This study is for patients who have been diagnosed with prostate cancer that is prostate-specific membrane antigen (PSMA)-positive and has spread despite treatment with another androgen receptor pathway inhibitor (ARPI). This study is testing an investigational drug called AAA817. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In this study, participants will be randomly assigned (like flipping a coin) to receive AAA817 alone, AAA817 with an androgen receptor pathway inhibitor (ARPI), or standard of care treatment. The primary purpose of this study is to determine whether AAA817, given alone or in combination with an ARPI, is safe and effective compared to standard of care treatments. This drug is given to participants as a radioligand therapy infusion. Participants in this study can expect to be in the study for up to 6.1 years, including two visits before starting treatment, visits every 4 weeks during treatment, and visits every 12 weeks during long-term follow-up for up to 5 years after treatment ends.. There will be a total of 9 patients enrolled locally.
This study is for patients that have been diagnosed with squamous cell, adenocarcinoma, or adenosquamous cervical cancer. This study is testing an investigational drug called pembrolizumab. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). A computer will be used to assign you to one of the study groups. This process is called "randomization." Like flipping a coin, everyone has an equal chance of being placed in any group. The primary purpose of this study is to determine whether induction immunotherapy (IO) and chemotherapy prior to concurrent chemoradiotherapy plus immunotherapy (CCRT+IO) improves progression-free survival (PFS) compared to CCRT+IO alone. The study drug is given by infusion. Participants in this study can expect to be on the study for 7 years.
This is an open-label, long-term study assessing the safety and efficacy of abrocitinib in participants aged 2 years and older with moderate-to-severe AD. It includes an extension cohort and a de novo cohort to meet regulatory requirements for a minimum of 300 participants exposed to 52 weeks of abrocitinib. Extension cohort participants must have completed 16 weeks of treatment in parent studies B7451023 or B7451030 and remain eligible. De novo cohort participants must be aged 6 to under 12 years at enrollment and not have participated in previous abrocitinib studies. Enrollment for the de novo cohort will begin after enrollment in Study B7451023 is complete. The study will have two periods lasting up to 2 years or until commercial availability, whichever comes first. All participants will receive abrocitinib oral suspension.
This study is for participants with symptoms of mast cell activation (SMAC). The primary purpose of this study is to learn about clonal mast cell diseases. Clonal mast cell diseases are hard to diagnose because symptoms are not specific, and they can overlap with other diseases. The tools currently used by doctors to look for clonal mast cell diseases in the blood may not identify all patients. This study is being done to develop an investigational blood test that looks for a change in a gene called KIT. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Two types of blood tests will be compared against each other. Participants in this study can expect to be in this study for about 6 months.
The main reason for this research study is for researchers to evaluate the relationship between congenital heart disease and development. Currently, there is not enough long-term information available to researchers to predict a child's development if they have been diagnosed with Ductal Dependent Pulmonary Blood Flow (DDPBF), a type of congenital heart disease.
This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.
The purpose of this study is to understand how exposure to harmful substances during military service may affect the health of Veterans with or without lupus. Lupus is an autoimmune disease that can increase the risk of cardiovascular problems.
We believe that Veterans who were exposed to toxic substances during their military service may develop more harmful antibodies that attack the lining of their blood vessels. These antibodies may contribute to poorer blood vessel and heart health, and could contribute to the development of lupus.
This study aims to improve our understanding of how toxic military exposures may increase the risk of blood vessel complications in Veterans with and without lupus. Ultimately, this research may help identify new ways to better prevent, monitor, or treat cardiovascular disease in this population.
Research procedures for this study will include:
1. The study team will check subject medical records to gather information about medical history and medications being taking. The study team may continue to follow updates in the medical record.
2. Subjects will be given a survey to assess military and occupational toxic inhalant exposures.
3. Subjects will have a brief physical examination during which vitals will be recorded (height, weight, heart rate, respiration, temperature). Women of childbearing ages will be asked for the date of their last menstrual cycle within the past 2 months.
4. Subjects will have blood pressure taken three times three minutes apart.
5. Subjects will then provide a urine sample. Urine collection will occur in a private restroom using a sterile container provided by the study team. For women of childbearing ages, a pregnancy dipstick test will be undertaken on urine to confirm subjects are not pregnant.
6. Subjects will undergo a blood draw where approximately 4 teaspoons of blood will be drawn.
Zasocitinib (TAK-279) is an oral TYK2 inhibitor being studied as a potential treatment for moderate-to-severe plaque psoriasis in children and adolescents, a group with limited safe and effective oral options. TYK2 plays a crucial role in immune pathways involved in psoriasis, especially through IL-23's activation of Th17 cells and production of proinflammatory cytokines. Current treatments include injectable biologics and the oral agent apremilast, but few oral therapies match the efficacy of biologics. In phase 2b trials, zasocitinib showed promising results, with over two-thirds of adult participants achieving PASI-75 at certain doses by week 12 and no major safety concerns. Ongoing phase 3 trials are evaluating zasocitinib as a potential new oral treatment for pediatric plaque psoriasis.
This is a Phase 3 randomized study to compare two new drug combinations of teclistamab with daratumumab and lenalidomide and talquetamab with daratumumab and lenalidomide versus standard of care in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. The study is expected to continue for approximately 9 years.The Medical University plans to enroll 12 participants. The duration of participation will depend on the response of the study treatment. Subjects will receive treatment weekly or every 2 weeks. Medical history and physical examination, including lab tests like blood work and imaging, as well as questionnaires will be completed. Known risks include Cytokine Release Syndrome (CRS) as a complication that can happen due to the activation of immune cells.
This is a Phase 1/2, open-label, multi-center clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of TSRA-196, a gene editing compound, in adults with severe alpha-1 antitrypsin deficiency (PiZZ genotype) and associated lung and/or liver disease. Participants will receive a single intravenous dose of TSRA-196 in a dose-escalation phase followed by dose-expansion cohorts.
The study will assess safety outcomes, pharmacokinetics, and changes in serum alpha-1 antitrypsin levels and lung function to determine whether TSRA-196 can safely increase functional AAT levels and inform selection of an appropriate dose for further clinical development.