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Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy...
Massachusetts General Hospital
Adhesive Capsulitis
Frozen Shoulder
Shoulder Frozen
The purpose of this study is to identify individuals 18 or older who have diagnostic
presentation of adhesive capsulitis and randomize them into two arms, distinguished by
use of physical therapy and steroid injections compared with steroid injections followed
by watchful waiting. This prospective... expand
The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm. Type: Interventional Start Date: Nov 2014 |
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Massachusetts General Hospital
Keratoconus
Ectasia
Crosslinking
Fuchs' Endothelial Dystrophy
We have developed novel Brillouin microscopy and we are testing its potential for
keratoconus and ectasia diagnostics. We plan to perform axial scans of the cornea in
human volunteers in order to compare biomechanical properties of Keratoconus vs. Normal
corneas and compare biomechanical properties... expand
We have developed novel Brillouin microscopy and we are testing its potential for keratoconus and ectasia diagnostics. We plan to perform axial scans of the cornea in human volunteers in order to compare biomechanical properties of Keratoconus vs. Normal corneas and compare biomechanical properties of post-LASIK ectasia vs. normal corneas. Type: Observational Start Date: Jun 2013 |
Physical Activity Monitoring in Myasthenia Gravis
Massachusetts General Hospital
Myasthenia Gravis
The goal of this observational study is to evaluate the feasibility of using wearable
sensor and digital technologies to measure motor and speech function in adults with
autoimmune Myasthenia Gravis (MG).
The main question[s] it aims to answer are:
- To measure the correlation of sensor-based... expand
The goal of this observational study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function in adults with autoimmune Myasthenia Gravis (MG). The main question[s] it aims to answer are: - To measure the correlation of sensor-based measures of motor function with existing outcome measures including the MG-ADL, MGQOL15r, QMG, MGComposite, and Neuro-QOL Fatigue scales. - To develop and validate tablet-based digital assessments of speech and facial expression and to compare with existing outcome measures. Participants will wear a pendant sensor for 7 days and then participate in tablet-based and in-person myasthenia-specific physical examinations. This will be performed in concert with routine care in the Massachusetts General Hospital MG clinic. Type: Observational Start Date: Feb 2024 |
Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
Massachusetts General Hospital
Liver Cirrhosis
Hepatic Cell Carcinoma
Portal Hypertension
A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study
to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols.
The specific hypotheses include:
- Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation
of hepatic... expand
A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols. The specific hypotheses include: - Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation of hepatic macro and microhemodynamics in cirrhotic patients - Dedicated simultaneously acquired DWI sequences might quantitate liver fibrosis and improve hemodynamic quantitation. - Ga-PSMA PET/MRI may allow noninvasive and reproducible quantitation of portal venous hypertension and predict its evolution, as well as response to treatments - Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of cirrhosis Type: Observational Start Date: Dec 2023 |
Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis...
Massachusetts General Hospital
Neurofibromatosis 1
This study will evaluate the effectiveness of skin cooling in increasing tolerability of
four treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments
are: a 980nm laser, a 755nm laser, radio-frequency injection, and a Kybella injection.
Each patient will have a treatment and... expand
This study will evaluate the effectiveness of skin cooling in increasing tolerability of four treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 980nm laser, a 755nm laser, radio-frequency injection, and a Kybella injection. Each patient will have a treatment and a control site.. Type: Interventional Start Date: Mar 2024 |
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM...
Jasper Gerritsen
Glioblastoma
High-grade Glioma
Glioblastoma, IDH-wildtype
Glioblastoma, IDH-mutant
Glioblastoma Multiforme, Adult
A greater extent of resection of the contrast-enhancing (CE) tumor part has been
associated with improved outcomes in high-grade glioma patients. Recent results suggest
that resection of the non-contrast-enhancing (NCE) part might yield even better survival
outcomes (supramaximal resection, SMR).... expand
A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively. The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM). Type: Observational Start Date: Jan 2022 |
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization
Massachusetts General Hospital
Uterine Bleeding
Uterine Fibroid
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid
treatment in patients undergoing UFE. expand
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE. Type: Interventional Start Date: Feb 2023 |
Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant
800 adult first time kidney transplant recipients will be enrolled in the Observational
Study and followed to evaluate their Human Leukocyte Antigen (HLA)-DR/DQ molecular
mismatch (mMM) score as a risk-stratifying prognostic biomarker. Six months after
transplant the study will identify those who... expand
800 adult first time kidney transplant recipients will be enrolled in the Observational Study and followed to evaluate their Human Leukocyte Antigen (HLA)-DR/DQ molecular mismatch (mMM) score as a risk-stratifying prognostic biomarker. Six months after transplant the study will identify those who meet the eligibility criteria for the Nested Randomized Control Trial (RCT). 300 eligible subjects will be randomized 2:1 to abatacept or Standard of care (SOC) in the randomization and followed for 18 months monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM). The primary objective of the Observational Study is to test the validity of the HLA-DR/DQ mMM score as a prognostic biomarker for stratification of post-transplant alloimmune risk. Whereas the objective of the Nested RCT is to test whether a superior outcome in kidney function (primary endpoint), as well as secondary endpoints (neurocognitive function, and life participation PROM), will be achieved in patients who are transitioned from Tacrolimus (TAC) to abatacept, while maintaining efficacy (freedom from biopsy proven acute rejection). Type: Interventional Start Date: Dec 2023 |
Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis
Cardiol Therapeutics Inc.
Acute Myocarditis
Multi-center, double-blind, placebo-controlled, parallel group design. Patients with
myocarditis will be screened and, if eligible, randomized within 10 days of the
diagnostic CMR to CardiolRx or placebo.
CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol
(THC<5... expand
Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo. CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests. The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers. Type: Interventional Start Date: Jun 2022 |
Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®
AO Innovation Translation Center
Hip Fractures
Tibial Fractures
Ankle Fractures
Humeral Fracture, Proximal
Distal Radius Fracture
Prospective data will be collected in approximately 3500 patients (700 per 5 injury
groups).
Patients will be followed up according to the standard (routine) for up to 1 year after
the treatment.
Data collection will include underlying disease, treatment details, patient reported
outcomes (PROs),... expand
Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups). Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes. Type: Observational Start Date: Feb 2021 |
Losartan in Prevention of Radiation-Induced Heart Failure
Massachusetts General Hospital
Breast Cancer
Myocardial Fibrosis
Radiation-Induced Fibrosis
This study is being done to see if losartan affects the chances of developing
radiation-induced heart failure in patients who are receiving radiation therapy as part
of standard of care treatment for breast cancer.
The interventions involved in this study are:
- Losartan
- Radiation... expand
This study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer. The interventions involved in this study are: - Losartan - Radiation Therapy (standard of care) Type: Interventional Start Date: Jan 2024 |
Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal)...
SK Life Science, Inc.
Partial Epilepsy
Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric
subjects 2-17 years of age with partial-onset (focal) seizures expand
Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures Type: Interventional Start Date: Jan 2022 |
Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic...
Massachusetts General Hospital
Gastroparesis
This is a single-center pilot study to be conducted at Massachusetts General Hospital.
The purpose of this study is to examine the non-pharmacological impact of Cognitive
Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities
such as pain, depression, anxiety, and catastrophizing.... expand
This is a single-center pilot study to be conducted at Massachusetts General Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and catastrophizing. CBT trial patients will undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function test (AFT), gastric emptying scintigraphy (GES), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis. Type: Interventional Start Date: Dec 2018 |
ON/OFF Stimulation and Reward Motivation in Patients With Deep Brain Stimulators
Massachusetts General Hospital
Obsessive Compulsive Disorder
Major Depressive Disorder
Epilepsy
We propose to study approach/avoidance behavior as measured by the Approach Avoidance
task in 20 epilepsy patients undergoing implementation of depth electrodes for seizure
monitoring in the Epilepsy Monitoring Unit at MGH. We will also study the effects of
VC/VS electrical stimulation on approach-avoidance... expand
We propose to study approach/avoidance behavior as measured by the Approach Avoidance task in 20 epilepsy patients undergoing implementation of depth electrodes for seizure monitoring in the Epilepsy Monitoring Unit at MGH. We will also study the effects of VC/VS electrical stimulation on approach-avoidance conflict in 20 adult patients who have undergone DBS implantation for severe MDD and/or OCD. There are 100-200 patients in the world with DBS electrodes in the VC/VS, and our research team cares for more than any other institution. Both participant groups will be assessed with respect to reward-aversion decision conflict using the task. The task will be performed with concurrent EEG recordings in DBS patients, and with continuous recording through our invasive neurophysiology rig in EMU subjects. Type: Interventional Start Date: Jan 2021 |
Pompe Disease Registry Protocol
Genzyme, a Sanofi Company
Glycogen Storage Disease Type II
Pompe Disease
The Pompe Registry is a global, multicenter, international, longitudinal, observational,
and voluntary program for patients with Pompe disease, designed to track the disease's
natural history and outcomes in patients, both treated and not. Data from the Registry
are also used to fulfill various global... expand
The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes. The objectives of the Registry are: - To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention. - To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. - To characterize the Pompe disease population. - To evaluate the long-term effectiveness of alglucosidase alfa. Type: Observational [Patient Registry] Start Date: Sep 2004 |
Recovery and Outcomes From Stroke
University of Cincinnati
Intracerebral Hemorrhage
The investigators will perform follow-up on 500 cases of deep and lobar intracerebral
hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations
of motor and cognitive function at baseline, 3 months and 6 months to determine
predictors of recovery, progressive cognitive... expand
The investigators will perform follow-up on 500 cases of deep and lobar intracerebral hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations of motor and cognitive function at baseline, 3 months and 6 months to determine predictors of recovery, progressive cognitive or functional impairment. Type: Observational Start Date: Aug 2017 |
A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception
Brigham and Women's Hospital
Amputation
The hypothesis of this research protocol is that the investigators will be able to
redesign the manner in which upper limb amputations are performed so as to enable
volitional control of next generation prosthetic devices and restore sensation and
proprioception to the amputated limb. The investigators... expand
The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels. The specific aims of the project are: 1. To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA) 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BEA and AEA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach This will be a phase I/pilot clinical trial to be performed over a three-year period as a collaborative initiative involving Brigham & Women's Hospital/Brigham & Women's Faulkner Hospital (BWH/BWFH), Walter Reed National Military Medical Center (WRNMMC), and the Massachusetts Institute of Technology (MIT). The investigators will plan to perform 6 of the 10 amputations at BWH/BWFH, and 4 of the amputations at WRNMMC. Type: Interventional Start Date: May 2019 |
Optimal Stimulation Parameters to Disrupt Epileptiform Activity
Massachusetts General Hospital
Refractory Epilepsy
Open-loop electrical stimulation has been found to reduce spike activity and seizures,
but determining the optimal parameters to achieve these effects requires a brute force
trial-and-error approach that relies on subjective physician discretion. We will compare
the performance of stimulation parameters... expand
Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. We will compare the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice. Type: Interventional Start Date: Jun 2023 |
Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure
Massachusetts General Hospital
Heart Failure,Congestive
The purpose of this study is to assess the acceptability, feasibility, and preliminary
effectiveness of implementing a 30-day digitally-enabled community health worker
intervention compared to usual care with a community health worker in reducing heart
failure 30-day readmissions within a pilot randomized... expand
The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of implementing a 30-day digitally-enabled community health worker intervention compared to usual care with a community health worker in reducing heart failure 30-day readmissions within a pilot randomized controlled trial. Type: Interventional Start Date: Aug 2022 |
National Pregnancy Registry for Psychiatric Medications
Massachusetts General Hospital
Pregnant Women
Psychotropic Drugs
The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating
the safety of psychiatric medications such as antidepressants, ADHD medications, sedative
hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a
wide range of mood, anxiety, executive... expand
The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited. Type: Observational [Patient Registry] Start Date: Nov 2008 |
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway...
Benjamin Medoff
Asthma
Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways
contribute to airway obstruction. The biological basis for airway inflammation is the
subject of intensive investigation. This work is designed to identify airway factors that
are responsible for recruiting cells... expand
Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction. The biological basis for airway inflammation is the subject of intensive investigation. This work is designed to identify airway factors that are responsible for recruiting cells and associate their airway presence with atopy and asthma. Type: Interventional Start Date: Jan 2008 |
Mucolipidosis Type IV Natural History Study
Massachusetts General Hospital
Mucolipidosis Type IV
The primary objectives of the study are: to describe the characteristics of the current
international MLIV population; to define the median age at which patients with MLIV
achieve or lose developmental milestones; to define the natural history of MLIV for the
Gross Motor Function Classification System... expand
The primary objectives of the study are: to describe the characteristics of the current international MLIV population; to define the median age at which patients with MLIV achieve or lose developmental milestones; to define the natural history of MLIV for the Gross Motor Function Classification System (GMFCS) (Morris and Bartlett, 2004) and the MLIV specific scale and test the validity of retrospectively applying these scales to medical record data; to define the rate of visual decline in patients with MLIV. Type: Observational Start Date: Mar 2023 |
Mobile CARE-App to Promote Coping for Caregivers of Patients Receiving Stem Cell Transplant
Massachusetts General Hospital
Bone Marrow Transplant Complications
Hematologic Malignancy
The goal of this research study is to determine whether a self-administered, psychosocial
mobile application (CARE app) is effective at improving the quality of life and
experience of caregivers of patients receiving hematopoietic stem cell transplantation
(HCT). expand
The goal of this research study is to determine whether a self-administered, psychosocial mobile application (CARE app) is effective at improving the quality of life and experience of caregivers of patients receiving hematopoietic stem cell transplantation (HCT). Type: Interventional Start Date: Jul 2023 |
IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pelvis Fractures
Massachusetts General Hospital
Cancer Metastatic
Trauma
Pathologic Fracture
The aim of this project is to assess the effectiveness of the IlluminOss pelvic implants
in patients with pelvic metastatic disease presenting with pain, risk of pathologic
fracture, non-displaced or minimally displaced pathologic fracture of the pelvis, and
geriatric patients with pelvic fragility... expand
The aim of this project is to assess the effectiveness of the IlluminOss pelvic implants in patients with pelvic metastatic disease presenting with pain, risk of pathologic fracture, non-displaced or minimally displaced pathologic fracture of the pelvis, and geriatric patients with pelvic fragility fractures. Results from this study will be used to confirm preliminary clinically and possibly statistically significant reductions in pain and improvements in function among these patients. Type: Observational Start Date: Nov 2021 |
Financial Incentives for Homeless Smokers: A Community-based RCT
Massachusetts General Hospital
Tobacco Smoking
This community-based randomized controlled trial will test the effect of contingent
financial rewards on smoking abstinence among homeless-experienced adult cigarette
smokers. Participants will be recruited from 3 Boston Health Care for the Homeless
Program locations: a shelter clinic, a day center... expand
This community-based randomized controlled trial will test the effect of contingent financial rewards on smoking abstinence among homeless-experienced adult cigarette smokers. Participants will be recruited from 3 Boston Health Care for the Homeless Program locations: a shelter clinic, a day center clinic, and a medical center clinic. All participants will be offered a varenicline prescription and tobacco coaching. Incentive arm participants will receive escalating financial rewards for saliva cotinine levels <30 ng/ml, assessed 10 times over 12 weeks. Embedded qualitative interviews will explore the mechanisms of on-treatment and post-treatment effects of financial incentives on smoking abstinence in the context of homelessness. Type: Interventional Start Date: Jun 2021 |
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