly and Company
Immune Thrombocytopenia (ITP)
The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is
tolerated and what side effects may occur. The phase 2 part of the study will further
investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo.
The study drug will be administered orally1 expand
The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo. The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening. Type: Interventional Start Date: Jul 2025 |