799 matching studies

Sponsor Condition of Interest
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Merrimack Pharmaceuticals Non-Small Cell Lung Cancer NSCLC Adenocarcinoma Heregulin
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC. expand

The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.

Type: Interventional

Start Date: Feb 2015

open study

HIV-to-HIV Transplant at MGH
Massachusetts General Hospital HIV Awaiting Organ Transplant
HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. HIV+ individuals who receive a solid organ transplant from HIV-uninfected donors will also... expand

HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. HIV+ individuals who receive a solid organ transplant from HIV-uninfected donors will also be followed.

Type: Observational

Start Date: Aug 2016

open study

Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)
MicroTransponder Inc. Cerebrovascular Stroke Upper Extremity Paresis
This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment. The randomization will be stratified by age (<30, >30) and baseline FMA UE... expand

This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment. The randomization will be stratified by age (<30, >30) and baseline FMA UE (20 to <35; >35 to 50). Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Type: Interventional

Start Date: Jul 2017

open study

Effect of VarIthena on Wound Healing in VLU
Provensis Ltd Venous Leg Ulcer
12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena expand

12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena

Type: Observational [Patient Registry]

Start Date: Sep 2017

open study

EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study)
Duke University Heart Failure
The primary objective of the study is to determine whether, in patients with symptomatic, advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696 for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect hemodynamic... expand

The primary objective of the study is to determine whether, in patients with symptomatic, advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696 for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect hemodynamic and clinical status, compared to treatment with valsartan.

Type: Interventional

Start Date: Mar 2017

open study

Ustekinumab for the Treatment of Giant Cell Arteritis
Massachusetts General Hospital Giant Cell Arteritis Temporal Arteritis Horton's Disease
The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA) expand

The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA)

Type: Interventional

Start Date: Dec 2016

open study

A Video Decision Support Tool to Assist Patients in Dialysis Decision-making Versus Conservative Kidney...
Massachusetts General Hospital Chronic Kidney Disease Decision-making
In the United States, it is estimated that there are approximately 630,000 patients who have ESRD with two-thirds of those patients subsequently receiving maintenance dialysis. Studies have demonstrated that the initiation and timing of dialysis for those with ESRD seem to vary... expand

In the United States, it is estimated that there are approximately 630,000 patients who have ESRD with two-thirds of those patients subsequently receiving maintenance dialysis. Studies have demonstrated that the initiation and timing of dialysis for those with ESRD seem to vary widely regionally - confirming the uncertainty of the benefits of chronic dialysis in this population Pre-dialysis education programs inform patients of all of their options allowing them to choose renal replacement therapy that is most consistent with their wishes. Recent evidence has supported using different methods of delivering education including videos to complement standard clinical care practices to promote informed decision making. This proposed study will serve to examine the effectiveness of a dialysis modality video decision support tool to inform chronic kidney disease patients of different dialytic and non-dialytic therapies.

Type: Interventional

Start Date: Feb 2016

open study

Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current...
Spaulding Rehabilitation Hospital Phantom Limb Pain Amputation, Traumatic
This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active... expand

This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT; active tDCS and sham MT (which consists of using a covered mirror for the therapy); and both sham tDCS and sham MT (covered mirror).

Type: Interventional

Start Date: Jul 2015

open study

Helping Olfaction and Nutrition On Renal Replacement
Massachusetts General Hospital End Stage Renal Disease Olfactory Disorders
This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients. expand

This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients.

Type: Interventional

Start Date: Oct 2015

open study

Molecular Epidemiology of ARDS
Massachusetts General Hospital Acute Respiratory Distress Syndrome Lung Diseases
To examine the possible relationship between genetic factors and the acute respiratory distress syndrome (ARDS). expand

To examine the possible relationship between genetic factors and the acute respiratory distress syndrome (ARDS).

Type: Observational

Start Date: Feb 2000

open study

STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
Massachusetts General Hospital Heart Failure
This research study will test whether atorvastatin, a drug commonly prescribed for reducing cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin is from a family of medications that are commonly called "statins" expand

This research study will test whether atorvastatin, a drug commonly prescribed for reducing cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin is from a family of medications that are commonly called "statins"

Type: Interventional

Start Date: Jan 2017

open study

Evaluating the Role of Neuroinflammation in Low Back Pain
Marco Loggia Low Back Pain Back Pain With Radiation Back Pain Without Radiation Back Pain Lower Back Chronic Back Ache
In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain. The efficacy of minocycline use for low back pain treatment will also be evaluated by observing whether short-term... expand

In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain. The efficacy of minocycline use for low back pain treatment will also be evaluated by observing whether short-term minocycline administration will reduce neuroinflammation and low back pain symptoms.

Type: Interventional

Start Date: Oct 2017

open study

Innovative Methods to Assess Psychotherapy Practices (imAPP)
Palo Alto Veterans Institute for Research Mobile Application-Based CBT Worksheet Collection Paper-Based Worksheet Collection
This project compares two methods of assessing the quality of cognitive behavioral therapy (CBT) that do not involve directly observing sessions: 1) adherence checklists embedded in clinical notes, and 2) rating the quality of worksheets that are completed with therapist guidance... expand

This project compares two methods of assessing the quality of cognitive behavioral therapy (CBT) that do not involve directly observing sessions: 1) adherence checklists embedded in clinical notes, and 2) rating the quality of worksheets that are completed with therapist guidance during sessions. It also examines whether ratings of worksheets completed on a mobile app are reliable and valid quality measures. This information can inform strategies to monitor and enhance CBT quality, which can ultimately improve the quality of care and clinical outcomes.

Type: Observational

Start Date: Apr 2017

open study

Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
Massachusetts General Hospital Osteoarthritis
The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with MCP to placebo for the treatment of knee osteoarthritis. expand

The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with MCP to placebo for the treatment of knee osteoarthritis.

Type: Interventional

Start Date: Jul 2016

open study

The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest
Western University, Canada Sudden Cardiac Death
Sudden cardiac death (SCD) remains a major cause of mortality within developed nations despite aggressive efforts to reduce its societal burden. Despite extensive clinical and genetic investigations, a subgroup of cardiac arrests remain unexplained, highlighting the potential... expand

Sudden cardiac death (SCD) remains a major cause of mortality within developed nations despite aggressive efforts to reduce its societal burden. Despite extensive clinical and genetic investigations, a subgroup of cardiac arrests remain unexplained, highlighting the potential contribution of additional cardiac conditions that may not be identified with contemporary diagnostic algorithms. The EPS ARREST study aims to evaluate the role of invasive electrophysiology study within this patient population.

Type: Observational

Start Date: May 2017

open study

Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant
Massachusetts General Hospital Kidney Transplant Type 1 Diabetes
Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured islets. Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks. expand

Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured islets. Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.

Type: Interventional

Start Date: Jan 2017

open study

Partners Calciphylaxis Biobank
Massachusetts General Hospital Calciphylaxis Calcific Uremic Arteriolopathy End Stage Renal Disease Chronic Kidney Diseases
Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles. There are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. At present, there is no effective... expand

Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles. There are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare incidence and lack of collaborative approach have been some of the major limiting factors towards treating calciphylaxis. The Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within calciphylaxis research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for a calciphylaxis repository.

Type: Observational [Patient Registry]

Start Date: Jan 2017

open study

Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
Massachusetts General Hospital Amyotrophic Lateral Sclerosis (ALS)
This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers in people with ALS to expand the understanding of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes. This pilot project... expand

This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers in people with ALS to expand the understanding of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes. This pilot project is tailored to produce imaging tools that will allow researchers to conduct future ALS clinical trials more efficiently which may in turn impact the pace for ALS drug discovery.

Type: Observational

Start Date: Nov 2015

open study

A Safety Study of SYNT001 in Subjects With Chronic, Stable Warm Autoimmune Hemolytic Anemia (WAIHA)
Syntimmune, Inc. Anemia, Hemolytic, Autoimmune
This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia (WAIHA) disease activity markers of intravenous (IV) SYNT001. expand

This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia (WAIHA) disease activity markers of intravenous (IV) SYNT001.

Type: Interventional

Start Date: Jan 2018

open study

BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
Massachusetts General Hospital Bipolar Disorder Depressive Episode
We propose to test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and safe for bipolar depression with the following specific aims: Aim #1. Proof-of-Concept Safety and Tolerability Aim: To assess the safety and tolerability of bezafibrate added to anti-manic... expand

We propose to test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and safe for bipolar depression with the following specific aims: Aim #1. Proof-of-Concept Safety and Tolerability Aim: To assess the safety and tolerability of bezafibrate added to anti-manic medication for bipolar depression, especially with regard to worsening manic symptoms and suicidal ideation. We will conduct a phase IIa, 8-week, open pilot trial of bezafibrate added to FDA-approved anti-manic medication in 30 participants with bipolar depression. We will monitor changes in manic symptoms (Young Mania Rating Scale), suicidal ideation, cognitive functioning specifically in attention and verbal memory, and treatment emergent adverse events (SAFTEE). We will also monitor changes in the Framingham Cardiovascular Risk Score. Aim #2. Preliminary Assessment of Efficacy: To assess the antidepressant efficacy of bezafibrate added to anti-manic medication for acute bipolar I major depressive episodes. Hypothesis: The bezafibrate group will have a statistically significant decrease in the Montgomery Asberg Rating Scale (MADRS) Scores over 8 weeks. The results of this proof-of concept phase IIa study will help us to plan a placebo-controlled randomized trial. In summary, we propose an 8-week, proof-of-concept open pilot trial of an adjunctive pan-PPAR agonist, bezafibrate, for 30 patients with an acute bipolar I major depressive episode. The study may have a profound impact on the development of a novel treatment consistent with the mitochondrial dysregulation hypothesis of bipolar disorder and, to the best of our knowledge, will be the first proof-of-concept trial to assess a pan-PPAR agonist for bipolar disorder.

Type: Interventional

Start Date: Sep 2015

open study

Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.
Massachusetts General Hospital Acute Kidney Injury
The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing prolonged cardiopulmonary bypass. expand

The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing prolonged cardiopulmonary bypass.

Type: Interventional

Start Date: Feb 2017

open study

Evaluation of Vitamin K Supplementation for Calcific Uremic Arteriolopathy
Massachusetts General Hospital Calciphylaxis Calcific Uremic Arteriolopathy
Calcific uremic arteriolopathy a.k.a. calciphylaxis is a vascular calcification disorder seen in dialysis patients. Calcific uremic arteriolopathy has 60-80% one-year mortality and significant morbidity associated with non-healing and extremely painful skin lesions. At present,... expand

Calcific uremic arteriolopathy a.k.a. calciphylaxis is a vascular calcification disorder seen in dialysis patients. Calcific uremic arteriolopathy has 60-80% one-year mortality and significant morbidity associated with non-healing and extremely painful skin lesions. At present, there is no effective treatment for calcific uremic arteriolopathy. Vitamin K is an important vitamin for inhibiting vascular calcification. It is known to increase the circulating levels of carboxylated Matrix Gla Protein, a potent inhibitor of vascular calcification. However, the effects of vitamin K supplementation in patients with calcific uremic arteriolopathy are unknown. The purpose of this study is to conduct a pilot randomized controlled trial to examine the effects of oral vitamin K supplementation on circulating levels of anti-calcification factor (carboxylated Matrix Gla Protein) and clinical outcomes in patients with calcific uremic arteriolopathy.

Type: Interventional

Start Date: Mar 2015

open study

Combined Bone Marrow and Renal Transplantation for Hematologic Disorders With End Stage Renal Disease
Massachusetts General Hospital Multiple Myeloma Amyloidosis
This pilot trial offers the unique opportunity for both the treatment of multiple myeloma or systemic AL amyloidosis for which hematopoietic stem cell transplantation would be ordinarily indicated and the reversal of end-stage renal failure, while avoiding the risks associated... expand

This pilot trial offers the unique opportunity for both the treatment of multiple myeloma or systemic AL amyloidosis for which hematopoietic stem cell transplantation would be ordinarily indicated and the reversal of end-stage renal failure, while avoiding the risks associated with long-term standard anti-rejection therapy used in renal transplantation. The primary objectives of this study are to assess renal allograft tolerance (that is, the acceptance of the kidney without the need for anti-rejection therapy), assess anti-tumor response rates in multiple myeloma and AL amyloidosis, and assess complication rates for genetically (HLA) matched related donor combined bone marrow and kidney transplantation using a low dose total body irradiation based preparative regimen.

Type: Interventional

Start Date: Feb 2015

open study

Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
Massachusetts General Hospital Consciousness Disorders Locked-In Syndrome
The primary aims of this study are: 1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS); 2. To determine if... expand

The primary aims of this study are: 1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS); 2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness; 3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness; 4. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Type: Interventional

Start Date: Mar 2016

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