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Prospective Study of Pregnancy in Women With Cystic Fibrosis
Amalia Magaret
Pregnancy Related
Cystic Fibrosis
In this study, the investigators aim to evaluate changes in lung function in women with
cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure
to highly effective cystic fibrosis transmembrane conductance regulator (CFTR)
modulators. expand
In this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. Type: Observational Start Date: Sep 2021 |
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients...
University of British Columbia
Aortic Stenosis
Coronary Artery Disease
Coronary Stenosis
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant
coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty
about the benefits and the optimal timing of revascularization for such patients. There
is currently clinical equipoise... expand
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance. The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure. The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elective transfemoral TAVR and randomized within 96 hours of successful balloon expandable TAVR. Complete Revascularization: Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a ≥70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR. Vs. Medical Therapy Alone: No further revascularization of coronary artery lesions. All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies. The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD. Type: Interventional Start Date: Dec 2020 |
The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease
Massachusetts General Hospital
Atherosclerosis
Stress
Inflammation
This study aims to evaluate the effect of 8 weeks of a stress reduction intervention on
atherosclerotic plaque inflammation in adults with stable coronary artery disease, as
quantified by positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in
individuals with increased psychosocial... expand
This study aims to evaluate the effect of 8 weeks of a stress reduction intervention on atherosclerotic plaque inflammation in adults with stable coronary artery disease, as quantified by positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in individuals with increased psychosocial stress. Type: Interventional Start Date: Nov 2021 |
MitraClip REPAIR MR Study
Abbott Medical Devices
Mitral Valve Regurgitation
The objective of this randomized controlled trial (RCT) is to compare the clinical
outcome of MitraClip™ device versus surgical repair in patients with severe primary MR
who are at moderate surgical risk and whose mitral valve has been determined to be
suitable for correction by MV repair surgery... expand
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. Type: Interventional Start Date: Jul 2020 |
Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.
Spaulding Rehabilitation Hospital
Parkinson Disease
This trial aims to understand the mechanism and to test whether transcranial direct
current stimulation (tDCS) combined with transcranial ultrasound (TUS) (tDCS+TUS)
combined with physical therapy (PT) will induce significant therapeutic effects in
postural instability in Parkinson's disease (PT)... expand
This trial aims to understand the mechanism and to test whether transcranial direct current stimulation (tDCS) combined with transcranial ultrasound (TUS) (tDCS+TUS) combined with physical therapy (PT) will induce significant therapeutic effects in postural instability in Parkinson's disease (PT) patients. The investigators designed a double-blinded, placebo controlled, randomized study to investigate the effects of 2 weeks of TDCS+TUS on postural instability in PD patients receiving PT. (Followed by biweekly sessions for 2 more weeks in Phase II) Type: Interventional Start Date: Jan 2020 |
Positron Emission Tomography (PET) Imaging of Thrombosis
Massachusetts General Hospital
Atrial Fibrillation
COVID-19
Cancer
Thrombosis
The purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR
imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in
the body, for instance in the left atrial appendage of patients with atrial fibrillation,
and thereby may provide a non-invasive... expand
The purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in the body, for instance in the left atrial appendage of patients with atrial fibrillation, and thereby may provide a non-invasive alternative to the current standard-of-care methods. Type: Interventional Start Date: Apr 2016 |
Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis...
Massachusetts General Hospital
Pulmonary Fibrosis
Lung Cancer
The goal of this study is to investigate the safety of [68Ga]CBP8 and its efficacy to
detect collagen deposition in pulmonary fibrosis. expand
The goal of this study is to investigate the safety of [68Ga]CBP8 and its efficacy to detect collagen deposition in pulmonary fibrosis. Type: Interventional Start Date: Aug 2018 |
Dosing and Tolerability of Deoxycholic Acid Versus Polidocanol in the Treatment of Neurofibromatosis...
Massachusetts General Hospital
Neurofibromatosis 1
This study will evaluate the tolerability and effectiveness of two treatments in
Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: Kybella and
Asclera injection. Each patient will have a treatment and a control site. expand
This study will evaluate the tolerability and effectiveness of two treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: Kybella and Asclera injection. Each patient will have a treatment and a control site. Type: Interventional Start Date: Dec 2022 |
Automated Imaging Differentiation of Parkinsonism
University of Florida
Parkinson Disease
Multiple System Atrophy, Parkinson Variant
Progressive Supranuclear Palsy
The purpose of this study is to test the performance of the AID-P across 21 sites in the
Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and
will upload the data to the web-based software tool. The clinical diagnosis will be
blinded to the diagnostic algorithm and... expand
The purpose of this study is to test the performance of the AID-P across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis. Type: Observational Start Date: Jul 2021 |
Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
Massachusetts General Hospital
Diabetes Mellitus, Type 1
Diabetes type1
Autoimmune Diabetes
The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG)
vaccinations can confer a beneficial immune and metabolic effect on pediatric Type 1
diabetes. expand
The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on pediatric Type 1 diabetes. Type: Interventional Start Date: Mar 2022 |
Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid...
Synthekine
Advanced Solid Tumor
Non Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Malignant Melanoma
Renal Cell Carcinoma
This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of
STK-012 as monotherapy and in combination with pembrolizumab in patients with selected
advanced solid tumors. expand
This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination with pembrolizumab in patients with selected advanced solid tumors. Type: Interventional Start Date: Jan 2022 |
Sensor-based Characterization of Depression
Massachusetts General Hospital
Unipolar Depression
This is a longitudinal study where individual with Major Depressive Disorder (MDD) will
be monitored for 12 weeks. The study aims to develop an objective, sensor-based,
algorithm able to detect the presence of depression as well as predict treatment
response. Measurement-based treatment is considered... expand
This is a longitudinal study where individual with Major Depressive Disorder (MDD) will be monitored for 12 weeks. The study aims to develop an objective, sensor-based, algorithm able to detect the presence of depression as well as predict treatment response. Measurement-based treatment is considered optimal and the development of a valid passive, objective, behavioral and biological assessment of depressive symptoms that does not rely on clinician interviews will improve monitoring and ultimately improve treatment significantly. Type: Observational Start Date: Jan 2020 |
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Weill Medical College of Cornell University
Sensation Disorders
Sensation, Phantom
Pain, Postoperative
Pain, Chronic
Numbness
During breast surgery, sensory nerves are cut which may lead to reduced sensation and
pain. Surgical reinnervation techniques have been developed with the aim of improving
postoperative sensation by preserving the nerves and connecting them to the nipple and
areola. The investigators aim to compare... expand
During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively. Type: Observational Start Date: Feb 2022 |
Lung Cancer Screening in High-risk Black Women
Massachusetts General Hospital
Lung Cancer
Lung Carcinoma
The goal of this research study is to study U.S. Black women with a history of smoking to
examine the feasibility, acceptability, and performance of low-dose computed tomography
(LDCT) screening among this population.
The name of the intervention used in this research study is:
Low-dose computed... expand
The goal of this research study is to study U.S. Black women with a history of smoking to examine the feasibility, acceptability, and performance of low-dose computed tomography (LDCT) screening among this population. The name of the intervention used in this research study is: Low-dose computed tomography (radiologic scan) chest scan Type: Interventional Start Date: Sep 2023 |
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Massachusetts General Hospital
Pulmonary Embolism
Venous Thromboembolism
Metabolomics
Oxygen Inhalation Therapy
A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE).
Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute
pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and
reducing pulmonary pressure (PA) pressure,... expand
A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE). Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven. Type: Interventional Start Date: Oct 2023 |
A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
K36 Therapeutics, Inc.
Multiple Myeloma
Myeloma
Myeloma Multiple
A Phase I study to evaluate the safety of a novel, orally available, selective, and
potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also
known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with
relapsed or refractory multiple myeloma (RRMM). expand
A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM). Type: Interventional Start Date: Feb 2023 |
Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
Massachusetts Eye and Ear Infirmary
Laryngeal Dystonia
Spasmodic Dysphonia
Tremor
Dystonia
The goals of this project are 1) to determine the incidence of neurological voice
disorders in patients with dystonia and essential tremor undergoing deep brain
stimulation (DBS), 2) investigate the neuroimaging and intracranial neurophysiology
correlates of voice dysfunction in these subjects, and... expand
The goals of this project are 1) to determine the incidence of neurological voice disorders in patients with dystonia and essential tremor undergoing deep brain stimulation (DBS), 2) investigate the neuroimaging and intracranial neurophysiology correlates of voice dysfunction in these subjects, and subsequently 3) determine the effects of DBS on voice function. Type: Interventional Start Date: Jun 2022 |
Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of...
Massachusetts General Hospital
Subarachnoid Hemorrhage, Aneurysmal
This is a single-site, single-arm, open-label pilot study assessing the safety,
feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS), gammaCore, for
the acute treatment of aneurysmal subarachnoid hemorrhage (SAH) subjects in a
neurocritical care setting. 25 patients will be enrolled,... expand
This is a single-site, single-arm, open-label pilot study assessing the safety, feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS), gammaCore, for the acute treatment of aneurysmal subarachnoid hemorrhage (SAH) subjects in a neurocritical care setting. 25 patients will be enrolled, all treated with an active device. The primary efficacy outcomes are reduced aneurysm rupture rate, reduced seizure and seizure-spectrum activity, minimized hemorrhage grades, and increased survival. Type: Interventional Start Date: Oct 2022 |
Extracellular RNA Biomarkers of Myotonic Dystrophy
Massachusetts General Hospital
Myotonic Dystrophy
Current methods of measuring the response to new treatments for muscular dystrophies
involve the examination of small pieces of muscle tissue called biopsies. The
investigators are interested in finding less invasive methods that reduce the need for
muscle biopsies. The purpose of this research is... expand
Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample. Type: Observational Start Date: Dec 2020 |
Extracellular RNA Biomarkers of Duchenne Muscular Dystrophy
Massachusetts General Hospital
Duchenne Muscular Dystrophy
Current methods of measuring the response to new treatments for muscular dystrophies
involve the examination of small pieces of muscle tissue called biopsies. The
investigators are interested in finding less invasive methods that reduce the need for
muscle biopsies. The purpose of this research is... expand
Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample. Type: Observational Start Date: Nov 2019 |
INTREPId (INTermediate Risk Erection PreservatIon Trial)
Dana-Farber Cancer Institute
Prostate Cancer
This research study is comparing the use of a new form of hormonal therapy used with
radiation as a possible treatment for intermediate risk prostate cancer. More
specifically, this research would help determine whether this new form of hormonal
therapy is as effective as the standard hormone therapy... expand
This research study is comparing the use of a new form of hormonal therapy used with radiation as a possible treatment for intermediate risk prostate cancer. More specifically, this research would help determine whether this new form of hormonal therapy is as effective as the standard hormone therapy while also preserving erectile function. Type: Interventional Start Date: Jun 2020 |
Developing Viability Index for Machine Perfused Livers
Massachusetts General Hospital
Liver Cirrhoses
Machine perfusion technology is nearing the point of rescuing discarded liver grafts in
the hope of proving them to be or improving them to the point of being transplantable.
However, there are no validated metrics to determine transplantability after machine
perfusion. This study involves collecting... expand
Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers. Type: Interventional Start Date: Oct 2018 |
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
St. Louis University
Giant Cell Tumor of Bone
The purpose of the clinical study is to investigate whether the local delivery of
bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of
bone coming back to the same location. The hypothesis is that the local administration of
bisphosphonate will decrease the rate of... expand
The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor. Type: Interventional Start Date: May 2018 |
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Duke University
Rheumatic Joint Disease
Continuation of the CARRA Registry as described in the protocol will support data
collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will
form the basis for future CARRA studies. In particular, this observational registry will
be used to answer pressing questions about... expand
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions. Type: Observational [Patient Registry] Start Date: Jul 2015 |
A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes
Massachusetts General Hospital
PSP
CBD
Progressive Supranuclear Palsy
FTD
Corticobasal Degeneration
The primary objective of this study is to enroll an observational cohort of approximately
60 patients with PSP over the course of 24 months using a multicenter study design and to
follow each of them for 12 months.
The secondary objective of this study is to develop a robust solution for multi-modal
remote... expand
The primary objective of this study is to enroll an observational cohort of approximately 60 patients with PSP over the course of 24 months using a multicenter study design and to follow each of them for 12 months. The secondary objective of this study is to develop a robust solution for multi-modal remote monitoring of motor symptoms and function in PSP that can be applied to other Frontotemporal lobar degeneration (FTLD) syndromes. Type: Observational Start Date: Jul 2023 |
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