Mass General - Division of Clinical Research

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Type: Interventional

Start Date: Dec 2017

open study

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Type: Interventional

Start Date: Mar 2016

open study

This is a clinical trial to evaluate the use of peritumoral injection of near-infrared dye indocyanine green to identify lung lesions and sentinel lymph nodes. The primary purpose is to determine if the use of ICG injected via navigational bronchoscopy, CT-guided or transthoracic allows us to identify the first lymph node that drains from the tumor, and thus would be the most likely site for metastatic disease, and remove it for analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells. Using this intraoperative imaging technique, we aim to improve the identification of lung nodules for resection and the intraoperative identification of sentinel lymph nodes in the event that a lymphadenectomy is performed.

Type: Interventional

Start Date: Jan 2015

open study

This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in participants with SBS. SBS participants treated and not treated with teduglutide will be enrolled.

Type: Observational [Patient Registry]

Start Date: Jun 2014

open study

This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.

Type: Interventional

Start Date: Nov 2016

open study

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment . Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EO-nonAD) participants,and (3) cognitively normal (CN) control participants.

Type: Observational

Start Date: Apr 2018

open study

The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo.

Type: Interventional

Start Date: May 2016

open study

This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.

Type: Interventional

Start Date: Jul 2015

open study

The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.

Type: Interventional

Start Date: Nov 2017

open study

The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.

Type: Interventional

Start Date: Dec 2018

open study

This research study is evaluating three drugs called Nivolumab, Bevacizumab, and Rucaparib as a possible treatment for relapsed Relapsed Ovarian, Fallopian Tube Or Peritoneal Cancer.

Type: Interventional

Start Date: Nov 2016

open study

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy. Inhibition of MDM2 is a novel mechanism of action in MCC. This study is Phase 2, Open-Label, Single-Arm Study of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma

Type: Interventional

Start Date: Apr 2019

open study

Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS), rate of complete remission (CR), Rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Subjects eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 392 subjects will participate in the study.

Type: Interventional

Start Date: Jun 2017

open study

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 7 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.

Type: Interventional

Start Date: Sep 2014

open study

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.

Type: Interventional

Start Date: Dec 2017

open study

We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) with a medication for anxiety disorders. We will use escitalopram, gold-standard SSRI treatment for patients with anxiety disorders, and will examine the comparative effectiveness of the two treatments on anxiety symptoms and other outcomes important to patients.

Type: Interventional

Start Date: Jun 2018

open study

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

Type: Interventional

Start Date: Feb 2018

open study

This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of GDC-0077 administered orally as a single agent in participants with locally advanced or metastatic Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA)-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Participants will be enrolled in two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants will be assigned to one of six regimens: GDC-0077 as a single agent (Arm A), GDC-0077 in combination with palbociclib and letrozole (Arm B), GDC-0077 in combination with letrozole (Arm C), GDC-0077 in combination with fulvestrant (Arm D), GDC-0077 in combination with palbociclib and fulvestrant (Arm E), and GDC-0077 in combination with palbociclib, fulvestrant, and metformin (Arm F).

Type: Interventional

Start Date: Dec 2016

open study

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who are not suitable for endocrine therapy.

Type: Interventional

Start Date: Jan 2018

open study

This phase I/II trial studies the best dose and side effects of navitoclax and how well it works when given together with vistusertib in treating patients with small cell lung cancer and solid tumors that have come back. Drugs used in chemotherapy, such as navitoclax, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vistusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving navitoclax and vistusertib may work better in treating patients with small cell lung cancer and solid tumors.

Type: Interventional

Start Date: Nov 2017

open study

This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU + cisplatin, in participants with solid tumors.

Type: Interventional

Start Date: Apr 2016

open study

This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing. Funding Source - FDA OOPD

Type: Interventional

Start Date: Jan 2017

open study

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Type: Interventional

Start Date: Feb 2018

open study

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

Type: Interventional

Start Date: Oct 2016

open study

Tears of the acetabular labrum appear to be common with the prevalence of asymptomatic tears in the general population approaching 66% and 70% based on cadaveric dissection and magnetic resonance imaging, respectively. Despite this prevalence, there is no currently accepted justification for performing labral repair in an asymptomatic patient despite the many postulated biomechanical benefits that an intact labrum imparts to the hip joint. Representing a smaller proportion of all tears, symptomatic tears of the acetabular labrum present a therapeutic challenge. Current treatment modalities range from conservative measures to open surgical intervention. Conservative measures have typically included: activity modification, the use of non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy (PT), core strengthening and improvement of sensory motor control. In the past two decades, technological advances in the form of surgical instrumentation and traction devices have facilitated less invasive arthroscopic techniques to diagnose and treat hip problems and as such is now the preferred treatment modality for many orthopedic surgeons treating patients with hip pathology. Determining which patients, using age and arthritic burden as predictors, can benefit from labral repair is paramount for several reasons. Showing arthroscopic repair is of little or no benefit to a specific cohort can reduce the number of unnecessary surgeries performed, increase the use of conservative therapy (if validated) and reduce the interval between diagnosis and total hip replacement.

Type: Interventional

Start Date: Oct 2013

open study