Maryland Paid Clinical Trials

Background: Immune bone marrow failure is a condition that occurs when a person s immune system attacks the cells of the bone marrow. This can lead to diseases including different types of anemias and blood cancers. Some of these diseases can be deadly. Better treatments are needed. Objective: To test a drug (ruxolitinib) in people with different types of immune bone marrow failure. Eligibility: Adults aged 18 and older with an immune bone marrow failure. Design: Participants will be screened. They will have a physical exam. They will give samples of blood and saliva. They will have a bone marrow biopsy: A large needle will be inserted into a small cut to remove a sample of the soft tissue inside the bone. Some participants may have a skin biopsy: A small piece of skin will be removed. Some may have a computed tomography (CT) scan: They will lie on a table that slides into a donut-shaped machine that uses X-rays to make pictures of the inside of the body. Ruxolitinib is a tablet taken by mouth. Participants will take the drug twice a day for up to 6 months. Participants will have blood tests every week while they are taking the drug. These tests can be done by the participant s own physician and the results sent to the researchers. Participants will have clinic visits after taking the drug for 3 months and 6 months and then after 1, 2, and 3 years. The blood tests and bone marrow biopsy will be repeated. Participants who improve while taking the drugs may go on to an extension phase of the study. Read Less

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]). * The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe (PFS) or in a 2 mL autoinjector (AI) for injection. All participants will receive ianalumab either monthly or every 3 months. * The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years. * The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up. Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding. Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study. Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens: * ianalumab 300 mg monthly or * ianalumab 300 mg once every 3 months Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study. Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe or a 2 mL autoinjector. Participants will be given the opportunity to self-inject at home on some visits after receiving training. Read Less

This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period Read Less

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD). Read Less

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL). Read Less

The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab. Read Less

This phase II trial tests the safety, side effects, and best dose of monosialotetrahexosylganglioside (GM1) and whether it works in reducing or preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving treatment with paclitaxel. Chemotherapy drugs, such as paclitaxel, 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. Exposure to chemotherapy drugs like paclitaxel may cause a side effect called CIPN, which is a condition of weakness, numbness, and pain from nerve damage (usually in the hands and feet). GM1 is a part of the body's natural system that insulates nerves and helps to protect nerves from damage. Giving GM1 may help reduce or prevent CIPN in breast cancer patients receiving treatment with paclitaxel. Read Less

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers. Read Less

Background: The microbiome is the bacteria and other microorganisms that live inside and on the body. The microbiome is important for our health. Researchers study how the microbiome help people stay healthy. They study how the microbiome affects the body when people get sick. To do this research, they need samples of the microbiome living on the bodies of many people. The purpose of this natural history study is to collect microbiome samples in a repository. These samples will be used for future research. Objective: To collect microbiome samples from the body that can be used for future research. Eligibility: People of any age. Only those older than 3 years will be seen at the NIH clinic. Design: Participants will fill out a questionnaire. Topics will include their medical history and foods they eat. Participants will be asked to give 1 or more of the following: Stool, urine, saliva, vaginal fluid, and breastmilk. These samples can be collected at home and sent to the researchers. Cells from participants cheek, nose, mouth, skin, rectum, and/or vagina. The cells may be collected by rubbing the area with a sterile cotton swab. These procedures can also be done at home. Blood. Blood may be drawn using a needle inserted into a vein in the arm. For young children, blood may be collected by a prick on the heel or finger. Intestinal tissue samples. These may be collected from participants who are having an endoscopy or colonoscopy for other reasons. Skin tissue samples. These may be collected from participants who are having biopsies for other reasons. Read Less

This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone. Read Less

Background: People who were born outside of the country are the largest group of adults infected with chronic hepatitis B virus (HBV) in the US. HBV affects the liver. If not treated, HBV infection can lead to serious liver disease, including cancer. One recent study showed that only 35% of foreign-born US adults were aware of their HBV infections. Foreign-born US adults may also have trouble getting proper care after they are diagnosed with HBV. In one small survey, language, cultural, and financial barriers were cited as the biggest reasons for not receiving care. To help more people with HBV, researchers want to learn how to find and overcome any barriers to care. Objective: This natural history study seeks to identify and better understand barriers that prevent foreign-born US adults from getting proper care for HBV infections. Eligibility: People aged 18 years and older with chronic HBV who were born outside of the US. Design: Participants will visit the NIH clinic 1 time. This visit will take about 20 minutes. Researchers will review participants medical records and collect information about their HBV. Participants will complete a survey. They will answer questions about: Where they came from. When they came to the US. How well they have adapted to living in the US. The health care they have received for HBV. Their age, gender, and education. Participants will be paid $10 for completing the survey. Read Less

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. Read Less