68 Clinical Trials for Various Conditions
An open-label, multi-site, validity and reliability study to obtain data on the Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests to assess scoring and normative ranges and compare against other cognitive tests within a diverse population.
Background: - People who have cancer have more medical problems if they smoke. Some studies show that smoking even makes cancer treatment less effective. Researchers want to teach people about how tobacco use affects people after a cancer diagnosis. They want to come up with questions for people who have cancer and who have survived cancer. The questions will be about using cigarettes and other tobacco products and about second-hand smoke. The questions will be used to understand how using tobacco affects people with cancer before, during, and after treatment. This will help doctors plan how to treat people with cancer and create programs to help people quit smoking in the future. Objective: - To evaluate and refine questions that assess tobacco use. Eligibility: - Adults age 21 or older who have cancer or are cancer survivors. The cancer can be at any site and any stage. Design: * This study will take about 1 hour. * Participants will meet one-on-one with an interviewer. They will fill out a questionnaire and talk about the questions. Participants will explain how easy or hard it was to answer the questions and how they decided on their answers. * All participants will be asked the same or very similar questions. Specific questions will be based on the participants own experiences with tobacco products. * There will be no follow-up activities.
Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker. The investigators objective in this proposal is to obtain imaging biomarker data in a group of individuals who are appropriate for establishing normative values for AD biomarkers. The investigators believe the most valid approach to establishing biomarker cut points is to base them on the upper bound of the range observed in young to early-middle-age subjects in whom the presence of occult AD pathology is extremely unlikely. Based on a large volume of community-based autopsy data, that upper age limit would be about 50 years old. The lower age bound for a group of subjects used to establish normative AD biomarker values would have to be based on considerations of brain maturation, which may continue into the middle- to late-20s. Thus, taking the above into consideration, the ideal age range for establishing normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages 30-49 years old.
The purpose of the study is to improve a questionnaire (the Pain Quality Assessment Scale) used for measuring different types of pain people may experience. An improved version of this questionnaire will help researchers better understand the impact of pain treatments on different types of pain through the use of this questionnaire.
This is a five year study conducted in cooperation with the Brain Health Registry (BHR), an internet-based registry which enrolls adult volunteers in order to facilitate clinical trials for the prevention of Alzheimer's disease (AD). The investigators goal is to validate the Brain Health Registry's online cognitive measures developed by Lumosity. Investigators will meet this goal by collecting data from the newly developed the BHR online cognitive screening battery along with standardized measures of memory, attention, executive functioning and speed of information processing currently used in clinical trials for Alzheimer's disease.
Background: - The Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey is designed to look at health-related topics. It is being developed for the Department of Health and Human Services. Researchers want to see how easy or difficult the FLASHE survey questions are to understand and answer. They will interview parents and teenagers to test the survey questions. Objectives: - To test the FLASHE survey questions on teenagers and their parents. Eligibility: * Adolescents between 11 and 18 years of age. * Parents of the participating adolescents. Design: * Participants will have a one-on-one interview to test the survey questions. The interview will last up to an hour and a half. Participants will be allowed to skip any questions that they do not wish to answer. * Participants will receive financial compensation for their time.
The purpose of the study is to examine the developmental trajectory of response control in boys and girls with ADHD entering adolescence. The investigators also want to determine the developmental trajectory of brain anatomy and brain connectivity in boys and girls with ADHD entering adolescence.
The proposed pilot study will provide safety and efficacy preliminary data regarding singular and combined effects of two therapeutic approaches, intranasal insulin and treatment with the sodium-glucose cotransporter type 2 inhibitor (SGLT2i) empagliflozin, to correct bioenergetic and vascular dysfunction in adults with preclinical Alzheimer's disease (AD) and amnestic mild cognitive impairment (aMCI) or early AD.
The SNIFF Device study will involve using one of three devices to administer insulin through each participant's nose or intra-nasally, accompanied by a lumbar puncture. This goal of this study is to measure how much insulin the device delivers to the cerebrospinal fluid (CSF). In addition, this study will look at the effects of insulin administered intra-nasally on memory, and on blood levels of insulin.
This is a randomized double-blind placebo-controlled trial of MHE in patients with cirrhosis using rifamycin SV-MMX 600mg BID vs placebo for 30 days with PK, safety, microbiota, brain function and brain MRI endpoints.
The SNIFF Device study will involve using a device to administer insulin through each participant's nose or intra-nasally. Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. This study is measuring how much insulin the device delivers. In addition, this study will look at the effects of insulin or placebo administered intra-nasally using a nebulizer-like device on memory, blood, and cerebral spinal fluid.
Background: - Some people have a mutation in the C9ORF72 gene that causes amyotrophic lateral sclerosis (ALS) or frontotemporal dementia (FTD). The mutation causes a small piece of DNA to repeat itself thousands of times. The C9ORF gene mutation mostly occurs in families. In those families, some persons have ALS and others have FTD. Occasionally the C9ORF gene mutation occurs in persons without a family history. Researchers want to understand how this gene causes different diseases. They will study how symptoms caused by the C9ORF gene develop and change over time. They will measure symptoms that occur in ALS and in FTD. In particular, they will measure strength, ability to move, thinking, and memory. They will also see if other tests are associated with progression of disease. These tests, called biomarkers, may help detect or measure C9ORF72 disease in the future. Objectives: - To understand how symptoms change over time in people with mutations in a gene called C9ORF72, which causes ALS and FTD. Eligibility: - Adults over age 18 who have this genetic mutation Design: * Participants will have up to 4 in-person visits and 3 telephone interviews over 3 years. Each in-person visit may take place over several days. They may be either inpatient or outpatient visits. * At each visit, participants will undergo a series of brain, language, and behavior tests. These will include: * Magnetic resonance imaging (MRI) of the brain. This uses magnets, radio waves, and computers to produce detailed pictures of the brain. * Collecting spinal fluid. The clinician will make the participant s back numb and then insert a needle to collect fluid. \<TAB\>- Blood samples will be taken. \<TAB\>- Participants will be asked to perform several language and movement tests. \<TAB\>- Small skin samples will be taken on one visit - Between visits, participants will answer questions about their health over the phone 3 times.
Background: - Repeated exposure to explosions may lead to changes in the way that people think or feel. Breachers (people trained to use explosives to get into buildings) are exposed to repeated blasts as part of their job. Researchers want to study how they might be affected by blast exposure. Breachers will be compared with other groups who have different levels of exposure to repeated blasts. Information will also be obtained from spouses or close companions. Objectives: - To study the effects of repeated exposure to low-level blasts on thinking, memory, behavior, and brain function. Eligibility: * Experienced military and civilian breachers, experienced active duty artillery operators, and active duty military without frequent blast exposure, 18 and 60 years of age. * Spouses or close companions of these individuals. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected and a urine pregnancy test will be required of participants (not companions) before MRI scanning. * Participants will spend up to 5-days as a NIH clinic outpatient, with about 6 hours of tests each day. Tests will include the following: * Medical and professional history, with questions about exposures to blasts * Tests of thinking, memory, and concentration * Balance tests * Hearing tests * Imaging studies, such as magnetic resonance imaging, to look at the brain * Overnight sleep study to monitor brain waves * Blood samples * Participants will return 1 year later for a 3-day followup visit. Some of the tests from before will be repeated. A spouse or close companion (if available) will be asked to complete questionnaires or have a telephone interview....
The overall goal of this study is to determine if atomoxetine treatment improves selective cognitive functions in abstinent cocaine users, compared to healthy controls. The study will also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates the cognitive effects of atomoxetine.
Recent data suggests that anesthetics can have prolonged effects on gene expression, protein synthesis and processing as well as cellular function in ways that the investigators are only beginning to understand, especially in the very young and the elderly. Within moments to days of emerging from anesthesia - cardiac or non-cardiac - some patients experience mild to very severe disorientation and changes in memory and thinking ability without apparent cause. For the vast majority of patients, this Post-Operative Cognitive Dysfunction (POCD), generally subsides, but for some with "diminished cognitive reserve" - especially the elderly, those with less education or prior CNS events such as stroke or early dementia - changes in memory and executive function may persist. If prolonged for more than three months, POCD has been linked to an increased risk of death. In 1-2% of elderly patients, the problem may ultimately continue for more than a year, leading to a loss of ability to care for themselves and early demise. Though this may seem like a small percentage, seniors will comprise up to 40% of the 50-75 million surgical procedures performed annually over the next 20-30 years. This amounts to 70,000 - 200,000 elder affected, and for them and their families, the cost of POCD in longer-term care, lost wages, and extended suffering will remain very high.
The overall objective of this study is to identify a 60 minute cognitive battery, for subsequent use in clinical trials, that detects cognitive deficits in early HD and late pre-manifest HD compared to controls, and that has a potential to show drug induced improvements.
This study will test the ability of magnetic resonance imaging (MRI) to detect damage in different parts of the brain in patients with multiple sclerosis and to see if cognitive problems in patients can be correlated with the presence of lesions or reduction in the size of certain part of the brain. Healthy subjects will also be studied to compare findings in patients with those of normal volunteers. Healthy subjects and patients with multiple sclerosis who are between 18 and 60 years of age may be eligible for this study. Patients must not have severe clinical disability and must have been receiving and responding to Interferon beta for at least 6 months prior to enrollment. Candidates are screened with a medical history, physical examination, MRI and possibly evoked potential testing, which measures the nervous system response to visual, auditory and somatosensory stimulation. Participants have two MRI scans within 1 week (inclusive of the one performed for screening). MRI uses a magnetic field and radio waves to obtain images of body tissues and organs. The scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the subject lies on a table that can slide in and out of the cylinder. Participants will be tested with magnet strengths of 1.5 and 3 Tesla; the higher the Tesla, the greater the ability to see brain changes. Each scan may last up to 90 minutes. In addition to the MRI scans, participants undergo cognitive testing that measures memory and thought processes and complete forms that test and quantify fatigue level, stress, anxiety and depression
This study will test whether primary lateral sclerosis (PLS) and amyotrophic lateral sclerosis (ALS) affect parts of the brain responsible for thinking, planning, memory and emotion. Healthy volunteers 18 years of age and older and patients with PLS and ALS may be eligible for this study. Participants undergo the following procedures: * Rating motor function: Subjects are asked to contract certain muscles in the face, arms and legs, to tap their finger on a keyboard rapidly, to walk 20 feet, and to read a paragraph out loud. * Electroencephalography (EEG): The electrical activity of the brain (brain waves) is recorded while subjects tap their finger very slowly. For this test, electrodes are placed on the scalp using a cap or an adhesive substance. A conductive gel is used to fill the space between the electrodes and the scalp to ensure good contact. * Surface electromyography (EMG): The electrical activity of the muscles is measured. Electrodes filled with a conductive gel are taped to the skin over the muscle tested. * Neuropsychological testing: Testing may include questionnaires, pen-and-paper or computerized tests, and motor tasks. * Magnetic resonance imaging (MRI): MRI uses a strong magnetic field and radio waves to produce images of the brain. The subject lies on a table that slides into the scanner. Scanning time varies from 20 minutes to 3 hours, with most scans lasting 45-90 minutes.
The purpose of this research protocol is to screen and enroll individuals who have bipolar disorder and to track each person's course of illness in order to study the long-term course of illness and to elucidate possible clinical and biological predictors of acute and sustained treatment response. As a part of this protocol, subjects will: systematically be administered psychiatric rating scales such as the life-chart method (LCM) for daily assessment of mood, sleep, and behavior; be asked to participate in non-invasive research procedures, such as blood drawing for measurement of thyroid antibodies and intracellular calcium; and be medicated as is clinically appropriate. This protocol also serves as a stepping stone to other protocols such as the comparative acute and long-term efficacy of three antidepressants (#95-M-0129), and the efficacy of omega-3 fatty acids (#00-M-0004), for which separate written informed consents are obtained. Patients in this study are participants in the larger NIMH-Stanley Foundation Bipolar Network (SFBN), which involves six academic sites focused on better understanding the long-term course and treatment of the illness. The current protocol thus serves as an entry point for individuals with bipolar disorder for screening and detailed longitudinal assessment both prior to and in between more formal blind randomized IRB approved treatment protocols.
The purpose of this study is to evaluate people with mild memory problems, those with dementia, those at risk for developing Alzheimer's disease (AD), and healthy volunteers to identify markers of AD before the changes that occur with the disease begin. The origin and markers of progression for Alzheimer's disease (AD) are relatively obscure. Despite increased understanding of the underlying biology of AD, its clinical diagnosis is still made only after progressive cognitive decline; definitive diagnosis is confirmed at autopsy. This study will examine biomarker changes over time in a distinct cohort of people with an increased risk of developing AD. The study will also identify and track biological changes that occur with progressive dementia and compare those changes to the known cognitive and emotional disturbances that characterize AD. Individuals with a first-degree relative with AD will be recruited into an at-risk cohort. They will be followed and compared to a group of healthy volunteers for a minimum of 8 years.
The study is a single, cross-sectional cognitive interview of FuRST 2.0, functional rating scale, administered to forty Huntington's Disease Gene Expansion Carriers (HDGECs) and potentially, their companions (the companion's participation is optional in this study). The scale will be tested as a patient reported outcome (PRO) in that the information will come directly from the HDGEC participant or the HDGEC participant together with his/her companion through self-report. The purpose is to identify real or potential comprehension or usage problems with scale items, response options, instructions and disclaimer statement, which are all components of the FuRST 2.0 scale. Through a structured cognitive interview with the HDGEC participants or the HDGEC participants together with their companions, followed by qualitative analysis, the final phrasing of the individual scale items, response options, instructions and disclaimer statement for the scale will be generated. Depending on the results of this study, an additional round of cognitive pre-testing may be required in a separate study.
The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion through self-report. The purpose of this study is to identify real or potential comprehension or usage problems with questionnaire items or response options. Through a process of structured cognitive de-briefing with HDGEC participants and companions, independently, followed by qualitative analysis, the final phrasing of the individual items and response options for the scale will be generated. Depending on the results of the first round of cognitive pre-testing, additional rounds of cognitive pre-testing may be required.
This protocol describes development and user testing of an educational shared decision making intervention to help men with prostate cancer who are on active surveillance make decisions with their health care providers about if and when to de-escalate surveillance testing. The project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. For these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.
This trial studies the effect of a form of cognitive-behavioral therapy, Take a Breath, on reducing the intensity and frequency of dyspnea (difficulty breathing) in patients with lung cancer. Take a Breath consists of individual therapy sessions that educate patients on dyspnea and provides coping strategies.
This study will evaluate the practicality (i.e. acceptability to stakeholders; outcome battery feasibility; recruitment, retention, and adherence rates) and the preliminary effect of a cognitive strategy training intervention in adults with post-concussive syndrome.
The goal of this research study to help develop a tool to assist patients in making decisions about care during treatment for colorectal cancer. Information collected during this study will be saved to help develop future studies about patient decision making in cancer treatment.
This study seeks to examine whether 12 weeks of home-based computerized cognitive training on Cognitive Motor Interference (CMI) will improve walking and cognitive function in persons with MS.
The purpose of this study is to examine the effects of immunotherapy on cognitive function of cancer patients and follow them clinically over a period of six months with the Montreal cognitive assessment (MoCA) to assess changes in cognition.
Using a randomized controlled trial (RCT) design, we will test feasibility and outcomes following an remotely delivered, nationwide 8-week prolonged nightly fasting (PNF) intervention compared to an health education control (HEC) in 50 obese, stressed mid-life adults to explore outcomes related to cognitive function, metabolism and associated lifestyle behaviors.
Background: * Currently, National Cancer Institute treatment trials use clinical staff reporting to monitor adverse side effects. The clinical staff reports draw on items from the Common Terminology Criteria for Adverse Events (CTCAE). * Several of the items in the CTCAE can be adapted for use in patient self-reporting of side effects. Researchers are interested in developing a patient-reported outcome (PRO) approach to the CTCAE. Objectives: * To develop questions that can be used to create a patient-reported outcome version of the CTCAE (PRO-CTCAE). * To evaluate patient comprehension of and test the usefulness of the PRO-CTCAE questions among diverse groups of patients. Eligibility: * Individuals 18 years of age and older who are receiving chemotherapy or radiotherapy as cancer treatment. * Participants must be able to speak and understand English. Design: * Researchers will conduct up to three rounds of interviews with patients currently receiving chemotherapy or radiation therapy treatments for cancer. * Participants will be recruited independently from four different clinical treatment sites. At least 25 percent of patients will have an educational attainment of high school or less. * Each patient will complete a two-part protocol, including a set of PROs that will be followed by a series of questions to evaluate patient comprehension, memory, perceived clarity, and judgment of the PROs. * The research will be completed in approximately 1 hour, and participants will receive a small amount of compensation for their time and participation.