76 Clinical Trials for Various Conditions
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of resmetirom and its major metabolite (MGL-3623) following oral administration of 100 mg resmetirom (QD x 6 days) in subjects with severe renal impairment (RI) compared to healthy matched control subjects with normal renal function.
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.
The investigators want to see if healthy people who are given 2 doses of a medication called anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then exposed to a form of air pollution, called Endotoxin, have less inflammation with the medication. Endotoxin is believed to be one of the causes of asthma attacks.
Background: The brain enzyme phosphodiesterase-4D (PDE4D) may affect thinking and depression. Drugs with some radioactivity can attach to enzymes and be seen on a scan. Researchers want to test a new radioactive drug, 11C-T-1650, to measure PDE4D in the brain and body. They also want to see if the new drug BPN14770 blocks 11C-T-1650 from the brain. They want to learn more about psychiatric disorders and possible treatments. Objectives: To study how well 11C-T-1650 helps show PDE4D on a scan and to see if BPN14770 blocks it. Eligibility: Healthy adults at least 18 years old Design: Participants will be screened in other protocols. Some participants will have 1 body PET scan. Some participants will have 2 brain PET scans and 1 brain MRI within 1 year. Some participants (ages 18 55) will: Have 3 brain PET scans and 1 MRI Take BPN14770 by mouth twice daily for 3 7 days Have blood and urine tests Have a follow-up physical exam and heart test PET (positron emission tomography) scans will take 2 3 hours. Participants will: Have a thin plastic tube (catheter) placed in an arm vein by needle. Get a small amount of 11C-T-1650 injected via catheter. Another catheter may be placed to draw blood. Lie quietly on a bed that slides into a donut-shaped scanner without sleeping. They may get a short break. Have heart and vital signs monitored. Have blood and urine tests. Learn about drinking fluids and urinating after the scan MRI (magnetic resonance imagining) scans will take 30 60 minutes: Participants will lie on a table that slides into a metal cylinder in a magnetic field. Sponsoring Institute: National Institute of Mental Health ...
The purpose of the study is to determine whether a particular type of nerve fibers, A-delta fibers, can be tested in an Electromyography (EMG) lab on a routine basis. Normal, healthy volunteers will be enrolled in this study.
This placebo-controlled crossover study is intended to measure the effect of three, common neuroactive medications on brain activity measured by magnetoencephalography (MEG) and electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple cognition testing on 15 healthy volunteers over 4 study days. Subjects will receive placebo on one of the study days, and either 100 mg modafinil p.o., 20 mg methylphenidate p.o., or 1 mg lorazepam p.o. on remaining study days. Medication administration will be randomized according to study day so that each subject will receive the medications in random order. Brain activity will be measured by MEG and EEG in each subject a total of 4 times each study day: prior to medication administration and 2, 4, and 6 hours after medication administration. Cognition testing will be performed at pre-medication baseline and immediately after each post-medication scan time. This study will test the hypothesis that changes in brain functional activity can be accurately measured in healthy volunteer subjects after single, acute doses of modafinil, methylphenidate and lorazepam.
The objectives of this investigator initiated study are to: 1. Determine if and when vascular abnormalities occur during early adolescence 2. Determine if poor diabetic control is related to vascular abnormalities. The development of vascular plaques and vascular contractility will be assessed through the use of the SyphmgnoCor equipment.
The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.
This study will use functional magnetic resonance imaging (fMRI) to examine what happens in the brains of adolescents when they are exposed to violent media and how imagining aggressive behavior affects brain function. The study will measure physiological changes (such as the amount of electricity generated by the skin, heart rate, and breathing rate) related to these tasks during fMRI. MRI uses a magnetic field and radio waves to obtain images of body organs and tissues. For fMRI, the subject performs certain tasks during the MRI scanning to examine changes in the brain regions that are involved with those tasks. During the scan, the subject lies in a metal cylinder (the scanner), wearing earplugs to muffle loud noises that occur with the scanning. Healthy right-handed native English-speaking males between 14 and 17 years of age may be eligible for this study. Candidates are screened with a neurological examination and neuropsychological testing that includes questions about their feelings, experiences, and behavior, and tests of reading level and intelligence. Participants undergo fMRI and fill out questionnaires before and after the scanning. Some children are asked to play 20 minutes of video games before the test. During the scan, the child views short neutral video clips and video clips of people fighting or imagine self-defense situations. The child is asked to rate the video clips for their aggressive content or tell how he or she feels about the imagined situations. Two small straps are wrapped around the child's index and middle fingers to measure changes in the amount of electricity generated by the skin, and a strap at the ring finger measures the child's heart rate. A band around the child's chest records breathing rates. Children who cannot or do not want to undergo MRI testing may be asked to view commercially available video clips of people fighting and neutral video scenes, such as sports scenes. They are asked to rate them on their violent content and excitement, or to rate the video games they have played on their violent/nonviolent content and their popularity. In addition, the children fill out questionnaires about their media use and exposure to violence. All participating families are contacted by telephone 1 day and 2 weeks after the experiment for parents to answer questions about how the child has been doing and for the children to answer questions about their feelings.
This study will explore whether the human herpes virus-6 is associated with epileptic seizures. The virus may be involved in brain scarring, called mesial temporal sclerosis, which is seen in some epilepsy patients. The virus is also thought possibly to interfere with neurotransmitters - chemicals that brain cells use to communicate with each other. This study will measure levels of two of these chemicals, GABA and glutamate, which are believed to play a role in the development of seizures. Patients with epilepsy, with or without mesial temporal sclerosis, and healthy control subjects 18 years of age and older may be eligible for this study. Control subjects may not be taking any medication on a regular basis. Epilepsy patients may take only phenytoin, carbamazepine, oxcarbazepine, lamotrigine, or levetiracetam. Candidates are screened with a physical examination and blood tests. Participants have blood drawn and undergo magnetic resonance imaging (MRI) and lumbar puncture (spinal tap). Blood Draw Up to four teaspoons of blood are drawn through a needle in the arm for this study. MRI MRI uses a magnetic field and radio waves to produce pictures of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a bed that slides into the cylinder, wearing earplugs to muffle loud noises the machine makes when the magnetic fields are switched. The scan takes about 90 to 120 minutes, during which time the subject can communicate with the technician. Lumbar Puncture For this test the subject sits upright or lies on his or her side with knees curled at the chest. A local anesthetic is injected at the lower back, and a needle is inserted in the space between the bones where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. Collection of the fluid usually takes from 5 to 20 minutes.
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function, including a subset of NASH subjects.
This research project is being conducted to look at the pharmacokinetics (PK; how the human body processes a substance), safety, and tolerability of a single dose of ETX2514 and sulbactam (ETX2514SUL) when concurrently administered by separate intravenous (IV) infusion in participants with various degrees of renal impairment (RI), in participants with end-stage renal disease (ESRD) who are on hemodialysis (HD), and in healthy matched control participants with normal renal function.
This is a single-dose, open-label, two part, parallel group study. This study is being conducted to determine the pharmacokinetics, safety and tolerability of GSK2336805 in subjects with varying degrees of hepatic impairment. Part 1 of the study will enroll subjects with mild and moderate hepatic impairment and healthy control subjects matched to the subjects in the moderate hepatic impairment category. The decision to commence Part 2 will be based on a review of the preliminary safety and pharmacokinetic data from subjects with moderate hepatic impairment. Part 2 will enroll subjects with severe hepatic impairment. Additionally, based on emergent data from Part 1, matched controls to the severe hepatic group may be enrolled (optional). Due to the potential difficulty in identifying eligible subjects with severe hepatic impairment, the study may be stopped prior to full enrollment in Part 2, provided that a minimum of 4 evaluable subjects with severe hepatic impairment have been enrolled. The study will consist of a Screening visit, a single dose Treatment Period and a Follow-up visit. Subjects will be screened for eligibility criteria within 30 days of enrolment. Subjects will be admitted to the clinical unit on Day -1; each subject will receive a single dose of GSK2336805 on Day 1 and will remain in the clinical unit for 5 days (check-out on Day 4). The follow-up visit will be conducted within 7-10 days after Day 1 dosing.
This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds to fight off infections in the body.
The purpose of this research is to measure the extent of inflammation in the brain between different groups of participants using a radioactive tracer called \[18F\]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body. This study will see how the tracer is taken up in the brain using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Participants will undergo approximately 60 minutes of dynamic scanning of the brain starting at approximately the time of injection of \[18F\]NOS. Participants are required to have a brain MRI performed within 1 year prior to study enrollment, or if the subject has not had a brain MRI that is deemed acceptable for use for this study they will be asked to undergo a research brain MRI after they have consented for this study.
To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects. These subjects will also be evaluated for beta-cell function as measured by the insulin and C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced conditions.
This will be a Phase 1, open-label, parallel group, two-part, single-dose adaptive study in adults with moderate and mild (if needed) hepatic impairment and matched, healthy control subjects with normal hepatic function. In Part 1, healthy control subjects (n=8) matched to subjects with moderate (n=8) hepatic impairment will be enrolled. If the geometric mean total plasma area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0-infinity\]) of GSK1265744 is increased by \>2-fold in moderately impaired subjects relative to matched controls, Part 2 will be conducted to evaluate GSK1265744 PK in subjects with mild hepatic impairment (n=8) and matched, control subjects (n=8). All subjects will receive a single 30 milligram (mg) oral dose of GSK1265744. The primary objective of the study is to compare plasma PK parameters of GSK1265744 in subjects with hepatic impairment to healthy controls matched in gender, age, and body mass index (BMI).
This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.
The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are: How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate? Participants will be asked to: * Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days * Stay overnight at MGH's research unit for two separate 2-week periods * Participate in two separate 24 hour periods of multiple MRIs and blood draws
In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the drug clemastine has a negative effect on patients' color discrimination, which is the ability to distinguish different hues and arrange them in the correct order. In an upcoming clinical trial studying the effect of clemastine on vision outcomes, our lab aims to assess color visual performance adding assessment of color defectiveness as a clinical endpoint. Color defectiveness is the ability to see certain colors, and is commonly referred to as color-blindness. Color discrimination and defectiveness can be related, but do not always correlate. This study aims to detect the effect, if any, that clemastine has on color defectiveness in healthy controls, which could confound its use as an outcome endpoint in future clinical trials relating to clemastine.
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations in subjects with type 2 diabetes.
The underlying goal of this study is to assess \[18F\] CFPyPB PET imaging as a tool to evaluate the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer Disease (AD) research participants.
Registry program for volunteers who are willing to serve as control subjects in future research studies.
To assess the dynamic uptake and washout of 123-I CLINDE, a potential imaging biomarker for inflammatory changes in brain, using single photon emission computed tomography (SPECT) in similarly aged healthy controls and subjects with Alzheimer (AD) or Parkinson disease (PD). To perform blood metabolite characterization of 123-I CLINDE in healthy and subjects with AD or PD to determine the nature of metabolites in assessment of 123-I CLINDE as a single photon computed tomography (SPECT) brain imaging agent. Evaluate the test/retest reproducibility of 123-I CLINDE, and SPECT in AD and PD subjects and healthy controls
Specific Objectives: * To determine if individuals who carry a decreased or non-functional variant of OCT1 exhibit differences in the pharmacokinetics of metformin in comparison to individuals who carry the common allele. * To determine if individuals who carry the decreased or non-functional variants exhibit differences in the response to metformin in comparison to individuals who carry the common allele.
This observational research is comparative in design, that is assessing the change in qMRI measures in degenerative changes of the TMJ in patients diagnosed with DJD. These patients will be imaged multiple times over the course of 18 months, using clinical 3T MRI scanners located at the Center for Magnetic Resonance Research (CMRR), and their findings will be compared to controls; individuals who are not diagnosed with DJD. No investigational agents or MRI contrast agents will be used.
This will be a single center, open label study comparing baseline characteristics of recovered sputum cells (collected on screening day) to those of cells recovered 6 hours after inhalational challenge with 20,000 EU Clinical Center Reference Endotoxin (CCRE, a component of air pollution)) within each group as well as cross group comparisons between individuals with allergic asthma (AA's)and normal volunteers (NV's). The primary objective of this study is to test the hypothesis that persons with allergic asthma will have an increased neutrophil response to challenge with 20,000 EU CCRE compared to normal volunteers. Secondary objectives include post CCRE comparison between AA's and NV's with regard to changes in airway cells and blood as well as changes in mucociliary clearance (MCC) in response to inhalation of 20,000 EU CCRE.
ALV003-0812 is a study of the safety and tolerability of a study drug (ALV003) in healthy adult volunteers and in patients with well-controlled celiac disease, following a meal that contains gluten.
To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease
The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone and in combination with ketoconazole in healthy adult volunteers.