27 Clinical Trials for Various Conditions
ActivSight™ combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively. Primary Objective: To determine the feasibility of ActivSight™ in detecting and displaying tissue perfusion and blood flow in the conduit and foregut anastomoses in esophageal resection/reconstructive surgery. The investigators will compare the precision and accuracy among the naked eye inspection, ICG and LSCI in assessing the vascularity of the conduit.
The aim of this project is to demonstrate that fluorescence-mediated photoplethysmography (FM-PPG) is capable of routinely acquiring the tissue perfusion data sufficient to detect and monitor skin tissue perfusion anomalies.
This is a single center, prospective, randomized, unblinded, open-label, active controlled pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel plus aspirin in patients with Rutherford Stage IV to VI PAD that have undergone a percutaneous transluminal angioplasty (PTA) of the lower extremities in the past 2 weeks.
Investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how this device compares to standard measurements using blood from a catheter. This may help treat patients who may not be getting enough oxygen to their body.
Little is known about chronic wound microenvironments, especially in peripheral vascular disease (PVD) and diabetic patients. At the demarcation line, the percentage of viable cells and tissue is unclear. A means to determine cell viability, particularly discerning an apoptotic or necrotic cell pathway would indicate where the line of demarcation should be drawn. The information generated would better predict clinical outcome using SPY Imaging. Cellular studies are needed to successfully confirm a clear line of demarcation to eliminate surgeon subjectivity.
The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. The hypothesis is that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.
The purpose of this study is to determine whether inhaled nitric oxide is an effective treatment for microcirculatory dysfunction and acute organ system failure in the early stage of sepsis therapy.
The purpose of this study is to measure peak skin interface pressures and the total area of the body exposed to skin interface pressure above 30 mm Hg at different areas of the body in the supine position on two different support surfaces applied to a standard North Atlantic Treaty Organization (NATO) litter (NSN: 6530-01-380-7309) and a Raven 90C Litter (NSN6530-01-432-5114). The support surfaces are the Warrior Evacuation Litter Pad (WELP) and the Dolphin Fluid Immersion Simulation Stretcher System (FIS). These pressure measurements and transcutaneous oxygenation readings will allow us to determine differences between support surfaces.
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Feasibility Study on Nitropaste Using Intraoperative SPY Imaging.
The overall goal of this study is to develop and test a novel method involving ultrasound imaging, in order to detect the development of type 1 diabetes. In this study the investigators will first establish a standard operating procedure for measuring pancreas blood flow speed and volume in the pancreas of human subjects. The investigators will then determine 1) whether these pancreas blood flow factors differ between healthy subjects and those who have recently developed type1 diabetes; and 2) how variable measurements are in healthy subjects and subjects that recently developed type1 diabetes, both between subjects and over time. To address these aims the investigators will perform pancreas ultrasound measurements in each subject using an approved injectable 'bubble' contrast agent that allows measurement of pancreas blood flow. The investigators will compare ultrasound measurement with characteristics of the subject's type 1 diabetes, including genetic factors, glucose levels and other circulating factors, as well as other factors that may influence blood flow in the pancreas independent of type1 diabetes. The successful conclusion of this study will indicate whether measuring pancreas blood flow speed/volume will be helpful in monitoring whether type1 diabetes will emerge and thus will allow a large scale study to answer this question.
This pilot study aims to examine the relationship between continuously measured CareGuide™ muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring techniques during the care of subjects with suspected established (Cohort A) or emerging (Cohort B) shock in the intensive care unit (ICU).
The main objective of the study is to evaluate the efficacy of indocyanine green (ICG) endoscopy to evaluate tissue perfusion during endoscopic neurosurgery. This includes patients with pituitary and intracranial tumors and treatment of vascular abnormalities such as aneurysms and compressive syndromes. ICG will be evaluated to determine the value of the additional visual information supplied during the treatment of these pathologies.
The purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. This study is important because the information we find out will help us know how best to administer vasopressors in patients with shock in the ICU.
The purpose of this study is to determine if 1) a continuous glucose monitoring system can measure glucose levels in transferred tissue during reconstructive surgery, and 2) if glucose measurements from a continuous glucose monitoring system correlate with tissue blood perfusion.
Trauma remains the leading cause of death and disability for Americans age 1-44. Trauma can cause internal bleeding, and this bleeding is often hard to detect without sophisticate tests that take time to complete and analyze. In addition, internal bleeding, including bleeding into the lung and chest cavity, as well as other blood loss, happens in many critically ill patients. For example, for hemorrhage, it is very difficult to detect active hemorrhage and to determine optimal rates of fluid and blood resuscitation. Diffuse optical spectroscopy has the potential to accurately assess adequacy of tissue perfusion, oxygenation, tissue oxygen extraction, and cytochrome oxidation states that may be critical to optimal treatment, end- organ preservation, and survival.
The purpose of this research is to develop a new method to study insulin action using positron emission tomography (PET). Insulin is the hormone made by your body to control the blood sugar level. We want to develop a way to image (look at) the following three things: 1) how insulin affects blood flow in skeletal muscle 2) how insulin affects glucose (sugar) transport (movement) into muscle, and 3) how insulin affects glucose metabolism (breakdown) in skeletal muscle of healthy individuals. The long term goal will be to later apply this method to the study of metabolic diseases, especially type 2 diabetes mellitus and obesity. PET imaging is a relatively non-invasive way to obtain a "metabolic picture" of body organs, and has been used successfully to study brain, heart and more recently skeletal muscle. In this research study, we will use PET with as many as four radioactive tracers (markers) to study skeletal muscle glucose transport in healthy volunteers.
The purpose of this study is to determine if intensive lowering of systolic blood pressure (SBP), using FDA approved medications (antihypertensive), reduces Alzheimer's Disease pathology (i.e., excessive brain amyloid and tau protein deposition) in older adults at high risk for memory decline or dementia.
This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.
This pilot clinical trial studies isolated limb perfusion with melphalan in treating patients with stage IIIB-IV melanoma or sarcoma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the arteries around the tumor may kill more tumor cells.
CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2) measurements. This monitor was recently FDA cleared for use on adult subjects.
Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers) in the heart using PET imaging. These tracers would be eventually used in evaluating the hearts of patients with heart disease. Normal healthy volunteers will be carefully screened for this study. Subjects will be given IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects not excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin according to standard procedures in our laboratory. These same subjects will have a F-18 FDG protocol after following a high fat, protein permitted, no carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The F-18 FDG radiotracer will be given through an IV.
Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and normal tissues based on physiologic properties including perfusion, vascular permeability and glucose metabolism. Demonstrating that these parameters are associated with clinical outcome, either efficacy or toxicity, could enhance the ability to select patients for different treatment strategies and improve the therapeutic ratio.
The purpose of this clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate the safety of PB127.
In the weightlessness of space and significant alterations of terrestrial 1 g (1 gravity equivalent) head-to-foot hydrostatic pressure gradients, astronauts experience a dramatic fluid redistribution of \~ 2 liters from the legs to the head and neck within the first 24-48 hours of flight, among other cardiovascular and physiologic system adaptations. After only 4 days in the weightlessness of low earth orbit (LEO), changes can be seen in baroreceptor responsiveness, causing orthostatic hypotension upon subsequent return to Earth. Fluid shifts may also result in headaches, congestion or facial puffiness that can contribute to deteriorating sleep patterns. The ability to manage, mitigate, or offset these fluid shifts is vital to maintain nominal health for short and long duration space flight and potentially improve readaptation to terrestrial gravity or other surface gravity fields, such as the moon or Mars. Fluid shifts towards the cephalic region during microgravity have been speculated to contribute towards spaceflight associated neuro-ocular syndrome (SANS). SANS is a distinct, microgravity-induced phenomenon of neuro-ophthalmic findings observed in astronauts following long-duration spaceflight including choroidal folds, optic disc edema, posterior globe flattening, refractive shift, and cerebral fluid shifts noted to be persistent at 6-month post-flight MRI scans. Thus, noninvasive approaches to studying real-time fluid shifts in weightlessness could serve as critical areas of research to further SANS study and effective countermeasure protocol development. For continuous fluid shift monitoring and management, the goal is to establish baseline assessments utilizing real-time point- of-care noninvasive imaging devices (NIID). Manual lymphatic drainage (MLD) therapy reduces lymphatic fluid in the affected limb, head, and neck to improve function and prevent progression of fluid build-up. MLD is a therapeutic massage that delivers light pressure through the skin to stimulate lymphatic vessel function. Randomized controlled trials have demonstrated statistically significant improvements in lymphatic function and pain following MLD. The main objectives of this pilot, retrospective study were to use NIID to examine temperature differential alterations, superficial venous flow patterns (head, neck, upper torso), and venous flow patterns along the lymphatic ventromedial bundles of the medial calves and thighs when in the 6-degree head down tilt (HDT) validated space analogue position and to analyze the effect of MLD therapy administered in the HDT position on lymphatic flow and temperature. HDT is the best validated space analogue currently available for evaluation of fluid redistribution in a timely manner.
This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.
This study has two purposes: 1) to understand the effect of a decline of dopamine in the brain during normal aging and in patients with Parkinson's disease, and 2) to investigate how medicines used to treat Parkinson's disease improve movement performance in patients. Patients with Parkinson's disease have difficulty performing precise finger movements, mainly because of a dramatic decrease of a substance called dopamine in parts of the brain. Medicines such as levodopa, which help restore dopamine levels, can greatly improve function; however, little is known about how these drugs work. In normal aging, dopamine decreases slightly in certain parts of the brain, but the importance of this decline is poorly understood. This study may provide new information about Parkinson's disease and normal aging that might lead to better treatment strategies. Patients with mild to moderate Parkinson's disease and healthy volunteers 21 years of age and older may be eligible for this study. All participants must be right-handed. All candidates will be screened with a medical history and physical and neurological examinations, including memory tests and mood examination. Brain function will be studied using functional magnetic resonance imaging (fMRI) study and positron emission tomography (PET). Participants may be asked to stop using medications that can affect the central nervous system, such as sleeping pills or drugs for depression or anxiety, for 1 week before each study visit. Patients with Parkinson's disease may also be asked to stop using antiparkinsonian medications at least 12 hours before each visit. In addition, all participants will be asked to abstain from alcoholic beverages at least 24 hours before the fMRI and PET scans, and from nicotine and caffeine for at least 12 hours before the scans. Participants will have fMRI, which uses a strong magnetic field and radio waves to create images of the brain. The subject lies on a table in a tunnel-like cylinder (the scanner) for 1 to 2 hours, lying still for 5 to 15 minutes at a time. He or she can communicate with the technician or researcher at all times during the test through an intercom system. Scans will be done while the subject is at rest and while he or she is performing finger movements. The movements involve pushing five buttons on a box-each button every 3 seconds on average in a specific order. Patients with Parkinson's disease will be studied off- and then on- medications that restore the levels of levodopa in the brain. Some participants may be asked to undergo a PET scan on a separate visit. A PET scanner is a doughnut-shaped machine similar in appearance to a CT (computed tomography) scanner. PET scans detect radioactivity used to provide information on brain activity. Before the test begins, subjects are given a dose of carbidopa-a medicine that increases the amount of levodopa in the brain. A catheter (thin, plastic tube) is then inserted into an arm or wrist vein, and a radioactive form of levodopa called 18Fluorodopa is injected through the catheter. A moldable plastic mask with large openings for eyes, nose, and mouth is placed on the face to help keep the head still during scanning. The total scan time is 2 hours or less.
The purpose of this study is to examine how a part of the brain called the hippocampus contributes to memory changes that occur with aging and Alzheimer's disease (AD). Memory problems are the most important early symptoms of AD. The hippocampal region of the brain may be responsible for many age- and AD-related memory disorders. This study will use magnetic resonance imaging (MRI) scans to examine the structure, chemical composition, and function of the hippocampus in participants with AD, participants with mild memory problems, participants who are healthy but are at risk for AD, and healthy volunteers. Participants in this study will undergo MRI scans of the brain. During the MRI, participants will perform memory tests to demonstrate hippocampal functioning.