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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 |
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 |
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 |
Project: Every Child for Younger Patients With Cancer
Children's Oncology Group
Adrenal Gland Pheochromocytoma
Carcinoma In Situ
Central Nervous System Neoplasm
Childhood Immature Teratoma
Childhood Langerhans Cell Histiocytosis
This study gathers health information for the Project: Every Child for younger patients
with cancer. Gathering health information over time from younger patients with cancer may
help doctors find better methods of treatment and on-going care. expand
This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care. Type: Observational Start Date: Nov 2015 |
IVIG for Infection Prevention After CAR-T-Cell Therapy
Fred Hutchinson Cancer Center
Lymphoma
This phase II trial compares the effects of immunoglobulin replacement therapy with a
placebo for preventing infectious complications in patients receiving CD19 chimeric
antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in
patients who receive CD19 CAR-T cell therapy.... expand
This phase II trial compares the effects of immunoglobulin replacement therapy with a placebo for preventing infectious complications in patients receiving CD19 chimeric antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in patients who receive CD19 CAR-T cell therapy. This is a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high. Immunoglobulin replacement therapy works by replacing the body's IgG antibodies with donor blood product derived IgG antibodies that may help prevent infection. IgG antibodies are often depleted as a result of CAR-T therapy. Giving immunoglobulin replacement therapy may prevent infectious complications in patients receiving CD19 CAR-T cell therapy. Type: Interventional Start Date: Jun 2024 |
Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
Spaulding Rehabilitation Hospital
Diabete Type 2
Amputation
The study will test a new approach to the design and implementation of socket and liner
technology in individuals who lost a lower limb secondary to diabetes mellitus type II
(herein referred to as dysvascular amputees). The technology-based intervention will be
combined with an exercise program designed... expand
The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees. Type: Interventional Start Date: Dec 2023 |
A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid...
Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Esophageal Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary
anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell
lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human
papilloma virus associated head and neck... expand
To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma. Type: Interventional Start Date: Apr 2023 |
RNS System LGS Feasibility Study
NeuroPace
Epilepsy
Lennox Gastaut Syndrome
Lennox-Gastaut Syndrome, Intractable
Seizures
Seizures, Generalized
To generate preliminary safety and effectiveness data for brain-responsive
neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the
frequency of generalized seizures in individuals 12 years of age or older with Lennox
Gastaut Syndrome (LGS) who are refractory to antiseizure... expand
To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS. Type: Interventional Start Date: Oct 2022 |
Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk
Raymond Chung
Liver Fibroses
Cirrhosis
Prospective randomized, multi-center, double blind placebo-controlled trial to assess the
chemopreventive impact of atorvastatin (20 mg oral) vs placebo in up to 60 adults with
advanced fibrosis at high risk of developing HCC. expand
Prospective randomized, multi-center, double blind placebo-controlled trial to assess the chemopreventive impact of atorvastatin (20 mg oral) vs placebo in up to 60 adults with advanced fibrosis at high risk of developing HCC. Type: Interventional Start Date: May 2023 |
Mitral Valve Screening Survey
Medstar Health Research Institute
Mitral Valve Disease
This study aims to examine the clinical profile/anatomical characteristics and natural
history of patients who subsequently fail screening for transcatheter mitral valve
intervention (TMVI). expand
This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI). Type: Observational [Patient Registry] Start Date: Aug 2021 |
Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study)
Massachusetts General Hospital
HIV/AIDS
Heart Failure With Preserved Ejection Fraction
Persons with HIV, even those well-treated, are at increased risk for heart disease when
compared to the general population. Two hormones called aldosterone and brain natriuretic
peptide (BNP), which have been shown to be abnormal in HIV, may be associated with
inflammation as well as early changes... expand
Persons with HIV, even those well-treated, are at increased risk for heart disease when compared to the general population. Two hormones called aldosterone and brain natriuretic peptide (BNP), which have been shown to be abnormal in HIV, may be associated with inflammation as well as early changes in structure and function of the heart. This study is being conducted to evaluate whether therapies to block aldosterone and increase BNP levels may reduce the burden and progression of heart failure to improve cardiovascular health. Type: Interventional Start Date: Sep 2020 |
Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema...
Massachusetts General Hospital
Breast Cancer
This research will compare the absolute volumes of the upper extremity using both the
LymphaTech Scanner and Perometer in a cohort of patients with a history of invasive or
in-situ carcinoma of the breast. expand
This research will compare the absolute volumes of the upper extremity using both the LymphaTech Scanner and Perometer in a cohort of patients with a history of invasive or in-situ carcinoma of the breast. Type: Interventional Start Date: Jan 2019 |
Multi-center Evaluation of the Clinical Utility of ESD in the Western Population
University of Florida
Endoscopic Submucosal Dissection
The aim of this multi-center study is to prospectively document the clinical utility of
ESD. expand
The aim of this multi-center study is to prospectively document the clinical utility of ESD. Type: Observational Start Date: Mar 2016 |
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial...
Cumberland Pharmaceuticals
Scleroderma, Diffuse
Scleroderma, Systemic
Scleroderma, Limited
Sclerosis, Progressive Systemic
Skin Diseases
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled,
study is to assess the safety and efficacy of ifetroban in patients with diffuse
cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension
(SSc-PAH). expand
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH). Type: Interventional Start Date: Jan 2017 |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Center for International Blood and Marrow Transplant Research
Hematologic Malignancies
Inherited Disorders of Metabolism
Inherited Abnormalities of Platelets
Histiocytic Disorders
Acute Myelogenous Leukemia (AML or ANLL)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications. expand
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. Type: Observational Start Date: Oct 2011 |
Mucopolysaccharidosis I (MPS I) Registry
Genzyme, a Sanofi Company
Mucopolysaccharidosis I (MPS I)
The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that
tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will
provide information to better characterize the natural history and progression of MPS I
as well as the clinical responses... expand
The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities. The objectives of the Registry are: - To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase) - To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I - To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care Type: Observational Start Date: Nov 2003 |
A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers
Massachusetts General Hospital
Cancer
Survivorship
Caregiver Burden
Psychological Distress
Coping Skills
The purpose of this pilot study is to examine the feasibility and acceptability of a
brief psychotherapy intervention to improve psychosocial coping and maintain couple
relationships among young adults (aged 25-39) with cancer and their caregiving partners. expand
The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners. Type: Interventional Start Date: Apr 2024 |
Phase I Study of ANK-101 in Advanced Solid Tumors
Ankyra Therapeutics, Inc
Advanced Solid Tumor
Cutaneous Tumor
Subcutaneous Tumor
Malignant Solid Tumor
Solid Tumor
This is a Phase 1, multicenter, open-label dose escalation study to determine the safety
and tolerability of intratumoral (IT) injection of ANK-101 in participants with advanced
solid tumors who have progressed during or after receiving standard of care (SOC) therapy
or who will not benefit from such... expand
This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of ANK-101 in participants with advanced solid tumors who have progressed during or after receiving standard of care (SOC) therapy or who will not benefit from such therapy. The study will be conducted in two parts; Part 1 will enroll participants with superficial lesions and Part 2 will enroll participants with visceral lesions. Type: Interventional Start Date: Jan 2024 |
Biomarker for Infection Risk in CLL and MM
Massachusetts General Hospital
Multiple Myeloma
Chronic Lymphocytic Leukemia
The aim of this research study is to use advanced immunology laboratory analysis to
identify a more precise blood test that will predict infection risk in patients with
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma
(MM). expand
The aim of this research study is to use advanced immunology laboratory analysis to identify a more precise blood test that will predict infection risk in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM). Type: Observational Start Date: Aug 2023 |
Immunomodulatory Effects of PCSK9 Inhibition
Massachusetts General Hospital
Atherosclerotic Cardiovascular Disease
Cardiovascular Diseases
Atherosclerosis
Arterial Inflammation
Vascular Diseases
Cardiovascular disease (CVD) represents the leading cause of death worldwide. While
medications, such as statins, significantly reduce atherosclerotic CVD (ASCVD) risk by
lowering low density lipoprotein levels, they may also have pleiotropic effects on
inflammation. The immunomodulatory effects of... expand
Cardiovascular disease (CVD) represents the leading cause of death worldwide. While medications, such as statins, significantly reduce atherosclerotic CVD (ASCVD) risk by lowering low density lipoprotein levels, they may also have pleiotropic effects on inflammation. The immunomodulatory effects of these medications are relevant to ASCVD risk reduction given that inflammation plays a central role in atherosclerotic plaque formation (atherogenesis) and influences the development of vulnerable plaque morphology. Patients on statins, however, may have residual inflammation contributing to incident ASCVD despite the potent LDL-lowering effects of statins. While new therapies, such as proprotein convertase subtilisin/kexin type 9 (PSCK9) inhibitors, further reduce incident ASCVD and drastically reduce LDL-C below that achieved by statin therapy alone, PCSK9 inhibitors may also have pleiotropic effects on inflammation. Thus, PCSK9 inhibitors may help reduce arterial inflammation to a level closer to that of patients without ASCVD. This study will apply a novel targeted molecular imaging approach, technetium 99m (99mTc)-tilmanocept SPECT/CT, to determine if residual macrophage-specific arterial inflammation is present with statin therapy and the immunomodulatory effects of PSCK9 inhibition. Given the continued high mortality and morbidity attributable to ASCVD, strong imperatives exist to better understand the immunomodulatory effects of lipid lowering therapies and residual inflammatory risk. This understanding, in turn, will inform the development of new ASCVD preventative and treatment strategies as well as elucidate other indications for established therapies. Type: Observational Start Date: Apr 2024 |
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602...
Marengo Therapeutics, Inc.
Advanced Solid Tumors
Genital Neoplasm, Female
Urogenital Neoplasms
Lung Neoplasm
Neoplasms by Site
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and
preliminary clinical activity of STAR0602 as a single agent administered intravenously in
participants with advanced solid tumors that are antigen-rich. expand
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich. Type: Interventional Start Date: Jan 2023 |
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