RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

Type: Interventional

Start Date: Feb 2024

open study

The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).

Type: Observational [Patient Registry]

Start Date: Jun 2023

open study

This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies - EN10.A/RAINBO BLUE: POLE-mutated EC - EN10.B/TAPER: p53 wildtype / NSMP EC

Type: Interventional

Start Date: Dec 2022

open study

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Type: Interventional

Start Date: May 2022

open study

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, 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. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.

Type: Interventional

Start Date: May 2017

open study

KB803-EYE-01 is a Phase 3 double-blind, randomized, placebo-controlled, crossover study to evaluate the safety and efficacy of KB803 versus matched placebo in pediatric and adult subjects with recurrent corneal abrasions due to dystrophic epidermolysis bullosa (DEB).

Type: Interventional

Start Date: Jun 2025

open study

The purpose of this study is to determine if the method for injecting local anesthesia affects patients' pain and opioid usage after surgery. The investigators will compare subcutaneous anesthesia, injections of anesthesia under the skin, to a method called erector spinae plane block (ESPB). An ESPB injection involves placing local anesthesia along the muscles and bones in the back, using a special type of x-ray called fluoroscopy for guidance. The Investigators will use patient reported outcomes (PROs) and track subjects' opioid usage to find out if there is a difference between ESPB and subcutaneous anesthesia. The investigators hypothesize that patients who get ESPB injections will use less opioids and report less pain after lumbar fusion surgery compared to patients who receive subcutaneous anesthesia injections.

Type: Interventional

Start Date: Sep 2024

open study

This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.

Type: Interventional

Start Date: Apr 2025

open study

This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients. Patients will receive 2/5 mg of letrozole daily.

Type: Interventional

Start Date: Jul 2024

open study

This observational study is being conducted to determine plasma concentrations of tetrahydrocannabinol (THC) and its metabolites, 11-OH-THC and THC-COOH, in plasma of pediatric patients who visit the emergency department due to acute cannabis-induced CNS depression.

Type: Observational

Start Date: Jun 2023

open study

This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo [¹⁸F]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such [¹⁸F]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of [¹⁸F]FAPI-74 PET/CT.

Type: Interventional

Start Date: Dec 2025

open study

The goal of this project is to test a novel bedside SDOH screening intervention coupled with post-discharge navigation for hospitalized patients with a diabetes diagnosis to reduce unmet social needs, compared to usual care.

Type: Interventional

Start Date: Jun 2026

open study

Accurate risk assessment is essential for the success of population screening programs and early detection efforts in breast cancer. Mirai is a new deep learning model based on full resolution mammograms. Mirai is a mammography-based deep learning model designed to predict risk at multiple timepoints, leverage potentially missing risk factor information, and produce predictions that are consistent across mammography machines. Mirai was trained on a large dataset from Massachusetts General Hospital (MGH) in the United States and found to be significantly more accurate than the Tyrer-Cuzick model, a current clinical standard. The primary aim of this study is to prospectively quantify the clinical benefit (i.e. MRI/CEM cancer detection rate) of Mirai-based guidelines and to compare them to the current standard of care. 1. Conduct a prospective study where patients who are identified as high risk by Mirai guidelines are invited to receive supplemental MRI within 12 months. 2. Compare cancer outcomes between patients only identified as high risk by Mirai and patients identified as high risk by existing guidelines The secondary aim is to study the impact of new guidelines by race and ethnicity, to ensure equitable improvements in cancer screening.

Type: Interventional

Start Date: Feb 2024

open study

This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).

Type: Interventional

Start Date: Dec 2019

open study

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

Type: Observational [Patient Registry]

Start Date: Sep 2017

open study

The goal is to identify the most impactful strategies for capturing attention and enhancing effectiveness of vaccine promotion messages. This will be done using an online survey that employs remote eye-tracking and self report measures to evaluate response to sample vaccine promotion social media content in rural populations in New England. Participants will be randomly assigned into one of 14 conditions in a 2(source: expert vs. influencer) by 7 (themes: constructs from 7C Vaccine Framework) experiment and view sample messages and then answer questions about their attitudes and beliefs while being monitored for eye-tracking.

Type: Interventional

Start Date: Dec 2025

open study

The proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device (Ear-Seizure Detection Device (EarSD)) by simultaneous recording with conventional video-EEG (Electroencephalogram) on patients with epileptic seizures in the Epilepsy Monitoring Unit of the hospital.

Type: Interventional

Start Date: Apr 2025

open study

Retropubic midurethral slings are a common and effective treatment for stress urine incontinence. The trocar that is attached to the mesh material can hit the bladder which is called a perforation. While there are no known long-term adverse outcomes from trocar-induced bladder perforations, it can prolong operative time and bleeding. At academic institutions, it has been reported that trocar-induced perforations occurs in the range of 14-34% of the time. This study is a randomized controlled trial to see if an intervention can decrease trocar-induced bladder perforation rates. The primary outcome of this study is to measure trocar-induced bladder perforations in subjects undergoing a retropubic midurethral sling. Subjects would be randomized to either receive the hydrodissection in a standardized manner or to not receive it. Secondary outcomes include bothersome urinary symptoms, pain, estimated blood loss during surgery, and voiding trial results

Type: Interventional

Start Date: Apr 2025

open study

The objective of this trial is to evaluate the effect of Bionix ShotBlocker on pain of injection of the first Hepatitis B vaccine in healthy newborns. ShotBlocker is a pain reducing tool used in babies, children, and adults for injections. Swaddling during the injection and administration of oral sucrose prior to the injection are established standards of care for painful procedures in neonates. The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response.

Type: Interventional

Start Date: Jan 2024

open study

This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL/SLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.

Type: Interventional

Start Date: Aug 2023

open study

The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.

Type: Interventional

Start Date: Jun 2019

open study