All Clinical Trials

The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI). Secondary objectives are: * To evaluate the efficacy of Fp/ABS eMDPI administered four times daily * To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks * To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit. Read Less

Child maltreatment is one of the most formidable public health crises in the United States, affecting millions of youth each year. The adverse consequences of maltreatment for youth, as well as for their families and entire communities, are pervasive, costly, and enduring. To intervene and reduce these consequences, it is imperative that victims provide clear and accurate accounts of their prior experiences. Currently, considerable skepticism exists regarding maltreated youth's ability to provide such accounts, especially for experiences that were stressful, leading to youths' reports being challenged or not believed. It is possible that this skepticism is unwarranted, and maltreated youth actually demonstrate better memory than their non-maltreated counterparts, but only for stressful salient personal experiences. This project will ethically and rigorously test this possibility via a short-term longitudinal experimental investigation that compares the effects of acute stress on memory between maltreated and demographically matched non-maltreated 12-17-year-olds. In an initial in-person session, youth will be randomly assigned (equal maltreated and non-maltreated youth across age) to complete standardized salient personal activities that are experimentally manipulated to vary in whether they induce higher or lower levels of acute stress. Immediately afterward, youth will complete an encoding task comprised of positive, negative, and neutral images. In subsequent sessions (two remote and one in person) spanning approximately one month, youth's memory will be tested for the images via a recognition task asking them to discriminate previously seen from unseen images and for the personal activities via recall and direct questions that probe for the extent and accuracy of memory. Youth's rumination about the personal activities will also be measured. The project's main hypothesis is that maltreatment will lead to particularly robust memory for the personal activities, but only when the youth complete these under conditions of high stress. By contrast, because the emotional and neutral images are not personally meaningful, maltreatment is expected to constrain youth's memory performance for the images. It is also hypothesized that rumination will serve as an important mediator of the links between stress and memory for the higher stress personal activities, most notably in the maltreated youth. Overall, the project's results will provide much-needed knowledge about the precise ways that maltreatment shapes different facets of youth's memory, knowledge. This knowledge will be enormously valuable in improving trust in maltreated youth's reporting of stressful experiences and hence in directing interventions for victimized youth. Read Less

This study evaluates the feasibility and accuracy of using saliva to remotely monitor cytomegalovirus (CMV) infection in individuals receiving treatment for ovarian cancer. Read Less

The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall health-related quality of life (HRQoL) experienced by Immunoglobulin A nephropathy (IgAN) patients and their caregivers. Read Less

The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Experimental Therapeutics and Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. In addition the protocol will allow clinicians to gain more experience in the use of a variety of polysomnographic and high-density EEG recordings. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); electrocardiography (EKG), magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request for medical records. Subjects may also be asked to complete questionnaires about attitudes towards research and motivation for research participation. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved ETPB protocols.... Read Less

Background: - Plaquenil (hydroxychloroquine) is an anti-inflammatory drug that is used to treat some autoimmune diseases such as lupus and rheumatoid arthritis. This drug can damage the retina by causing a condition called plaquenil-induced retinal toxicity, which may lead to vision loss. However, most people taking plaquenil do not develop this problem. Researchers are interested in studying whether differences in a person s genes explain why some people develop plaquenil-induced retinal toxicity while others do not. Objectives: - To investigate possible correlations between certain genes or genetic mutations and plaquenil-induced retinal toxicity. Eligibility: * Individuals at least 18 years of age who have previously used plaquenil. * Both individuals who have and have not developed plaquenil-induced retinal toxicity will be eligible for this study. Design: * The study requires one or two visits to the National Eye Institute or an outpatient study clinic over a maximum 2-year period. * Participants will provide a personal and family medical history, and will have a full eye examination. * Participants will also provide blood samples for testing. * No treatment will be provided as part of this protocol. Read Less

Background: * Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. * Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States. * The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis. * Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease. Objectives: -To allow sample acquisition for use in the study of mesothelioma. Eligibility: * All patients age greater than or equal to 2 years with malignant mesothelioma * Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18 Design: * Up to 1000 subjects will be enrolled. * Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma. * Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking. * Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies. Read Less

Background: The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments. Objectives: To see if Nivolumab slows the growth of some types of cancer or stops them from getting worse. To test the safety of the drug. Eligibility: People 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders or EBV-positive non-Hodgkin lymphomas with no standard therapy Design: Participants will be screened with: Medical history Physical exam Blood and urine tests CAT scan of the chest, abdomen, and pelvis Tumor and bone marrow biopsies (sample taken) Magnetic resonance imaging scan of the brain Lumbar puncture (also known as spinal tap) Positron emission tomography/computed tomography scan with a radioactive tracer Every 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also have: Physical exam Blood and pregnancy tests Review of side effects and medications During the study, participants will repeat most of the screening tests. They may also have other biopsies. After stopping treatment, participants will have a visit every 3 months for 1 year. Then they will have a visit every 6 months for years 2-5, and then once a year. They will have a physical exam and blood tests. Read Less

The purpose of this study is to evaluate the use of Cereset Research to improve autonomic function in participants with symptoms of stress, anxiety, or insomnia. Read Less

The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations. Read Less

This phase II trial studies the effect of calorie reduction while undergoing stereotactic ablative radiation therapy in treating patients with breast cancer. Stereotactic ablative radiation therapy (sABR) is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organ. Giving SABR before surgery may make the tumor smaller. Adding dietary restrictions in combination with radiation therapy may help increase local control and decrease the spread of the cancer to other places in the body. The purpose of this trial is to identify if there is a decrease in tumor tissue in patients undergoing caloric restriction during pre-operative SABR, compared to patients undergoing pre-operative SABR alone. Read Less

The primary objective is to determine if the addition of a 12-week course of treatment with VIB4920 to TNFi treatment will result in improved clinical disease control in patients with RA who have had an inadequate response to a TNFi. Read Less