Mass General - Division of Clinical Research

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.

Type: Observational

Start Date: Oct 2016

open study

For participants enrolled prior to Version 6 of the protocol: This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of balovaptan in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient [IQ] greater than or equal to [>=] 70). For participants enrolled according to Version 6 of the protocol: This is a Phase II multi-center, randomized, double-blind, 24-week, parallel group, placebo-controlled, 2-arm study with participants assigned either to a 10 milligram (mg) or equivalent dose of balovaptan, or placebo. All other study parameters remain as stated above. All participants that complete the 24-week treatment period will be eligible to participate in an optional 52-week open-label extension (OLE) during which they will receive balovaptan treatment.

Type: Interventional

Start Date: Nov 2016

open study

HIV-infected individuals treated with antiretroviral medications are living longer, but have an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV population in association with with increased belly fat and altered glucose metabolism. Elevations in aldosterone hormone may also be associated with abnormal blood flow, inflammation, and coronary plaque in the heart. This study is being conducted to evaluate whether therapies to reduce the actions of aldosterone may decrease the burden and progression of heart disease in the HIV population.

Type: Interventional

Start Date: Jan 2017

open study

The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive compulsive disorder. Additionally, this study aims to identify the mechanisms of action of TMS and potential biomarkers and predictors of treatment response.

Type: Interventional

Start Date: May 2015

open study

This study is being conducted to determine if losartan, an angiotensin receptor blocker (ARB), is safe and effective in the treatment of posttraumatic stress disorder (PTSD) symptoms. The study is also intended to determine if certain genetic markers are useful in predicting PTSD symptom reduction with losartan. Approximately 160 subjects with chronic PTSD ages 18-65 will participate in this study across five sites. Subjects will be assigned by chance to take either flexibly dosed losartan (up to a maximum dosage of 100 mg) or placebo (which resembles the study drug but has no active ingredients), once a day for 10 weeks. Furthermore, it is hypothesized that CC homozygotes for rs4311 SNP in the ACE gene will have a superior response to losartan on PTSD symptoms compared to T carriers.

Type: Interventional

Start Date: Jul 2016

open study

The purpose of this study is to determine whether night time eating that coincides with elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the MTNR1B risk allele.

Type: Observational

Start Date: Jan 2017

open study

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation. Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017. As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints) As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated study Primary Completion date is July 2018 and the Study Completion Date is July 2024. COAPT CAS is presently recruiting subjects.

Type: Interventional

Start Date: Aug 2012

open study

This study will investigate if metformin can help people with obesity and high pressures inside their lung blood vessels. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat diabetes, but metformin is not approved by the FDA to treat pulmonary hypertension. This study will examine whether Metformin will improve the high pressure inside lung blood vessels in people who are obese. The study will help understand the effect of metformin on pressures inside lung blood vessels.

Type: Interventional

Start Date: Nov 2017

open study

Dual medication (guanfacine and morphine) as a standard treatment for chronic pain.

Type: Interventional

Start Date: Nov 2013

open study

RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

Type: Interventional

Start Date: Mar 2016

open study

Combination of guanfacine with opioid medication as a standard treatment for chronic pain.

Type: Interventional

Start Date: Sep 2014

open study

This phase I/II trial studies the side effects and best dose of dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients with BRAF mutant melanoma or solid tumors that have spread to other parts of the body or cannot be removed by surgery. Dabrafenib, trametinib, and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Type: Interventional

Start Date: Oct 2013

open study

Single-arm, prospective, multi-center, post-approval U.S. registry

Type: Observational [Patient Registry]

Start Date: Dec 2018

open study

This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, inoperable, locally advanced or MBC who experienced disease recurrence or progression during or after treatment with CDK4/6i therapy for at least 8 weeks.

Type: Interventional

Start Date: Sep 2018

open study

This is a multicenter, cross-sectional, cohort study which will collect contemporary SC values from approximately 1000 CF patients prescribed and currently receiving commercially approved CFTR modulator therapies.

Type: Observational

Start Date: Jan 2018

open study

Previous research shows that individuals with Body Dysmorphic Disorder (BDD) misinterpret ambiguous social information in a negative and threatening manner. These erroneous threat appraisals are thought to maintain disorder symptomatology and psychosocial impairment by reinforcing individuals' distorted self-image and ideas of social undesirability. Thus, maladaptive interpretation biases represent an important treatment target for this population; however, existing bias assessments and modification protocols are limited by the hypothetical and distal nature of scenarios and do not capture momentary experiential threat processes. The proposed study seeks to test virtual reality (VR) technology as a novel, in vivo means of eliciting, identifying, and measuring threat interpretation biases in a clinical sample to better understand the fear/threat structure activated during social interactions in BDD. Findings have the potential to enhance our understanding of disorder maintenance and identify more nuanced treatment targets. This study represents a critical first step in the long-term goal of harnessing VR gaming technology to supercharge existing treatment approaches for this debilitating illness.

Type: Observational

Start Date: Mar 2019

open study

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients.

Type: Interventional

Start Date: May 2017

open study

The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR>3 wood units.

Type: Interventional

Start Date: Nov 2018

open study

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it. Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor. Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation. In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor. The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas.

Type: Interventional

Start Date: Dec 2012

open study

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

open study

The purpose of this study is to find risk factors for hemorrhagic stroke.

Type: Observational

Start Date: Sep 1997

open study

This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.

Type: Interventional

Start Date: Jun 2018

open study

The purpose of this study is to compare total opioid consumption by subjects in different treatment groups. Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction using EXPAREL.

Type: Interventional

Start Date: Mar 2019

open study

This is a Phase 1/2, open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

Type: Interventional

Start Date: May 2017

open study

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

Type: Interventional

Start Date: Aug 2017

open study