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Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC
University of Kansas Medical Center
Triple Negative Breast Cancer
Breast Cancer
This study will assess if the presence of immune system cells in and around the tumor
impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for
triple-negative breast cancer. expand
This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer. Type: Interventional Start Date: Dec 2022 |
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
Chris Goss
Cystic Fibrosis
Cystic Fibrosis Pulmonary Exacerbation
The purpose of this study is to look at pulmonary exacerbations in people with cystic
fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into
a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory
symptoms in people with CF that needs medical... expand
The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation: - Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)? - Is taking one type of antibiotic just as good as taking two types? Type: Interventional Start Date: Apr 2023 |
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian,...
ImmunoGen, Inc.
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and
efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with
platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate
receptor-alpha (FRα) expression. expand
GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression. Type: Interventional Start Date: Dec 2022 |
A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With...
Iovance Biotherapeutics, Inc.
Unresectable Melanoma
Metastatic Melanoma
Stage III Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in
adult participants with unresectable or metastatic melanoma or advanced non-small-cell
lung cancer (NSCLC). expand
This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC). Type: Interventional Start Date: Jul 2022 |
Pulmonary Hypertension Biorepository and Registry
University of Kansas Medical Center
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Pulmonary Hypertension Due to Left Heart Disease
Pulmonary Hypertension, Primary
Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Establish a pulmonary hypertension registry and biorepository to lead towards a further
understanding of the disease. expand
Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease. Type: Observational [Patient Registry] Start Date: Aug 2020 |
User-friendliness of a Portable Driving Simulator
University of Kansas Medical Center
Parkinson Disease
Multiple Sclerosis
Stroke
The use of simulators to retrain driving skills of patients with stroke, Parkinson's
disease (PD), or multiple sclerosis (MS) is very limited because of cost, space required,
and incidence of simulator sickness in high fidelity simulators. The Principal
investigator recently developed a low cost low... expand
The use of simulators to retrain driving skills of patients with stroke, Parkinson's disease (PD), or multiple sclerosis (MS) is very limited because of cost, space required, and incidence of simulator sickness in high fidelity simulators. The Principal investigator recently developed a low cost low fidelity portable driving simulator (PDS). In this pilot study, the study team will (1) determine the ease of use and occurrence of simulator sickness while operating the low fidelity PDS in a clinic setting and (2) the efficacy of the low fidelity PDS to reproduce the benefits from retraining impaired driving skills of stroke survivors in a high-fidelity simulator. Participants: 30 participants, separated according to neurological condition including stroke, PD, or MS, will be randomly allocated to either the PDS or fixed-base high-fidelity simulator training. Each participant will undergo a pre-training evaluation, five hours of designated training and a post-training assessment, similar to the pre-training evaluation. Data will be analyzed according to study aims. The investigators hypothesize that the simple set up of the PDS will make it easier to use and better decrease the incidence of simulator sickness that typically leads to stopping therapy than the high-fidelity simulator. The investigators hypothesize that improvements in lane maintenance, adherence to speed limits, reaction to traffic lights, and overall reaction time after training using the PDS will not be significantly different from improvements observed after training using the high-fidelity driving simulator. Type: Interventional Start Date: Aug 2019 |
Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
Novartis Pharmaceuticals
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Diffuse Large B-cell Lymphoma
Acute Lymphoblastic Leukemia
Large B-cell Lymphoma
This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor
efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will
be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL) and... expand
This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL). Type: Interventional Start Date: Jun 2019 |
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Yale University
Intracerebral Hemorrhage
Atrial Fibrillation
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the
composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in
patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in... expand
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. Type: Interventional Start Date: Jan 2020 |
Quantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization
University of Kansas Medical Center
Pelvic Congestive Syndrome
Pelvic Pain
The primary objective is to quantify the degree of pain relief in patients undergoing
gonadal vein embolization with coils as well as identify clinical or imaging factors that
are predictive of a positive response to treatment, or poor response to treatment. expand
The primary objective is to quantify the degree of pain relief in patients undergoing gonadal vein embolization with coils as well as identify clinical or imaging factors that are predictive of a positive response to treatment, or poor response to treatment. Type: Observational Start Date: May 2019 |
Sinus Disease in Young Children With Cystic Fibrosis
University of California, Los Angeles
Cystic Fibrosis in Children
Cystic Fibrosis
Chronic Rhinosinusitis (Diagnosis)
Olfactory Disorder
Olfactory Impairment
This is a prospective, observational study examining the impact of highly effective
cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic
rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic
fibrosis (YCwCF). This study involves two groups: children... expand
This is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic fibrosis (YCwCF). This study involves two groups: children 2-8 years old, inclusive at initial visit, receiving highly effective modulator therapy (HEMT), and a control group of children 2-8 years old, inclusive at initial visit, not receiving HEMT. Outcomes will include sinus magnetic resonance imaging (MRI) scans, olfactory tests, and quality of life surveys obtained over a two-year period. Type: Observational Start Date: Apr 2023 |
Chemotherapy Combined With Immunotherapy vs Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung...
National Cancer Institute (NCI)
Advanced Lung Non-Small Cell Carcinoma
Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
This phase III trial compares the effect of adding chemotherapy to immunotherapy
(pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung
cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the
body's immune system attack the cancer, and... expand
This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs 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. Giving pembrolizumab and chemotherapy may help stabilize lung cancer. Type: Interventional Start Date: Jul 2024 |
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
AtriCure, Inc.
Ischemic Stroke
Systemic Embolism
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority
trial. The objective of this trial is to evaluate the effectiveness of left atrial
appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial
embolism in subjects undergoing cardiac... expand
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke. Type: Interventional Start Date: Jan 2023 |
Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
Allergy Therapeutics
Peanut Allergy
This phase I clinical trial is designed to evaluate the safety and tolerability of VLP
Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial
will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the
immunotoxicity profile and the degree... expand
This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA. Type: Interventional Start Date: Oct 2022 |
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously...
Gilead Sciences
Triple Negative Breast Cancer
PD-L1 Negative
The primary objective of this study is to compare the progression-free survival (PFS)
between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in
participants with previously untreated, locally advanced, inoperable or metastatic
triple-negative breast cancer whose tumors... expand
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1. Type: Interventional Start Date: Jul 2022 |
A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small...
Fujifilm Pharmaceuticals U.S.A., Inc.
Advanced Urothelial Carcinoma
Advanced Non Small Cell Lung Cancer
To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection)
given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab
given intravenously Day 1 of the same 21-day cycle, for treatment of advanced urothelial
and non-small cell lung cancer expand
To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced urothelial and non-small cell lung cancer Type: Interventional Start Date: Jun 2022 |
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
Lyra Therapeutics
Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Multicenter, phase III, randomized, blinded, controlled, parallel group. expand
Multicenter, phase III, randomized, blinded, controlled, parallel group. Type: Interventional Start Date: May 2022 |
Phenotype, Genotype and Biomarkers 2
University of Miami
Amyotrophic Lateral Sclerosis
Hereditary Spastic Paraplegia
Primary Lateral Sclerosis
Progressive Muscular Atrophy
Frontotemporal Dementia
The purpose of this study is to learn more about amyotrophic lateral sclerosis (ALS) and
other related neurodegenerative diseases, including frontotemporal dementia (FTD),
primary lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive
muscular atrophy (PMA) and multisystem proteinopathy... expand
The purpose of this study is to learn more about amyotrophic lateral sclerosis (ALS) and other related neurodegenerative diseases, including frontotemporal dementia (FTD), primary lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive muscular atrophy (PMA) and multisystem proteinopathy (MSP). More precisely, the investigator wants to identify the links that exist between the disease phenotype (phenotype refers to observable signs and symptoms) and the disease genotype (genotype refers to your genetic information). The investigator also wants to identify biomarkers of ALS and related diseases. Type: Observational Start Date: Jan 2021 |
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
PolyNovo Biomaterials Pty Ltd.
Burns
This is a multi-center, pivotal study to assess the safety and effectiveness of a new
method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM). expand
This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM). Type: Interventional Start Date: Sep 2021 |
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
European Organisation for Research and Treatment of Cancer - EORTC
Retroperitoneal Sarcoma
Liposarcoma
Leiomyosarcoma
This is a multicenter, randomized, open label phase lll trial to assess whether
preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the
prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma)
patients as measured by disease free survival.
After... expand
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm. Type: Interventional Start Date: Jan 2021 |
Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
Duke University
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started
recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018,
the registry expanded to include recruitment of participants with other chronic fibrosing
interstitial lung diseases (ILDs) with... expand
The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018, the registry expanded to include recruitment of participants with other chronic fibrosing interstitial lung diseases (ILDs) with progressive phenotype also referred to as progressive fibrosing interstitial lung diseases in the Chronic Fibrosis Interstitial Lung Disease with Progressive Phenotype (ILD-PRO) Registry. When the third phase of the registry begins, the IPF-PRO registry will enroll additional patients with idiopathic pulmonary fibrosis. This IPF-PRO registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) or of another chronic fibrosing interstitial lung disease (ILD) with progressive phenotype established at the enrolling centers. In addition, blood samples and chest image studies will be collected and banked for future research projects. Type: Observational [Patient Registry] Start Date: Jun 2014 |
Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects with Non-Ischemic NYHA Class III Heart...
Asklepios Biopharmaceutical, Inc.
Congestive Heart Failure
This is a Phase 2 adaptive, double-blinded, placebo-controlled, randomized, multi-center
trial study to evaluate the safety and efficacy of a single dose of AB-1002, administered
via antegrade intracoronary artery infusion, in males and females age >18 years with
non-ischemic cardiomyopathy and NYHA... expand
This is a Phase 2 adaptive, double-blinded, placebo-controlled, randomized, multi-center trial study to evaluate the safety and efficacy of a single dose of AB-1002, administered via antegrade intracoronary artery infusion, in males and females age >18 years with non-ischemic cardiomyopathy and NYHA Class III symptoms of HF. Subjects will be randomized into one of three treatment groups in a 1:1:1 Type: Interventional Start Date: Oct 2023 |
Effects of Metformin on Airway Ion Channel Dysfunction in Cystic Fibrosis-related Diabetes
University of Kansas Medical Center
Cystic Fibrosis-related Diabetes
Cystic Fibrosis
The purpose of this study is to assess the efficacy of metformin to improve airway ion
channel function in those with CF-related diabetes (CFRD) expand
The purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with CF-related diabetes (CFRD) Type: Interventional Start Date: Feb 2022 |
Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib)...
National Cancer Institute (NCI)
Advanced Renal Cell Carcinoma
Chromophobe Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
Collecting Duct Carcinoma
Kidney Medullary Carcinoma
This phase II trial studies whether adding radium-223 dichloride to the usual treatment,
cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the
bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to
cancer cells and minimize harm to... expand
This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone. Type: Interventional Start Date: Jul 2020 |
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by...
ECOG-ACRIN Cancer Research Group
ALK Gene Rearrangement
ALK Gene Translocation
ALK Positive
Stage IB Non-Small Cell Lung Carcinoma AJCC v7
Stage II Non-Small Cell Lung Cancer AJCC v7
This randomized phase III trial studies how well crizotinib works in treating patients
with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a
mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in
ALK can make it very active and important... expand
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation. Type: Interventional Start Date: Mar 2015 |
HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry
University of Kansas Medical Center
Heart Failure
The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect
relevant patient-level demographic, clinical, laboratory, and hemodynamic data from
patients implanted with pulmonary artery pressure sensor at participating centers to
advance scientific knowledge about ambulatory... expand
The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research. Type: Observational [Patient Registry] Start Date: Oct 2022 |
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