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 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.

This study is enrolling subjects with advanced solid tumors with the TP53 Y220C alteration in cancer cells. This alteration is a mutation of the tumor that can be found through laboratory tests that use a sample of tissue, blood, or other fluids to check for signs of cancer. This study involves research testing the safety, best dose, side effects and timing of the study drug called PC1486. You will take the study drug, PC14586, in the form of a tablet. If assigned to the combination treatment arm (Part 1), you will also be given pembrolizumab as an intravenous (IV) infusion. Pembrolizumab is a type of immunotherapy that is FDA approved to treat your kind of cancer. The study drug PC1486 is not approved by the Food and Drug Administration (FDA). This study drug targets the TP53 Y220C genetic alteration in tumor cells. During the pre-screening portion, participants will provide either archived tissue or a fresh tumor sample to test for the genetic alteration. If the participants show the genetic tumor alteration in the cancer cells, they may be asked to participate in the trial. Treatment arms are groups or subgroups of participants in a clinical trial. This study will have two arms: one studies PC1486 alone and the second arm studies PC1486 in combination with Pembrolizumab against advanced solid tumors. PC14586 is a small molecule (chemical) that is designed to act on the genetic alteration TP53 Y220C in cancer cells to slow the growth of cancer, and it is taken orally. This study involves blood tests, a possible tumor biopsy, CT, and MRI scans. The study will last approximately 6 months of treatment, followed up by a check-up after the first 3 weeks and every 3 months after. Some common risks (observed in greater than 20% of people) include: Nausea, Vomiting, Abnormal liver tests, Abnormal kidney test (possible kidney damage

This is a study to evalaute the device's safety, function, and effects on heart function, and clinical outcomes of using the Edwards APTURE system (study device) in subjects with heart failure.

Major study activities include 3 right heart catheterizations (RHC) with exercise, a computed tomography (CT) scan with contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits.

The information obtained from this study will show how safe and effective this approach is in treating the symptoms of heart failure. Alternative treatment for heart failure depends on the cause, but may include diet and exercise, managing stress, medication (such as medications to treat leg swelling, high blood pressure, or abnormal heart rate), participation in another research study or continuing with current medical therapy

This study aims to improve the breastfeeding skills of premature or sick term infants with non-invasive, transcutaneous vagus nerve stimulation (taVNS). taVNS is microcurrent stimulation to the ear, which targets a vagus nerve branch. Pairing taVNS with motor activity, such as breast feeding, may help with motor learning in infants as it does in adults with stroke. Ten premature infants older than or equal to 35 weeks gestational age, or convalescing sick term infants whose mothers want to breastfeed will participate in this study with parental consent. Infants will receive 1 taVNS treatment paired with breastfeeding per day for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort. This level of electrical stimulation will be delivered by a TENS unit (Transcutaneous elecrical nerve stimulation) and neonatal electrodes applied just in front of the ear and our custom made carbon electrode used in the BabyStrong studies (#10881, #67997). Stimulation will be timed with latching and sucking for the duration of the feed and will be on with sucking and off with rest. Pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow efficiency will be recorded. Parental satisfaction will be assessed by questionnaires at the beginning, after 1 and 2 weeks, and 3 months after the end of treatment to assess infants' progress in and maintenance of breastfeeding abilities.
If pairing breastfeeding with taVNS is able to improve effective breastfeeding in infants in the neonatal intensive care units, it might help premature and sick term infants to successfully breastfeed at the time of discharge and maintain breast feeding at home after discharge. Premature infants may benefit from longer time receiving maternal breastmilk.

This is a research study to find out if anxiety in patients with autism spectrum disorder are affected by a form of ear stimulation called transcutaneous auricular vagus nerve stimulation, or taVNS. Participants will learn how to self-administer ear stimulation treatments at home before starting the study. Over the course of a month, participants will self-administer ear stimulation treatments twice a day for a month. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study. There will also be a smaller number of questionnaires completed electronically on a weekly basis. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and sleep.

This clinical investigation is a prospective, non-randomized, single-arm, multi-center early feasibility study of the Aria CV Pulmonary Hypertension (PH) System implanted in patients with pulmonary arterial hypertension (PAH). The device will be implanted in the pulmonary artery and the gas reservoir of the device will be in the abdominal cavity. The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient, and to evaluate its performance in treating patients with PAH. Some procedures involved in the study include but not limited too: Questionnaires, physical exams, right heart catherization, echocardiograms, blood work and more. The study will be conducted in a maximum of 10 centers in the United States. Up to 45 patients will be consented, and up to 15 patients will receive implants. There is a total of 11 visits over the course of 2.5 years for the study. Because this is an investigational device under the FDA, there may be risk that include but are not limited to: arrhythmia, device infection, endocarditis, and heart failure. If the Aria CV device performs as intended, you may potentially benefit from reduction in or relief of symptoms caused by PH, and depending on your overall health conditions, prolonged life expectancy and/or improvement in your overall quality of life.

The purpose of this study is to evaluate investigational treatments (study drug) for unresectable metastatic colorectal cancer to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab. The study consists of two stages, Stage 1 - Safety Lead-In Dose Escalation and Stage 2- Dose Optimization. ABBV-400 is not FDA approved. Bevacizumab is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, and numbness, tingling, or weakness in arms and legs. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

This study aims to investigate innovative approaches to managing chronic pain and opioid use. This study consists of two phases, each offering different treatment options. Participation is voluntary.

This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) transcranial magnetic stimulation by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at follow-up.

Phase 1:
In this initial phase, all participants will have a 1-week open-label trial of buprenorphine (worn as a patch on the arm, shoulder or upper-back). This trial aims to assess the safety and effectiveness of buprenorphine in managing chronic pain and opioid use. During this phase, participants will have the opportunity to experience the effects of buprenorphine under close monitoring.

Phase 2:
After completing Phase 1, participants will have the opportunity to choose their next course of treatment. They can decide to continue with buprenorphine, and undergo a 1-week trial of either real buprenorphine or a placebo (an inactive substance). They will be randomly assigned to receive either real or placebo buprenorphine. If participants respond well to buprenorphine treatment, they may continue the medication under the care of their physician.

Alternatively, participants can explore an alternative treatment called repetitive transcranial magnetic stimulation (rTMS) in Phase 2. If they opt for rTMS, they will receive either real rTMS or a sham version interspersed with cognitive-behavioral therapy for pain. Participants will be randomly assigned to receive either real or sham rTMS.

In both phases, participants will receive close monitoring and attend regular study visits to assess safety and progress. Throughout the study, they will be asked to complete questionnaires about pain, functioning and opioid use, undergo physiological monitoring and blood samples will be collected at specific points.

It's important to note that there are potential risks associated with the study medication, such as difficulty sleeping, nausea, and dizziness. Additionally, for the rTMS arm, there is risk of mild headache, pain at the stimulation site, and there may be unknown risks related to the brain stimulation.

Participants' experience in Phase 1 will involve an open-label trial of buprenorphine, and participants' decisions in Phase 2 will determine the treatment path. While the effectiveness of these treatments is uncertain, participants will receive thorough monitoring throughout the study, and have the option to withdraw at any time. Improvement in participant symptoms is possible but not guaranteed.

Patients with large abdominal aortic aneurysms (AAA) (>5.5cm) are recommended to have surgery, but there is no therapy for small AAA (3-5cm). The purpose of this study is to collect ultrasound images and blood from patients with normal abdominal aorta as well as from patients with small AAA. Study participants include patients scheduled for an aortc ultrasound aorta and may fall into one of these categories. By analyzing the aortic wall ultrasound images and the blood levels of particular proteins, we hope to identify a target for drug therapy to stop AAA growth. Voluntary participation in this study does not change the original intent of the ultrasound and does not change patient treatment. The pictures gathered here are in addition to the standard ultrasound and cause no additional risk. Participation would include the standard aorta ultrasound, specific extra pictures (less than 5 minutes to collect), and collection of a blood sample. If a participant's aorta is within normal limits, no additional ultrasound visits or study visits will be indicated. If the participant has a small AAA, standard of care would be to return once per year for repeat ultrasound. Ongoing participation in the study will be to have the extra ultrasound images captured and repeat blood sampling, for a total of 3 years.