525 Clinical Trials for Various Conditions
This will be a single-center, investigator-initiated, double-blinded, randomized, bilateral-comparison pilot study of injectable Calcium hydroxylapatite with and without Triamcinolone acetate for the treatment of volume loss to the dorsum areas of the hands.
Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.
Use of on-line blood volume monitoring during continuous renal replacement therapy can improve volume management in acute kidney injury patients requiring renal replacement
We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the "transition to stable phase".
The aim of this study is to determine whether a modified fasting protocol can reduce the potential risk of aspiration for patients currently prescribed GLP1-RAs.
The purpose of this study is to confirm the safety and efficacy of linac based Volumetric Modulated Arc Therapy (VMAT) for craniospinal irradiation (CSI) in solid tumor cancer patients with leptomeningeal metastasis. The primary aim is to determine if linac based VMAT CSI for leptomeningeal metastasis improves central nervous system (CNS) progression free survival (PFS) compared to the historical standard control CNS PFS in patients treated with Involved Field Radiation Therapy (IFRT).
We used a new and easy-to-measure iPad 3D scanner to measure swelling in lower limbs because current technology is not easily available or affordable. We want to see how reliable the measurements are and what might affect how consistent they are.
The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination. The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, euhydrated men and women.
Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC). NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. In Cohort 1, participants will receive either NOA VOLUME or VOLUMA XC with a fixed follow-up period. In Cohort 2, participants will receive either NOA VOLUME or VOLUMA XC with a variable follow-up period. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States. Participants will receive either NOA VOLUME or VOLUMA XC as subcutaneous and/or supraperiosteal plane injections in the cheek on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 for Cohort 1 and at Month 12, 15, or 18 for Cohort 2 and will be followed up for up to 22 months.
Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds. ELBW infants initially remained NPO for several days before initiating trophic feeds. However, data then showed that there was no increase in mortality and morbidity if trophic feeds were initiated earlier. Then data showed that a short duration of trophic feeds did not increase mortality and morbidity when compared to a prolonged duration. More recent data showed that enteral feeding should be initiated early, preferably within 24 hours of birth, because it may promote feeding tolerance, shorten the time to reach total enteral feeding, and reduce the incidence of extrauterine growth restriction and late onset sepsis without increasing the risk of developing NEC. The management of enteral nutrition in ELBW infants is still very variable. For example, there is no consensus on the optimal time point after birth at which enteral nutrition can be started. This study evaluates the benefits of starting feeds by 6 hours of life Purpose: The primary aim of this study is to evaluate if in infants ≤ 1000g birth weight, is there a benefit initiating feeds by 6 hours of life (compared to current feeding practice data of 3 days of life) on decreasing the time to attain full feeds in the first 30 days of life. The secondary aim is to evaluate if antenatal feeding discussions would streamline feeding management post-delivery.
The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.
Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection. The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.
This is a West Philadelphia based community project to improve adherence to lung cancer screening. The overall objective of this project is to demonstrate the impact of a community support program (CSP) on improve adherence to LCS follow-up guidelines in an urban environment. The study will target individuals in the Penn Medicine healthcare system residing in Philadelphia with an upcoming or missed follow-up screening or orders placed but who have not yet scheduled their screenings by offering free transportation coordination to and from the appointment. The study team will also offer to connect those with placed but unscheduled low dose CT orders to connect with Penn Medicine's scheduling staff.
Patients with heart failure (HF) exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Reduction of cerebral blood flow has been suggested as the pathophysiological pathway linking HF and structural brain changes. Indeed, lower cardiac index levels were related to lower cerebral blood flow in older adults without stroke, dementia, or heart failure. A few prior studies have examined the subcortical structural differences in patients with HF compared to controls. Brain volume loss (including putamen and hippocampal volumes) have been reported in patients with low ejection fraction. Significant gray matter loss was found in specific brain regions of HF patients and included structures that serve demonstrated roles in cognitive functions. In the investigator's previous study (Comprehensive Imaging Exam of Convalesced COVID-19 Patients - COVID-19 RELATED SUBMISSION-IRB00252436), involving 100 participants (volunteers with normal heart function (ejection fraction; 50%)), the investigators observed significant correlations between thalamic volumes and ventricular stroke volumes in volunteers. Building on these findings, the investigators intend to expand the research to include individuals with heart failure (HF), employing the same MRI protocol. The study will involve obtaining a set of T1-weighted brain images to measure the volumes of seven subcortical structures. The investigators goal is to explore the relationship between subcortical volumes and cardiac parameters. Additionally, the investigators will examine whether patients with HF experience a more rapid reduction in subcortical volumes compared to those with normal cardiac function (EF;50%).
Background: Lung problems develop in up to 20% of people after they have surgery. While under general anesthesia, people breathe slower and draw in less air. They may have difficulty returning to normal deep breathing as they recover. Some may develop life-threatening complications. An approved device called an incentive spirometer is used to help measure and improve a person s breathing after surgery. Researchers want to find out if a motion sensor placed on the chest can also measure the volume of air a person inhales as they breathe. Objective: To determine if a motion sensor on the chest can measure the volume of air a person breathes. Eligibility: Healthy adults aged 18 years and older. Design: Participants will have 1 clinic visit. The visit will last 10 to 30 minutes. They will fill out a form with their age, sex, height, and weight. A small, plastic motion sensor will be taped to their chest on 1 or both sides. Participants will breathe through a tube attached to an incentive spirometer. They will take 18 breaths of different volumes, both deep and shallow. Researchers will use the data collected from the motion sensors to measure how the chest moves at different levels of breathing. The motion sensor data will be used to create a software program that converts chest wall motion to the volume of air inhaled for a given breath in real time.
Lipedema is an inflammatory and painful disease of subcutaneous adipose tissue (SAT) in women that is associated with vein disease and lymphedema. There is controversy on whether there is edema in lipedema. This study seeks to determine: 1. Is there is edema in lipedema? 2. Can edema, lipedema subcutaneous adipose tissue (SAT), symptoms, and quality of life be improved by an advanced intermittent pneumatic compression device (IPCD)? During the course of the study subjects will be seen three times in the clinic for assessment and measurements. All subjects will be provided a compression legging at the first clinic visit. Half of the subjects (the treatment group) will be provided and use an advanced intermittent pneumatic compression device with pants-type appliance that applies dynamic compression therapy to the abdomen, hips, buttocks, legs and feet, starting at the second visit, for 30 days at home, along with daytime use of the compression legging. The other half (the control group) will use the compression leggings only. At the third visit, final measurements will be obtained. The measurements in the study include volume measurements using tape measure and a scanner; body composition measurements (bioimpedance); ultrasound and biopsy of the skin; timed walking and gait measurements; and questionnaires about pain and quality of life. Deidentified (without names) patient medical records will be examined for information on vein disease, body mass index, weight, age, and stage of lipedema (any stage or type). After the third visit, results will be analyzed.
The goal of this observational study is to determine whether the existing model for calculating gastric volume based on an ultrasound-measured cross sectional area is accurate in adults who have had a previous gastric sleeve procedure. The main questions it aims to answer are: Can the existing model accurately calculate gastric volume in patients who have had a previous gastric sleeve procedure? If the existing model is not accurate in this population, can a model be developed to predict gastric volume in these patients based on ultrasound-measured cross section area? Participants will be asked to fast prior to presenting for a gastric ultrasound scan. Following a fasted scan, patients will drink a small volume of water and undergo a second gastric scan.
Catheter ablation using radiofrequency (RF) energy has been widely adopted for management of atrial fibrillation (AF) for the past several years. However, heterogeneity of outcomes and complication rates are still reported that have been partly attributed to operator's experience and center's procedure volume (1). In a meta-analysis of 14 studies, both hospital volume of ≥50 and ≥100 procedures per year were associated with significantly lower complication rate compared to \<50/year (2). Pulse-field ablation (PFA) is an emerging technology for AF management that has demonstrated tremendous potential in terms of preferential tissue ablation with no damage to the adjacent organs. In the MANIFEST-PF survey, 24 European centers participated that had a mean of 704 ablations per year with 73.3 (range 7-291) PFA ablations annually (3). No post-PFA esophageal complications, PV stenosis or persistent phrenic nerve injury were reported. There appeared to be a trend toward fewer complications with center experience, particularly for pericardial tamponade (3). However, the impact of number of PFA performed on procedure-success and safety has not been evaluated in the US. This multicenter prospective study is designed to compare the incidence of adverse event (AE) and long-term procedural success of pulse-field ablation for AF in low volume (\<100/year) vs. high volume (≥100/year) centers.
The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.
The purpose and aim of this study are to compare changes in pulse volume to non-invasively predict active bleeding or high-risk stigmata in patients undergoing a gastrointestinal endoscopy to assess feasibility of the flow meter clinically.
SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day.
Standard planning constraints for liver SBRT incorporate strict dose-volume limits for normal liver parenchyma to minimize the risk of radiation-induced liver disease. The presence of diurnal and fasting/fed variations in liver volume therefore carry substantial potential for introducing errors into estimates of dose-volume distribution within normal liver tissue, as well as affecting day-to-day setup fidelity and organ alignment for treatment. This prospective study will examine how diurnal and fast-fed variations in liver volume affect treatment planning for abdominal SBRT.
This is a retrospective analysis to assess if high-volume hospital facilities experience greater or lesser rates of incidence in patients with esophageal cancer than low-volume facilities.
Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients.
The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy.
This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. The study will assess if higher ECV levels correlate with increased risks of AF recurrence, hospitalization, and poor cardiac function recovery. Positive findings could make ECV a key factor in deciding AF treatment strategies.
This study is to investigate the relationship between arterial carbon dioxide (CO2) concentration and vitreous pressure on the choroidal volume by integrated intraoperative OCT imaging under eye exams under anesthesia.
Prior to surgery the anesthesia team will be putting a breathing tube into the patient's windpipe and attaching it to a mechanical ventilator (breathing machine). This is to provide oxygen and anesthetic gas, and to help the child breathe while they're asleep. The ventilator also controls the amount of air that moves in and out of the lungs with each breath. This is called tidal volume and that amount is programmed into the machine by the anesthesia team. All of this is standard of care. As part of the study the investigators will put a small flow sensor between the patient's breathing tube and the tubing from the ventilator. This will measure the amount of air that is moving in and out of the breathing tube. The study team will record the tidal volume that is set on the ventilator and compare it to the airflow measured by the ventilator and the airflow measured by the sensor and see if there is a difference.
The purpose of this study is to evaluate whether pulmonary blood volume (PBV) derived from contrast echocardiography can serve as a non-invasive surrogate for invasive pulmonary artery wedge pressure (PAWP) during exercise. Also, to compare changes in PBV with exercise in patients with and without heart failure and pulmonary vascular disease.
Veterans with mid to later stage Parkinson's disease (PD) may not be able to work out as hard as they need to, to prevent brain cell loss. Maybe they could work out longer and more frequently to make up for this during their good times and good weeks and then rest during the bad weeks. The investigators will compare how effective working out a lot one week per month with a break of three weeks is to continuously exercising weekly with no breaks in people with mid stage PD. The investigators will look at how fast participants walk per minute, whether they become more physically active, the biochemicals in their blood, and at how stiff their blood vessels are before and after the exercise.