271 Clinical Trials for Various Conditions
The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults. The study will also investigate the biochemical molecular pathways involved in laser therapy by analyzing hair follicle gene expression before and after laser treatment. The main questions it aims to answer are: 1. Does a non-ablative laser work to effectively treat scarring alopecia? 2. What molecular pathways are associated with the laser's effects on hair follicles in scarring alopecia? Participants with scarring alopecia will: * Receive 3 laser treatments, spaced 1 month apart (Month 1, Month 2, Month 3), and attend 5 follow-up visits (Month 4, Month 6, Month 9, Month 12 and Month 15) * Have hair follicle samples collected via hair plucking of 10 hairs prior to the start and 1-month post-completion of laser treatments for gene expression analysis of inflammatory and fibrosis pathways implicated in scarring alopecia. Hair samples will be de-identified and kept anonymous. * Fill out questionnaires at each visit * Keep a diary of any side effects from laser treatments
The study aims to observe changes in dopaminergic genes expression in peripheral tissue upon prolonged dopamine agonist treatment on patients with Restless Legs Syndrome (RLS). Similar studies in Parkinson's disease have shown changes in alpha-synuclein expression, which might offer insights into the dopaminergic gene regulation seen in RLS. The dopamine agonist drugs to be included in this study are: Pramipexole (Mirapex), Ropinirole (Requip), Rotigotine (Neupro), Apomorphine (Apokyn), Bromocriptine (Parlodel). Specifically, the study will collect nasal swabs of participants partitioned into two groups, those who have not used a dopamine agonist or been on a dopamine agonist for less than 1 month compared to those who have been on the medication for 6 or more months. This research could provide insight into changes in dopaminergic gene expression associated with Augmentation Syndrome (AS) which occurs after long term dopamine agonist treatment in RLS patients.
The purpose of this study is to evaluate the effect of bimekizumab on gene expression biomarkers at Week 48 in a subset of study participants with moderate to severe plaque psoriasis (PSO) and moderate to severe plaque PSO with concomitant active psoriatic arthritis (PsA) who have provided skin biopsies for reverse transcription-polymerase chain reaction (RT-PCR).
The goal of this observational study is to develop and validate a molecular heart rejection diagnostic system based on targeted transcriptome as a novel monitoring companion tool for heart allograft precision diagnostics applicable to formalin-fixed paraffin-embedded endomyocardial biopsies. The primary outcome will be the biopsy-proven rejection, that will be predicted with molecular classifiers (cellular and antibody-mediated rejection scores).
The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients."
Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected.
GEODESIC is a prospective descriptive cohort investigation that will examine the generalizability of the novel host gene expression biomarkers, SeptiCyteTM LAB, SeptiCyteTM VIRUS, SeptiCyteTM BACT, and SeptiCyteTM TRIAGE (collectively 18 genes or SeptiCyteTM LVBT) and SeptiCyteTM RAPID, for differentiating children with bacterial sepsis, versus severe viral illness, versus non-infectious related systemic inflammatory response syndrome.
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months after transplant to help inform immunosuppression (IS) optimization. Approximately 20 patients will be enrolled in the study. Study outcomes will include 1-year graft survival, 1 year BPAR and clinically treated rejection rates, number of changes to IS based on the results of Trugraf, eGFR and immune mediated issues. TruGraf®, (Transplant Genomics, Inc., a member of Eurofins Transplant Diagnostics) is a non-invasive blood-based test to assist the clinician in lowering immunosuppression in liver transplant patients. It is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients. Unfortunately, achieving the tight control of therapeutic levels of immunosuppression that is required to maintain the balance between "too much" and "too little" can be difficult. TruGraf liver can help clinicians confirm immune "quiescence" prior to, as well as following, immunosuppression reduction in patients with stable graft function, minimizing the risk of overt graft injury due to rejection. The clinical context of use for TruGraf is to provide reassurance to the clinician who is contemplating a preemptive reduction in IS therapy that a patient's immune status is "quiescent" thus reducing the risk of triggering acute rejection with that IS reduction. Having the ability to assess whether the patient's immune status is "quiescent" or activated when considering an increase or decrease in IS therapy allows the clinician greater confidence in decision making.
This study will compare the performance of Gene Expression Profile (GEP)/ Donor derived cell free deoxyribonucleic acid (dd-cfDNA) tests, to the following tests: Molecular Microscope (MMDx) and histopathology (study of changes in tissues caused by disease) in their ability to diagnose (exactly identify) various types of injury within the transplanted kidney.
To compare gene expression stimulated by a semi-permanent filler and a biostimulator via punch biopsy
The purpose of this study is to evaluate both genotypic differences and differences in local gene expression in individuals who develop acute traumatic compartment syndrome relative to control patients with at-risk lower extremity fractures who do not develop compartment syndrome.
Little is known regarding the effect of antenatal COVID-19 on pregnancy outcomes. The purpose of this study is to determine of COVID-19 alters histopathology and gene expression of the placenta, as evidenced by analysis at time of delivery. The analysis will aim to identify whether resulting abnormal placental pathology or altered metabolism is associated with severity of symptoms (specifically pneumonia, or need for admission), gestational age at onset, and/or placenta efficiency. Histological and gene expression analysis of the placental post-delivery will determine if COVID-19 alters overall placental structure, vascularization, and/or the transcriptome.
This research study will evaluate the association of Androgen Receptor (AR) gene expression and COVID-19 disease severity and mortality. The research procedure involves collection of a single saliva sample which will be mailed to the participants by the study team. This saliva will be used in a COVID-19 Androgen Sensitivity Test (CoVAST) which will detect AR gene expression. Eligible participants are males, at least 18 years or older, and have tested positive for COVID-19.
Study Title: Gene Expression, Meditative Movement and Emotional Distress (GME) Background and Objectives: Breast cancer survivors (BCS) often report decrements in cognitive functioning. Cognitive impairment (CI) is generally understood as resulting from chemotherapy or radiation, but may also result from chronic emotional distress experienced by breast cancer patients and survivors. Meditation and exercise are both known to reduce stress, with growing evidence for the potential of each to also improve cognitive functioning in cancer patients and survivors. A Meditative Movement (MM) program (Qigong/Tai Chi Easy) offers the potential of combining both benefits of meditation and exercise for breast cancer survivors. This is a pilot study, testing the MM program to effect changes in cognitive functioning and associated symptoms/conditions such as anxiety, depression, sleep quality and using gene expression factors as biomarkers to potentially measure the molecular signature of these changes. Forty BCS will be consented and assigned to an intensive eight week MM program. Cognitive functioning and associated symptoms/conditions will be assessed before and after the 8-week MM program to examine the participants' behaviors and symptoms. Peripheral blood samples will be collected before and after the 8-week MM program and will be analyzed for gene expression changes. If successful, this study may provide preliminary data for a full powered randomized control trial if results show promise in the psycho-behavioral outcomes and genomic expression results.
This study does not involve any particular diagnosis. The goal of this research study is to explore the effects of artificial sunlight (ultraviolet B radiation; UVB) on the skin of young adults versus geriatric adults. Sunlight exerts many effects on the body. There is evidence that in response to ultraviolet B radiation (UVB), which are the burning rays of sunlight, young adult skin responds differently than geriatric skin. In fact, researchers feel that this difference in how the skin reacts to UVB is why skin cancers are found in older skin. Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1), whereas geriatric skin has very little. The current study will test how young adult versus geriatric skin responds to UVB, and if geriatric skin treated with an injection of small amount of IGF-1 drug will then act like young skin.
This pilot project will provide an understanding of the contextual variables responsible for chronic low back pain. These variables include, genetic variation, pain sensitivity, reactivity, pain catastrophizing, perceived stress and kinesiphobia. The purpose is to understand the initial efficacy of self-management (SM) strategies on each of these contextual variables, in an effort to inform a personalized approach to managing chronic low back pain and its effect on improved health outcomes.
The overall goal of the study is to investigate the functional, biochemical, and gene expression effects of Interferon-gamma 1-b (IFN-γ) on the neutrophils of patients with Chronic Granulomatous Disease (CGD). The investigators hypothesize that the clinical effects demonstrated in patients with CGD treated with IFN-γ (decreased number and severity of infections) are the result of biochemical processes and upregulation of specific genes, which lead to enhanced functionality of this immune cell population.
A clinical trial is proposed, to clinically validate, in a US population, the diagnostic performance of a new genetic test (ThyroidPrint). It will determine the nature of thyroid nodules that have been informed as indeterminate by cytology through a fine needle aspiration (FNA). The Genetic Classifier for Indeterminate Thyroid Nodules is a test that determines the expression of a panel of 10 biomarkers (CXCR3, CCR3, CXCl10, CK19, TIMP1, CLDN1, CAR, XB130, HO-1 and CCR7). Gene expression data is analyzed through an algorithm that generates a composite score that predicts the risk of malignancy. It´s intended use is for patients with thyroid cytology as indeterminate (Bethesda III and IV, according to The Bethesda System for Reporting Thyroid Cytopathology). This test uses a fine needle aspiration (FNA) sample.
This study aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation. Hypothesis: 1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids 2. Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity 3. Biomarker analysis will provide useful insights for future targeted therapies for keloid scars
This is a pilot study of a new 9-session individually delivered cognitive behavioral intervention targeting sexual minority stress. In this study, 40 HIV+ men sexual minority men will be recruited for the study then will be randomly assigned to either the new 9 session intervention or a writing task condition.
To verify and validate a biodosimetry test for determining absorbed ionizing radiation dose by analyzing gene expression signatures of blood samples collected from patients treated with Total Body Irradiation (TBI).
The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.
Objectives: 1. To better define the differences in molecular genetics of parathyroid tumors in patients with MEN1, single gland parathyroid disease in patients less than 50 years old and single gland disease in patients greater than 50 years old. 2. To better define the incidence of HRPT2 mutation in young patients with primary hyperparathyroidism and determine whether routine testing in these patients is indicated.
There continues to be debate as to how much vitamin D an adult requires to be vitamin D sufficient. A multitude of association studies have suggested that improving serum 25(OH)D \>30 ng/mL may reduce risk of many chronic illnesses and improve immune function. The aim of this study is to define dynamic changes in PTH, broad gene expression in circulating immune cells, metabolomics, and microbiome profile in response to varying doses of vitamin D supplementation.
Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation between gene expression, oral somatosensory stimulation, feeding behavior, and neurodevelopmental outcomes at 18 months corrected age (CA) on 180 extremely preterm infants \[EPIs\] (24 0/7-26 6/7 GA and 27 0/7 - 28 6/7 GA) enrolled at three neonatal intensive care units: Catholic Health Initiative (CHI) Health St. Elizabeth (Lincoln, NE), Tufts Medical Center (Boston, MA), and Santa Clara Valley Medical Center (San Jose, CA). EPIs will be randomized to a blind pacifier (SHAM) or PULSED NTrainer treatment groups, and stratified by GA, sex, and bronchopulmonary dysplasia status (BPD vs non-BPD). We hypothesize that the combination of the NTrainer® intervention for improved oral feeding skills, along with objective salivary gene expression data to monitor response to treatment and feeding development, will result in a novel, objective, and personalized approach to neonatal oral feeding and reduce the duration of time to attain oral feeds while improving feeding, growth and neurodevelopmental outcomes at 18 months' CA.
The purpose of this study is to examine the immune response to traumatic injury and subsequent infections in critically ill adults. Traumatic injuries lead to severe dysregulation of the immune system, and predispose to severe infections. Diagnosing these infections in a timely manner is paramount in reducing morbidity and mortality, but diagnosis is made difficult by the inflammatory response to trauma. The main purpose of the study is to prospectively test the diagnostic power of the expression of an 11-gene set which the investigators recently published (Sweeney et al., Sci Transl Med, 2015). Since the timing of an acquired infection cannot be determined a priori, this study is designed to be a longitudinal examination of a cohort of traumatically injured adults. The investigators will draw blood at regular intervals, as well as at day of diagnosis of infection for any patient that are diagnosed with an infection. The investigators will then assay the blood for gene expression levels post hoc, and correlate the molecular profiles with clinical information to establish a prospective estimate of diagnostic power.
Up to 25 subjects will be enrolled and randomized. Randomized subjects will receive one single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's scheduled facelift procedure, resected tissue will be obtained for analysis.
This study plans to learn more about Down syndrome. The investigators think there is a different level of the AIRE gene in individuals with Down syndrome. The investigators think that the AIRE gene level can provide more insight about depressed immune cell function in individuals with Down syndrome. Patients are being asked to be in this research study because the investigators want to see if their blood contains more of less of the AIRE gene.
This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic antagonist propranolol is effective in decreasing gene expression of stress-mediated beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic stem cell transplant (HCT) for multiple myeloma.
This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Age/Sex/Gene Expression score (ASGES) also knows as Corus CAD testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously.