Mass General - Division of Clinical Research

This research study examines how a medication called lumateperone may affect mood symptoms, and inflammation in adults with bipolar disorder over approximately 6 weeks. An MRI scan to calculate biological age of the brain will also be obtained at the start of the study.

Type: Interventional

Start Date: Sep 2026

open study

The goal of this clinical trial is to determine whether a personalised blood clot prevention plan is more effective than standard treatment in adults with peripheral artery disease (PAD) who have undergone a procedure to restore blood flow to their legs. The main questions it aims to answer are: - Does the personalized plan lower the rate of blood clots in the treated leg one year after the procedure? - Does the personalized plan lower rates of amputation, repeat procedures, bleeding, and death compared to standard treatment? Researchers will compare the personalized TARGET plan which uses a blood test to tailor each person's blood clot prevention medication to the standard treatment to see if the personalized approach works better. Participants will: - Be randomly assigned to either the personalized TARGET plan or standard treatment after their procedure - Have blood tests at 1 week and at 1, 3, 6, 9, and 12 months after their procedure - Have medications adjusted based on blood test results if assigned to the TARGET group

Type: Interventional

Start Date: Apr 2025

open study

We are doing the research to see if a CT scan without the dye can help find pulmonary emboli. If you agree to join the study, you will be asked to sign this consent form before we do any research procedures. If you join the research, we will ask you to blow into a small device known as a spirometer to train you to hold your breath after you inhale and exhale. Spirometer is a small handheld device to find out how well your lungs work when you inhale and exhale. For this research, we will obtain two extra sets of CT images at very low levels of radiation dose. The two extra sets of images will take less than 1 minute. Your total participation time is about 5 minutes. We will also review your medical record for up to 30 to 90 days after your CT scan. The main risks of being in the study are exposure to ionizing radiation which may have health risks, and minor inconvenience from the spirometer test. You will not benefit from taking part in this research study. If you take part in this study, your participation may help people in the future. If you decide not to be in the study, you will still have the standard-of-care chest CT with the dye ordered by your doctor. You will not be paid for taking part in this research study.

Type: Interventional

Start Date: Jul 2026

open study

The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: - Take lirafugratinib regularly as instructed by their study doctor. - Visit the clinic as instructed for checkups and tests. - Keep a diary recording each time a dose of lirafugratinib is taken.

Type: Interventional

Start Date: Jun 2026

open study

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.

Type: Interventional

Start Date: Dec 2025

open study

A pivotal, randomized, double-blind, placebo-controlled, multi-center therapeutic study for patients age 4 and older with a confirmed diagnosis of CACNA1A. The objective of this study is to evaluate the safety, tolerability and efficacy of N-acetyl-L-leucine (IB1001) compared to standard of care.

Type: Interventional

Start Date: Aug 2026

open study

The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.

Type: Interventional

Start Date: May 2026

open study

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Type: Interventional

Start Date: Oct 2025

open study

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on participants who have advanced ovarian cancer. The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab, REGN10597 and a standard chemotherapy drug, pegylated liposomal doxorubicin [PLD]), referred to as "combination drugs'. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug and its experimental combinations - How much study drug and fianlimab is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations

Type: Interventional

Start Date: May 2025

open study

The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.

Type: Interventional

Start Date: Sep 2024

open study

This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. Study visits may include a bone marrow aspirate, physical exam, echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and questionnaires.

Type: Interventional

Start Date: Dec 2024

open study

This is a research study in women to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

Type: Interventional

Start Date: Sep 2024

open study

The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).

Type: Interventional

Start Date: Jan 2025

open study

The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

Type: Interventional

Start Date: Oct 2024

open study

This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.

Type: Interventional

Start Date: Mar 2024

open study

This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.

Type: Interventional

Start Date: Jan 2025

open study

Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.

Type: Interventional

Start Date: Jul 2024

open study

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.

Type: Interventional

Start Date: May 2023

open study

This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). MIS is a surgical procedure that uses small incision(s) and is intended to produce minimal blood loss and pain for the patient. Laparotomy is a surgical procedure which allows the doctors to remove some or all of the tumor and check if the disease has spread to other organs in the body. MIS may work the same or better than standard laparotomy after chemotherapy in prolonging the return of the disease and/or improving quality of life after surgery.

Type: Interventional

Start Date: Aug 2020

open study

This is a randomized trial of vaginal microbiome transplant vs. saline placebo to restore a Lactobacillus dominant vaginal microbial community in women with recurrent bacterial vaginosis.

Type: Interventional

Start Date: Apr 2021

open study

This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as [intervention], work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Type: Interventional

Start Date: Sep 2017

open study

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

The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism. The main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events. As an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications. The primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.

Type: Observational [Patient Registry]

Start Date: Mar 2001

open study

The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)

Type: Interventional

Start Date: Aug 2026

open study

The goal of this clinical trial is to conduct a randomized controlled trial (RCT) to test the feasibility of two dose- and time-matched pain management programs, delivered via live video, for adults with chronic (lasting at least 3 months) and non-arthritic hip-related pain (HRP). Following pre-determined benchmarks, findings from this trial will be used to assess the feasibility, credibility, and acceptability of both programs (HIPS-1, HIPS-2). In preparation for a future clinical trial powered to test efficacy, we will optimize the protocol for patient recruitment, study protocol, and fidelity materials.

Type: Interventional

Start Date: Jul 2026

open study