This is a seamless, Phase 1b/2 Multiple Ascending Dose (MAD)/Proof of Concept (POC) Study (hereafter referred to as Phase 2 Program) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary involvement. The study is comprised of two parts: Part A is a randomized double-blind placebo-controlled multiple dose-escalating study, and Part B is a randomized double-blind placebo-controlled POC study.
The objective of Part A is to evaluate the safety and tolerability of MADs of XTMAB-16, and to determine the recommended Phase 2 dose and frequency for Part B for XTMAB-16 administration in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations.
The objective of Part B is to confirm preliminary efficacy of XTMAB-16 as measured by the ability to reduce background oral corticosteroid use in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations.

This study is designed to learn about the safety and effectiveness of a new gene therapy called KB408 for Alpha-1 Antitrypsin Deficiency (AATD). AATD is an inherited condition in which a person has low blood levels of a protein known as alpha-1 protease inhibitor (called Alpha1-PI). AATD causes an increased risk of chronic obstructive pulmonary disease (COPD) in the form of emphysema (long term lung disease) and, less frequently, other diseases.
KB408 delivers copies of the genes that produce AAT to the lungs and is given by inhaling a mist (called nebulization). The genes are carried and delivered by a modified herpes simplex virus type 1 (HSV-1). This virus is not harmful and simply acts as a vehicle to deliver the genes to the lungs. The genes that are delivered by KB408 do not change a person's own DNA. This is an open-label study, meaning that the participants, the study doctor, and the sponsor all know that the participants are receiving KB408. KB408 is an investigational product, meaning it is not approved for commercial use by the FDA.
Eligible participants will receive one of three doses of KB408. Participants will have a screening visit first to make sure that they are able to participate in the study. After the screening visit, participants will need to return to the study center for follow up visits. The number of follow up visits depends on which cohort the subject is enrolled in. At the second visit, participants will receive the study drug. In Cohort 2b, subjects will have repeat dosing. Each visit will take between 2 and 8 hours to complete. Study procedures include medical history collection, vitals, physical exam, ECG, spirometry and DLCO, urine cotinine test, blood work, cheek swab, sputum sample, and bronchoscopy.
Possible side effects of KB408 include temporary increases in certain cell types in the lungs and temporary increases in the breathing rate after dosing. Since this is the first time that KB408 has been given to humans, it is possible that participants may have an immune reaction to the study drug. There is also a risk with genetic testing and a risk to confidentiality. Participants may not receive any personal benefit from being in this study. There is no guarantee that the Study Drug will help. The information that is collected from the study may help other people in the future.

The proposed research study evaluates the potential of an oral FDA-approved medication, suvorexant, as compared with a placebo control to improve symptoms of sleep disturbance and insomnia in breast cancer survivors currently on hormonal based therapies. Eligible participants will randomly be selected to receive either the suvorexant or a placebo control for a duration of 4 Weeks. Participation in the study will include a screening process for eligibility including information on medical history and surveys regarding symptoms at the start of the study and additionally at 2 and 4 weeks. Potential benefits include improved sleep for individuals randomized to the study medication and potential study risks include loss of confidentiality of health information and a risk of sedation and complex sleep behaviors associated with the medication, suvorexant.

This study will evaluate the associations and interactions between bar-lab/naturalistic drinking variables with participant characteristics in individuals with bipolar disorder and alcohol use disorder. This study includes 4 study visits over approximately 1 week. Questionnaires and clinical interview measures will be completed at study visits.

This study compares the effectiveness of in-person versus virtual delivery of an evidence-based intervention to reduce rates of postpartum emergency department visits. The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

This study compares the effectiveness of in-person versus virtual delivery of an evidence-based intervention to reduce rates of postpartum emergency department visits. The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

This study compares the effectiveness of in-person versus virtual delivery of an evidence-based intervention to reduce rates of postpartum emergency department visits. The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

The goal of this study proposal is to develop a biorepository which will collect and store central nervous system (CNS) tissue, connective tissue, blood, or cerebral spinal fluid (CSF) for future research. This material will be collected from children with CNS conditions or defects. This will be a very useful resource to scientists who work to develop new approaches to prevent and treat conditions that affect children's brains and nervous systems.

The ECHO Cohort is a longitudinal prospective multi-site study aiming to understand how the environment and things that happen early in children's lives - even before they are born - affect their development, health, and well-being. This research program includes many study sites across the United States. ECHO will combine information about 20,000 pregnant participants, more than 50,000 children, and their families. With so many participants from across the country, researchers can answer important childhood health questions.

HIV infected cocaine users have uncontrolled viral levels and impaired immunity to control infection compared to HIV infected non-drug users. We ask the questions why cocaine use makes HIV infected cocaine users more sick than other patients. The goal is to improve immunity to control HIV infection in cocaine users. Both uninfected cocaine users and HIV-infected cocaine users are especially needed in this study.