[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institutes of Health Clinical Center (CC)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":479},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,48,60,86,109,134,161,183,203,226,254,278,300,327,352,378,400,428,454],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053233","characterization-of-nociception-phenotype-in-individuals-with-intellectual-disability-100053233",false,"NCT05473429","Characterization of Nociception Phenotype in Individuals With Intellectual Disability","Characterization of the Nociception Phenotype in Individuals With Intellectual Disability","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nFor All Participants\n\n* Provision of signed and dated informed consent form by participant or parent \u002F Legally Authorized Representative (LAR) of patient.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female, aged 8-30 years of age.\n* Agreement to avoid use of analgesics, NSAIDs, caffeine (24 hours before procedures), illicit substances and alcohol within 2 days prior to enrollment and during study participation.\n\nHealthy Adult Controls\n\n* IQ 85 OR General Adaptive Composite ABAS-3 score above 85\n* Must be fluent in the English Language.\n\nHealthy Children\n\n* OR ABAS-3 score above 85.\n* Must be fluent in the English Language.\n\nPatients\n\n-Diagnosis of Intellectual Disability.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nAll participants\n\n* NIH employees or children of NIH employee who subordinate to an investigator in this study will be excluded. This will ensure that participation or refusal to participate cannot be perceived as having any beneficial or adverse effects on their employment. There will be no direct solicitation of employees or of employees' children by the employee's supervisor.\n* Allergic reactions to EEG water based gel.\n* History of concussions in individuals with an IQ\\>85.\n* Uncontrolled seizures.\n* Pregnancy (verbal confirmation). Pregnant women will be excluded as there is no data on the effects of nociception in pregnancy.\n* For healthy volunteers only - known history of neurological, psychiatric or pain disorders.\n* History of head injury resulting in prolonged loss of consciousness in individuals with an IQ\\>85.\n\nHealthy Children\n\n-Children who have been diagnosed with neurodevelopmental disorders or treated in early intervention programs.\n\nPatients\n\n-Subjects who are on opioids, NSAID, gabapentin, or pregabalin chronically.",true,"ALL","8 Years","30 Years",{"count":21,"type":22},215,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background:\n\nPeople with intellectual disability (ID) often have physical disabilities as well. These physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts. All of these issues can also cause pain. Yet little research has been done on pain in people with ID.\n\nObjective:\n\nTo compare brain responses to unpleasant stimuli in people with and without ID.\n\nEligibility:\n\nPeople aged 8 to 30 years diagnosed with an ID. Healthy volunteers without an ID are also needed.\n\nDesign:\n\nThe study requires only 1 visit of up to 4 hours. Participants with ID may come for up to 5 shorter visits instead.\n\nParticipants will take a test to measure their level of ID. They will have a physical exam.\n\nBoth groups will answer questions about pain and how their bodies react to it. They will answer questions about how they respond to things they see, feel, hear, smell, and taste. They will answer questions about their social behaviors. Caregivers may answer questions if the participant cannot.\n\nBoth groups will have a test to measure their brain activity. Participants will wear a special cap, like a swim cap, with sensors and wires. Sensors to examine the heart will be placed on the skin of their chest with stickers. An elastic band will be placed around the middle of their body to measure how fast they are breathing. Sensors to measure sweat will be placed on two fingers.\n\nParticipants will have heat, cold, brushing, and mild electrical stimuli to different parts of their body. Participants will rank how each stimulus feels using a scale with numbers or a scale with faces.",[28],"Intellectual Disability",[30,31,32,33,34],"EEG","fNIRS","Pain Thresholds","Brain Signals","Quantitative Sensory Testing","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-03-27",{"date":43,"type":22},"2026-10-06",{"name":45,"class":46},"National Institutes of Health Clinical Center (CC)","NIH",1,{"id":49,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":26,"conditions":52,"keywords":53,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":59,"locationsCount":47},"100475630",{"count":21,"type":22},[25],[28],[30,31,32,33,34],"2026-06-30",{"date":56,"type":39},"2026-07-01",{"date":41,"type":39},{"date":43,"type":22},{"name":45,"class":46},{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":16,"sex":17,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":4,"leadSponsor":85,"locationsCount":47},"100196174","cerebral-palsy-and-the-study-of-brain-activity-during-motor-tasks-100196174","NCT01829724","Cerebral Palsy and the Study of Brain Activity During Motor Tasks","Near-infrared Spectroscopy and Electroencephalography to Assess and Train Cortical Activation During Motor Tasks","* INCLUSION CRITERIA\n* Age 5 years and older\n* Surgery free for six months in either the upper or lower extremities.\n* Free from botulinum toxin injections within four months in either the upper or lower extremities.\n* Either a healthy volunteer or have a diagnosis of a childhood-onset (before 13 years of age) brain injury resulting in motor impairment of one arm and one leg on the same side of the body or motor impairment of both legs or have a diagnosis of childhood-onset (before 13 years of age) peripheral injury resulting in sensory or motor impairment of any limb or multiple limbs.\n* Able to understand and follow simple directions that include how to perform a repetitive task and when to start and stop doing the task, based on parent report if the subject is a child and physician observation during history and physical examination.\n* Able to walk at least 20 feet without stopping with or without a walking aid\n* Able to provide informed consent (Guardian or parent of child participants) or verbal\u002Fwritten assent as appropriate (for child participant).\n* Agreement to not drink caffeine or alcohol for 24 hours before each assessment session because both agents can modify brain activity and may confound outcome measures. This restriction does not apply to the training sessions in Objective 3.\n\nEXCLUSION CRITERIA:\n\n* Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than childhood-onset brain or peripheral injury that would affect the ability to mentally concentrate or move a body part repetitively for short periods of time. Examples of this include, but are not limited to, congestive heart failure, end stage cardiac disease, or fractures that have not completely healed.\n* Uncontrolled seizures.\n* Concurrent use of medicines for muscle tone (e.g., baclofen, trihexyphenedyl, dantrolene sodium, tizanidine, or carbidopa\u002Flevodopa). If patients are taking these medications daily, the treating physician will be contacted by the MAI to determine if it is acceptable for the subject to temporarily discontinue the medication(s) for 24 hours prior to participating in testing for this study for each of the first 2 objectives. If that is not deemed to be safe, the subject will be excluded. Subjects who are on these medications will not be allowed to participate in Objective 3.\n* Pregnancy: Childbearing potential will be determined during the history and physical exam and urine pregnancy test may be required\n* Adult who can t consent for themselves.\n\nTo participate in Objective 1, it is preferable that all subjects be willing and able to have, or have previously had, a structural MRI to aid in the interpretation of results. Inability or refusal to complete an MRI, or to provide access to a previous structural MRI scan, will not constitute an exclusion criterion for this study.\n\nAdditional exclusion criteria for MRI\n\n* Inability to lie flat on the back for up to 45 minutes without sedation.\n* Discomfort being in small spaces for up to 45 minutes.\n* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth that cannot be safely removed.\n\nAdditional exclusion criteria for EEG\n\n-History of allergic reaction to water-based electrode gel","5 Years","100 Years",{"count":70,"type":22},320,"OBSERVATIONAL","Background:\n\n\\- Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS) and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it is active. EEG records electrical activity in the brain. Both have been used safely for many years, even in very young children. NIRS or EEG can be used while a person is moving to show which parts of the brain are the most active. Researchers want to use NIRS and EEG to study brain activity during movement in people with cerebral palsy and healthy volunteers. Learning more about how people with and without cerebral palsy use their brain to control their muscles may lead to new ways of training people with cerebral palsy to move better.\n\nObjectives:\n\n\\- To study how the brain controls body movement in people with and without cerebral palsy.\n\nEligibility:\n\n* Individuals at least 5 years of age who have cerebral palsy.\n* Healthy volunteers at least 5 years of age.\n\nDesign:\n\n* This study has three parts. People with cerebral palsy will be selected for all three. Healthy volunteers will be asked to do only two of them. Everyone who participates will have NIRS and\u002For EEG exams during movement. People with cerebral palsy may also have biofeedback sessions to train coordination of movement and brain activity.\n* Participants will be screened with a physical exam and medical history. Urine samples may be collected.\n* All participants will have at least one session of NIRS and\u002For EEG imaging studies. Sessions may also include the following tests:\n* Magnetic resonance imaging to look at the brain\n* Electromyography to measure electrical activity of the muscles\n* Motion analysis of specific body parts\n* Ultrasound to measure activity of the muscles\n* Motorized, robotic, and electrical stimulation of the muscles\n* Other clinical tests of muscle movement as needed.\n* Participants with cerebral palsy will have biofeedback sessions. These sessions will help them learn to coordinate muscle movement and brain activity.",[74,75],"Cerebral Palsy","Children",[77,74,78,79,80],"Functional Brain Imaging","Motion Analysis","Macro-EMG","Natural History","2026-06-27",{"date":54,"type":39},{"date":84,"type":39},"2013-08-22",{"name":45,"class":46},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":68,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":47},"100187213","phase-2-spironolactone-for-pulmonary-arterial-hypertension-100187213","NCT01712620","Spironolactone for Pulmonary Arterial Hypertension","A Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial Hypertension","* INCLUSION CRITERIA:\n\n  1. WHO Group 1 PH patients on either no medical therapy or stable medical therapy for at least the past 4 weeks (defined as no new PAH-specific therapy, no change in the dose of current PAH-specific therapy and no change in NYHA\u002FWHO functional classification within the past 4 weeks) are eligible. The following parameters on RHC are required to meet the hemodynamic definition of PAH:\n\n  \u003C!-- -->\n\n  1. mean pulmonary artery pressure of \\> 25 mmHg at rest,\n  2. pulmonary capillary wedge pressure of less than or equal to 15 mmHg (or a left ventricular end-diastolic pressure of less than or equal to 12 mmHg) and\n  3. pulmonary vascular resistance of \\> 3 Wood units (240 dyn.s.cm\\^-5).\n\nIf clinically indicated at the time of enrollment, then a RHC will be performed at the NIH Clinical Center upon study entry under a procedural consent.\n\n2\\) Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and for the duration of study participation.\n\nEXCLUSION CRITERIA:\n\n1. Patients with WHO Group 1 PH and evidence of right heart failure as defined by:\n\n   1. NYHA\u002FWHO class IV symptoms and\n   2. Echocardiographic evidence of severe RV dysfunction and\n   3. Clinical evidence of right heart failure which may include, but is not limited to elevated jugular venous pressure, ascites, and lower extremity edema\n2. Patients with WHO Group 1 pulmonary hypertension and a prior diagnosis of cirrhosis with portal hypertension as evidenced by a history of ascites, hepatic encephalopathy and\u002For varices prior to enrollment\n3. Patients with WHO Group 1 pulmonary hypertension and evidence of active infection, (HIV patients with two consecutive viral loads of \\\u003C 500 on their most recent determinations within the past 12 months will be considered to have inactive infection)\n4. Patients with WHO Group 1 pulmonary hypertension who have taken spironolactone or eplerenone within the last 30 days\n5. Known or suspected allergy to spironolactone\n6. Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)\n7. Age \\\u003C18 years\n8. Inability to provide informed written consent for participation in the study\n9. Chronic kidney disease (an estimated glomerular filtration rate of \\\u003C 35 mL\u002Fmin\u002F1.73m\\^2 of body surface area)\n10. Serum potassium at the time of enrollment of \\> 5 mEq\u002FL\n11. Concurrent use of an ACE inhibitor and angiotensin II receptor blocker\n\n    OR\n\n    Patients currently taking the maximum recommended dose of an ACE inhibitor or an angiotensin II receptor blocker \\[For patients taking one of these medicines (ACE-Inhibitors or ARBs), the investigators agree to do due diligence by consulting a clinical center pharmacist and\u002For a standard pharmacy reference (i.e. Micromedex) to certify whether or not the patient is on a maximum dose of the drug.\\]\n12. Women currently taking drospirenone-containing oral contraceptives\n\nThe estimated glomerular filtration rate (eGFR) will be calculated using the IDMS-traceable Modification of Diet in Renal Disease (MDRD) equation and corrected for body surface area.\n\neGFR = 175 x (serum creatinine in mg\u002FdL)\\^-1.154 x (age in years)\\^-0.203 x \\[1.212 if African-American\\] x \\[0.742 if female\\]\n\n(http:\u002F\u002Fwww.nkdep.nih.gov\u002Fprofessionals\u002Fgfr\\_calculators\u002Fidms\\_con.htm)\n\nExclusion Criteria for MRI\n\nThese contraindications include but are not limited to the following devices or conditions:\n\n1. Implanted cardiac pacemaker or defibrillator\n2. Cochlear Implants\n3. Ocular foreign body (e.g. metal shavings)\n4. Embedded shrapnel fragments\n5. Central nervous system aneurysm clips\n6. Implanted neural stimulator\n7. Any implanted device that is incompatible with MRI\n8. Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and severe dyspnea at rest\n9. Subjects requiring monitored sedation for MRI studies\n10. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)\n11. Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.\n\nEXCLUSION CRITERIA FOR GADOLINIUM BASED MRI STUDIES ONLY:\n\n1. History of severe allergic reaction to gadolinium contrast agents despite pre- medication with diphenhydramine and prednisone\n2. Chronic kidney disease (an estimated glomerular filtration rate of \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 of body surface area)","18 Years",{"count":95,"type":22},70,[97],"PHASE2","Background:\n\n\\- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. In spite of recent advances in treatment, the death rate remains unacceptably high. Lung blood vessel function can be harmed by progressive injuries, such as inflammation, leading to worsening of the disease. A drug called spironolactone has been known to improve blood vessel function and reduce inflammation. Some people with PAH take spironolactone to help treat fluid retention. However, its effect on inflammation and blood vessel function in patients with PAH is not known. Researchers want to see if spironolactone can help these conditions in people with PAH.\n\nObjectives:\n\n\\- To test the effectiveness of spironolactone in treating pulmonary arterial hypertension.\n\nEligibility:\n\n\\- Individuals at least 18 years of age with pulmonary arterial hypertension.\n\nDesign:\n\n* This study will last for 24 weeks. Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.\n* Participants will take either spironolactone or a placebo. They will take their study drug or placebo for 7 weeks. Treatment will be monitored with regular blood tests.\n* In Week 8, participants who have had no reaction to the treatment will receive a higher dose of the drug or placebo.\n* In Week 12, participants will have a study visit with heart and lung function tests. They will also have a 6-minute walk test, and provide blood and urine samples.\n* After additional study visits for blood samples, participants will have a final visit in Week 24. The tests from Week 12 will be repeated at this visit.",[100],"Pulmonary Arterial Hypertension",[102],"Magnetic Resonance Imaging",{"date":54,"type":39},{"date":105,"type":39},"2014-01-10",{"date":107,"type":22},"2026-12-31",{"name":45,"class":46},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":16,"sex":17,"minAge":67,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":4,"leadSponsor":133,"locationsCount":47},"100061867","mri-study-of-musculoskeletal-function-100061867","NCT00051857","MRI Study of Musculoskeletal Function","Virtual Function Anatomy (VFA)","* INCLUSION CRITERIA:\n\nAffected Participants:\n\n* Must be between the ages of 5-95 years.\n* Minors \\\u003C 18 years of age, they must be capable of providing assent (verbal or written) with parental or legal guardian permissions obtained.\n* Adults 18 \\>= years of age, they must be able to provide informed consent.\n* Have the presence of a bone, muscle, soft tissue, connective tissue injury, impairment or related muscular skeletal system pathology.\n* Ability to have an MRI Scan.\n\nHealthy Volunteer Participants\n\n* Must be between the ages of 5-95 years.\n* Minors \\\u003C 18 years of age, they must be capable of providing assent (verbal or written) with parental or legal guardian permissions obtained.\n* Adults 18 \\>= years of age, they must be able to provide informed consent.\n* Ability to have an MRI Scan.\n\nEXCLUSION CRITERIA:\n\nAffected Participants:\n\n-For the MR imaging portion of this study, all participants must complete the NIH Diagnostic Radiology screening questionnaire. If any potential contraindication is found, either the volunteer s doctor (with knowledge of the potential contraindication) or the radiology department at the NIH will be contacted to determine if the potential contraindication would exclude them from the specific MR scans being proposed.\n\nHealthy Volunteer Participants\n\n* Any relevant medical problems\n* Clinical signs of an impairment in the joint\u002Flimb being studied.\n* Any serious injury to the joint\u002Flimb being studied, previous surgery on the joint\u002Flimb being studied or extreme pain at the joint\u002Flimb being studied.\n* Neurologic Pathology affecting the muscular skeletal system\n* For the MR imaging portion of this study, all participants must complete the NIH Diagnostic Radiology screening questionnaire. If any potential contraindication is found, either the volunteer s doctor (with knowledge of the potential contraindication) or the radiology department at the NIH will be contacted to determine if the potential contraindication would exclude them from the specific MR scans being proposed.","95 Years",{"count":118,"type":22},750,"This study will use magnetic resonance imaging (MRI) and ultrasound images to study how muscles, tendons, and bones work together to cause motion. The procedure is one of several tools being developed to characterize normal and impaired musculoskeletal function, with the goal of developing improved methods of diagnosis and treatment of movement disorders.\n\nHealthy normal volunteers must be age 5 to unlimited, with or without joint impairment, may be eligible for this study. Volunteers with joint impairment may not have serious injury to the joint being studied, previous surgery on the joint being studied, or extreme pain at the joint being studied.\n\nMRI uses a strong magnet and radio waves to create images of the inside of the body. The subject lies on a long narrow couch inside a metal cylinder (the scanner) for up to 3 hours while the scanner gathers data. Earplugs are worn to muffle loud noises caused by electrical switching of radiofrequency circuits used in the scanning process. A special pad or tube may be placed over or around the region being scanned to improve the quality of the data. The subject will be asked to repeatedly move a specific joint, such as the knee, for brief periods, usually less than 5 minutes. The subject can communicate via intercom with the person performing the study at all times during the procedure, and may request to stop the study at any time.\n\n...",[121,122,123],"Abnormalities","Imaging","Patellofemoral Pain Syndrome",[125,126,127,128,129,80],"Patello-Femoral","Knee","Motion","MRI","Kinematics",{"date":54,"type":39},{"date":132,"type":39},"2003-03-05",{"name":45,"class":46},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":47},"100592799","toward-ubiquitous-lower-limb-exoskeleton-use-in-children-and-young-adults-100592799","NCT06998134","Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults","Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults: Exploratory Observational Analysis of Novel Robotic Control Strategies","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.\n* Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.\n* Age 5 to 25 years old. Importantly, we included young adults (18-25 years old) because longterm outcomes for adults with cerebral palsy include loss of ambulatory ability. While studies of conventional gait training in this population have been conducted, use of exoskeletons in this population is very limited. Given the potential benefit of exoskeletons to reduce knee extension deficiency, it is important to determine whether novel controllers we develop are also tolerated and effective in this age group.\n* Either has a gait pathology arising from a diagnosis of CP, MD, SB, or iSCI or has no gait pathology.\n* Knee joint range of motion of at least 25 degrees in the sagittal plane (knee extension\u002Fflexion) assessed with the hip extended in a supine position. Hamstring contracture as assessed by the straight leg raising test does not limit ability to participate in the study.\n* Ankle joint range of motion of at least 15 degrees in the sagittal plane (dorsi-plantarflexion) with the foot in neutral alignment.\n* Able to walk at least 10 feet without stopping with or without a walking aid.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Any neurological, musculoskeletal, or cardiorespiratory injury, health condition, or diagnosis other than CP, MD, SB, or iSCI that would affect the ability to walk as directed with the robotic exoskeleton.\n* A history of uncontrolled seizures in the past year.\n* Pregnancy based on self-reporting. We excluded pregnancy due to confounding factors of pregnancy on gait.\n* Adult unable to consent for themselves at screening visit.","25 Years",{"count":143,"type":22},23,"People with cerebral palsy (CP), muscular dystrophy (MD), spina bifida, or spinal cord injury often have muscle weakness, and problems moving their arms and legs. The NIH designed a new brace device, called an exoskeleton, that is worn on the legs and helps people walk. This study is investigating new ways the exoskeleton can be used in multiple settings while performing different walking or movement tasks, which we call ubiquitous use. For example, we will ask you to walk on a treadmill at different speeds, walk up and down a ramp, or walk through an obstacle course. Optionally, the exoskeletons may also use functional electrical stimulation (FES), a system that sends electrical pulses to the muscle to help it move the limb.",[146,147],"Muscle Weakness","Problems Moving Their Arms and Legs",[149,150,151,152],"Cerebral Palsy (CP)","muscular dystrophy (MD)","Spina Bifida","incomplete spinal cord injury","2026-06-26",{"date":155,"type":39},"2026-06-29",{"date":157,"type":39},"2026-06-23",{"date":159,"type":22},"2028-08-18",{"name":45,"class":46},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":68,"enrollmentInfo":167,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},"100642046","pulmonary-hypertension-ph-biorepository-for-translational-research-100642046","NCT07647549","Pulmonary Hypertension (PH) Biorepository for Translational Research","* INCLUSION CRITERIA:\n* Provision of signed and dated informed consent form\n* Males and females aged \\>=18 years old\n* Suspected of or diagnosed with PH\n* Able to understand and willing to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nAny individual who does not meet all inclusion criteria or is deemed by the local investigator not to be a blood draw candidate will be excluded from participating in this study.",{"count":168,"type":22},1000,"Background:\n\nPulmonary hypertension (PH) is high blood pressure in the blood vessels of the lungs. It can lead to heart failure and death if not treated. Researchers want to create a repository of blood samples and health information collected from people with PH. They hope to use this information to find better ways to diagnose and treat PH.\n\nObjective:\n\nTo collect blood samples and health information from people suspected of or diagnosed with PH.\n\nEligibility:\n\nPeople aged 18 years and older who have or may have PH.\n\nDesign:\n\nResearchers will collect information from participants medical records.\n\nParticipants will have blood drawn from a vein. About 3 tablespoons will be collected during the study visit. The visit will last about 1 hour.\n\nParticipants may choose to provide new blood samples at follow-up visits. Updated medical information may also be collected.\n\nParticipants may continue to participate as long as the study is ongoing. Participants may opt out of providing new blood samples but remain in the study.\n\nAll study samples will be stored at the National Institutes of Health. Health information will be stored in secure databases.",[171],"Pulmonary Hypertension",[171,173],"Biorepository","NOT_YET_RECRUITING",{"date":176,"type":39},"2026-06-24",{"date":178,"type":22},"2026-08-03",{"date":180,"type":22},"2036-06-01",{"name":45,"class":46},3,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":16,"sex":17,"minAge":93,"maxAge":68,"enrollmentInfo":189,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":190,"conditions":191,"keywords":195,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":4,"leadSponsor":202,"locationsCount":47},"100142856","imaging-techniques-in-mri-100142856","NCT01130545","Imaging Techniques in MRI","* INCLUSION CRITERIA:\n\nA. Volunteer individuals\n\nB. Lab Eligibility parameters (for contrast scans within 4 weeks of gadolinium injection):\n\nC. Creatinine below upper normal limit\n\nD. eGFR \\>= 60 mL\u002Fmin\u002F1.73m2\n\nE. Age \\>= 60 or history of renal disease: test GFR within 1 week prior to contrast\n\nF. Willing to travel to the NIH for follow-up visits.\n\nG. 18 years old\n\nH. Able to understand and sign informed consent\n\nI. No MRI scan with gadolinium injection in the last 6 months under this protocol.\n\nEXCLUSION CRITERIA:\n\nA. Implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damages from twisting in a Magnetic field. Examples:\n\n* Aneurysm clip, implanted neural stimulator,\n* Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical or metallic devices,\n* Cochlear implant, ocular foreign body (metal shavings),\n* Any implanted device (pumps, infusion devices, etc.),\n* Shrapnel injuries,\n* History of metal in head or eyes or other parts of the body.\n\nB. Pregnant women\n\nC. Paralyzed hemidiaphragm\n\nD. Over 500 lbs and\u002For a body circumference that prevents the study subject from laying flat in the scanner\n\nE. Surgery of uncertain type\n\nF. Untreatable claustrophobia otherwise requiring anesthesia.\n\nG. Any contraindications that the Physician identifies from the subject, MRI Safety Questionnaire, and\u002For History and Physical.\n\nEXCLUSION FOR PARTICIPANTS FOR GADOLINIUM CONTRAST:\n\n(Inclusive of the above exclusion criteria):\n\nA. Allergy to gadolinium for scans using contrast; will be eligible for non-contrast scans.\n\nB. Acute renal failure, renal transplant, dialysis and renal failure individuals (eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2 and\u002For clinically diagnosed).\n\nC. Individuals with a history of liver transplant or severe liver disease.\n\nD. Lactating women\n\nE. Individuals with hemoglobinopathies or severe asthma.\n\nF. Patient preference to not undergo intravenous line placement and\u002For receive gadolinium contrast. Contrast administration is optional and participants may still undergo a non-contrast study.\n\nG. GBCA with an MRI scan in the last 6 months. This includes scan performed with GBCA at any outside institution and \u002F or at the clinical center .In addition, they cannot have reached their maximum of 4 GBCA imaging studies under this protocol. They will be excluded from having a contrast enhanced MRI, but will not be excluded from the protocol for non-contrast MRI studies.",{"count":168,"type":22},"Background:\n\n\\- Magnetic resonance imaging (MRI) scans must be performed according to specified sets of parameters that provide optimal images of each organ and each area of the body. These scanning parameters are often specific to the institution or organization at which they are employed, and may also depend on the manufacturer of the MRI scanning equipment. Because MRI scanning equipment is always being updated and upgraded, researchers are interested in developing new and optimized scanning parameters for MRI scans.\n\nObjectives:\n\n\\- To improve current methods and develop new techniques for magnetic resonance imaging.\n\nEligibility:\n\n* Individuals 18 years of age and older who are either volunteers or current NIH protocol participants.\n* Participants must not have any medical history factors (e.g., extreme claustrophobia, history of metal implants) that would prevent them from receiving MRI scans.\n\nDesign:\n\n* Participants will have at least one MRI scan that will last from 20 minutes to 2 hours (most scans will last between 45 and 90 minutes). The total time commitment for most visits will be approximately 4 hours from start to finish.\n* Some MRI techniques require standard monitoring equipment or specific procedures during the scanning, such as an electrocardiogram.\n* Participants will have blood samples taken at the time of the scan. Some MRI studies will require the use of a contrast agent that will be administered during the scan.\n* Volunteers may be asked to return for additional MRI scans over the course of a few years. Follow-up scans may be done on the same part of the body or on different parts of the body. No more than one MRI scan will be performed in any 4-week period for this protocol....",[192,193,194],"Cardiac Risk Factors","Healthy","Healthy Volunteers",[196,102,197,80,198],"Healthy Volunteer","Gadolinium","HV",{"date":176,"type":39},{"date":201,"type":39},"2010-06-05",{"name":45,"class":46},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":16,"sex":17,"minAge":67,"maxAge":141,"enrollmentInfo":210,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":47},"100554400","investigating-new-methods-to-study-movement-in-children-and-young-adults-with-movement-disorders-100554400","NCT06498596","Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders.","A Natural History Study Evaluating the Use of Multimodal Signal Acquisition Techniques to Characterize Movement in Children and Young Adults With Movement Disorders","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet criteria 1-4 and 5a as given below. If they also meet 5b, 5c or 6, they will perform the tasks related to the respective joint(s) for which criteria are met, and\u002For walking.:\n\n1. Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.\n3. Age 5 to 25 years old.\n4. Group A: Have a gait pathology arising from a diagnosis of cerebral palsy.\n\n   Group B: Healthy volunteers who are age and sex matched to individuals recruited in Group A.\n5. Sufficient range of motion to perform the target acquisition task, specifically:\n\n   1. Knee joint range of motion of at least 50 degrees in the sagittal plane (knee extension\u002Fflexion) assessed with hip extended in supine position. Limited hamstring flexibility as assessed by straight leg raising test does not limit ability to participate in the study.\n   2. Ankle joint range of motion of at least 40 degrees in the sagittal plane (dorsiplantar- flexion) with the foot in neutral alignment.\n   3. Wrist joint range of motion of at least 50 degrees in the frontal plane (wrist extension\u002Fflexion) assessed with hip extended in standing position.\n6. Able to walk at least 1 minute on a treadmill without stopping with or without holding onto side or front support rails. This assessment will be completed by the physician during the medical history and physical exam.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to move the required joints through the necessary range of motion or walk as directed on a treadmill.\n2. A history of multiple seizures that have occurred in the past year that are not controlled by medication.\n3. Pregnancy.",{"count":211,"type":22},30,"Background:\n\nCerebral palsy (CP) is the most common motor disorder that affects children. People with CP have weak muscles; they may have trouble controlling the movements of their arms and legs. Researchers have been developing braces called robotic exoskeletons for people with CP. These devices can adapt to the person s movements and help them move better. This natural history study will explore new technologies that may tell us more about how people with CP move and improve how these exoskeletons work.\n\nObjective:\n\nTo test new technologies to measure people s movements and brain function while they move with and without a robotic exoskeleton.\n\nEligibility:\n\nPeople aged 5 to 25 years with CP. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 3 to 5 clinic visits in 2 months.\n\nParticipants will be fitted with an exoskeleton that will be worn on one of their legs.\n\nAt each visit, participants will be asked to move their wrist, ankle, and knee while the following measurements are taken:\n\nUltrasound. A bar will be placed against the skin. It will send soundwaves into the body to take pictures of the muscles.\n\nElectroencephalography (EEG). Participants will wear a cap with sensors. Their brain waves will be recorded.\n\nElectromyography (EMG). Small metal discs will be taped to the skin. They will measure electrical activity of muscle.\n\nParticipants will flex and extend each joint (wrist, ankle, or knee) on one side of their body. These movements will be done on their own and while assisted by two devices:\n\nFunctional electrical stimulation (FES). Small adhesive pads will be placed on the skin and electric. Pulses will stimulate muscles to help move the limb. This will be done for the wrist, ankle and knee.\n\nRobotic Exoskeleton. A leg brace will be placed on one limb with a motor that will help move the knee. The exoskeleton can be used with or without FES.\n\nParticipants will also walk on a treadmill at their own pace.\n\nPhotographs and videos will record how they move.",[74],[74,215,30,216,217,218],"Ultrasound","Exoskeleton","Functional Electrical Stimulation","Walking","2026-06-19",{"date":157,"type":39},{"date":222,"type":39},"2025-02-20",{"date":224,"type":22},"2027-12-31",{"name":45,"class":46},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":233,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":236,"conditions":237,"keywords":241,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":4,"leadSponsor":253,"locationsCount":47},"100063668","study-of-lung-proteins-in-patients-with-pneumonia-100063668","NCT00077909","Study of Lung Proteins in Patients With Pneumonia","Biomarkers and Protein Mass Expression Profiles in Bronchoalveolar Lavage From Patients With Lung Infiltrates","* INCLUSION CRITERIA:\n* All eligible patients undergoing diagnostic bronchoscopy who provide consent for proteomic analysis of BAL fluid supernatant and chart review of patient characteristics will be included in this study.\n* A parent\u002Fguardian may provide consent for a child age 17 or under and a Legally Authorized Representative (LAR) may provide consent for adults unable to consent.\n\nEXCLUSION CRITERIA:\n\nPatients undergoing bronchoscopy but not wanting to participate with either the chart review or the proteomic analysis of BAL fluid supernatant will be excluded.","3 Years","99 Years",{"count":118,"type":22},"This study will examine the different types of proteins present in the lungs of patients with pneumonia to explore the causes of different types of the disease. Pneumonia is a condition that causes lung inflammation AND is often caused by an infection. It is usually diagnosed by lung x-rays and listening to the chest with a stethoscope. This method can diagnose pneumonia, but it does not provide information on the cause of the inflammation - information that might be helpful in guiding treatment. This study will measure proteins in the lungs of patients to see if certain proteins are associated with specific forms of pneumonia, and can thus serve as biomarkers for disease.\n\nPatients undergoing diagnostic bronchoscopy at the NIH Clinical Center may participate in this study. Patients will undergo bronchoscopy and bronchoalveolar lavage as scheduled for their medical care. For this procedure, the patient's mouth and throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways carefully. Saline (salt water) is then injected through the bronchoscope into the air passage, acting as a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the current study will use some of the fluid obtained from the lavage to examine for protein content.\n\nIn addition to the bronchoscopy and bronchoalveolar lavage, participants will have about 2 tablespoons of blood drawn to compare blood test results with the results of the lung washings. Patients' medical records will be reviewed to obtain information on past medical history, current medical treatment, vital signs, and results of x-ray tests.",[238,239,240],"Pneumonia","Pulmonary Disease","Lung Disease",[242,243,238,244,245,80,246,239,247],"Proteomics","Infection","Mass Spectrometry","BAL","Lung","Lung Infiltrates","2026-06-18",{"date":250,"type":39},"2026-06-22",{"date":252,"type":39},"2004-02-20",{"name":45,"class":46},{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":16,"sex":17,"minAge":93,"maxAge":68,"enrollmentInfo":260,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":262,"conditions":263,"keywords":267,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":4,"leadSponsor":277,"locationsCount":47},"100054778","collection-and-distribution-of-blood-components-from-healthy-donors-for-in-vitro-research-use-100054778","NCT00001846","Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use","* ELIGIBILITY CRITERIA:\n\nDonors must meet the eligibility criteria for volunteer blood donation, defined in the Code of Federal Regulations 21 CFR 640, and AABB Standards as modified in the 2007 FDA\u002FCBER Guidance Document: Eligibility Criteria for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, with the exception of foreign travel history and other conditions, as noted below:\n\n* Ability of subject to understand, ask questions, and the willingness to provide written informed consent\n* Age greater than or equal to 18 years\n* Weight greater than 110 pounds\n* Female subjects should not be pregnant\n* No known heart, lung, kidney disease, or bleeding disorders\n* No history of sickle cell disease\n* No history of engaging in high-risk activities for exposure to the AIDS virus, as defined in the AABB Donor Education Materials distributed to all donors. Deferral periods for high-risk activities (MSM, IV drug use or receipt of money or drugs in exchange for sex) will not exceed the corresponding deferral period as defined for allogeneic blood donors.\n* No history of malaria in the past 12 months\n* Donors who have a family history of CJD, donors who have undergone tattooing or body piercing, donors who have received a graft such as bone, skin or dura mater, donors who are taking finasteride or retinoids, and donors who have had sexual contact within the past 12 months with a person who has symptomatic hepatitis C infection or donors who have lived with a person who has hepatitis in the last 12 months, are similarly eligible for research-use only donations on this protocol.\n* Donors who have traveled to Europe, Africa, Asia, and areas of South America, who are rendered ineligible for allogeneic donation due to malarial risk, Zika risk and vCJD risk, are eligible for research donations\n* Donors with a history of repeat false positive HTLV I\u002FII, who are rendered ineligible for allogeneic donation, are eligible for research donations.\n* Donors with a positive antibody to hepatitis B core antigen (anti-HBc) only, without other positive infectious disease markers,are eligible for research donations.\n* Donors with HLA antibodies are eligible for research donations\n* Donors who have received an experimental drug, agent, or vaccine, and who are referred for a research blood, plasma or leukocyte collection, specifically because they were given this drug, agent, or vaccine, are acceptable only if their research product is collected for use by the PI who administered the experimental drug, agent, or vaccine. Otherwise, they are deferred for one year after receiving an experimental drug, agent, or vaccine.\n* Donors who have received a xenotransplant are eligible for research donations.\n* Granulocyte donors may not receive dexamethasone if they have poorly controlled hypertension or diabetes, or if they have a history of cataracts. Hetastarch (also known as hydroxyethyl starch or \"HES\") and dexamethasone may elevate blood pressure and raise blood glucose levels, and repetitive steroid administration may increase the risk of posterior subcapsular cataract formation or progression.\n* Granulocyte donors must have an estimated glomerular filtration (eGFR) rate of \\> 45ml\u002Fmin\u002F1.73m\\^2.\n* Granulocyte donors may not receive filgrastim if they have a history or symptoms of coronary heart disease.\n\nInvestigators are informed that eligibility standards for research donors differ from those for transfusion donors through an electronic \"User Agreement\" which they electronically sign when they register to receive blood components on this protocol.",{"count":261,"type":22},5000,"This protocol is designed to provide a mechanism for the Department of Transfusion Medicine, Clinical Center to collect and process blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory use. Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques. The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. NIH and FDA investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research. This protocol also provides a detailed schema for careful and frequent laboratory safety monitoring of repeat research apheresis donors.\n\nBlood components for research use will be distributed with a unique product number, and the DTM principal and associate investigators will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood and components collected in this study will be used is not the subject of this protocol, and is not possible to describe, since it involves basic investigative efforts in greater than 170 different NIH and FDA laboratories. The intent of this protocol is not to approve the research itself, but to provide adequate and complete informed consent for the donor, and to assure that the education, counseling, and protection of the study subjects (research blood donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal regulatory standards...",[264,265,266],"Blood Donors","Research Subjects","Apheresis",[268,269,270,271,272,80],"Volunteer Donor","Research Samples","Leukapheresis","Plateletpheresis","Plasmapheresis","2026-06-17",{"date":248,"type":39},{"date":276,"type":39},"2001-01-11",{"name":45,"class":46},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":16,"sex":17,"minAge":93,"maxAge":68,"enrollmentInfo":285,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":287,"conditions":288,"keywords":289,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":4,"leadSponsor":299,"locationsCount":47},"100188549","natural-history-study-of-biomarkers-in-pulmonary-arterial-hypertension-100188549","NCT01730092","Natural History Study of Biomarkers in Pulmonary Arterial Hypertension","A Natural History Study of Novel Biomarkers in Pulmonary Arterial Hypertension","* ELIGIBILITY:\n\nThe study will enroll subjects with confirmed and suspected NYHA\u002FWHO Group 1 PH (68) as well as age and sex matched control subjects. Subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. There is no exclusion based on race or sex.\n\nINCLUSION AND EXCLUSION CRITERIA FOR PAH SUBJECTS:\n\nInclusion Criteria:\n\nThe following parameters on RHC are required to meet the hemodynamic definition of PAH (NYHA\u002FWHO Group I PH):\n\n* mean pulmonary artery pressure of \\> 25 mmHg at rest,\n* pulmonary capillary wedge pressure of \\\u003C 15 mmHg (or a left ventricular end-diastolic pressure of \\\u003C 12 mmHg), and\n* pulmonary vascular resistance of \\> 3 Wood units (240 dyn s cm-5).\n\nFor patients with suspected PAH (Group I PH) who have not undergone a RHC and\u002For additional testing to confirm the diagnosis, this testing will be completed as clinically indicated under a procedural consent. If clinically indicated (diagnostic) testing indicates that the subject with suspected PAH does not in fact meet standard criteria for PAH (Group I PH), then the subject will be removed from the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)\n* Age less than 18 years\n* Inability to provide informed written consent for participation in the study\n\nINCLUSION AND EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS:\n\nInclusion Criteria for Control Subjects\n\nAny healthy man or woman who is the appropriate age and sex for matching to a PAH patient\n\n* Must be eligible for MRI and Gadolinium Based MRI studies\n* Must be eligible for CT and Iodine Based Contrast CT studies\n\nExclusion Criteria for Healthy Control Subjects\n\n* Current pregnancy or breastfeeding (All women of childbearing potential will be required to have a screening urine or blood pregnancy test)\n* Electrocardiographic evidence of clinically relevant heart disease\n* Symptoms of coronary or cardiac insufficiency\n* More than one major risk factor for coronary artery disease (excluding age and sex)\n* Obesity (defined as a body mass index \\> 30 kg\u002Fm\\^2)\n* History of underlying conditions\u002Frisk factors associated with pulmonary hypertension such as collagen vascular disease, HIV infection, use of appetite suppressants, chronic liver disease or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, hypoxemia and\u002For significant pulmonary parenchymal disease\n* Systemic hypertension that is not well controlled (i.e. blood pressure at the time of screening \\>140\u002F90 mmHg in adults \\\u003C 60 years old or \\>150\u002F90 mmHg in adults 60 years or older) on medications. Subjects taking \\> 2 anti-hypertensive medications will be excluded irrespective of their current blood pressure at time of screening\n* Anemia, thrombocytopenia or coagulopathy\n* Renal insufficiency (defined as an estimated glomerular filtration rate of \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 of body surface area)\n* Active tobacco use (\\> 6 months) in the past ten years, any tobacco use within 3 months prior to the screening evaluation or any tobacco use prior to completion of the study\n* Inability to provide informed written consent for participation in the study\n* History of recreational drug use with the exception of marijuana (as long as marijuana use was \\> 3 months from the time of study screening).\n\n  * Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.\n\nExclusion Criteria for MRI in Healthy Control Subjects and Subjects with PAH\n\nThese contraindications include but are not limited to the following devices or conditions:\n\n1. Implanted cardiac pacemaker or defibrillator\n2. Cochlear Implants\n3. Ocular foreign body (e.g. metal shavings)\n4. Embedded shrapnel fragments\n5. Central nervous system aneurysm clips\n6. Implanted neural stimulator\n7. Any implanted device that is incompatible with MRI\n8. Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and severe dyspnea at rest\n9. Subjects requiring monitored sedation for MRI studies\n10. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)\n11. Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.\n\nExclusion Criteria for Gadolinium Based MRI Studies Only:\n\n1. History of severe allergic reaction to gadolinium contrast agents despite pre- medication with diphenhydramine and prednisone\n2. Chronic kidney disease (an estimated glomerular filtration rate of \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 of body surface area)\n\nExclusion Criteria for Cardiac Computed Tomography in Healthy Control Subjects and Subjects with PAH:\n\n1\\) Subjects with a condition precluding entry into the scanner (e.g. morbid\n\nobesity, claustrophobia, etc.)\n\nExclusion Criteria for Iodine Based Contrast CTA Studies Only:\n\n1. Serum creatinine \\> 1.4 mg\u002FdL\n2. History of multiple myeloma\n3. Use of metformin-containing products less than 24 hours prior to contrast administration\n4. History of significant allergic reaction to CTA contrast agents despite pre-medication with diphenhydramine and prednisone",{"count":286,"type":22},270,"Background:\n\n\\- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause. Researchers want to follow the natural history of all PAH patients to understand how PAH progresses in order to discover targets for future research into new treatments. To further identify treatment targets, they will compare healthy volunteers to patients with PAH.\n\nObjectives:\n\n\\- To study the natural history of PAH.\n\nEligibility:\n\n* Individuals at least 18 years of age who have PAH.\n* Healthy volunteers at least 18 years of age.\n\nDesign:\n\n* Participants with PAH will have periodic visits to the National Institutes of Health Clinical Center. After the first visit, they will return in 6 months and then yearly or every other year for as long as the study continues.\n* The first visit will take up to 3 days. It will involve the following tests:\n* Physical exam and medical history\n* Blood and urine samples\n* Heart and lung function tests and imaging studies\n* Six-minute walk test\n* Questions about exercise and physical activity\n* Healthy volunteers will have only one visit to the Clinical Center, during which they will undergo screening tests, and complete many of the same tests as patients with PAH",[239,171],[290,291,292,293,102,80],"Vascular Inflammation","Microarray","Right Ventricular Function","Endothelial Dysfunction","2026-06-13",{"date":296,"type":39},"2026-06-16",{"date":298,"type":39},"2013-07-15",{"name":45,"class":46},{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":16,"sex":17,"minAge":93,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":47},"100175088","phase-4-improving-white-blood-cell-collection-from-healthy-donors-100175088","NCT01553214","Improving White Blood Cell Collection From Healthy Donors","Collection of Granulocytes by Apheresis of Healthy Donors Stimulated With Filgrastim (G-CSF) and Dexamethasone","* INCLUSION CRITERIA:\n* Donors shall meet all donor eligibility criteria for allogeneic blood donors, as defined in the most recent editions of the AABB Standards and FDA Code of Federal Regulations (21CFR640). In addition, donors shall meet the following restrictions:\n* Age greater than or equal to18 and less than or equal to 75 years\n* If hypertension is present, must be well-controlled on medications\n* If peptic ulcer disease has been diagnosed in the past, symptoms must be well-controlled on medications\n* If cataracts have been diagnosed in the past, records from subject s ophthalmologist must be obtained indicating type of cataract. If PSC was diagnosed in the past, subject may receive G-CSF but not dexamethasone. The only exception to this is a history of bilateral cataract extractions due to PSC.\n\nEXCLUSION CRITERIA:\n\n* Information obtained from health history screen that does not meet the allogeneic donor eligibility criteria of the AABB Standards or the FDA CFR.\n* Weight less than 50 kg (110 lbs).\n* History of coronary heart disease\n* Uncontrolled hypertension (systolic BP \\>160, diastolic BP \\>100)\n* Diabetes mellitus requiring insulin\n* Active, symptomatic peptic ulcer disease\n* History of iritis or episcleritis\n* Sickle cell disease (sickle trait is acceptable). Testing for hemoglobin S is not required.\n* Lithium therapy\n* Pregnancy or nursing (breast feeding)\n* Renal function eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m(2)","75 Years",{"count":168,"type":22},[310],"PHASE4","Background:\n\n\\- White blood cells called granulocytes help the body fight infection. People who have had chemotherapy or bone marrow transplants may have very low numbers of these cells. Transfusions of these cells can help improve the body's ability to fight infection. However, most of the cells are located in the bone marrow or spleen, and are hard to collect from healthy donors. Two drugs, filgrastim and dexamethasone, can help move the cells to the bloodstream to be collected by apheresis. Researchers want to study the best ways to collect these white blood cells. They also want to monitor the effects of the injections and donations on the volunteer donors.\n\nObjectives:\n\n\\- To improve the amount and quality of granulocytes (white blood cells) collected by apheresis for donation.\n\nEligibility:\n\n\\- Healthy volunteers between 18 and 75 years of age.\n\nDesign:\n\n* Participants will be screened with a physical exam and medical history. Initial blood tests will be done to check for eligibility.\n* Participants will donate granulocytes by apheresis a maximum of 12 times in 1 year. Donations will not usually be requested more often than every 4 weeks. Donors will be allowed to decline participation at any time.\n* Participants will have one injection of filgrastim 12 to 24 hours before donation. They will also have two tablets of dexamethasone 12 hours before donation.\n* White blood cells will be collected through apheresis. The apheresis will last about 2 hours.\n* Participants will be eligible to donate until they reach their 76th birthday.",[313],"Allogeneic Granulocyte Donation",[315,243,316,317,318,196,198],"Neutrophils","Granulocytapheresis","Mobilization","Transfusion","2026-06-05",{"date":321,"type":39},"2026-06-08",{"date":323,"type":39},"2012-12-31",{"date":325,"type":22},"2032-01-01",{"name":45,"class":46},{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":16,"sex":17,"minAge":93,"maxAge":68,"enrollmentInfo":334,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":47},"100305247","samples-from-human-subjects-to-facilitate-basic-translational-and-clinical-research-100305247","NCT03253705","Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research","Obtaining Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research","* INCLUSION CRITERIA FOR RESEARCH SUBJECTS WITH DISEASES RELATED TO CARDIOVASCULAR SYSTEM AND\u002FOR INFLAMMATION AND\u002FOR ENDOTHELIAL DYSFUNCTION SUCH AS BUT NOT LIMITED TO ARTERIOSCLEROSIS, TRANSPLANTATION, PULMONARY HYPERTENSION, OTHER ADVANCED LUNG OR HEART DISEASE\n\n  1. Males or females of age greater than or equal to 18 years old.\n  2. Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)\n\nEXCLUSION CRITERIA FOR RESEARCH SUBJECTS WITH DISEASES RELATED TO CARDIOVASCULAR SYSTEM AND\u002FOR INFLAMMATION AND\u002FOR ENDOTHELIAL DYSFUNCTION SUCH AS BUT NOT LIMITED TO ARTERIOSCLEROSIS, TRANSPLANTATION, PULMONARY HYPERTENSION, OTHER ADVANCED LUNG OR HEART DISEASE\n\n1. Hemoglobin \\\u003C7.0 g\u002FdL\n2. Currently receiving infusion of epinephrine; or dopamine at an infusion rate of \\>2.5 microgram\u002Fkg\u002Fmin, norepinephrine of \\> 20mcg\u002Fmin, or vasopressin \\> 0.04 units\u002Fmin\\*\n3. In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \\\u003C90 mmHg. In the absence of known CAD a SBP \\\u003C80 mmHg or mean arterial pressure (MAP) \\\u003C60 mmHg with or without vasopressors\\*.\n\n   * For critically ill patients with shock (on vasopressors), no more than 20mL of blood may be obtained within a 24 hour period. (No more than 200ml over eight weeks.)\n\nResearch subjects may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.\n\nINCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML.\n\n1. Males or females of age greater than or equal to 18 years old.\n2. Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)\n\nEXCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML)\n\n1. Hemoglobin \\\u003C7.0 g\u002FdL\n2. In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \\\u003C90 mmHg. In the absence of known CAD a SBP \\\u003C80 mmHg or mean arterial pressure (MAP) \\\u003C60 mmHg.\n\nINCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n1. Males or females of age greater than or equal to 18 years old\n2. Ability of subjects to understand and the willingness to sign an informed consent document.\n\nEXCLUSION CRITERIA FOR HEATLHY VOLUNTEERS:\n\n1. Blood or platelet donation within the last 6 weeks.\n2. Hemoglobin below normal (e.g. below 11.2 g\u002Fdl for females and below 13.7 mg\u002Fdl for males at the NIH CC); subjects may return for evaluation at a later date. (After initial enrollment, hematocrit does not need to be done prior to subsequent blood draws unless there is interval development of symptomatic anemia)\n3. History of recreational drug use with the exception of marijuana (as long as marijuana use was \\>3 months from the time of study screening).\n4. Active acute illness (i.e viral syndrome). Subjects may return for evaluation at a later date once the acute illness resolves.\n5. Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer, such as, active tobacco use (\\> 6 months) in the past ten years, any tobacco use within 3 months prior to the screening evaluation, a history of clinically relevant and active cardiopulmonary disease (e.g. Including but not limited to any cardiopulmonary diseases not well controlled by medications, EKG with evidence of clinically relevant heart disease, COPD with hypoxemia and forced expiratory volume\u002Fforced vital capacity (FEV1\u002FFVC) \\> 2 standard deviations from normal, etc.).",{"count":168,"type":22},"Background:\n\nThis study is designed to provide samples to help us study the genes your blood cells are making as well as the proteins, sugars, fats, vitamins and other metabolites found in your blood or urine. Blood samples may also be collected to make special cells. These are called induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be converted into any type of cell. Researchers want to study in the lab iPSCs that are derived from blood samples.\n\nObjective:\n\nTo collect samples to help study genes, proteins, sugars, fats, vitamins, and other metabolites found in blood or urine.\n\nEligibility:\n\nHealthy volunteers and patients ages 18 and older\n\nDesign:\n\nFirst-time research study participants at NIH will have an initial visit for this study that should last no more than 1 hour. All other visits should last 20 30 minutes.\n\nParticipants will undergo a limited history and physical exam.\n\nParticipants may have routine blood and urine tests.\n\nIf participants are giving a blood sample, they must have a hemoglobin level checked in the past 12 months to make sure it is safe for them to give a blood sample for research.\n\nParticipants may have a venous blood collection. They may do this at several visits. They will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or tubes.\n\nParticipants may be asked to provide urine in an appropriate container...",[293,337,194],"Inflammation in Cardiopulmonary and Vascular Disease States",[339,340,341,342,343,80],"Assay Development","Gene Expression","Metabolomics","Induced Pluripotent Stem Cells","PBMCs\u002FDNA\u002FRNA","2026-04-23",{"date":346,"type":39},"2026-04-24",{"date":348,"type":39},"2017-09-14",{"date":350,"type":22},"2027-08-01",{"name":45,"class":46},{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":377,"locationsCount":47},"100452354","dietary-intake-and-dietary-behaviors-in-adults-with-sickle-cell-disease-100452354","NCT05170412","Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease","Observational Study of Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, the participant must:\n\n1. State their willingness to complete all study procedures for the duration of the study\n2. 18 years of age or older at the time of screening\n3. Have a documented clinical diagnosis (upon review of medical records) of SCD or presence of a SCD hemoglobinopathy genotype HbSS, HgSC, HbSB 0 or HBSB+\n\nEXCLUSION CRITERIA:\n\nThe following criteria will exclude any individual from participating in the study:\n\n1. Less than 18 years of age\n2. Unable to speak, read, write, and\u002For understand English\n3. Presence of a condition or illness that will hamper the individual from giving informed consent (e.g. cognitive impairment)\n4. SCD trait genotype\n5. Currently undergoing inpatient treatment in any hospital for SCD at the time of screening\n6. Pregnancy at the time of screening","120 Years",{"count":361,"type":22},80,"Background:\n\nSickle Cell Disease (SCD) causes blood cells form a crescent shape. It is caused by a genetic mutation in the hemoglobin gene. People with SCD are at increased risk for illnesses like stroke, chronic pain, and heart problems, as well as decreased overall health and well-being. Researchers want to learn more about how nutrition and diet can help relieve or reduce the symptoms of SCD.\n\nObjective:\n\nTo understand how diet, dietary patterns and behaviors, nutrition, and other related factors in adults with SCD affect their overall health.\n\nEligibility:\n\nAdults aged 18 and older with SCD.\n\nDesign:\n\nParticipants will be screened with a review of their medical records. They will take a pregnancy test if needed.\n\nParticipants will have a physical exam and medical history. Their height, weight, and waist and hip circumference will be measured. They can complete this exam (1) via telehealth along with a visit to an outpatient laboratory center or (2) by going to the NIH Clinical Center.\n\nParticipants will complete 2 interviews about their diet. They will talk about the foods they ate in the past 24 hours. They will also complete 1 interview about diet-related behaviors such as food shopping and cooking. They can complete the interviews in person, by phone, or by telehealth visit.\n\nParticipants will complete surveys about their demographics (such as age and gender), SCD pain, mood, stress, diet, and nutrition. It may take about 1 hour to complete all of the surveys.\n\nParticipants will give blood and urine samples. They will need to fast for at least 8 hours overnight before giving blood samples.\n\nParticipation will last for about 2 weeks.",[364],"Sickle Cell Disease",[366,367,368,369,370,80],"cross-sectional design","Nutritional Status","physical health","psychosocial health","clinical phenotypes","2026-04-15",{"date":373,"type":39},"2026-04-16",{"date":375,"type":39},"2022-05-26",{"date":224,"type":22},{"name":45,"class":46},{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":17,"minAge":233,"maxAge":68,"enrollmentInfo":385,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":47},"100585568","metagenomics-next-generation-sequencing-approach-to-detect-microbial-dnarna-overtime-in-individuals-undergoing-hematopoietic-stem-cell-transplant-100585568","NCT06904053","Metagenomics Next-generation Sequencing Approach to Detect Microbial DNA\u002FRNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant","Metagenomics Next-Generation Sequencing Approach to Detect Microbial DNA\u002FRNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study; an individual must meet all the following criteria:\n\n1. Male or female, aged 3 years or older.\n2. Co-enrolled on another study at the NIH CC, under which they will undergo HSCT.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual with any condition that, in the opinion of the investigator, contraindicates participation in this study, will be excluded.",{"count":211,"type":22},"Infections are a major cause of morbidity and mortality in patients undergoing hematopoietic stem cell transplant (HSCT). The purpose of this study is to evaluate if metagenomic next-generation sequencing (mNGS) can detect microbial signatures in people undergoing HSCT, and if microbial identification can be correlated with clinical features of infection (e.g., fever). Participants undergoing HSCT as part of other studies at the NIH Clinical Center (CC) will provide blood before the transplant and through 6 months after. Total nucleic acid will be extracted from plasma and subjected to mNGS.\n\nThe primary objective of this study is to investigate if by using plasma and an mNGS approach, we can detect bacterial, fungal, protozoan, or viral DNA\u002FRNA over time, in immunocompromised patients undergoing transplantation.\n\nSecondary objectives are to: (1) To correlate microbial identification with episodes of fever or clinical suspicion of infection; and to (2) correlate change in microbial signatures in patients with suspected immune reconstitution inflammatory syndrome.\n\nThe study is conducted at the NIH Clinical Center. Participants, aged 3 years and older, on other research studies at the NIH CC who are undergoing HSCT are invited to take part of this study. Expected participation is up to six months.",[388],"Hematopoietic Stem Cell Transplantation",[390,391],"Microbial DNA\u002FRNA","Hematopoietic stem cell transplant (HSCT)","2026-04-03",{"date":394,"type":39},"2026-04-06",{"date":396,"type":39},"2025-04-09",{"date":398,"type":22},"2030-12-30",{"name":45,"class":46},{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":16,"sex":17,"minAge":93,"maxAge":68,"enrollmentInfo":407,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":427,"locationsCount":47},"100568688","the-impact-of-heavy-alcohol-use-on-saliva-and-oral-health-100568688","NCT06684483","The Impact of Heavy Alcohol Use on Saliva and Oral Health","Quantifying Associations of Stress and Inflammation-Associated Oral Biomarkers With Oral Health, Oral Health Behaviors, Systemic Biomarkers and Clinical Phenotype in Individuals With Alcohol Use Disorder (AUD)","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\nAUD participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Treatment-seeking individuals aged 18 years or older.\n* Able to read and speak English.\n* Admitted and consented for 14-AA-0181 at the NIH CC for inpatient treatment.\n* Part 1 Only: Agree for audio recording of cognitive interview.\n* Part 2 Only: BMI less than or equal to 30 kg\u002Fm\\^2.\n\nHealthy Control Participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Individuals aged 18 years or older.\n* Able to read and speak English.\n* Self-reported to be in good physical health.\n* Part 1 Only: Agree for audio recording of cognitive interview.\n* Part 2 Only: BMI less than or equal to 30 kg\u002Fm\\^2.\n* AUDIT score of 7 or below.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nPatients with AUD and Healthy Control Participants:\n\n* The presence of a condition or illness that would hamper the individual giving informed consent (e.g., cognitive impairment).\n* Part 2 Only: Self-reported presence of a condition or illness that would prevent the individual to have a diagnostic oral examination (e.g., oral cancer of the mouth, Sjogren's syndrome).\n* Part 2 Only: Currently taking or have taken any of the following medications within the last month by self-report; Antibiotics, Corticosteroids, Immunosuppressive or Cytotoxic agents. Topical antibiotics and\u002For corticosteroids on areas other than the oral cavity are not exclusion criteria.\n* Pregnant or breastfeeding\n* Subjects who participate in Part 1 of the protocol will not be eligible for Part 2.\n* Non-English speakers: we do not have a Spanish version of OHBA, and we are exploring cognitive interviewing of the instrument in English currently. Also, the pt's on 1SE (half of the focused population for this study) are not typically Spanish speakers. We also do not have many of the surveys we plan to administer in Spanish, and they may not be available in other languages.",{"count":408,"type":22},72,"Background:\n\nPeople with alcohol use disorder (AUD) have a higher rate of dental and gum disease. Poor oral health can increase the risk of other diseases, such as diabetes and stroke. Researchers want to learn more about how to identify developing inflammation in the mouth. They also want to know how improved oral health education and behaviors can affect inflammation in people with AUD.\n\nObjective:\n\nThis study has 2 goals: (1) to test the usefulness of a new questionnaire about oral health and (2) to learn more about how oral health behaviors affect inflammation in people with AUD.\n\nEligibility:\n\nPeople aged 18 years and older who are staying on an inpatient unit being treated for AUD. Healthy volunteers are also needed.\n\nDesign:\n\nThe study is divided into 2 parts: People will participate in either one part or the other.\n\nIn part 1, participants will have 1 visit. They will have a physical exam. They will answer 18 questions for a survey about how they care for their teeth.\n\nIn part 2, participants with AUD will have a physical exam. They will provide saliva and blood samples. They will have a dental exam with X-rays. They will fill out questionnaires about their health, mental health, social habits, diet, and sleep. They will keep a diary of their nicotine use for 4 weeks while inpatient.\n\nHealthy volunteers will have 1 visit. They will have a physical exam and provide blood and saliva samples. They will have a dental exam with X-rays. They will fill out questionnaires.",[411,412],"Alcohol Use Disorder","Alcohol Dependence",[414,411,415,416,417,418,419,420],"Oral Health Behaviors","Salivary Bioscience","Stress","Health Behaviors","Salivary Biomarker","Inflammation","Neuropsychological Symptoms","2026-02-14",{"date":423,"type":39},"2026-02-17",{"date":425,"type":39},"2025-01-09",{"date":107,"type":22},{"name":45,"class":46},{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":17,"minAge":435,"maxAge":68,"enrollmentInfo":436,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":438,"conditions":439,"keywords":442,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":47},"100538202","a-natural-history-study-of-ryr1-related-disorders-100538202","NCT06287762","A Natural History Study of RYR1-Related Disorders","A Single-Center Prospective Natural History Study of RYR1-Related Disorders","* INCLUSION CRITERIA (CENTRALIZED ARM)\n\n  1. Stated willingness to comply with all study procedures, availability for the duration of the study, and submission of medical records to research team prior to screening.\n  2. Male or female, aged \\>=7 years of age.\n  3. Genetically confirmed RYR1-related disorder, evidenced by pathogenic or likely pathogenic variants identified by CLIA testing (whole genome, exome, targeted, partial or full RYR1 sequencing) OR variant of uncertain significance with supporting clinical phenotype.\n  4. Agreement to adhere to Lifestyle Considerations throughout study duration.\n  5. Ability of subject to communicate their understanding of the purpose of the study, and willingness to provide assent and\u002For to sign a written informed consent document.\n  6. Resides in the United States.\n\nEXCLUSION CRITERIA (CENTRALIZED ARM)\n\n1. Participation in an IND, IDE, or equivalent clinical study in the past six months\n2. Severe disability or mobility issues (inability to walk 10 meters with or without assistance)\n3. Requires mechanical ventilation or tracheotomy\n4. Other neuromuscular diseases resulting in muscle weakness\n5. Ongoing medical condition that is deemed by the Principal Investigator to interfere with the conduct or assessments of the study (e.g. active infection) or safety of the subject.\n\nINCLUSION CRITERIA (DE-CENTRALIZED ARM)\n\n1. Stated willingness to comply with all study procedures, availability for the duration of the study, and submission of medical records to research team prior to screening.\n2. Male or female, aged \\> 7 years of age.\n3. Genetically confirmed RYR1-related disorder, evidenced by pathogenic or likely pathogenic variants identified by CLIA testing (whole genome, exome, targeted, partial or full RYR1 sequencing) OR variant of uncertain significance with supporting clinical phenotype.\n4. Ability of subject to communicate their understanding of the purpose of the study, and willingness to provide assent and\u002For sign a written informed consent document.\n5. Resides in the United States\n\nEXCLUSION CRITERIA (DE-CENTRALIZED ARM)\n\n1. Participation in an IND, IDE, or equivalent clinical study in the past six months\n2. Other neuromuscular diseases resulting in muscle weakness\n3. Ongoing medical condition that is deemed by the Principal Investigator to interfere with the conduct or assessments of the study (e.g. active infection) or safety of the subject","7 Years",{"count":437,"type":22},150,"Background:\n\nCongenital myopathies (CM) are genetic disorders that can cause decreased muscle tone and muscle weakness. Most CMs in the United States are related to the ryanodine receptor 1 (RYR1) gene. Researchers need more natural history data to learn about these CMs in children and adults.\n\nObjective:\n\nTo learn more about the signs, symptoms, and course of RYR1-related disorders.\n\nEligibility:\n\nPeople aged 7 years and older with an RYR1-related disorder.\n\nDesign:\n\nAmbulatory participants will come to the Clinical Center and non-ambulatory participants will visit via telehealth.\n\nVisits will be once a year for 3 or 5 years. Clinical Center visits will take 2 to 3 days.\n\nAll participants will undergo tests including:\n\nPhotos and videos. These will be taken to document the participant s condition.\n\nBlood and urine tests.\n\nActivity Tracker. Participants will wear a device to record their activity.\n\nQuestionnaires. Participants will answer questions about their health, pain, fatigue, stress, quality of life, and other topics.\n\nParticipants who visit the Clinical Center will also undergo:\n\nTests of heart and lung function.\n\nMotor skills and strength tests. Participants will walk, climb stairs, kneel, crawl, stand up, and perform other movements to test their strength and abilities. They will squeeze and pinch a handheld device to test their grip.\n\nImaging scans.\n\nSkin biopsy. Adult participants may opt to have a sample of skin taken (one time only).\n\nEye exam",[440,441],"Ryanodine Receptor 1-Related Myopathy","Ryanodine Receptor 1 Related Disorders",[443,444,80,445],"RYR1","Muscle Disease","Congenital Myopathy","2026-01-22",{"date":448,"type":39},"2026-01-23",{"date":450,"type":39},"2025-03-11",{"date":452,"type":22},"2031-12-30",{"name":45,"class":46},{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":17,"minAge":233,"maxAge":461,"enrollmentInfo":462,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":469,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":47},"100495085","evaluating-long-term-use-of-a-pediatric-robotic-exoskeleton-prexagilik-to-improve-gait-in-children-with-movement-disorders-100495085","NCT05726591","Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX\u002FAgilik) to Improve Gait in Children With Movement Disorders","A Phase I\u002FII Trial Evaluating Long-Term Use of a Pediatric Robotic Exoskeleton (P.REX\u002FAgilik) to Improve Gait in Children With Movement Disorders","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.\n* Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.\n* Age 3 to 17 years old.\n* Have a gait pathology involving the knee joint, from a diagnosis of cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.\n* Knee joint range of motion of at least 25 degrees in the sagittal plane (knee extension\u002Fflexion) assessed with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.\n* Ankle joint range of motion of at least 15 degrees in the sagittal plane (dorsi-plantar flexion) with the foot in neutral alignment.\n* A measured foot-thigh angle of -15 to 30 degrees in prone position.\n* Able to walk at least 10 feet without stopping with or without a walking aid.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed with the robotic exoskeleton.\n* A history of uncontrolled seizure in the past year.\n* Pregnancy. A urine test will be performed for all participants who are able to become pregnant at the initial screening visit and in the case of a positive test, the participant will be excluded from participation. Further monitoring will rely on self-reporting of interruption in menstruation that would require re-testing for pregnancy at the next visit.\n* Any acute cardiopulmonary condition which limits exercise to less than 60 minutes per session or less than 5 days per week.","17 Years",{"count":463,"type":22},44,[25],"Background:\n\nPeople with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.\n\nObjective:\n\nTo learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.\n\nEligibility:\n\nPeople aged 3 to 17 years with a gait disorder involving the knee joint.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. Their walking ability will be tested.\n\nParticipants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.\n\nThe study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.\n\nDuring another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.\n\nDuring the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.\n\nParticipants walking ability will be retested after each phase....",[74,467,151,468],"Muscular Dystrophy","Incomplete Spinal Cord Injury",[30,470,74,126,152],"Muscular Dystophies","2025-10-24",{"date":473,"type":39},"2025-10-27",{"date":475,"type":39},"2023-05-02",{"date":477,"type":22},"2027-10-31",{"name":45,"class":46},""]