Mass General - Division of Clinical Research

The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.

Type: Observational [Patient Registry]

Start Date: Dec 2018

open study

Individuals with immune thrombocytopenia (ITP) frequently report difficulties with attention and memory. The main question this study seeks to answer is: Do patients with ITP have evidence of cognitive impairment as detected by a cognitive function test battery? To address this issue, participants will take a cognitive function test and complete surveys on quality of life, fatigue, depression, and cognitive symptoms. The primary aim of the study is to evaluate for the presence and extent of cognitive impairment in patients with ITP. The study will also assess whether cognitive impairment in ITP is associated with patient-reported impacts on quality of life, fatigue, mood, and cognitive symptoms as well as clinical characteristics such as ITP disease and treatment history.

Type: Observational

Start Date: Sep 2024

open study

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future. PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.

Type: Observational

Start Date: Sep 2005

open study

The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports "The Learning Health System" and "Epilepsy Across the Spectrum: Promoting Health and Understanding". The ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care.

Type: Observational [Patient Registry]

Start Date: Mar 2019

open study

The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment of HALT with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of HALT. The study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) or bioprosthetic valve degeneration. Enrollment will continue until 30 patients with HALT are identified for completion of phase 1. Based on a HALT incidence rate of 10%, we anticipate enrolling 300 patients. Patients are enrolled prior to undergoing transfemoral TAVR. Blood samples, clinical data and echocardiograms will be collected at the following timepoints: baseline (pre-TAVR, T0), post-TAVR (pre-discharge, T1), 30-day follow-up (window 3-9 weeks, T2), and 6-month follow-up (T3). Cardiac 4D CT will be performed at the 30-day follow-up visit to screen for the occurrence of HALT. Patients with HALT will be treated with systemic anticoagulation for 5-6 months, at which point a follow-up CT scan and blood sample will be obtained. Control subjects will also undergo a 6-month study visit with blood sample collection. The study will be conducted within two phases. Phase 1 will serve as a derivation / discovery study in which candidate protein biomarkers of HALT will be identified. Once this is successfully completed, a second cohort will be enrolled within phase 2. Phase 2 will be performed under the auspices a future contract or amendment and will seek to cross-validate the initial study findings.

Type: Interventional

Start Date: Jun 2020

open study