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Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases
SWOG Cancer Research Network
Anatomic Stage IV Breast Cancer AJCC v8
Invasive Breast Carcinoma
Metastatic HER2 Negative Breast Carcinoma
Metastatic Malignant Neoplasm in the Brain
Prognostic Stage IV Breast Cancer AJCC v8
This phase II trial studies the effect of sacituzumab govitecan in treating patients with
HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab
govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug,
called govitecan. Sacituzumab is... expand
This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse. Type: Interventional Start Date: Jun 2021 |
CAR-T Long Term Follow Up (LTFU) Study
Novartis Pharmaceuticals
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Per Health Authorities guidelines for gene therapy medicinal products that utilize
integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of
treated patients is required. The purpose of this study is to monitor all patients
exposed to CAR-T therapied for 15 years following... expand
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence. Type: Interventional Start Date: Jan 2016 |
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Celldex Therapeutics
Eosinophilic Esophagitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult
Eosinophilic Esophagitis patients. expand
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients. Type: Interventional Start Date: Jun 2023 |
Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions
University of Kansas Medical Center
Obesity
Obesity, Morbid
The purpose of this study is to compare two methods for managing obesity in rural primary
care patients. The first method includes quarterly 1:1 meetings with the participant and
their primary care provider and the second includes a group lifestyle intervention over
Zoom paired with quarterly team... expand
The purpose of this study is to compare two methods for managing obesity in rural primary care patients. The first method includes quarterly 1:1 meetings with the participant and their primary care provider and the second includes a group lifestyle intervention over Zoom paired with quarterly team meetings with the participant, their primary care provider and their lifestyle coach, the coach joining via Zoom. Investigators will evaluate which method is best at helping participants lose weight over 18 months. Type: Interventional Start Date: Mar 2023 |
Obeticholic Acid for Prevention in Barrett's Esophagus
National Cancer Institute (NCI)
Barrett Esophagus
This phase II trial studies the effect of obeticholic acid in treating patients with
Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to
neoplastic progression in Barrett's esophagus. Obeticholic acid has shown
anti-cholestatic, anti-inflammatory and anti-fibrotic... expand
This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression. Type: Interventional Start Date: Jan 2024 |
Brain Responses to Contextual Influences on Drinking Decisions
University of Kansas Medical Center
Alcohol Drinking
This study is using functional magnetic resonance imaging (fMRI) to examine brain
activity associated with making decisions about drinking alcohol in everyday situations,
some of which may involve important activities happening the next day. The secondary aims
are to determine whether severity of... expand
This study is using functional magnetic resonance imaging (fMRI) to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks. Type: Interventional Start Date: Feb 2023 |
Changing Talk Online Training (CHATO) National Trial
University of Kansas Medical Center
Dementia
Alzheimer Disease
Communication
The National Plan to Address Alzheimer's disease has identified education of dementia
care providers as a top priority to address the need for quality care for the population
of persons with dementia that will triple in the next 30 years. This study will test new
online interactive training for nursing... expand
The National Plan to Address Alzheimer's disease has identified education of dementia care providers as a top priority to address the need for quality care for the population of persons with dementia that will triple in the next 30 years. This study will test new online interactive training for nursing home staff that improves staff communication and also reduces behavioral symptoms of persons with dementia that they care for. Innovative approaches to reach care providers are essential to achieve implementation of evidence-based practices to improve care. Type: Interventional Start Date: Apr 2021 |
A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic...
Beam Therapeutics Inc.
Lymphoblastic Lymphoma
T-Cell Lymphoblastic Leukemia/Lymphoma
Lymphoblastic Leukemia
This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of
BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase
1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort
(will enroll patients ages 1... expand
This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to < 12 years), and a Phase 2 cohort. Type: Interventional Start Date: May 2023 |
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
Marker Therapeutics, Inc.
Non-Hodgkin Lymphoma, Adult
Non-Hodgkin Lymphoma, Refractory
Non-Hodgkin Lymphoma, Relapsed
Non Hodgkin Lymphoma
Hodgkin Lymphoma
This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion
evaluating safety and efficacy of MT-601 administration to patients with Relapsed or
Refractory Lymphoma. The starting dose administered is 200 x 10^6 cells (flat dosing). expand
This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10^6 cells (flat dosing). Type: Interventional Start Date: Jan 2023 |
Hyperpolarized 129Xe MRI Lung Health Cohort
University of Kansas Medical Center
Healthy
A subset of young adults participating in the American Lung Association (ALA) Lung Health
Cohort (LHC) will be imaged using Hyperpolarized 129Xe MRI to assess lung structure and
function. Images will be used to improve the understanding of lung health and early lung
abnormalities that may lead to... expand
A subset of young adults participating in the American Lung Association (ALA) Lung Health Cohort (LHC) will be imaged using Hyperpolarized 129Xe MRI to assess lung structure and function. Images will be used to improve the understanding of lung health and early lung abnormalities that may lead to chronic lung disease. Type: Observational Start Date: Nov 2023 |
The Impact of MeMed BV® on Management of Patients with Suspected Lower Respiratory Tract Infections (LRTI)...
MeMed Diagnostics Ltd.
Lower Respiratory Tract Infection
This is a Prospective, multi-center study enrolling adults subjects presented to the
ED/Urgent care, with symptoms consistent with lower respiratory infection (LRTI).
The reason of this study is to demonstrate the MeMed BV can help clinicians make
decisions about using antibiotics in patients with... expand
This is a Prospective, multi-center study enrolling adults subjects presented to the ED/Urgent care, with symptoms consistent with lower respiratory infection (LRTI). The reason of this study is to demonstrate the MeMed BV can help clinicians make decisions about using antibiotics in patients with lower respiratory track infections and see how it would impact clinical outcomes, antibiotics use, hospitalizations, ED clinicians find ways to improve health and medical care. Type: Interventional Start Date: Jan 2023 |
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine,...
Kura Oncology, Inc.
Acute Myeloid Leukemia
Mixed Lineage Acute Leukemia
Mixed Lineage Leukemia Gene Mutation
Mixed Phenotype Acute Leukemia
Refractory AML
This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic
activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and
7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r. expand
This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r. Type: Interventional Start Date: Jul 2023 |
Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Advanced Microsatellite Stable Colorectal Carcinoma
Hematopoietic and Lymphatic System Neoplasm
Metastatic Malignant Solid Neoplasm
Metastatic Microsatellite Stable Colorectal Carcinoma
This phase I/II trial studies the side effects and best dose of temozolomide and M1774
and how well they works in treating patients with cancer that has spread from where it
first started (primary site) to other places in the body (metastatic) and may have spread
to nearby tissue, lymph nodes, or... expand
This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone. Type: Interventional Start Date: Sep 2023 |
Study of M5049 in DM and PM Participants (NEPTUNIA)
EMD Serono Research & Development Institute, Inc.
Dermatomyositis
Polymyositis
The purpose of this study is to evaluate the efficacy and safety of orally administered
M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and
polymyositis (PM) participants for 24 weeks. expand
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks. Type: Interventional Start Date: Jan 2023 |
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Nikki Nollen, PhD, MA
Smoking Reduction
This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th
generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from
combustible cigarettes to e-cigarettes in adult menthol smokers. expand
This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers. Type: Interventional Start Date: Nov 2022 |
Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Black Diamond Therapeutics, Inc.
Non-Small Cell Lung Cancer
Advanced Non-Small Cell Squamous Lung Cancer
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Lung Cancer
NSCLC
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study
designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous
system (CNS) activity, and antitumor activity of BDTX-1535. The study population
comprises adults with either advanced/metastatic... expand
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently enrolling. Type: Interventional Start Date: Mar 2022 |
MRI for Screening and Monitoring Scleroderma ILD
University of Kansas Medical Center
Scleroderma
The purpose of this study is to test MRI methods for evaluating patients with
Scleroderma-associated interstitial lung disease. expand
The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease. Type: Observational Start Date: May 2022 |
The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation
State University of New York - Upstate Medical University
Stroke
Sleep Wake Disorders
Rehabilitation
Recovery of Function
Sleep is critical for health and quality of life; however, little is known about the
prevalence or impact of non obstructive sleep apnea (non-OSA) sleep disorders in people
with stroke. The proposed study aims to characterize the proportion of people with stroke
that have non-OSA sleep disorders and... expand
Sleep is critical for health and quality of life; however, little is known about the prevalence or impact of non obstructive sleep apnea (non-OSA) sleep disorders in people with stroke. The proposed study aims to characterize the proportion of people with stroke that have non-OSA sleep disorders and their impact on recovery of activities of daily living, functional mobility, and participation along the continuum of recovery in people with stroke. Type: Observational Start Date: Mar 2021 |
An Assessment of Cognitive Improvement Training Among Mid-life Individuals
University of Kansas
Delay Discounting
Many health-relevant decisions involve intertemporal (now vs. later) tradeoffs. Extensive
literature indicates that many negative health and financial consequences suffered in
mid-life are linked to adversity and disadvantage during early developmental periods of
life. Individuals who continue to... expand
Many health-relevant decisions involve intertemporal (now vs. later) tradeoffs. Extensive literature indicates that many negative health and financial consequences suffered in mid-life are linked to adversity and disadvantage during early developmental periods of life. Individuals who continue to engage in these types of unhealthy behaviors despite awareness of the health consequences are exhibiting an inability to delay gratification. Delay discounting (DD) is quantified in human studies by determining the rate at which an individual discounts a delayed reward, while executive function (EF) is defined as the set of cognitive processes that are responsible for helping individuals manage life tasks and achieve goals. This research will attempt to reduce DD via EF training in a population of mid-life individuals with risk factors established during early-life disadvantage. Type: Interventional Start Date: Nov 2014 |
A Study of DS-7011a in Patients With Systemic Lupus Erythematosus
Daiichi Sankyo
Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized
by autoantibody production, inflammation, and tissue damage in multiple organs. Standard
of care therapies used to treat SLE are only partially effective and have a wide range of
toxicities. There is a need for... expand
Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized by autoantibody production, inflammation, and tissue damage in multiple organs. Standard of care therapies used to treat SLE are only partially effective and have a wide range of toxicities. There is a need for more effective and safer therapies for patients with SLE. Type: Interventional Start Date: Jun 2023 |
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
Regulus Therapeutics Inc.
Autosomal Dominant Polycystic Kidney Disease
ADPKD
Polycystic Kidney, Autosomal Dominant
Primary Objectives
- To assess the safety and tolerability of RGLS8429
- To assess the impact of RGLS8429 on ADPKD biomarkers
Secondary Objectives
- To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
- To characterize the pharmacokinetic (PK) properties... expand
Primary Objectives - To assess the safety and tolerability of RGLS8429 - To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives - To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) - To characterize the pharmacokinetic (PK) properties of RGLS8429 - To assess the impact of RGLS8429 on renal function Type: Interventional Start Date: Oct 2022 |
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Microvention-Terumo, Inc.
Intracranial Aneurysm
The objective of this study is to generate contemporaneous clinical data to facilitate a
reasonable comparison of the performance of the FRED™ X™ device with the performance of
the FRED™ device. The data generated from this study will be compared to the safety and
effectiveness of the FRED™ device... expand
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study. Type: Interventional Start Date: Sep 2022 |
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Daewoong Pharmaceutical Co. LTD.
Idiopathic Pulmonary Fibrosis
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate
the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis. expand
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Jul 2022 |
Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
Duke University
Metastatic Renal Cell Carcinoma
ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer
management and health-related quality of life in patients with mRCC in routine real-world
clinical practice in the United States, including both community and academic treatment
settings. expand
ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings. Type: Observational Start Date: Apr 2022 |
DALY II USA/ MB-CART2019.1 for DLBCL
Miltenyi Biomedicine GmbH
Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Relapsed Diffuse Large B Cell Lymphoma
High Grade B-cell Lymphoma (HGBCL)
Primary Mediastinal B-cell Lymphoma (PMBCL)
Transformed Lymphoma
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy,
safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients
with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at
least two lines of therapy. expand
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Type: Interventional Start Date: May 2021 |
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