All Clinical Trials

The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit. Read Less

A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL). Read Less

The investigators propose to expand our previous work to test whether 10 repeated administrations of the cTBS procedure over a two-week period can lead to longer-term improvements in sleep, perhaps up to 3-months. For this 3-year study, 120 people with insomnia will be recruited to participate. There will be an initial screening, with the first consent form being for the screening questions, a psychological interview, and a one night at home sleep monitoring session with our equipment. If participants pass this first phase, they will reconsent for the main portion of the study. They will then undergo a physical examination, then a week-long at-home monitoring phase where they will wear a wristwatch sleep monitor as well as wear a portable brain wave monitor to bed each night to record sleep. Participants will continue to use this equipment throughout the treatment phase and for one week post treatment. After the first monitoring phase, each participant will be randomly assigned to one of four different conditions (i.e., 30 assigned to each group). Three of the conditions will involve cTBS focused on different brain locations (i.e., stimulation to the middle front, middle back, or side of the skull), while the fourth condition will provide inactive sham stimulation as a control. All participants will complete 10 treatment visits to the lab over two-to-three weeks, during which they will get a brief cTBS or sham stimulation each time. In addition, all participants will complete a brain scanning and cognitive testing session at the beginning and end of the two-to-three week treatment period. Participants will also complete 1-month and 3-month online follow-up assessments to examine long-term effects. Read Less

The goal of this clinical trial is to learn if a new contact lens device can record patterns in eye pressure for 24 hours in adults with glaucoma and in healthy participants. The main questions it aims to answer are: * Is the contact lens device able to detect patterns in eye pressure that happens naturally between nighttime and daytime? * Are the contact lens recording patterns similar when repeated one week later? * What eye problems do participants have when wearing contact lens for up to 24 hours? Researchers will compare if the recordings detected by the contact lens over 24 hours are similar to the patterns measured by an eye pressure measuring instrument used in a doctor's office. Participants will * Wear contact lens in one eye for up to 24 hours * Take recordings in that eye with smartphone camera every 15 minutes when awake * For those participants who are able to stay overnight at a hotel for the trial, researchers will measure the eye pressure in the other eye every 1 to 2 hours when awake with an eye pressure measuring instrument. Read Less

This project aims to study whether a structured wellness program intervention can improve quality of life among people living with Neuromyelitis Optica Spectrum Disorder (NMOSD). This pilot will test a multi-modal wellness program tailored to NMOSD patients that includes services from physical therapists, dietitians, social workers, nurse practitioners and cognitive therapists. The trial will be designed as a randomized controlled trial, randomizing patients to immediately starting the program as well as a 6 month delayed start. The intervention would leverage an existing clinical comprehensive MS wellness program at the Corinne Dickinson for Multiple Sclerosis (MS) at Mount Sinai Medical Center. The primary endpoint of this study would be evaluating quality of life, as assessed by MS-Quality of Life -54. Read Less

A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation Read Less

The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group. The primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by: * no secondary surgical intervention (SSI) and * an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. Researchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement). Subjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement. Read Less

This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and wound dehiscence in an outpatient setting. The trial is sponsored by Reprise Biomedical, Inc. and aims to explore whether the addition of Miro3D-a three-dimensional, acellular porcine-derived wound matrix-enhances wound healing outcomes compared to SOC alone. Purpose of the Study: The primary purpose of the study is to determine whether applying Miro3D in combination with SOC leads to improved healing of diabetic foot ulcers compared to SOC alone. Specifically, the study seeks to assess early wound healing progress at four weeks (as measured by percent area reduction and granulation tissue formation) as a predictor of complete healing by twelve weeks. Key Question the Study Seeks to Answer: Does the addition of Miro3D to standard wound care improve the healing rate and overall wound outcomes for patients with Wagner Grade 1 diabetic foot ulcers or dehisced wounds compared to standard care alone? Study Design Overview: Subjects who meet inclusion/exclusion criteria will be randomized into one of two groups: 1. Miro3D + SOC arm - receiving Miro3D weekly for 4 weeks, then biweekly if needed, for up to 12 weeks. 2. SOC alone (control) arm - receiving SOC without Miro3D. If the wound remains unhealed at 12 weeks in the SOC alone arm, participants may "crossover" to receive Miro3D treatment under the same schedule for an additional 12 weeks. Primary Endpoint: 1. Percent Area Reduction (PAR) and granulation tissue formation at 4 weeks, serving as predictors for wound healing at 12 weeks. Secondary Endpoints: 1. Quality of Life (QOL) improvements, including pain, mobility, and emotional well-being, assessed using a validated Wound/Ulcer-QOL tool. 2. Pain levels using a Visual Analog Scale (VAS) at each visit. Population: Approximately 30 adult subjects (15 per arm) with Wagner Grade 1 diabetic foot ulcers or dehisced wounds will be enrolled. Subjects must have adequate blood flow, demonstrate wound size criteria, and commit to offloading and follow-up care. Follow-Up: Subjects will be followed weekly through the 12-week study period. Healed subjects will undergo confirmation visits at 2 and 4 weeks post-closure. Subjects in the crossover arm will be followed for an additional 12 weeks if their wound was unhealed at the primary endpoint. Statistical Considerations: Data will be summarized using descriptive statistics, including wound measurements, infection status, and healing rates. Comparative analysis will be conducted between treatment groups and schedules (weekly vs. biweekly Miro3D application). Adverse events (AEs), serious adverse events (SAEs), and device-related events will also be documented. This study aims to generate clinical evidence supporting the use of Miro3D as a beneficial adjunct to standard wound care in promoting early and complete healing of diabetic foot ulcers. Read Less

Background: - Skin disease can have many causes. It can have widespread consequences, and in rare cases can lead to death. Researchers want to determine the causes of various types of skin diseases and find a way to treat them. Objectives: - To determine the causes of various skin diseases and find ways to treat them. Eligibility: * People ages 2 and older who have: * A skin disease or at risk of developing a skin disease OR * A family member of persons with a skin disease * Healthy volunteers ages 2 and older Design: * Participants will be screened under a separate protocol. * Participants may take a survey about how their skin condition affects their quality of life. * Participants will have a medical history and a physical exam including a detailed skin exam. Pictures will be taken of their skin to document any skin disease. * Participants will have specimens collected. This may include: * Several teaspoons of blood taken at each visit * Stool samples * Nail and body fluid (like saliva) samples * Cheek swabs. The inside of the cheek will be scraped for about a minute in each direction to collect cells. * Collection of skin samples with: * A swab (like a Q-tip) * Gently scraping skin to remove the outer layers of cells * Applying and removing 1-inch pieces of tape * Participants may have up to 4 skin biopsies in 12 months, with 4 separate biopsies taken each time. * An area of skin will be numbed with an injection. * A piece of skin the size of a pencil eraser will be removed using a small instrument. * A flat scar usually develops at the biopsy site. Read Less

Background: The drug venetoclax treats chronic lymphocytic leukemia (CLL). Researchers want to find better treatments for CLL. To do that, they need to learn how the drug affects CLL cancer cells and the immune system. Objective: To learn about genetic changes that happen during treatment of CLL with venetoclax. Eligibility: Adults ages 18 and older with relapsed or refractory CLL after at least 1 prior therapy Design: Participants will be screened under a separate protocol. In Phase 1, participants will get venetoclax free of charge through the NIH. Venetoclax is started at a low dose. The dose will be increased every week until participants reach their maximum tolerable dose. This usually take about 5 weeks. Participants will visit the NIH at least once per week. Visits will be about 4 hours. They may have to stay in the hospital to be observed. In Phase 2, participants will continue to get the drug through their local cancer doctor and their health insurance. Patients will also visit the NIH every 6 months, or if their disease progresses. At the NIH participants will have regular health assessments. These will include physical exams and a review of the medicines they are taking. They will talk about how they are feeling. The study included the following tests: Blood draws CT scans: Participants will lie in a machine that takes pictures of the body (maximum 3 per year) Bone marrow biopsies: A small amount of marrow will be taken out of the participant s hip bone with a needle. Optional lymph node biopsies: A small piece of the participant s tissue will be taken out with a needle. The study will last at least 2 years. Read Less

The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research. Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. There is a need for level one evidence drawn from randomized clinical trials to prove the safety, feasibility and efficacy of knee embolotherapy compared to standard of care. This randomized pilot study will assign 10 patients with mild-moderate OA to undergo geniculate artery embolization plus standard of care (defined in this study as: physical therapy and oral anti-inflammatory medications, with a maximum of 1 joint injection at the time of enrollment) and 10 patients to receive only medical standard of care (also having had a maximum of 1 joint injection prior to enrollment). The goal of this pilot study is to obtain preliminary estimates of safety and efficacy of embolotherapy to provide sustained symptom control and modify disease progression in patients with mild to moderate knee OA. Read Less

The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response. Read Less