This study is for patients that have been diagnosed with locally advanced or metastatic solid tumor, including non-small cell lung cancer (NSCLC), triple-negative breast cancer, gastric cancer, esophageal cancer (or gastroesophageal cancer), head and neck squamous cell cancer, ovarian cancer, endometrial cancer, or cervical cancer. The study is testing and investigational drug called NRM-823. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety and tolerability of NRM-823 as monotherapy and in combination with pembrolizumab. The study drug is given as an injection into the stomach (or another place, like the thigh). An injection is like a shot between the skin and muscle so that the drug can enter your body. Participants can expect to be on this study until the first radiographic disease progression.
This study is for patients that have been diagnosed with diagnosed with primary advanced or recurrent endometrial cancers that express high levels of the human epidermal growth factor receptor 2 (HER2) protein and that have a genetic characteristic known as mismatch repair proficiency (pMMR). The study is testing investigational drugs called Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The purposed of this study is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy. The study drugs are given by infusion. Participants in this study can expect to be in this study for as long as you are receiving benefit from the treatment.
This study is recruiting pediatric patients who have been diagnosed with rhabdomyosarcoma (RMS). RMS is a type of cancer that occurs in the soft tissues of the body. The goal of the study is to compare the effects, good and/or bad, of giving less chemotherapy drugs to people with very low risk-RMS to find out which is better. Patients will be separated into two groups based on their tumor type: Low Risk and Very Low Risk. Participants in the Low Risk group will receive Vincristine, Dactinomycin and Cyclophosphamide. Participants in the Low Risk group will receive Vincristine and Dactinomycin. All participants will be tested for genetic differences (called MYOD1 and TP53). If any participant is found to have these genetic differences, they will receive Vincristine, Dactinomycin and Cyclophosphamide. Common side effects of chemotherapy include nausea, vomiting, hair loss, and fatigue (tiredness). Participants will receive the medications through an IV in their arm. Study participation is expected to last up to one year.
This study is for patients that have been newly diagnosed with GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL). This study is testing an investigational drug called zilovertamab vedotin. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In the study, participants will be randomized to two different groups (like flipping a coin). The first group will receive zilovertamab vedotin plus R-CHP [rituximab, cyclophosphamide, doxorubicin, and prednisone]. The second group will receive the standard care regimen: polatuzumab vedotin plus R-CHP. The drugs will be given through an IV, and prednisone may be given to participants by mouth. The primary purpose of the study is to learn if zilovertamab vedotin plus R-CHP is safe and effective for treating DLBCL. Participants in this study can expect to be in this study for up to 5.5 years. The first six months will be participation in treatment, and the following five years will be follow-up.
This is a randomized, double-blind, placebo-controlled, multicenter, 2-arm (1:1), parallel group, efficacy, and safety/tolerability fixed-dose study of SPN-812 in preschool-age children (4 to 5 years old) with a DSM-IV-TR diagnosis of ADHD. Approximately 286 subjects will be randomized to either SPN-812 or matching placebo in a 1:1 ratio (143 subjects per arm). Following up to 4 weeks of screening, subjects will be treated with study medication (SM) for 6 weeks, then will either be enrolled in a separate OLE study or followed for an additional 1 week for safety. The total duration of the study is up to 10 weeks.
This study will continue using the study drug levosiminden to determine if it can help people with the heart failure with preserved ejection fraction with pulmonary hypertension (HFpEF-PH). Levosimenden is an investigational drug. Investigational means that this drug is not yet approved for use in any settings outside of clinical research studies like this one. This drug is thought to assist in helping with decreasing your heart failure symptoms and increase your quality of life.
Participation in this study will last up to 60 month and will consist of about 13 clinic visits. Some tests required include physical exams, and dispensing of study medication, bloodwork.
The study aims to evaluate if an experimental drug called SAR441566 can improve signs and symptoms of moderate to severe ulcerative colitis (UC). SAR441566 is a new drug that inhibits Tumor necrosis factor receptor 1 (TNFR1) signaling. This study will also help the Sponsor to understand which dose of SAR441566 is most effective and safe in participants with moderate to severe UC. To do this, 3 different doses of SAR441566 will be tested along with a placebo. The study will last about 1 year, will include about 260 adult participants across over 26 countries.
The purpose of this research study is to confirm the safety of the study drug (Prismocitrate 18) and the study device for patients with acute kidney injury receiving a type of dialysis treatment known as Continuous Renal replacement Therapy (CRRT). When a patient receives CRRT, a blood thinner (also known as an "anticoagulant") is frequently given. In the United States (U.S.), an anticoagulant called, Heparin, is commonly used for CRRT. Some patients have a high risk of bleeding and cannot be given heparin, because it can cause harm to them. For these patients, an anticoagulant, called citrate, can be used. The study drug being tested contains citrate. The study drug works as an anticoagulant and may also help cleanse your blood during the CRRT treatment.
To improve the diagnosis of metabolic dysfunction-steatotic liver disease (MASLD) in primary care, this study will develop, test, and internally validate a predictive model for MASLD in a cross-sectional sample of patients with no known chronic liver disease. Patient metabolic variables, like weight, blood pressure, and blood sugar will be considered for inclusion in the model, and ultrasound-based vibration-controlled elastography will be used for determining the outcome. This work will dramatically enhance MASLD diagnosis and management in primary care.
This study is for participants that have been diagnosed with Intermediate or High-risk Primary or Secondary Myelofibrosis. This study is testing an investigational drug called Nuvisertib. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to evaluate the efficacy and safety of Nuvisertib. Nuvisertib is an oral PIM1 selective inhibitor. A PIM1 selective inhibitor is a drug that specifically targets and blocks the activity of the PIM-1 kinase, an enzyme implicated in cancer cell growth. This drug is given to participants by mouth. Participants in this study can expect to be in the treatment phase of this study for 19 months and the long term follow up phase for 3 years.