Iron deficiency is the most common nutritional deficiency worldwide and is a leading cause of anemia, which can result in symptoms such as fatigue, weakness, shortness of breath, and reduced quality of life. This study aims to better understand why some people develop iron deficiency by examining how the body absorbs iron and how this may relate to diet and proteins involved in iron absorption. Participants will complete questionnaires, provide blood, urine, and stool samples, undergo an oral iron absorption test, and complete a short food diary. If an upper endoscopy is already being performed as part of routine medical care, one additional biopsy sample will be collected during the procedure for research purposes. The information gathered may help improve the diagnosis and evaluation of iron deficiency anemia in the future. Participation involves two study visits over approximately one month. There is no direct medical benefit to participants, but the knowledge gained may benefit future patients with iron deficiency anemia.
Select Late will be looking at treatment outcomes in patients presenting with severe blood clot blocking a blood vessel in your brain (ischemic stroke) specifically in one of the large arteries in the brain effecting the front of the brain presenting between 24 and 72 hours after stroke start. The study will be looking at patient outcomes when treated with the standard of care medical management compared to medical management plus endovascular thrombectomy (a surgical procedure to remove a blood clot).
This study will enroll patients with different types of cancer, as well as healthy patients with no history of cancer, into four cohorts to collect urine and/or blood samples only. The study will collect biospecimen samples to support further development of a urine-based ctDNA test. The study will enroll a total of 920 patients over 4 years.
This study is looking for patients who have been diagnosed with advanced non–small cell lung cancer (NSCLC) that have certain biomarkers (negative for PD-L1, and positive for KRAS p.G12C). This study is being conducted to determine how well participants respond to treatment with chemotherapy (carboplatin and pemetrexed) combined with either sotorasib or pembrolizumab. The study will determine whether sotorasib and chemotherapy reduces the risk of this type of cancer getting worse and improves participants survival (i.e., increases the chance of you living longer) compared to the current standard treatment with pembrolizumab and chemotherapy. It is anticipated that participants will be enrolled in this study for approximately 5 and a half years. There will be a total of approximately 15 visits to the study site during the study depending on how well participants tolerate or respond to the study drug. The visits will take several hours each and will take place approximately every 3 weeks.
We will gather feedback from healthcare providers and pregnant or up to two years postpartum adult women to better understand their needs and experiences related to traumatic stress and alcohol use during pregnancy. We will conduct focus groups with maternal health and mental health professionals, as well as conduct 60-minute interviews along with a survey/questionnaire with pregnant women who are experiencing both alcohol-related challenges and trauma-related symptoms. What we learn from these conversations will help us tailor services to address the unique needs of women during pregnancy and the postpartum period.
This is a treatment plan to provide recombinant Bacillus Calmette-Guérin (rBCG) to patients with bladder cancer who are eligible to receive TICE® BCG and may benefit from its use. The treatment plan will end if the product is approved for use in the United States or if a Food and Drug Administration (FDA) clinical trial proves rBCG treatment to be ineffective. The drug is not currently FDA approved for bladder cancer.
Subjects will receive rBCG. They will have tests, exams and procedures that are part of standard of care (SoC) and for treatment plan purposes. Participants will receive treatment based on TICEBCG protocol at their local institutions.
The PRE-EMPT study is designed to identify people who may have early signs of heart disease even though they are considered to be at low risk for heart problems. Participants will undergo specialized heart scans to look for plaque buildup in the arteries that supply blood to the heart. Individuals found to have early plaque may be invited to participate in a treatment phase of the study. In this phase, participants will receive either study medications (rosuvastatin and/or colchicine) or placebo tablets and will also receive support for healthy lifestyle behaviors through a digital health platform. Patients will be randomized to one for four treatment groups. Researchers will follow participants for approximately two years to determine whether these treatments and lifestyle interventions can slow or reduce plaque buildup in the heart arteries. Information gained from this study may help improve strategies for detecting and treating early heart disease in the future.
This study will compare the efficacy and safety of SD-101-6.0 cream with SD-101-0.0 (placebo) in approximately 80 patients with Epidermolysis Bullosa (EB), including Simplex, Recessive Dystrophic, and JEB-nH subtypes. Patients will apply SD-101-6.0 or placebo topically once daily to the entire body for 60 days. Each patient will have one target wound that is 21 days or older and 10–50 cm² in size selected at baseline. The primary goal is to determine how many patients in each treatment group achieve complete closure of the target wound (skin re-epithelialization without drainage) by Month 1.
Patients will return for follow-up visits around Days 14, 30, and 60 to assess wound healing using the ARANZ SilhouetteStar™ device, with the target wound measured at each visit until it is documented as closed. Secondary assessments include changes in total wound burden based on body surface area (BSA), itching, and incidence of skin infections across the entire body. Itching will be evaluated at multiple time points but will not be recorded as an adverse event. Patients who complete this trial may be eligible to enroll in an open-label extension study (SD-008) to receive active treatment. Safety will be monitored through adverse event reporting, tolerability assessments, and physical examinations, with urine pregnancy testing performed at the investigator's discretion.
This study is for patients that have been diagnosed with platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study is testing and investigational drug called INCB123667. "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 efficacy and safety of INCB123667 in terms of objective response rate (ORR) as assessed by an independent review committee (IRC). The drug is given to participants orally. Participants can expect to be on this study for approximately 24 months.
This study is being conducted to determine how well participants with stage IV or advanced stage IIIB/C nonsquamous non-small cell lung cancer (NSCLC), that has certain biomarkers (negative for PD-L1, and positive for KRAS p.G12C) respond to treatment with chemotherapy (carboplatin and pemetrexed) combined with either sotorasib or pembrolizumab. The study will determine whether sotorasib and chemotherapy reduces the risk of your cancer getting worse and improves your survival (i.e. increases the chance of you living longer) compared to the current standard treatment with pembrolizumab and chemotherapy. In this study, participants will be screened and if they meet criteria will be enrolled into the main study and assigned, by chance, into one of 2 groups. You will have an equal chance of taking sotorasib platinum doublet combination chemotherapy or pembrolizumab platinum doublet combination chemotherapy. It is hoped that the information gained from the study will help refine future chemotherapy programs.