143 Clinical Trials for Various Conditions
This is a case-control study to clinically validate the performance of PancreaSure, a protein biomarker test, to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control patients not diagnosed with PDAC but at increased risk of disease due to familial/genetic history or clinical symptoms.
This is a case-control study to clinically validate the performance of a protein biomarker test to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control patients not diagnosed with PDAC but at increased risk of disease due to familial/genetic history or clinical symptoms.
The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI. To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI.
The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.
The purpose of this study is to establish the reasonableness of using food-based photo diaries and continuous glucose monitors (CGM) to engage in counterfactual thinking strategies. These strategies may improve food choices among participants diagnosed with prediabetes (intervention group).
Concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard. There is currently no objective measurement for concussion and the reliance on subjective reporting and clinical judgement is imperfect. In previous clinical studies the investigators determined cutoff values of plasma phosphatidylcholines that provided strong indication that a concussion had occurred. Based on this data, the investigators have developed a custom assay, which will work together with a capillary blood collection device. The current clinical trial will be conducted in two parts. Part A will allow the investigators to determine precise AUC cut-off values for the propriety, novel custom assay, and in Part B the investigators will assess the safety and efficacy of this device for concussion diagnosis in adolescent athletes aged 13-17.
Cerebral cavernous malformations (CCMs), one of the most common microvascular malformations in the capillary beds of the brain, are susceptible to hemorrhagic stroke. As an autosomal dominant disorder with incomplete penetrance, the majority of CCM gene mutation carriers are largely asymptomatic but when symptoms occur, the disease has typically reached the stage of focal hemorrhage with irreversible brain damage. Currently, the invasive neurosurgery removal of CCM lesions is the only treatment option, despite the recurrence of the symptoms after surgery. Therefore, there is a grave need for prognostic/monitoring biomarkers as risk predictors for stroke prevention. The objective of the proposal is to develop a set of blood prognostic/monitoring biomarkers as precise risk indicators for stroke prevention. In this project, the plan is to validate the novel serum biomarkers identified in Ccms animal models and human CCMs patients, and utilize these biomarkers with statistical algorithms for risk prediction of hemorrhagic CCMs. This proposal has been formulated based on recent findings of five serum etiological biomarkers associated with disruption of the Blood-Brain Barrier (BBB), the first step for hemorrhagic CCMs in Ccm mice models. This work will lay the groundwork for larger human trials for final validation and revolutionary potential clinical applications.
This study determines whether non-invasive evaluation using repeated magnetic resonance imaging (MRI) scans and repeated blood biomarker measurements can be used to predict changes in a person's mental functions that result from radiation exposure to the brain. This study may let researchers monitor patient responses to treatment and the disease better and possibly make changes to patient treatment, if needed.
Pilot study to test feasibility of 6 months of bazedoxifene (BZA) plus conjugated estrogens (CE) to modulate breast MRI parameters.
Pilot study to test feasibility of 6 months of Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes.
The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy. Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Biomarker testing in the study may include genetic biomarkers. This is an investigational study. MRIs on this study are performed using FDA-approved and commercially available methods. Having added scans and blood tests is investigational. Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). All will take part at MD Anderson.
Repetitive head impacts in sports and military may cause deleterious effects in the nervous system. Investigators' previous works in football players have shown promising results in prediction of concussion and prevention of long-term defect using eye-movement paradigm (ocular-motor system) and blood biomarker. However, acute head impact effects on aforementioned parameters remain unknown. Thus, to answer a critical research question that whether or not ocular-motor system and brain-derived blood biomarker may be acutely altered following 10 successions of controlled soccer heading. To answer the question, investigators hypothesized that acute bout of soccer heading will not elicit noticeable change in subject's symptoms but to induce a transient defect in the ocular-motor system and increase plasma expression of brain-derived biomarker.
Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different types of emollients to soften the scale. A deeper understanding of this disease is required to develop better treatments. There are different types of cells and cell-produced signals (biomarkers) that are being studied in order to help find these new treatments. Looking at biomarkers has been successful in helping us to understand other skin disorders better. The purpose of this study is to determine which blood and skin biomarkers characterize ichthyosis. Hypothesis: We predict that the biomarkers correlating with disease activity in Netherton syndrome will be different than the biomarkers found to correlate with the lamellar and other ichthyosis phenotype.
Currently, there are no cures or disease modifying therapies for Parkinson's disease (PD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for PD. Several detection parameters will be assessed through enrollment of Parkinson's patients and age matched healthy volunteers over 50 years of age to learn more about the analytical process and biological variability.
Currently, no cures or disease modifying therapies exist for Alzheimer's disease (AD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for stratification of Alzheimer's disease patients and healthy volunteers. This study may lead to future blood tests that may help earlier diagnosis of Alzheimer's disease and detect the disease progression.
A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the Presence or Absence of Aggressive Prostate Cancer
To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS) before and after sinus surgery.
This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion of OSA.
The purpose of this study is to identify genetic or other factors in the subjects blood that may predispose them to getting a particular disease or tell researchers how the disease will behave, for example how fast it will progress or what areas of the body might be affected. A second goal is to relate such factors to how such a condition affects the subjects clinically as well as how it affects the electrical functions of nerves and muscles.
This is a pilot, non-randomized, single institution, observational study investigating the effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer in tissue and blood as well as on imaging in women at elevated risk for breast cancer. Twelve months after bariatric surgery, 50% of excess weight is generally expected. Eligible women at elevated risk for breast cancer who are already planning to undergo bariatric surgery will be consented to undergo imaging (MRI and mammogram), breast tissue biopsy, and fasting blood draw prior to bariatric surgery, approximately 14 days after bariatric surgery, and approximately 1 year after bariatric surgery. In parallel we will also be assessing 40 normal breast tissue specimens as well as blood samples from the Komen Tissue Bank (elevated risk but normal BMI) to establish a normal BMI, elevated risk control group for our study. The KTB samples will be matched for general risk of breast cancer (\>20%), age, race and menopausal status.
Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder of children, affecting 10-20% of children and 1-2% of adults. This skin disorder can be associated with unbearable itchiness and an increased susceptibility to skin infections. The cause of AD is currently poorly understood; therefore, there are no targeted treatment options at present. There have been recent studies in adults with AD that explain the cause and give us new routes to investigate treatment options, however no major studies in this arena have been done in children. We hope to evaluate the skin and blood biomarkers that are found in pediatric AD and compare them to adult AD. Hypothesis: The immune system worsens the skin barrier issues that are common in atopic dermatitis. We believe there are similar immune and skin abnormalities in adult versus pediatric atopic dermatitis. Finally, blood levels of the activated molecules in atopic dermatitis can serve as surrogates for skin immune activation and will correlate with disease severity.
Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study.
Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.
We hypothesize that a peripheral blood biomarker or biological signature (gene or protein expression pattern) of idiopathic interstitial pneumonias (IIPs) will simplify and improve the accuracy of diagnosis of IIP and diagnose individuals at an earlier, more treatable, stage of their disease.
This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.
This is a three-cohort, randomized, double-blinded , sham-controlled, single-center, early feasibility research trial to determine whether organ-specific biologic effects on platelet activity and coagulation are achievable through selective ultrasound of the spleen utilizing low-energy (diagnostic-level) insonification. * Group 1: Focused insonification at center of the spleen. * Group 2: Prolonged duration insonification at center of the spleen * Group 3: Prolonged duration insonification across the spleen. Participants will receive 30 minutes of sham stimulation in the randomized group that is assigned to them, followed by active stimulation within the same group. Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device
This study is designed as a randomized, double-blind, sham-controlled, single-center research study in which healthy adults will be randomized 1:1 into one of two experimental groups, to receive transcutaneous auricular vagus nerve stimulation (taVNS) targeting either the auricular branch of the vagus nerve (ABVN) or tAN, which targets the ABVN and the auriculotemporal nerve (ATN): 1. Group 1: Sham taVNS followed by active taVNS 2. Group 2: Sham tAN followed by active tAN Participants will receive 30 minutes of sham stimulation (taVNS or tAN), followed by active stimulation (taVNS or tAN). Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device.
This observational study will examine the association of chronic traumatic cerebrovascular injury and cardiovascular risk factors with TBI-related cognitive impairment and vascular dementia. Cerebrovascular, inflammatory, and neurodegenerative blood biomarkers as well as clinical and neuroimaging data
Repetitive blast exposure has been shown to lead to more severe neurobehavioral impairments versus a single exposure. Blast-induced Traumatic Brain Injury (TBI) can lead to short- and long-term adverse outcomes Even mild brain injuries can impair neurocognitive performance, and repeated injuries can amplify negative outcomes. Service members with repeated exposure to low-level blasts as a necessary part of their job or training display altered neural activity during a memory task that is paralleled by a reduction in accuracy on neurocognitive memory tasks. As a result, it is important to monitor service members that are exposed to multiple blast-generated mTBIs to allow the earliest identification of acute or chronic brain and body insult and provide individualized measures of time to recovery. While TBI is clinically diagnosable, the methods of diagnosis have up to now been typically expensive and immobile, and treatments and interventions sparse. The investigators will conduct a longitudinal assessment of mTBI brain biomarkers by collecting repeated measures of FDA approved mTBI brain injury biomarkers, correlated with sound and blast exposure, as well as continuous monitoring through smart watches (activity, sleep, biometrics, calorie expenditure, balance) and analyte data through analyte sensors (glucose, lactate, ketones). Study data will be organized into categories and presented to participants daily within the application and will be securely stored within the application. At the completion of the study, participants will be provided with the study data digitally within the mobile application and study data will also be provided to the credentialed unit medical provider to enable it to be ported to the participants' electronic medical record. This study will create a continuous record of blast overpressure and sound exposures and correlate those to the participants health state over the course of several 9-week courses. This will enable an assessment of individualized susceptibility to brain injury as well as providing novel data on time to recovery. The investigators hope to develop dynamic and accurate risk profiles that are individual and will lead to further understanding of how to protect participants from mTBI (mild TBI) events.
The goal of this clinical trial is to learn about how genetics and the response to stress predicts cognitive decline in individuals with mild cognitive impairment. The main question\[s\] it aims to answer are: * Does the hormone response to acute stress predict the degree of cognitive impairment following acute stress? * Do genes associated with the risk for Alzheimer's disease influence the relationship between stress hormone response to stress and cognitive impairment following stress? * Do cognitive impairment following acute stress and genes associated with the risk for Alzheimer's disease predict cognitive decline and change in biomarkers for Alzheimer's disease 2 years later? Participants will have 3 in-person study visits. The first 2 will occur at baseline and the 3rd visit will occur 2 years later. During the visits, participants will provide blood and saliva samples, undergo a 10-minute social stress procedure, complete questionnaires, and take tests of memory and other thinking skills. Someone who knows the participant (a "study partner") will be asked questions about the participant's daily functioning at the first and 3rd study visits.