395 Clinical Trials for Various Conditions
The swelling of the gum, or periodontitis, is the leading cause for tooth loss, and currently affects up to 65 million adults only in the United States. One of the reasons for the widespread of periodontitis is because currently there are no definitive methods to detect the onset of gum disease. This lack of foresight impedes medical professionals to enact any preventive measures before the disease already manifests itself. We wish to expand our understanding towards the development of periodontitis by studying the expression and activity of salivary markers that have been associated with advanced stages of the disease, wherein the supporting tissues of tooth (periodontium) are already irreversibly destroyed. We hypothesize that a progressive shift in the expression of such salivary markers can indicate a change or evolution of periodontitis staging. In specific, we seek to establish a quantifiable relationship among levels of salivary proteases called MMPs, level of metal ions in different stages varying from health to periodontitis. The overall goal of this proposal is to enhance the predictability of periodontitis, as we are currently unable to diagnose the disease until the manifestation of its clinical signs and symptoms.
The purpose of this study is to assess the use of technology including remote vital sign monitoring in improving quality of patient care, decreasing hospital admissions and re-admissions, decreasing hospital length of stay and decreasing use of personal protective equipment.
The purpose of this study is to evaluate an interactive game designed to increase people's ability to identify cancerous moles.
Sickle cell disease is a life-threatening genetic disorder that can be effectively treated following early diagnosis via newborn screening. However, sickle cell disease is most prevalent in low-resource regions of the world, where newborn screening is rare due to the cost and logistical burden of laboratory-based methods. In many such regions, \>80% of affected children die, undiagnosed, before the age of five years. A convenient and inexpensive point-of-care test for sickle cell disease is thus crucially needed. In this study we will conduct a blinded, multicenter, prospective diagnostic accuracy study of HemoTypeSC(TM), an inexpensive 15-minute point-of-care immunoassay for detecting sickle cell disease, hemoglobin C disease, and trait phenotypes in newborns, children, and adults.
This protocol will utilize the lymphedema indentometer, or durometer (a novel, noninvasive piece of equipment that measures skin elasticity), to better characterize disease progression in patients with lymphedema. Beth Israel Deaconess Medical Center patients who undergo treatment of lymphedema will be candidates for this noninvasive test. This device and the data it generates will help understand the incidence of lymphedema at Beth Israel Deaconess Medical Center compared to national data and the outcomes of surgical treatment of lymphedema.
According to the guidelines for reporting thyroid fine needle aspirations known as The Bethesda System, the category of atypical cells known as AUS/ FLUS category has an estimated rate of 5 to 15% for malignancy. This study aims to determine the rate of malignancy of this category in our institution and to evaluate the clinical outcome of the participants.
There are large differences in knowledge between patients and healthcare providers (i.e. physicians, physician assistants and nurse practitioners), and there is a strong interest on the part of both industry and academia to reduce the gap in knowledge between patients and healthcare providers. Currently, about 1 in 20 searches on Google are health related. Among internet users, 72% reported searching for health information, and among persons who use mobile phones, 31% of cell phone users and 52% of smartphone users have looked up health or medical information. Oftentimes, patients will search on Google or other search engines in order to find health conditions that explain their symptoms prior to visiting their healthcare provider. With the launch of Google's new health search tools for mobile devices (i.e. smartphones, tablets, etc.) it is important to understand how patients use these search platforms and what their effects are on clinical encounters. The main objective of this study is to understand the accuracy of differential diagnoses generated by Google searching; the investigators hypothesize that searching on Google using a tablet or mobile device will be more accurate than not using any search tool, and that the new health search experience will improve accuracy over the standard search platform.
Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to determine the etiology and stage of LD. Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-gauge needle, therefore in this study the investigators hope to compare the tissue yields of a 22-gauge fine needle biopsy (FNB) needle, in comparison to conventional 19-gauge. The investigators predict that 19 and 22 gauge FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly the investigators predict the safety to be equal.
The purpose of this study is to determine the reliability of a low-cost rapid diagnostic test for COVID-19. The method of the testing procedure uses electrochemistry to detect COVID-19 spike proteins within human samples. To test the effectiveness of this new method, patients will be recruited as they present for testing at ambulatory Penn testing sites. Patients will be asked to self-collect one anterior nares samples under the supervision of authorized study personnel.
Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels. The investigators plan to conduct a prospective randomized trial comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed state on routine gestational diabetes screening results.
Eosinophilic esophagitis (EoE) is a prevalent chronic inflammatory condition of the esophagus characterized by esophageal eosinophilia that can lead to inflammation and stricture formation. To assess remission, esophagogastroduodenoscopies (EGD) with biopsies are performed. This can lead to multiple EGDs, which are invasive and costly procedures. EsoCheck is a promising noninvasive device. It is an encapsulated balloon that can be easily swallowed and collect cells from the distal esophagus. The primary aim of this study is to determine the feasibility and safety of EsoCheck compared with standard endoscopy and biopsies in the assessment of EoE. This will be a prospective cross-sectional study of adult patients (greater than or equal to 22 years of age) at the University of Pennsylvania with a diagnosis of EoE scheduled for a clinically indicated upper endoscopy.
Patient perception of pain on periodontal probing using a controlled-force, electronic probe was not significantly affected by the use of a modified (ball-end) probe tip design except for in the maxilla, where a standard straight probe tip appeared to be more comfortable for patients.
This pilot early phase I trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign lesions found during computed tomography screening.
The goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (GI) diseases. This research study intends to enroll participants across a range of demographics and GI disease states including colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn\'s disease, and Celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific GI disease. The main questions it aims to answer are: 1. Does the platform identify a disease signal within each disease cohort, compared to normal controls? 2. How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?
The goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. This study aims to characterize the vaginal microbiome in participants undergoing allogeneic hematopoietic cell transplantation (HCT). The main questions it aims to answer are: * Is the vaginal microbiome altered during allogeneic HCT? * What changes may help researchers understand the development of vulvovaginal GVHD? Participants will be asked to undergo an assessment of vulvovaginal symptoms through a vulvovaginal symptom questionnaire once pre-transplant, 6 months post-transplant, and twelve12 months post- transplant. Participants will also be asked to undergo a vaginal microbiome (collection of bacteria, fungi, and viruses that live on our bodies) evaluation through a vaginal exam performed by a gynecologist with collection of vaginal samples once pre-transplant and again six months post-treatment and twelve months post-transplant. If a participant develops symptoms of vulvovaginal GVHD at any point in time during the post-transplant follow up, the participant may partake in additional vaginal exams to diagnose GVHD at the time of symptom onset.
The investigators propose to evaluate the use of a telemedicine tool, the TELE-ASD-PEDS (TAP), that is designed to assess for autism spectrum disorder (ASD) symptoms in toddlers. The TAP was developed at VUMC by a team of clinical psychologists with expertise in the early identification of ASD. The TAP has been studied in controlled laboratory settings, with high levels of family and clinician satisfaction, as well as excellent agreement with blinded comprehensive ASD evaluation. The TAP has also been used to complete direct-to-home telemedicine assessments during the COVID-19 pandemic. However, the investigators have not yet compared direct-to-home assessments using the TAP with gold standard, in-person ASD assessments. It has also not yet been studied in a diverse sample of families or with providers outside of VUMC. This study will allow the investigators to address those gaps.
Alcohol dependence is among the most common and costly public health problems affecting the nation. Among individuals with alcohol use disorder (AUD), those with (vs. without) a co-occurring anxiety disorder (AnxD) are as much as twice as likely to relapse in the months following AUD treatment. Dysregulation of biological stress-mood systems predict and correlate with AUD relapse and AnxD symptomatology. In contrast, stress system re-regulation correlates with improved AUD treatment outcomes but has not been examined with respect to AUD recovery and relapse in co-occurring AUD+AnxD.
This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.
The purpose of this study is to compare the effectiveness of rapid next generation sequencing (NGS, such as whole genome sequencing1) with current practice to provide diagnostic or prognostic information or treatment guidance in acutely ill neonates and infants, particularly with respect to clinical care, cost and outcomes.
The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases.
Every year, millions of Americans are admitted to the intensive care unit. Due to advances in critical care, mortality rates are decreasing, increasing the number of ICU survivors. Survivors of critical illness, however, often face physical, functional, and cognitive deficits that place them at risk for a cycle of re-hospitalization that frequently culminates in premature death. Moreover, post-ICU interventions may be resource-intensive and may be most cost-effective only in a subgroup of patients at highest risk. Whether a multi-disciplinary program to facilitate recovery from critical illness can prevent hospital readmission and improve quality of life among high-risk ICU survivors remains unknown. The primary aim of this pilot is to examine the feasibility of implementing a multidisciplinary ICU Recovery Program and the influence of such a program on process measures including contact with the ICU recovery team and attendance of ICU recovery clinic. The secondary aims are to compare the effect of an ICU Recovery Program on 30-day same-hospital readmission and other clinical outcomes.
The study seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound Doppler signals obtained from lung tissue. A standard ultrasound device in a Doppler mode is placed on the chest wall and the unique software the investigators have developed analyzes the signals reflected from within the lung. On the basis of of pilot studies performed previously the investigators expect to receive different signals from different diseases that will enable diagnosis of different lung diseases.
This study aims to use mass spectrometry techniques to analyze exhaled patient breath in non-COVID ICU-admitted patients requiring ventilation for a rapid and accurate early detection of pulmonary diseases and inflammatory markers.
The purpose of this study is to investigate how we can detect Alzheimer's disease early by using an online memory test and a simple blood test. These new methods for early diagnosis could allow people to begin treatment sooner, with the potential to improve the lives of millions of people.
The purpose of this study is to compare magnetic resonance angiography (MRA) using gadoterate meglumine to clinically obtained MRA using gadobutrol. The specific aims are to show: 1. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable image quality and diagnostic confidence to MRA using gadobutrol. 2. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable accuracy for vascular lesion and stenosis detection compared to MRA using gadobutrol.
This study evaluates the use of an EEG device using Event Related Potentials to help diagnose Alzheimer's Disease in the outpatient clinical setting.
The purpose of this study is to determine if a mobile sensing platform can passively and objectively detect the presence of clinically significant mood disorder symptomatology and symptom progression over time. Meeting this goal will allow for improved risk categorization, prediction of relapse, and measurement of disease progression in a lifetime prevalence population.
* To determine whether retinal abnormalities, as measured by high definition optical coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a clinical biomarker to monitor disease progression overtime in patients with Parkinson disease. * To establish whether these measures can be used to identify patients with PD in the premotor phase. * To define the rate of progression of retinal abnormalities in PD (both in the motor and premotor stages) for potential use as a clinical outcome measure
The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.
The cause of Parkinson's disease (PD) is currently unknown. Both environmental and genetic factors have been found to contribute to PD pathogenesis. The pathology of PD is distributed throughout the entire nervous system including the central, peripheral, and enteric nervous system. There is evidence that inflammation plays a major role in neurodegeneration in PD. In both the striatum and substantia nigra of PD patients activated microglia were found and proinflammatory cytokines (TNF, IL-1B, IL-6, iNOS) are increased in the CSF. An inflammation-driven animal model has emerged and has been widely accepted as a model of the disease based on lipopolysaccharide (LPS) induced neurotoxicity. LPS is an endotoxin found on the outer membrane of gram negative bacteria and humans are exposed to LPS through the intestinal tract. The intestinal tract and thus the enteric nervous system serve as a conduit to the central nervous system. It has been posited that the inflammatory process could gain access to the lower brainstem via the vagal nerve and then ascend through the basal mid- and forebrain until it reaches the cerebral cortex, producing various pre-motor and motor symptoms of PD along the way. LPS may be one of the inflammatory triggers involved in this process. Systemic exposure to bacterial endotoxin can be determined by measuring plasma LPS binding protein (LBP). A study of 9 patients with early PD (median Hoehn and Yahr stage 2) and age matched controls found that the PD subjects had a significantly lower mean level of plasma LBP compared to control subjects. The aim of the research plan is to establish LBP as a potential biomarker for PD across a spectrum of disease severity.