This is a prospective, multicenter, observational study in an international setting (North America, Europe, and Israel) to follow clinical outcomes for patients with complex fistulizing conditions for 24 months after undergoing surgical intervention to treat the index fistula. During participation, standardized data on exposure and outcomes (clinical, patient reported outcomes (PROs), and Healthcare Resource Utilization (HCRU)) will be collected from electronic data capture forms (EDCs). Following the surgical intervention for the fistulizing condition (index date), outcomes will be assessed at 3 months, 6 months, 12 months, and 24 months post-surgery (post-index).

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 a multicenter, randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of ExoFlo for the treatment of moderate-to-severe ARDS (Acute Respiratory Distress Syndrome). The purpose of this study is to research and evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles, ExoFlo, as treatment for Moderate-to-Severe ARDS. Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles is an investigational drug created from human bone marrow being studied for the treatment of moderate-to-severe ARDS. This is a research study that will involve monitoring oxygen and inflammation levels after taking the investigational product and assessing the safety of the investigational product. The experimental treatment is a biologic product called Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles Allograft Product ExoFlo, which is purified from the bone marrow of a healthy well-screened individual. Participants will receive either 15mL of the investigational product with 85 mL of normal saline or 100 mL of normal saline only (placebo). The expected duration of participation in the study is a maximum of 61 days, which includes 1-day screening prior to treatment and 60 days following the first treatment.

The Alpha-1 Foundation Therapeutic Development Network (TDN) aims to make it easier to design and carry out clinical trials that enhance the treatment of patients with Alpha-1 Antitrypsin Deficiency (AATD). To achieve this, the TDN will establish a network of clinical trial centers that have enough patients to gather a comprehensive database of clinical and genetic information. This data will be crucial in determining the criteria for including or excluding participants in the trials and in recruiting suitable subjects.

Specifically, this study will enroll participants by in person or remote consent who will allow collection of medical records to be entered into an Alpha-1 TDN database. Participants will then be invited to future clinical trials.

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.

This is a 12-month, randomized study that involves pre-transplant procedures, a kidney transplant, and post-transplant procedures. After kidney transplantation, every patient, whether in a research study or not, must take immunosuppressive medications to prevent their immune system from rejecting their new kidney. A rejection can harm your new kidney which can lead to lower kidney function. The purpose of this research is to test the safety and effectiveness of siplizumab for kidney transplant patients. Study participants who receive the new study treatment will be compared to participants receiving the most common approved immunosuppressive treatments referred to as "standard of care". You will be randomized into either the study group or the "standard of care" group, like flipping a coin. Because this is a research study, siplizumab will only be given to you during the research study as in infusion treatment. Siplizumab is an investigational medication, which means it has not been approved by the Food and Drug Administration (FDA) and is currently not "on the market" in any country. The potential risks of siplizumab are infusion reactions, inflammatory reactions, immunosuppression, and infections. The benefits of the study treatment are unknown but are suspected to decrease chances of rejection and increase the chance of effective kidney function. An alternative to this study would be to not participate and pursue the standard of care treatment after your kidney transplant.

The purpose of this registry is to collect safety data in patients undergoing aortic aneurysm repair, peripheral vascular intervention, hemodialysis access intervention or peripheral embolization with an eligible Medtronic market-released product(s), including but not limited to balloon catheters, peripheral or carotid stents, stet grafts, and coils, in a real-world setting.

This is a Phase I (determine the safety of a drug) study that is looking at how long the contrast agent gadoquatrane stays in the plasma (part of blood not including red cells) after a single injection during an MRI in children aged 0-18 years. Gadoquatrane is an investigational drug, which means that it is not approved by the FDA. This study will be assessing the safety of gadoquatrane for up to 8 days following the administration of gadoquatrane at the MRI. Blood samples will be collected three times within the 8 hours following the MRI for analysis of how much gadoquatrane is left in the blood.

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.