The study will aim to link data collected during the DELIVER Randomized Contolled Trial (RCT) to Real World Data (RWD) during the 10 year period following subject participation in the clinical trial. Only individuals who participated in the DELIVER clinical trial will be approached to participate in this research. The study team will need to collect some of the subject's personal health identifiers. A research team at Brigham and Women's Hospital, the coordinating center for the DELIVER Trial, will then use the subject's personal identifiers to obtain data from subjects' health insurance and/or hospital systems.
Patients with chronic pancreatitis often suffer from severe abdominal pain that reduce their quality of life. The major purpose of this study is evaluate the safety and efficacy of an infusion of donor derived mesenchymal stem cells to relieve chronic pain. After cell infusion into the vein, the participant will be followed for 6 months to evaluate their pain and other outcomes. There are a total of 5 clinic visits with a total study participation of up to 7 months.
This is a randomized, double-blind, dose-ranging, placebo-controlled study to see how effectively and how safely two different doses of bexotegrast (160 and 320 mg) can be taken every day for 52 weeks (about 12 months) by subjects with IPF (Idiopathic Pulmonary Fibrosis) who are taking or not taking background therapy (other drugs for IPF include nintedanib or pirfenidone). The study is designed to test the study drug in subjects who are taking or not taking background therapy and will include about 80 subjects who are not taking background therapy at study entry. Subjects who are not taking background therapy at study entry will be allowed to start it at any time during the study. The study will consist of an up to 28-day Screening Period, a 52-week Treatment Period, and a 14-day Safety Follow-up Period. Participants will undergo an end-of-study visit at the end of the Safety Follow-up Period.
The purpose of this registry study is to gather more information to answer research questions about upper tract urothelial carcinoma (UTUC) and the use of Jelmyto as a treatment. Jelmyto is not an experimental medication. It has been approved by the Food and Drug Administration (FDA) in the United States for the treatment of low grade UTUC since April 2021. For this study, data will be collected from the medical record including type and location of UTUC, treatments and surgeries received, and health status following treatments and surgeries. Approximately 400 people will participate in this study. Participation in this study will last three (3) years.
Patients who previously had been treated with either intravenous ganciclovir or oral
valganciclovir as an infant or toddler, either as part of a previous Collaborative Antiviral Study Group (CASG) study or through routine clinical care at a current or former CASG study site, will be offered enrollment on this retrospective follow-up study.
This study will include individuals who complain of a softer speaking volume due to their diagnosis of Parkinson's disease. Participants will receive the standard of care for voice therapy for persons with Parkinson's disease. Voice therapy will be provided three days a week, one hour per session, for 6 weeks. At the start and end of treatment, participants and their caregivers will complete surveys and questionnaires. The surveys and questionnaires will tell us about the impact of your Parkinson's disease diagnosis on the family unit, spousal relationship, communication, and quality of life. Three months after treatment ends, participants and caregivers will participate in a brief structured interview to discuss the supports and barriers to maintaining the vocal exercise program.
Children spend more time than ever using screens — increasingly on portable digital media devices like tablets and smartphones, but our understanding about how these devices impact health is lagging. This project proposes to uncover how patterns of digital media use are formed and maintained and examine how those patterns predict mental health and cardiovascular health risk over time. The novel forms of media measurement used in this project – including passive mobile sampling, ecological momentary assessment and accelerometry – will allow us to uncover the unique and complex ways in which digital media impacts health behaviors.
The purpose of this study is to evaluate investigational treatments (study drug) for unresectable metastatic colorectal cancer to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab. The study consists of two stages, Stage 1 - Safety Lead-In Dose Escalation and Stage 2- Dose Optimization. ABBV-400 is not FDA approved. Bevacizumab is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, and numbness, tingling, or weakness in arms and legs. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
This clinical investigation is a prospective, non-randomized, single-arm, multi-center early feasibility study of the Aria CV Pulmonary Hypertension (PH) System implanted in patients with pulmonary arterial hypertension (PAH). The device will be implanted in the pulmonary artery and the gas reservoir of the device will be in the abdominal cavity. The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient, and to evaluate its performance in treating patients with PAH. Some procedures involved in the study include but not limited too: Questionnaires, physical exams, right heart catherization, echocardiograms, blood work and more. The study will be conducted in a maximum of 10 centers in the United States. Up to 45 patients will be consented, and up to 15 patients will receive implants. There is a total of 11 visits over the course of 2.5 years for the study. Because this is an investigational device under the FDA, there may be risk that include but are not limited to: arrhythmia, device infection, endocarditis, and heart failure. If the Aria CV device performs as intended, you may potentially benefit from reduction in or relief of symptoms caused by PH, and depending on your overall health conditions, prolonged life expectancy and/or improvement in your overall quality of life.
This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.