This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Type: Observational

Start Date: Nov 2015

open study

This study is a pharmacoepidemiologic method study based on the secondary use of pre-existing data that examines whether TriNetX, a global health research network encompassing a worldwide electronic health record (EHR), database in the US is an appropriate real-world data (RWD) source for conducting chlamydia-related research to support the chlamydia trachomatis (CT) messenger Ribonucleic acid (mRNA) vaccine program. There are two primary objectives for this study: 1. To determine the validity of ICD, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic codes to identify patients with chlamydial infections using TriNetX EHR data in the US 2. To describe screening or diagnostic testing and treatment patterns in patients with chlamydia using TriNetX EHR data in the US There are also two secondary objectives for this study: 1. To explore the feasibility of developing a modified algorithm for identifying patients with chlamydia applicable for Merative MarketScan Commercial Claims and Encounters (CCAE) database based on the findings from the primary objectives 2. To compare patient characteristics, use of screening or diagnostic testing, and treatment patterns among patients with chlamydia between TriNetX EHR data and the MarketScan CCAE data in the US

Type: Observational

Start Date: Jan 2025

open study

Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 34 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). We received supplemental funding to extend analyses to include extended postpartum maternal health outcomes. The original sample size of 420 remains the basis for the parent trial's primary and secondary NICU caregiving outcomes, while the supplemental funding (effective January 2026) enables analysis of secondary maternal health outcomes up to 12 months postpartum using an expanded analytic cohort. The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development.

Type: Interventional

Start Date: Oct 2024

open study

The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis).

Type: Interventional

Start Date: May 2024

open study

This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

Type: Interventional

Start Date: Sep 2023

open study

The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.

Type: Interventional

Start Date: Jul 2023

open study

This study is investigating whether a cranberry-based dietary supplement, rich in polyphenols and fiber, can enhance gut health in individuals with Crohn's disease. People with Crohn's disease often have an imbalance in their gut microbiome (the community of bacteria in the gut). Previous research suggests that cranberry compounds may help support beneficial gut bacteria. In this study, adults with Crohn's disease will be randomly assigned to one of two groups: one group will receive a cranberry supplement to take once daily for 10 weeks, and the other group will receive a placebo (a supplement with no active ingredients). All participants will be asked to complete online questionnaires and collect samples of their blood, urine, and stool at four time points over a total of 15 weeks. These samples will help researchers understand how the cranberry supplement affects the gut microbiome, inflammation, and overall health. Participation is voluntary, and participants can withdraw from the study at any time. The results of this study may help identify new diet-based approaches to improve gut health in individuals with Crohn's disease.

Type: Interventional

Start Date: Oct 2025

open study

The purpose of the study is to quantitatively characterize the flow in the pelvic venous structures using 2D and 4D flow MRI with the objective of establishing physiologic and pathologic parameters for downstream computational fluid dynamics analysis. Arm 1: To establish the baseline flow characteristics of the iliac veins in patients with no imaging evidence of iliac venous disease. Arm 2: To assess the flow characteristics of the iliac veins in patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome). Arm 3: To assess the flow characteristics of the iliac veins in patients status post iliac stent placement.

Type: Interventional

Start Date: Apr 2025

open study

The goal of this study is to collect additional information on the safety of long-term treatment with AGAMREE® and to explore long-term clinical impact of AGAMREE® on quality of life, as assessed by standardized patient-reported outcome measures (QoL questionnaires) in male patients aged 2 years and older with Duchenne muscular dystrophy (DMD).

Type: Observational [Patient Registry]

Start Date: Sep 2024

open study

This study will build on data from mice and humans implicating TRPV1 nociceptors in the pathogenesis of the type-17 chronic inflammatory skin disease Hidradenitis Suppurativa (HS). In this study, the investigators will test the hypothesis that inhibiting neuropeptide activity with botulinum toxin reduces pathogenic inflammation.

Type: Observational

Start Date: Jun 2022

open study

The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.

Type: Observational

Start Date: Sep 2020

open study

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign.

Type: Interventional

Start Date: May 2025

open study

This pilot study will examine the effects of a digital health approach, Moms@Home, on home blood pressure monitoring in a diverse population of pregnant women with hypertension.

Type: Interventional

Start Date: May 2025

open study

The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.

Type: Interventional

Start Date: Jun 2025

open study

This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6,12, 18, and 24. At Month 24, participants will be randomized (2:1) to one of two Arms with randomized treatment beginning at Month 30: Arm 1: placebo infusions every 6 months; or Arm 2: OCR infusions every 6 months. The treatment period will be for a total of 48 months.

Type: Interventional

Start Date: Jan 2023

open study

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol 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. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Type: Interventional

Start Date: Oct 2019

open study

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

Type: Interventional

Start Date: Jun 2017

open study

The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol. Participants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).

Type: Interventional

Start Date: Apr 2024

open study

This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-SC may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.

Type: Interventional

Start Date: Nov 2024

open study

The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia (RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae that cause pneumonia) included in 20vPnC vaccine. This study is seeking participants who: - are male or female ≥65 years of age. - are hospitalized with physician suspicion of community acquired pneumonia (CAP). - have pneumonia confirmed with imaging like a chest x-ray Participants will be asked to provide demographic and medical history information, and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae. We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC. Participants will actively take part in the study for about 1-2 days. Information on participant's illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review.

Type: Observational

Start Date: Oct 2022

open study

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: - Screening period - 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) - 12-week Sub-Study 3 (Extended Induction for non-responders) - 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Type: Interventional

Start Date: Oct 2025

open study

The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group. The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk percutaneous coronary interventions (HR-PCI).

Type: Interventional

Start Date: Jul 2025

open study

The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.

Type: Observational

Start Date: Apr 2023

open study

PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study.

Type: Interventional

Start Date: Sep 2022

open study

The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.

Type: Interventional

Start Date: Apr 2025

open study