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Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Celgene
Neoplasms
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for
all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy
participating in a previous Celgene sponsored or Celgene alliance partner sponsored
study.
Participants who received at least... expand
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol. Type: Interventional Start Date: Jun 2018 |
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic...
Juno Therapeutics, a Subsidiary of Celgene
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Small Lymphocytic
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety
of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will
include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in
subjects with relapsed or refractory CLL or... expand
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated. Type: Interventional Start Date: Nov 2017 |
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive...
Alliance for Clinical Trials in Oncology
Intracranial Meningioma
Recurrent Meningioma
NF2 Gene Mutation
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor
GSK2256098, and capivasertib work in treating patients with meningioma that is growing,
spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098,
capivasertib, and abemaciclib may stop the... expand
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Type: Interventional Start Date: Aug 2015 |
Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction
Northwestern University
Heart Failure
Heart Failure With Preserved Ejection Fraction
The purpose of this study is to identify changes in heart tissue structure and biological
function in patients with heart failure by performing an endomyocardial biopsy (EMB or
heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use
this information to develop new treatments... expand
The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure. Type: Observational [Patient Registry] Start Date: Aug 2024 |
Study of REM-422 in Patients With AML or Higher Risk MDS
Remix Therapeutics
Myelodysplastic Syndromes
Higher Risk Myelodysplastic Syndromes
Acute Myeloid Leukemia
Acute Myeloid Leukemia Refractory
The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB
mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML expand
The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML Type: Interventional Start Date: Apr 2024 |
Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Cure HHT
Hereditary Hemorrhagic Telangiectasia
Arteriovenous Malformations
Telangiectasia
Epistaxis
GastroIntestinal Bleeding
The Comprehensive HHT Outcomes Registry of the United States (CHORUS) is an observational
registry of patients diagnosed with Hereditary Hemorrhagic Telangiectasia (HHT). The
purpose of this study is to better understand HHT, the symptoms and complications it
causes, and the impact the disease has... expand
The Comprehensive HHT Outcomes Registry of the United States (CHORUS) is an observational registry of patients diagnosed with Hereditary Hemorrhagic Telangiectasia (HHT). The purpose of this study is to better understand HHT, the symptoms and complications it causes, and the impact the disease has on people's lives. The investigators will collect long-term information about the participant, allowing us to understand how the disease changes over time, and what factors can influence those changes. Ultimately, this should help improve treatments for the disease. Another important goal of the study is to provide a way to contact people to participate in future clinical trials and other research. The registry will be a centralized resource for recruitment for clinical trials. People in the registry will not be obligated to join any of these additional studies, but if interested, can agree to be contacted if they may be eligible for a study. Participants will: - Be asked to provide permission to collect information from their medical records, including things like demographic information, diagnosis information, family history, test results, treatment information, symptoms, complications, lifestyle and other relevant medical information. - Be asked study-related questions by phone or at a clinic visit. - Be asked study-related questions every year after enrollment for up to 10 years or until the study ends. A member of the study team will communicate with participants by phone or at clinic visits to collect information regarding any changes to their health over the previous year/s including new test results, treatment information, symptoms, and complications from HHT. Type: Observational [Patient Registry] Start Date: Nov 2023 |
A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
Eli Lilly and Company
Metastatic Solid Tumor
Recurrent Solid Tumor
Advanced Solid Tumor
Urinary Bladder Neoplasm
Triple Negative Breast Cancer
The purpose of this study is to find out whether the study drug, LY4101174, is safe,
tolerable and effective in participants with advanced, or metastatic solid tumors. The
study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase
Ib (dose-expansion). The study will... expand
The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years. Type: Interventional Start Date: Mar 2024 |
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy...
Massachusetts General Hospital
Atrial Fibrillation
The primary objective of this clinical investigation is to demonstrate the safety and
12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation
in the treatment of subjects with symptomatic paroxysmal and persistent atrial
fibrillation using the pulsed field ablation... expand
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator. Type: Interventional Start Date: Dec 2023 |
The Molecular Basis of Inherited Reproductive Disorders
Stephanie B. Seminara, MD
Hypogonadotropic Hypogonadism
Reproductive Disorder
Kallmann Syndrome
Delayed Puberty
The goal of this study is to learn more about the genes that control puberty and
reproduction in humans. expand
The goal of this study is to learn more about the genes that control puberty and reproduction in humans. Type: Observational Start Date: Jan 2021 |
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
Memo Therapeutics AG
BK Viremia; BKV DNAemia
The purpose of this study is to evaluate the safety, tolerability, and efficacy of
AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney
transplant recipients. This study has an operationally seamless phase II/III design. The
phase II part will evaluate the safety of... expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients. This study has an operationally seamless phase II/III design. The phase II part will evaluate the safety of AntiBKV in kidney transplant recipients and establish antiviral proof of concept. The phase II part includes a dose-comparison part to generate additional PK and PD data of AntiBKV. The phase III part will assess the efficacy of AntiBKV in kidney transplant recipients. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every four weeks). In phase II, 60 participants will be first randomized (1:1) to receive either four doses of 1,000 mg of AntiBKV or placebo. In an additional dose-comparison extension, another 30 participants will be enrolled and randomized (1:1:1) to receive either four doses of 1,000 mg AntiBKV, four doses of 500 mg AntiBKV, or placebo. Based on a Day 141 analysis after phase II the sample size for the phase III part of the trial will be defined. Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a four-week interval. For the first ten participants enrolled in the study, the infusion time will be at least 60 minutes. Provided there are no safety concerns observed with the first ten participants the duration of subsequent infusions will be at least 30 minutes. After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and if clinically indicated. Type: Interventional Start Date: Apr 2023 |
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults...
Cytokinetics
Obstructive Hypertrophic Cardiomyopathy (oHCM)
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274)
compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy
and left ventricular outflow tract obstruction expand
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction Type: Interventional Start Date: Jun 2023 |
Blood Pressure Variability and Ischemic Stroke Outcome
Yale University
Acute Ischemic Stroke
Blood Pressure Variability
The goal of this observational study is to evaluate the role of blood pressure (BPV)
variability in patients suffering from acute ischemic stroke. The main questions it aims
to answer are:
1. To determine the association of BPV with functional/cognitive outcome after ischemic
stroke.... expand
The goal of this observational study is to evaluate the role of blood pressure (BPV) variability in patients suffering from acute ischemic stroke. The main questions it aims to answer are: 1. To determine the association of BPV with functional/cognitive outcome after ischemic stroke. 2. To determine a pathophysiologic mechanism of BPV's deleterious effect on functional outcome. 3. To evaluate potential treatment targets to pharmacologically reduce BPV after ischemic stroke. Type: Observational Start Date: Jul 2024 |
Intervention for Fatigue in HCT Recipients
Massachusetts General Hospital
Hematologic Cancer
Hematologic Malignancy
The purpose of this study is to assess whether a cognitive-behavioral therapy (CBT) for
fatigue intervention is acceptable, feasible, and effective at managing fatigue and
improving quality of life for patients following hematopoietic stem cell transplant
(HCT). expand
The purpose of this study is to assess whether a cognitive-behavioral therapy (CBT) for fatigue intervention is acceptable, feasible, and effective at managing fatigue and improving quality of life for patients following hematopoietic stem cell transplant (HCT). Type: Interventional Start Date: Nov 2023 |
Nutrition for Precision Health, Powered by the All of Us
RTI International
Nutrition
Health
Dietary Habits
The goal of this investigational study is to develop algorithms that predict human
response to foods. The main question it aims to answer are:
- How does varying foods and eating patterns impact one's biological and physiological
responses?
- In what ways can novel dietary assessment... expand
The goal of this investigational study is to develop algorithms that predict human response to foods. The main question it aims to answer are: - How does varying foods and eating patterns impact one's biological and physiological responses? - In what ways can novel dietary assessment measures be used to improve dietary assessments and to prescribe assessments to people in future research with increased precision? - Can artificial intelligence and machine learning techniques be combined to prescribe foods and eating patterns to individuals for optimization of their health? There are 3 Modules participants may take part in: - Module 1- A participant's dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, as well as physiological responses to a liquid mixed meal tolerance test will be measured. - Module 2- Participants will undergo three controlled dietary interventions provided for 14-days each and separated by washout periods of at least 14 days. Physiological responses following a diet-specific meal test will be measured. - Module 3- Participants will undergo the same three dietary interventions during the same 14 day periods as Module 2 while being studied in-residence. Physiological responses following a liquid mixed meal tolerance test and a diet-specific meal test will be measured. Type: Interventional Start Date: Apr 2023 |
A Study to Investigate LYL845 in Adults With Solid Tumors
Lyell Immunopharma, Inc.
Melanoma
Non-small Cell Lung Cancer
Colorectal Cancer
This is an open-label, multi-center, dose-escalation study with expansion cohorts,
designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically
reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed
or refractory (R/R) metastatic or locally... expand
This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). Type: Interventional Start Date: Dec 2022 |
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal...
Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy
This registry evaluates patient characteristics, real-world treatment patterns, and
short- and long-term outcomes in a population of patients in the United States and Europe
with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving
mavacamten, receiving other treatment for obstructive... expand
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment. United States Sub-Study: The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Europe Sub-Study: The purpose of this study is to evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Type: Observational [Patient Registry] Start Date: Aug 2022 |
Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity...
Massachusetts General Hospital
Attention Deficit Disorder
Attention Deficit Disorder With Hyperactivity
The investigators are investigating whether home-based tDCS over the course of four weeks
can improve ADHD symptom severity and improve dysexecutive functioning (cognitive
control). Further, the investigators are investigating whether there is a dose-dependent
response to tDCS. expand
The investigators are investigating whether home-based tDCS over the course of four weeks can improve ADHD symptom severity and improve dysexecutive functioning (cognitive control). Further, the investigators are investigating whether there is a dose-dependent response to tDCS. Type: Interventional Start Date: Jul 2022 |
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic...
Regor Pharmaceuticals Inc.
Breast Cancer
This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety,
tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B
administered orally as monotherapy OR in combination with Hormonal Therapy in subjects
with HR+, HER2- locally advanced and unresectable... expand
This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR+, HER2- locally advanced and unresectable (Stage III) or metastatic (Stage IV) breast cancer whose disease has progressed during prior therapy with an approved CDK4/6i plus hormonal therapy. Type: Interventional Start Date: Mar 2022 |
PARADIGM: Amplatzer Valvular Plug for PVL Closure
Abbott Medical Devices
Paravalvular Aortic Regurgitation
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the
safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for
clinically significant PVLs following surgical implant of a mechanical or biological
heart valve implanted in the aortic or... expand
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position. Type: Interventional Start Date: Dec 2020 |
PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
Michael J. Fox Foundation for Parkinson's Research
Parkinson Disease
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD)
progression in study participants with manifest... expand
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability. Type: Observational Start Date: Jul 2020 |
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases...
Mundipharma Research Limited
Candidemia
Mycoses
Fungal Infection
Fungemia
Invasive Candidiasis
The purpose of this pivotal study is to determine if intravenous Rezafungin is
efficacious and safe in the prevention of invasive fungal diseases when compared to the
standard antimicrobial regimen. expand
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen. Type: Interventional Start Date: May 2020 |
Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer:...
Massachusetts General Hospital
Breast Cancer
This research is to evaluate the effectiveness of Talazoparib as a potential treatment
for metastatic breast cancer with a BRCA 1 or BRCA 2 mutation. expand
This research is to evaluate the effectiveness of Talazoparib as a potential treatment for metastatic breast cancer with a BRCA 1 or BRCA 2 mutation. Type: Interventional Start Date: Nov 2021 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
Stroke
CPAP
The purpose of this study is to determine whether treatment of obstructive sleep apnea
(OSA) with positive airway pressure starting shortly after acute ischemic stroke (1)
reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after
the event, and (2) improves stroke outcomes... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards Lifesciences
Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve
Repair System in patients with degenerative mitral regurgitation (DMR) who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in
patients with functional mitral regurgitation... expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Type: Interventional Start Date: Nov 2018 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
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