The study is for patients who have been diagnosed with non-squamous non-small cell lung cancer (NSCLC). The investigational drug in this study is ivonescimab (AK112). The study drug is an antibody, it blocks two proteins in the body that help cancer cells live, grow and spread. The study drug will be given in addition to pemetrexed and carboplatin. There are two groups that a participant may be assigned to, which group a subject is assigned on will be determined by type of cancer treatments that they have previously received. Treatment Group A will receive the study drug along with pemetrexed and carboplatin. Treatment Group B will receive placebo along with pemetrexed and carboplatin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will last about 36 months. The study consist of a screening visit, treatment visits, and a safety follow up visit.

This study is part of what is called a platform study. This platform study, called the "PRACTICAL" study is designed so that various interventions can be evaluated at the same time against standard therapy. This allows researchers to compare these newer interventions to each other as well as to the established usual practice and helps them explore different ways to potentially improve the management of lung injury. Within the platform study there are various different sub-studies that have their own interventions and procedures. This domain sub-study is the "Mechanical Ventilation Study" and it is a multi-centre, randomized, open-label trial that will evaluate multiple ventilation strategies in comparison to conventional lung-protective ventilation in patients with acute hypoxemic respiratory failure (AHRF). This domain will enroll perpetually, as interventions are added, continued, or discontinued. Researchers for this study are looking for different types of ventilation strategies (ways that the ventilators control settings can be adjusted) that may be the most helpful for people in their recovery, while also reducing lung damage caused by the ventilator.

This is a phase 4, prospective, multicenter, single-arm, open-label study designed
to evaluate the effect of early and rapid treprostinil therapy on mean pulmonary artery pressure (mPAP) reduction to improve Right ventricular (RV) function and reverse RV remodeling in patients with PAH. This study will use the CardioMEMS™ HF System (CardioMEMS) to measure and monitor mPAP, but may allow mPAP monitoring via RHC (right heart catheterization), if CardioMEMS is NOT available at a subject's Baseline Visit (Day 1) or if the CardioMEMS™ PA Sensor implantation is unsuccessful.

Participation is expected to be up to 37 months and will include about 10 office visits to the study doctor. This will be divided up into a 30-day Screening Period, a 12-month Treatment Period, and a 24-month Extended Treatment Period.

The purpose of this study is to assess the feasibility and safety of modified surgical eyeglasses to view bevonescein intraoperatively and the safety of bevonescein as it shows nerve tissue in the body. Bevonescein is an investigational drug being developed to help doctors identify nerves within the body during surgery.
The drug is administered through a vein in the arm and into the blood stream.t Bevonescein then travels through the blood where it makes nerve tissue fluorescent so that it can then be detected by the modified surgical eyeglasses used in this study by a surgeon. This may help the surgeon (study doctor) to tell the difference between nerve tissue and other tissue during surgery. Bevonescein and the modified surgical eyeglasses that your surgeon will wear (ReVealTM 475) are considered investigational because they are not approved by the Food and Drug Administration (FDA) to help with the visualization of nerves during surgery Alternatives to this study can include to undergo surgery without the study drug.

The duration of this study is about 2 months. The procedures of this study include administration of the study drug once (500 mg), collection of blood and urine samples, and ECGs. Surgery will happened as planned by the study doctor but as part of the research, the surgeon will ear modified surgical eyeglasses to view nerves and may take pictures or video clips. The glasses are FDA cleared but the modified filter and its use in combination with bevonescein is considered experimental.

The most commonly expected risks of fluorescein are nausea, vomiting, and stomach discomfort. Because bevonescein is cleared through the urine, there may be a potential risk to the kidneys and renal (kidney) system. The most serious risks of fluorescein may include severe local tissue damage, anaphylaxis, convulsions, cardiac arrest, and death.

The purpose of this study is to learn about the effects of an experimental treatment called RO7198457. This study is for patients with Stage II or III colon or rectal cancer, which has been treated surgically and with chemotherapy, and your blood has been found to have ctDNA (circulating tumor DNA) during a ctDNA screening test. RO7198457 (autogene cevumeran) is an immunotherapy that is individualized to a tumor and designed to mount an immune response against it. Treatment includes RO7198457 being injected in the vein, physical exams, blood sample collections, and CT scans for up to a year. Risks include fatigue, fever, and headache. Patients may or may not receive direct benefit while on the study, however, information collected during this study will help people with colon and rectal cancer in the future. RO7198457 is considered "experimental" because it has not been approved by the U.S. Food & Drug Administration (FDA) for the treatment of any disease.

This study is enrolling subjects who are scheduled for a ventricular tachycardia (VT) ablation. Ventricular tachycardia is a fast heartbeat that starts with an abnormal signal in the lower chambers of the heart, which are the ventricles. An ablation is a procedure where a catheter (thin, flexible tube) with a tip that can deliver energy is used to burn the heart tissue where those abnormal signals are coming from. The catheter being used in this study is called the FlexAbilityTM Ablation Catheter and was recently approved for commercial use by the Food and Drug Administration. (FDA) Since it is newly approved, the FDA wants to continue collecting more information about the catheter and its use, so this study is called a post approval study. Participation in this study will take about 1 year. During this year, data will be collected including your medical history, cardiac medication use, ablation procedure, and any medical events that may occur. You will be seen or contacted 4 times. There is a risk of loss of confidentiality and there may be risks that are not yet known. There may be no direct benefit to you but it is hoped the information learned may contribute to knowledge in this field.

The protocol aims to improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.

Trials within this protocol can be adaptive, will be randomized, and will have superiority as the primary objective. Comparisons in the trials may be between an unlicensed agent to a blinded placebo plus standard of care (SOC), between an approved off-label agent to a blinded placebo plus SOC, among several active interventions (blinded or non-blinded; i.e., a comparative effectiveness study), or among different treatment strategies.

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 purpose of this clinical trial is to evaluate the safety and efficacy of BIA-28-6156 in subjects with Parkinson's Disease (PD). BIA -28-6156 is an investigational drug meaning that its safety, effects and how it works are still being studied. This is a randomized (assigned by chance), placebo-controlled study, which means that some participants will receive a fake treatment (placebo) while others get the real treatment. The placebo treatment looks like the BIA-28-6156 medications but doesn't contain any active ingredient. The medication is in a pill form and will be administered orally. This research is also double blind, meaning that neither the participants nor the researcher will know which treatment they will be receiving. In Part A of this study, participants will be asked to give a blood sample for a genetic screening test. If genetic testing in part A indicates the person can participate, they may be asked to volunteer for part B. Duration of Part B is about 87 weeks, this includes 5 weeks for screening, 78 weeks for the double-blind treatment period, and 4 weeks for follow up. There are at least 11 visits in total in 20 months (9 clinic visits, 2 remote phone/video visits); this does not include unscheduled visits. During visits, participants should anticipate tests including electrocardiograms (ECGs), vitals measurements (including temperature, blood pressure, and heart rate), and a physical/neurological examination. Some of the risks includes fatigue, headache, drowsiness, muscle aches and possible worsening of PD symptoms. As for benefits, participants who receives the BIA drug may see their PD progression slowing.

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 6 more times over 2 months. At the second visit, participants will receive the study drug. Each visit will take between 2 and 6 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 (only for participants in cohorts 3a and 3b).
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.