783 matching studies

Sponsor Condition of Interest
Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study
Massachusetts General Hospital Congestive Heart Failure
The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard... expand

The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.

Type: Observational

Start Date: Dec 2015

open study

A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth...
Massachusetts General Hospital Hemangioma
The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many... expand

The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many side effects. Hemangioma is a common type of birthmark. These birthmarks happen when many new blood vessels grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood through the body. No one knows what causes blood vessels to group together. Most birthmarks don't hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns have these birthmarks on their bodies, like between the eyebrows. These birthmarks usually disappear within the first few months to years of life. These birthmarks tend to disappear spontaneously. Most hemangiomas are not treated unless the hemangioma threatens the child's health, which occurs in about 1 in 3 children with hemagiomas. Pulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug Administration (FDA) for treating hemangioma. The FDA has approved timolol maleate to treat glaucoma in adults, but the FDA has not approved timolol maleate to treat hemangiomas in children. About 7 infants with hemangiomas have received timolol maleate. The results so far show that timolol maleate may be helpful and safe in treating hemangiomas in infants. An important question being tested in this study is whether pulsed-dye laser or timolol maleate can prevent hemangioma from growing when used very early after birth.

Type: Interventional

Start Date: Feb 2011

open study

ON/OFF Stimulation and Reward Motivation in Patients With Deep Brain Stimulators
Massachusetts General Hospital Obsessive Compulsive Disorder Major Depressive Disorder
The primary aim of this study is to test the effects of excitation of ventral striatal circuitry via DBS (e.g. DBS-on versus DBS-off) on reward motivation. The investigators predict that stimulation will increase subject willingness to expend effort for rewards and facilitate... expand

The primary aim of this study is to test the effects of excitation of ventral striatal circuitry via DBS (e.g. DBS-on versus DBS-off) on reward motivation. The investigators predict that stimulation will increase subject willingness to expend effort for rewards and facilitate motivation for reward learning. The investigators further predict that individual differences in the effects of DBS on reward motivation as will be associated with effects of DBS treatment on anhedonic symptoms.

Type: Observational

Start Date: Jun 2012

open study

(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
Massachusetts General Hospital Migraine
To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies. expand

To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.

Type: Interventional

Start Date: Dec 2017

open study

Biorepository Studying the Relationship Between Biomarkers and Heart Failure
Massachusetts General Hospital Heart Failure With Normal Ejection Fraction Heart Failure With Reduced Ejection Fraction
This study aims to prospectively evaluate the relationship between serial measurement of several biomarkers, such as insulin-like growth factor binding protein 7 (IGFBP7), bone morphogenic protein 1 (BMP1), carboxyterminal propeptide of type-I procollagen (PICP), tissue inhibitor... expand

This study aims to prospectively evaluate the relationship between serial measurement of several biomarkers, such as insulin-like growth factor binding protein 7 (IGFBP7), bone morphogenic protein 1 (BMP1), carboxyterminal propeptide of type-I procollagen (PICP), tissue inhibitor of metalloproteinases 1 (TIMP1) and matrix metallopeptidase 9 (MMP9), and echocardiographic features in three groups, including patients with heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), and patients without a history of heart failure (HF). The relationship between these biomarkers and one year major adverse events will also be evaluated.

Type: Observational [Patient Registry]

Start Date: Apr 2016

open study

Pilot Study of the Effect of Laser on Reversing Chronic Radiation Injury
Massachusetts General Hospital Chronic Radiation Dermatitis
Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic process in the skin which can lead to increased risk of malignancy, poor wound healing, pain and limitation of movement, and permanent loss of skin appendages with hyper/hypopigmentation, decreased... expand

Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic process in the skin which can lead to increased risk of malignancy, poor wound healing, pain and limitation of movement, and permanent loss of skin appendages with hyper/hypopigmentation, decreased sweating and xerosis, posing significant cosmetic and quality of life issues. Advances in laser therapy has led to the use of fractional laser treatment (FLT) to treat fibrosis associated with in hypertrophic scars and morphea, leading to tissue repair, scar remodeling. The investigators propose a pilot clinical study to test the hypothesis that FLT can normalize the fibrotic process and induce normal scar remodeling in patients affected by chronic radiation injury. Understanding and correcting this underlying fibrotic process can help restore normal skin functions in patients affected with chronic radiation dermatitis (RD) and other debilitating fibrotic diseases in dermatology such as scleroderma, morphea, or nephrogenic systemic fibrosis.

Type: Interventional

Start Date: Nov 2013

open study

Imaging of LAA Thrombosis
Massachusetts General Hospital Atrial Fibrillation
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 in the left atrial appendage of patients with atrial fibrillation, thereby may provide a non-invasive alternative... 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 in the left atrial appendage of patients with atrial fibrillation, thereby may provide a non-invasive alternative to the current standard-of-care, transesophageal echocardiography.

Type: Interventional

Start Date: Aug 2016

open study

Effect of High Doses of Radiation on Bone Structure and Metabolism
Massachusetts General Hospital Malignant Bone Tumors
This study is designed to characterize the effects of high energy radiation on bone breakdown, with a specific interest in reducing the rate of sacral fractures. Although radiation is very important in managing tumors, it is related to complications such as bone fractures. In... expand

This study is designed to characterize the effects of high energy radiation on bone breakdown, with a specific interest in reducing the rate of sacral fractures. Although radiation is very important in managing tumors, it is related to complications such as bone fractures. In this research study, the investigators are looking to determine changes in blood markers, bone density, and bone structure following radiation and to better understand the reason for these changes.

Type: Interventional

Start Date: Jul 2015

open study

Natural History Evaluation of Charcot Marie Tooth Disease (CMT) Types CMT1B, CMT2A, CMT4A, CMT4C, and...
Michael Shy Charcot Marie Tooth Disease
This is an observational longitudinal study to determine the natural history and genotype-phenotype correlations of disease causing mutations in Charcot Marie Tooth disease (CMT) type 1B (CMT1B), 2A (CMT2A), 4A (CMT4A), and 4C (CMT4C). The investigators will also be determine... expand

This is an observational longitudinal study to determine the natural history and genotype-phenotype correlations of disease causing mutations in Charcot Marie Tooth disease (CMT) type 1B (CMT1B), 2A (CMT2A), 4A (CMT4A), and 4C (CMT4C). The investigators will also be determine the capability of the newly developed CMT Pediatric Scale (CMT Peds scale) and the Minimal Dataset to measure impairment and perform longitudinal measurements in patients with multiple forms of CMT over a five year window

Type: Observational

Start Date: Apr 2010

open study

Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation
Brigham and Women's Hospital Acute Kidney Injury
This study is of a clinical decision support tool for clinicians taking care of patients with severe acute kidney injury in the intensive care unit. Nephrologists will be given a standardized clinical assessment and management plan (SCAMP), which is a tool to assist clinicians... expand

This study is of a clinical decision support tool for clinicians taking care of patients with severe acute kidney injury in the intensive care unit. Nephrologists will be given a standardized clinical assessment and management plan (SCAMP), which is a tool to assist clinicians in decision making on the need for renal replacement therapy (Mendu et al., CJASN 2017). In alternating months, nephrologists will be given the SCAMP vs. another simplified form. The goal is to test whether patients whose clinicians are asked to fill out the SCAMP have improved outcomes compared to the control group. The investigators are also collecting information about provider adherence to the SCAMP and deviations from the SCAMP recommendations to understand clinical decision making related to renal replacement.

Type: Interventional

Start Date: Jul 2017

open study

Validity and Feasibility of the CRSR-FAST
Massachusetts General Hospital Disorder of Consciousness Traumatic Brain Injury
The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings. One limitation of the CRS-R is the lengthy administration time... expand

The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings. One limitation of the CRS-R is the lengthy administration time required to obtain a total score. Administration time can vary from approximately 15-30 minutes, depending on the patient's level of responsiveness. For this reason, the CRS-R is rarely administered in the acute hospital setting. Less time-consuming scales and metrics are used to assess conscious awareness in the acute hospital/ICU setting, but they lack specificity and sensitivity and have not been validated, increasing the potential for misdiagnosis. In conjunction with the developers of the Neuroscore (an unpublished, abbreviated version of the CRS-R), we have developed the CRSR-FAST and aim to test its validity, inter- and intra- rater reliability. We anticipate that, compared with the CRS-R, the CRSR-FAST will be less time-consuming to administer and score, but will maintain a high level of sensitivity to detecting signs of consciousness in severely brain injured patients.

Type: Observational

Start Date: Aug 2018

open study

Collateral Ligation in Failing Fistulas
Massachusetts General Hospital Hemodialysis Access Failure
Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is narrowing of the artery or vein (stenosis). Another potential cause is the presence of collateral or side branch veins that steal blood flow from... expand

Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is narrowing of the artery or vein (stenosis). Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. Some believe that occluding these veins might help maturation of those failing AVFs. To evaluate if this actually works, patients with FTM will be randomly assigned to side branch vein ligation (or not), and rates of AVF maturation of the two groups will be compared.

Type: Interventional

Start Date: May 2018

open study

Using Imaging to Assess Effects of THC on Brain Activity
Massachusetts General Hospital Intoxication Alcohol Intoxication THC Intoxication Combined Alcohol THC
To assess effects of THC (n=150) and THC + alcohol (n =50) in MJ users on prefrontal brain activity with functional near infrared spectroscopy (fNIRS) during resting state and during memory task performance. To do so, 150 participants will complete fNIRS testing 120 minutes... expand

To assess effects of THC (n=150) and THC + alcohol (n =50) in MJ users on prefrontal brain activity with functional near infrared spectroscopy (fNIRS) during resting state and during memory task performance. To do so, 150 participants will complete fNIRS testing 120 minutes following THC or identical placebo at a clinically determined dose of 20-50mg dronabinol (synthetic THC) and 50 participants will complete fNIRS testing following THC/ethanol, THC/placebo ethanol, placebo THC/ethanol, and placebo THC/placebo ethanol, each at at clinically determined doses designed to produce intoxication. During peak intoxication in participants determined to be intoxicated, (intoxication defined as self reported intoxication >50 on 100 point VAS, by field sobriety testing by a Drug Recognition Expert, and by clinical evaluation, the fNIRS HbO signal will be significantly greater than at baseline and than at a post-peak assessment, and/or resting state connectivity will increase with THC.

Type: Interventional

Start Date: Nov 2018

open study

Development of an Intervention to Enhance Cancer Pain Management
Massachusetts General Hospital Other Cancer
This research study is being done to understand how patients with chronic cancer pain take their long-acting opioid medications, and to develop an intervention to enhance cancer pain management. expand

This research study is being done to understand how patients with chronic cancer pain take their long-acting opioid medications, and to develop an intervention to enhance cancer pain management.

Type: Interventional

Start Date: Apr 2014

open study

A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer
Massachusetts General Hospital Lung Cancer
This research study is studying a combination of drugs as a possible treatment for EGFR mutation-positive lung cancer. The drugs involved in this study are: - EGF816 - Gefitinib expand

This research study is studying a combination of drugs as a possible treatment for EGFR mutation-positive lung cancer. The drugs involved in this study are: - EGF816 - Gefitinib

Type: Interventional

Start Date: Oct 2017

open study

Dabrafenib + Trametinib + PDR001 In Colorectal Cancer
Massachusetts General Hospital Metastatic Colorectal Cancer
This research study is studying a combination of drugs as a possible treatment for metastatic colorectal cancer characterized by BRAF V600E mutation. The names of the study drugs involved in this study are: - Dabrafenib - Trametinib - PDR001 expand

This research study is studying a combination of drugs as a possible treatment for metastatic colorectal cancer characterized by BRAF V600E mutation. The names of the study drugs involved in this study are: - Dabrafenib - Trametinib - PDR001

Type: Interventional

Start Date: Oct 2018

open study

Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy
Massachusetts General Hospital Adenoid Cystic Carcinoma Squamous Cell Carcinoma Sinonasal Carcinoma Sinonasal Undifferentiated Carcinoma Mucoepidermoid Carcinoma
The purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy (IMRT) or proton radiation therapy would result in improved local control rate and lowered toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result... expand

The purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy (IMRT) or proton radiation therapy would result in improved local control rate and lowered toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result in equivalent or improved local control rate with similar or lower toxicity compared to IMRT, in the treatment of locally advanced sinonasal malignancy. Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in promising outcome in patients with sinonasal malignancy. To this date, no prospective study has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton radiation therapy. This Phase II trial is the first prospective study conducted to determine the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer. IMRT and proton radiation therapy are the two most established and most commonly employed advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly controversial whether one is superior to the other in terms of local control and toxicity outcome. It is also not clear if a subset of patients would benefit more from one treatment technology versus the other. Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam is only available at a few centers in the United States, it is not feasible at present to do a Phase III study randomizing patients between IMRT and proton radiation therapy. In this study, a planned secondary analysis will be performed, comparing the treatment and toxicity outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial will be used to design future multi-center prospective trials and to determine if randomized trial is necessary. In this study, the treatment technique employed for an individual case will not be determined by the treating physician(s), but rather by the most advanced technology available at the treating institution for the treatment of the sinonasal cancer. At the Massachusetts General Hospital (MGH), proton beam therapy will be used for patients who meet the eligibility criteria. For institutions where protons are not available or institutions where the proton planning systems have not been optimized, IMRT exclusively will be used for the treatment of sinonasal cancer. Patient and tumor characteristics are expected to be comparable between IMRT- and proton- institutions

Type: Interventional

Start Date: Jul 2011

open study

A Registry to Determine the Clinical and Genetic Risk Factors for Torsade De Pointes
Massachusetts General Hospital Long qt Syndrome Torsade de Pointes
This is a registry to examine genetic and clinical predictors of torsade de pointes events. expand

This is a registry to examine genetic and clinical predictors of torsade de pointes events.

Type: Observational [Patient Registry]

Start Date: Oct 2013

open study

Genetics of QT Prolongation With Antiarrhythmics
Massachusetts General Hospital Long QT Syndrome Drug Toxicity
To assess the ability of common genetic variants in aggregate to predict drug-induced QT prolongation in patients being loaded with dofetilide or sotalol, and validate the feasibility of using a smartphone device for measuring QT interval. expand

To assess the ability of common genetic variants in aggregate to predict drug-induced QT prolongation in patients being loaded with dofetilide or sotalol, and validate the feasibility of using a smartphone device for measuring QT interval.

Type: Observational

Start Date: Jan 2014

open study

Diffusion MRI in Heart Failure
Massachusetts General Hospital Heart Failure Myocardial Infarction Left Ventricular Hypertrophy
The development of symptomatic heart failure is frequently preceded by a pre-clinical period of structural remodeling in the heart. The remodeling process driving this transition, however, remains poorly understood. The investigators hypothesize that imaging the diffusion of... expand

The development of symptomatic heart failure is frequently preceded by a pre-clinical period of structural remodeling in the heart. The remodeling process driving this transition, however, remains poorly understood. The investigators hypothesize that imaging the diffusion of water in the heart with MRI will allow its microstructure to be resolved. The investigators further hypothesize that the characterization of microstructural changes in the heart will help elucidate the pathogenesis of heart failure and the transition from a compensated to a decompensated state. Patients with recent myocardial infarcts and left ventricular hypertrophy, who are at risk for the development of heart failure, will be enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the heart to characterize changes in myocardial microstructure over time.

Type: Interventional

Start Date: Jun 2017

open study

Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix
Massachusetts General Hospital Uterine Cancer Cervical Cancer
Proton beam radiation therapy is known to spare surrounding normal tissues from radiation. Proton beam radiation delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation... expand

Proton beam radiation therapy is known to spare surrounding normal tissues from radiation. Proton beam radiation delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy which tends to unavoidably include more normal tissue along with tumor target tissue. In this research study, the investigators are looking to determine if proton beam radiation is effective in controlling your cancer growth. The investigators are also looking to see if proton beam radiation can reduce side effects when compared to standard radiation treatment (photon radiation).

Type: Interventional

Start Date: May 2013

open study

A Study to Prospectively Assess Disease Progression in Male Children With X-ALD
NeuroVia, Inc. X-Linked Adrenoleukodystrophy
This is a non-interventional, multi-center study that follows general principles of periodic assessment of X-ALD patients in routine practice. No study drug treatment will be given and no changes to patient treatment are necessary. expand

This is a non-interventional, multi-center study that follows general principles of periodic assessment of X-ALD patients in routine practice. No study drug treatment will be given and no changes to patient treatment are necessary.

Type: Observational

Start Date: Feb 2018

open study

Study of Pregnancy Regulation of Insulin and Glucose
Massachusetts General Hospital Gestational Diabetes Mellitus
It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors... expand

It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of GDM. To elucidate the pathophysiology underlying GDM, the investigators will attempt to discover these factors and characterize pregnancy-associated changes in insulin secretion and sensitivity in women with and without GDM.

Type: Observational

Start Date: Feb 2016

open study

Stroke Motor Rehabilitation and Recovery Study
Massachusetts General Hospital Stroke, Ischemic
SMaHRT (Stroke Motor reHabilitation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic stroke. expand

SMaHRT (Stroke Motor reHabilitation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic stroke.

Type: Observational

Start Date: Jun 2017

open study

Advanced MRI Applications Development
Massachusetts General Hospital Brain Tumors
The goals of this study are to: 1. To improve upon and develop new innovative magnetic resonance imaging techniques that refine image quality and enhance performance. Improvements in these areas will have positive implications for medical diagnosis and treatment.... expand

The goals of this study are to: 1. To improve upon and develop new innovative magnetic resonance imaging techniques that refine image quality and enhance performance. Improvements in these areas will have positive implications for medical diagnosis and treatment. 2. To correlate MRI images with underlying disease pathophysiology in order to ensure that imaging accurately reflects the disease process.

Type: Observational

Start Date: Jan 2014

open study