[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Indiana University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":636},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,173,0,25,[9,50,76,99,127,158,186,214,233,274,300,328,353,375,393,415,437,459,478,506,532,557,575,592,610],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100610326","the-effects-of-cognitive-behavioral-therapy-on-insulin-resistance-in-people-with-hiv-100610326",false,"NCT07226128","The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV","A Randomized, Controlled Trial Assessing the Effects of Cognitive Behavioral Therapy to Prevent Worsening Insulin Resistance in Depressed, Virologically-Suppressed, Antiretroviral-Treated Adults With HIV","Inclusion Criteria:\n\n* HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load.\n* Age ≥ 18 years.\n* Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to Screening\n* Meets the depression definition for this trial:\n\n  * (1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND\n  * (2) PHQ-9 depressive disorder diagnosis (2 or more of the 9 depressive symptoms, including depressed mood or anhedonia, present in the past 2 weeks), AND\n  * (3) functional impairment (using the tenth PHQ-9 item assessing social\u002Foccupational impairment), AND\n  * (4) no evidence that the direct physiological effects of a substance, medication, or medical condition clearly account for the depressive symptoms, AND\n  * (5) no bipolar or psychotic disorders\n\nNOTE: The use of antidepressant medications is not exclusionary.\n\n* HbA1c \\\u003C 6.5% at Screening\n* HIV-1 RNA level \\\u003C 75 copies\u002FmL at Screening\n\nNOTE: There are no CD4 cell count eligibility criteria for this trial.\n\nExclusion Criteria:\n\n* Inability to complete written, informed consent\n* Inability to read and understand English as seen on a computer screen\n* Diagnosed diabetes mellitus or any previously recorded HbA1c ≥6.5%\n* History of bipolar disorder or a psychotic disorder, including schizophrenia\n\nNOTE: Depressive disorders are not exclusionary.\n\n* Incarceration at the time of any study visit\n* Active suicidality at Entry, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix).\n* Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases).\n\nNOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation\n\n* End stage renal disease requiring renal replacement therapy (dialysis, transplantation).\n* Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.\n\nNOTE: Localized treatment for skin cancers is not exclusionary.\n\n• Therapy for serious medical illnesses within 14 days prior to the Entry Visit\n\nNOTE: Therapy for serious medical illnesses that overlaps with a study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.\n\n* Pregnancy or breastfeeding during the study.\n* Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit\n\nNOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled\u002Fnasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors\n\nNOTE: Use of NSAIDS and aspirin are allowed\n\n• Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if depression treatment improves insulin resistance, or how the body uses insulin to lower blood sugar, in people with HIV on HIV treatment. Researchers will compare an internet-based (online) depression treatment program called cognitive behavioral therapy with depression education. In the online group, participants will undergo 9 weekly treatment sessions. The education group will receive learning materials about depression and will be monitored every month. All participants will have 4 study visits over 12 months.",[27,28,29,30],"HIV","Depression in Adults","Insulin Resistance","Cognitive Behavior Therapy",[32,33,34,35,36],"hiv","depression","insulin resistance","diabetes","cognitive behavioral therapy","RECRUITING","2026-08-20",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":41},"2026-04-10",{"date":45,"type":21},"2029-08-31",{"name":47,"class":48},"Indiana University","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100561781","smart-pillows-for-enhancing-sleep-quality-100561781","NCT06594627","Smart Pillows for Enhancing Sleep Quality","Smart Pillows for Enhancing Sleep Quality_Pilot Study","Inclusion Criteria:\n\n* Inclusion criteria for individuals with snoring issues or OSA\n\n  * Individuals 50 years of age or older.\n  * Individuals who experience snoring issues and\u002For OSA that may impact their perceived sleep quality or that of their sleep partner.\n  * Individuals who currently use and do not use snoring and\u002For OSA treatment (participants will not be asked or required to discontinue any current snoring and\u002For OSA treatments that they are prescribed or using.)\n  * Individuals who have a smartphone or a smart mobile device (Apple iOS 15 and higher or Android 10 or higher).\n  * Individuals with and without a sleep partner.\n  * Individuals who do not have a pacemaker.\n  * Individuals who do not have intracranial electrodes.\n  * Individuals who do not have neck pain related to the cervical spine problems, including disc, muscle, and neurological issues.\n\nInclusion criteria for sleep partners\n\n* Individuals aged 18 years and older.\n* Individuals who share the same sleeping space with their sleep partner (who has snoring issues and\u002For OSA) more than four times a week.\n* Individuals whose sleep partner (who has snoring issues and\u002For OSA) agrees to participate in this study.\n\nExclusion Criteria:\n\n* Any participant who is not able to consent or complete study interventions independently, as determined by the investigator.","50 Years",{"count":59,"type":21},24,[24],"The purpose of this study is to examine the impact of smart pillows on the sleep quality of individuals who experience a snoring issue and\u002For obstructive sleep apnea (OSA), as well as their sleep partners. Furthermore, this study will explore whether enhancements in sleep quality positively influence depressive symptoms, physical activity, heart rate, blood oxygen levels, and cognitive functions.",[63,64],"Snoring","Obstructive Sleep Apnea",[66,67,68,69],"assistive device","sleep quality","snoring","obstructive sleep apnea",{"date":40,"type":41},{"date":72,"type":41},"2024-11-18",{"date":74,"type":21},"2027-07-11",{"name":47,"class":48},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":49},"100499893","early-phase-1-interaction-of-cyp2b6-genotype-and-efavirenz-with-methadone-and-tizanidine-pk-100499893","NCT05789173","Interaction of CYP2B6 Genotype and Efavirenz With Methadone and Tizanidine PK","Effect of CYP2B6 Genotype and Efavirenz on the Disposition and Pharmacodynamic of Methadone and Tizanidine in Healthy Volunteers","Inclusion Criteria:\n\nSubjects will be included in the study if participants:\n\n* are male and female (approximately 1:1) volunteers between the age of 18 and 65 years old\n* are judged healthy without any significant medical condition as determined by and decided from a pre-enrollment screening session that include medical history, laboratory tests such as blood and urine tests, vital signs, and an electrical tracing of the heartbeat (electrocardiogram, EKG). The pre-enrollment screening will be done no more than six weeks before the start of the study.\n* are able and willing to adhere to the study medication restrictions two weeks before initiating the study and during the conduct of the entire study. These will include refraining from taking any prescriptions medications, over-the-counter medications, and herbal, dietary, and alternative supplements that may interact with the metabolism of those study drugs at least 2 weeks prior to the start of the study and until study completion.\n* are nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at least two weeks prior to and until the completion of the study.\n* are willing to commit the time requested for this study.\n\nExclusion Criteria:\n\n* Subjects will be excluded from the study if participants:\n\n  * are underweight (weigh less than 50 kg or 110 lb.) or overweight \\[BMI greater than 32\\]. Body mass index is calculated using height and weight to estimate how much body fat subjects have.\n  * have laboratory results that do not fall in a healthy range\n  * have an electrical tracing (baseline EKG readings) that are abnormal as decided by the study physician (medical doctor).\n  * have history of intolerance, allergic reactions (e.g., rash) or other forms of hypersensitivities to any of the study medications (efavirenz, tizanidine or methadone).\n  * Have a hemoglobin count below the normal range (male \\\u003C13.4 gm\u002FdL: and female \\\u003C12 gm\u002FdL)\n  * have a positive pregnancy urine test (if female) obtained just prior to each study.\n  * are sexually active, who is unable or unwilling to use an appropriate and effective method of birth control (for example barrier methods like diaphragms or condoms) to avoid the possibility of becoming pregnant\n  * are night shift workers in which case taking efavirenz may interfere with their work.\n  * have any significant health condition such heart, liver, or kidney disease\n  * have history or current seizures which may lead to collapse.\n  * have history or current mental illness (brain) such as feeling sad or unhappy, loss of interest in normal activities, worried or suicidality (thoughts about or an unusual preoccupation with ending own life) or suicide attempts.\n  * have gastrointestinal (digestive) disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs.\n  * have history or current psychiatric disorders such as depression, anxiety, or suicidality or suicide attempts that may be exacerbated by participation in the study\n  * have a history of or current HIV infection or have a lifestyle that places participants at a higher risk for contracting HIV (e.g., drug abuse, excessive alcohol drinking, and having multiple sexual partners).\n  * take more than 2 alcoholic drinks per day on a regular basis for two weeks prior to the study and unwilling to stop alcoholic drinks during the study\n  * unwilling or unable to stop taking drugs of abuse, including tobacco products or marijuana, two weeks prior to and during the entire study period\n  * have a systolic blood pressure lower than 70 mm Hg which may place subjects on high risk for tizanidine induced hypotension\n  * have participated in a research study involving intensive blood sampling or have donated blood within the past two months.\n  * are taking prescription medications, over-the-counter medications, herbal or dietary supplements, and alternative medicines that may interfere with the metabolism of the study drugs (e.g., inhibitors or inducers of CYP2B6 or CYP1A2) and are unable or unwilling to stop taking these medications two weeks prior to and during the entire study period.\n  * are employees or students under supervision of any of the study investigators.\n  * cannot state a good understanding of this study including risks and requirements\n  * are unable to follow the rules of this study.\n  * cannot or unwilling to commit the time requested for this study.",true,"65 Years",{"count":86,"type":21},60,[88],"EARLY_PHASE1","The main goal of this clinical study is to test how CYP2B6 genetic variations and efavirenz (cornerstone in HIV-1 therapy) dictate the disposition (PK) of CYP2B6 substrate (methadone) and PK and effect (PD) of CYP1A2 substrate (tizanidine). Specifically, the investigators will test whether efavirenz produces CYP2B6 genotype dependent unanticipated DDIs with CYP2B6 (methadone) and CYP1A2 (tizanidine), leading to lack of efficacy or increased toxicity. Healthy volunteers genotyped for CYP2B6\\*6 and \\*18 alleles will be grouped in to three genotype predicted phenotype groups: 20 normal metabolizer (NM) (CYP2B6\\*1\u002F\\*1); 20 intermediate metabolizer (IM) (\\*1\u002F\\*6, or \\*1\u002F\\*18); and 20 poor metabolizer (PM) (\\*6\u002F\\*6, \\*6\u002F\\*18 or \\*18\u002F\\*18). Each phenotype group will receive methadone and tizanidine (separated by a washout period) on two occasions: at baseline (control) and after treatment with efavirenz (600 mg\u002Fday for 17 days).",[91],"Drug-Drug Interaction","2026-08-19",{"date":38,"type":41},{"date":95,"type":41},"2023-10-06",{"date":97,"type":21},"2027-05",{"name":47,"class":48},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":49},"100488671","enhancing-shared-decision-making-to-guide-care-for-people-with-dementia-and-diabetes-100488671","NCT05643144","Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes","Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes","CGM ASSIST","Patient-Caregiver Dyad Inclusion Criteria:\n\n* patient must have dual diagnosis of MCI or ADRD and diabetes (DM)\n* patient must have active prescriptions for DM\n* patient must have had at least one visit to an Eskenazi or IU Health primary care clinic within 12 months\n* patient must be able to provide assent and have a legally authorized representative (LAR) consent on their behalf if patient lacks capacity to consent\n* patient must have a caregiver aged 18 years or older who interacts daily, or almost daily, with the patient\n* patient and caregiver must both speak English\n* patient and caregiver must both reside in the community\n* dyad must have internet access\n\nPatient-Caregiver Dyad Exclusion Criteria:\n\n* patient has terminal illness\n* use of an automated insulin delivery system\n* patient is receiving dialysis\n* patient is taking ascorbic acid during monitoring period\n* patient has existing implanted medical devices\n* patient has a bleeding disorder\n* patient has a pre-existing arm skin lesions\n* patient has an allergy to medical adhesive or isopropyl alcohol\n* patient has plans for imaging or diathermy treatment during the study period",{"count":108,"type":21},62,[24],"The goal of this study is to test CGM ASSIST. This is a digital tool that uses an interactive information display-an easy-to-read screen designed to help people with dementia (or memory loss) and diabetes, as well as their caregivers and doctors.\n\nManaging diabetes is often difficult for people with memory issues. This study uses a Continuous Glucose Monitor (CGM), which is a device that tracks blood sugar levels in real-time. CGM ASSIST adds a new way to see this data through interactive displays. These displays show clear information and medical guidelines to help patients and caregivers make sense of the glucose readings.\n\nThe study aims to:\n\n* Increase Awareness: Help patients and caregivers recognize the dangers of low blood sugar (hypoglycemia) and how to treat it.\n* Improve Teamwork: Encourage \"shared decision-making,\" where patients, caregivers, and doctors work together to make health choices.\n* Test Feasibility: See if it is easy and helpful for people with memory loss to use these interactive displays in their daily lives.\n* Understand Experiences: Learn how the thoughts and feelings of patients and families affect how they manage diabetes.\n\nBy using these interactive displays, the researchers hope to make it easier for families to understand their health needs and communicate better with their medical team.\n\nParticipants will:\n\n* Answer a survey about how they manage their diabetes\n* Learn how to use a Continuous Glucose Monitor and wear it for 14 days\n* Answer 3 brief telephone surveys during these 14 days\n* Complete a clinic visit with their doctor and answer a final survey on how this visit went using the CGM ASSIST report",[112,113,114,115],"Diabetes","Alzheimer's Disease (Incl Subtypes)","Dementia","Hypoglycemia",[117,118,119,120],"Continuous glucose monitoring","Shared decision-making","Human factors","Primary care",{"date":38,"type":41},{"date":123,"type":21},"2026-09-07",{"date":125,"type":21},"2027-06-30",{"name":47,"class":48},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":49},"100652926","vica-a-virtual-care-assistant-for-dementia-caregivers-100652926","NCT07779785","VICA: A Virtual Care Assistant for Dementia Caregivers","Virtual Informal Care Assistant for Alzheimer'S-related Dementia (VICA): A Pilot Randomized Controlled Trial","VICA","Inclusion Criteria: Patient\n\n* Age ≥ 65 years\n* Community-dwelling\n* Diagnosed with ADRD\n* Clinical notes indicate behavioral and psychological symptoms of dementia (BPSD) Inclusion Criteria: Informal Caregiver\n* Age ≥ 21 years\n* Self-identified informal caregiver of a community-dwelling patient diagnosed with ADRD\n* Provides ≥ 10 hours\u002Fweek of care to the patient with ADRD\n* Regular access to a computer and\u002For smart device with internet\n* English-literate; assessed as \"adequate\" on the Single Item Literacy Screener\n\nExclusion Criteria: Patient\n\n* Life expectancy less than 6 months\n\nExclusion Criteria: Informal Caregiver\n\n* Clinician-reported cognitive impairment\n* Clinician-reported severe mental illness or substance use disorder\n* Clinician-reported life expectancy of less than 6 months\n* Unable to provide informed consent","21 Years",{"count":137,"type":21},120,[24],"This pilot randomized controlled trial evaluates the feasibility and preliminary efficacy of VICA, an AI-powered virtual care assistant that delivers evidence-based education, symptom monitoring, and coaching to informal caregivers of people living with Alzheimer's disease and related dementias (ADRD). Sixty caregiver-patient dyads will be randomized 1:1 to VICA or an attention-control education app (Dementia Guide Expert) for 3 months. The study will assess recruitment, VICA acceptance\u002Fusability, and engagement (Aim 1), and estimate effect sizes for reducing patient behavioral and psychological symptoms of dementia (BPSD) and caregiver distress (Aim 2).",[141,142],"Alzheimer Dementia (AD)","Caregiver Burden of People With Dementia",[144,145,146,147,148,149],"behavioral and psychological symptoms of dementia","conversational AI","avatar","informal caregiver","digital therapeutic","ABC collaborative dementia care model","NOT_YET_RECRUITING","2026-08-18",{"date":40,"type":41},{"date":154,"type":21},"2026-08-17",{"date":156,"type":21},"2027-05-30",{"name":47,"class":48},{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":83,"sex":17,"minAge":4,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":176,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":49},"100638947","cerebral-physiology-of-nows-100638947","NCT07610746","Cerebral Physiology of NOWS","Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.","NIRS for NOWS","Inclusion Criteria:\n\nInfants with prenatal opioid exposure:\n\n* Term born or near-term born (\\> 36w) infants\n* Birth weight \\> 2 Kg\n* History of prenatal opioid exposure\n\nControl infants:\n\n* Term born or near-term born (\\> 36w) infants\n* Birth weight \\> 2 Kg\n\nMothers of infants with prenatal opioid exposure:\n\n* greater or equal to 19 years of age\n* Use of opioid substances during pregnancy - Defined as pregnant women who 1) are clinically diagnosed as having an opioid use disorder and are on methadone or buprenorphine maintenance program or 2) have a urine drug test positive for prescribed or illicit opioids\n\nMothers of control infants:\n\n* greater than or equal to 19 years of age\n\nExclusion Criteria:\n\nInfants with prenatal opioid exposure:\n\n* APGAR score at 5 min \\\u003C 7\n* Any major congenital malformations or genetic syndromes\n* Need for positive pressure ventilation in the delivery room\n\nControl infants:\n\n* APGAR score at 5 min \\\u003C 7\n* Any major congenital malformations or genetic syndromes\n* Need for positive pressure ventilation in the delivery room\n* Any history of prenatal opioid exposure\n\nMothers of infants with prenatal opioid exposure:\n\n* Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)\n\nMothers of control infants:\n\n* Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)\n* Tobacco, SSRI or any opioid use during pregnancy","1 Day",{"count":168,"type":21},46,[24],"This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.",[172,173,174,175],"Neonatal Opioid Withdrawal","Neonatal Opioid Withdrawal Syndrome","Opioid Use Disorder","Intrauterine Exposure",[177,178,179],"neonatal opioid withdrawal syndrome","near infrared spectroscopy","diffuse correlation spectroscopy",{"date":92,"type":41},{"date":182,"type":41},"2026-08-11",{"date":184,"type":21},"2027-08",{"name":47,"class":48},{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":83,"sex":17,"minAge":57,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":205,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":49},"100582854","ketone-ester-and-salt-keas-in-older-adults-100582854","NCT06868719","Ketone Ester And Salt (KEAS) in Older Adults","Ketone Supplementation as a Strategy to Reduce the Negative Health Effects of High Dietary Salt in Older Adults","KEAS-O","Inclusion Criteria:\n\n* Between the ages of 60-85\n* Resting blood pressure no higher than 150\u002F90\n* BMI below 35 kg\u002Fm2 (or otherwise healthy)\n* Free of any metabolic disease (diabetes or renal), pulmonary disorders (COPD, severe asthma, or cystic fibrosis), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular)\n* Do not have any precluding medical conditions that prevent participants from exercising (i.e., cardiovascular issues, or muscle\u002Fjoint issues including painful arthritis) or giving blood (e.g., blood thinners)\n\nExclusion Criteria:\n\n* High blood pressure - greater than150\u002F90 mmHg\n* Obesity (BMI \\> 30 kg\u002Fm2)\n* History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, \\& cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).\n* Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle\u002Fjoint issues including painful arthritis)\n* Medical issues that prevent giving blood (e.g., blood thinners).\n* Current smoking, using smokeless tobacco, or vaping (within past 12 months)\n* Current pregnancy","85 Years",{"count":196,"type":21},35,[24],"Most Americans consume excess dietary salt based on the recommendations set by the American Heart Association and Dietary Guidelines for Americans. High dietary salt impairs blood pressure control by affecting systemic blood vessels and the kidneys. These changes contribute to excess salt consumption being associated with increased risk for chronic kidney disease and cardiovascular disease, the leading cause of death in America. Salt is particularly deleterious in older adults who are more likely to exhibit salt-sensitive hypertension. However, salt consumption remains high in the United States. Thus, there is a critical need for strategies to counteract the effects of high dietary salt as consumption is likely not going to decrease. One promising option is ketones, metabolites that are produced in the liver during prolonged exercise and very low-calorie diets. While exercise and low-calorie diets are beneficial, not many people engage in these activities. Limited evidence indicates that ketone supplements improve cardiovascular health in humans. Additionally, published rodent data indicates that ketone supplements prevent high salt-induced increases in blood pressure, blood vessel dysfunction, and kidney injury. Our human pilot data also indicates that high dietary salt reduces intrinsic ketone production, but it is unclear whether ketone supplementation confers humans' protection against high salt similar to rodents. Therefore, the investigators seek to conduct a short-term high-dietary salt study to determine whether ketone supplementation prevents high dietary salt from eliciting increased blood pressure, blood vessel dysfunction, and kidney injury\u002Fimpaired blood flow. The investigators will also measure inflammatory markers in blood samples and isolate immune cells that control inflammation. Lastly, the investigators will also measure blood ketone concentration and other circulating metabolites that may be altered by high salt, which could facilitate novel therapeutic targets to combat high salt.",[200,201,202,203,204],"Salt; Excess","Hypertension","Aging","Inflammation","Blood Pressure",[204,206,202,203,207],"Salt","Cardiovascular Disease",{"date":92,"type":41},{"date":210,"type":41},"2025-03-06",{"date":212,"type":21},"2027-12-31",{"name":47,"class":48},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":83,"sex":17,"minAge":222,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":232,"locationsCount":49},"100481169","ketone-ester-and-salt-keas-in-young-adults-100481169","NCT05545501","Ketone Ester and Salt (KEAS) in Young Adults","Ketone Supplementation as a Strategy to Reduce the Negative Health Effects of High Dietary Salt in Young Adults","KEAS","Inclusion Criteria:\n\n* Between the ages of 19-39\n* Resting blood pressure no higher than 150\u002F90\n* BMI below 35 kg\u002Fm2 (or otherwise healthy)\n* Free of any metabolic disease (diabetes or renal), pulmonary disorders (COPD, severe asthma, \\& cystic fibrosis), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular)\n* Do not have any precluding medical conditions that prevent participants from exercising (i.e., cardiovascular issues, or muscle\u002Fjoint issues including painful arthritis) or giving blood (e.g., blood thinners).\n\nExclusion Criteria:\n\n* High blood pressure - greater than 150\u002F90 mmHg\n* Obesity (BMI \\> 30 kg\u002Fm2)\n* History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, \\& cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).\n* Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle\u002Fjoint issues including painful arthritis)\n* Medical issues that prevent giving blood (e.g., blood thinners).\n* Current smoking, using smokeless tobacco, or vaping (within past 12 months)\n* Current pregnancy","19 Years","39 Years",{"count":196,"type":21},[24],"Most Americans consume excess dietary salt based on the recommendations set by the American Heart Association and Dietary Guidelines for Americans. High dietary salt impairs the ability of systemic blood vessels and the kidneys to control blood pressure, which contributes to excess salt consumption being associated with increased risk for chronic kidney disease and cardiovascular disease, the leading cause of death in America. There is a critical need for strategies to counteract the effects of high dietary salt as consumption is likely not going to decrease. One promising option is ketones, metabolites that are produced in the liver during prolonged exercise and very low-calorie diets. While exercise and low-calorie diets are beneficial, not many people engage in these activities. However, limited evidence indicates that ketone supplements improve cardiovascular health in humans. Additionally published rodent data indicates that ketone supplements prevent high salt-induced increases in blood pressure, blood vessel dysfunction, and kidney injury. Our human pilot data also indicates that high dietary salt reduces intrinsic ketone production, but it is unclear whether ketone supplementation confers humans protection against high salt similar to rodents. Therefore, the investigators seek to conduct a short-term high dietary salt study to determine whether ketone supplementation prevents high dietary salt from eliciting increased blood pressure, blood vessel dysfunction, and kidney injury\u002Fimpaired blood flow. The investigators will also measure inflammatory markers in blood samples and isolate immune cells that control inflammation. Lastly, the investigators will also measure blood ketone concentration and other circulating metabolites that may be altered by high salt, which could allow us to determine novel therapeutic targets to combat high salt.",[200,201],{"date":92,"type":41},{"date":230,"type":41},"2023-03-24",{"date":212,"type":21},{"name":47,"class":48},{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":250,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":49},"100652548","sensor-ankle-brace-for-special-operations-rehabilitation---phase-2-100652548","NCT07776223","Sensor Ankle Brace for Special Operations Rehabilitation - Phase 2","Inclusion Criteria:\n\n* Healthy adults: ages 18 - 40 years\n* considered \"healthy to exercise\" as determined by the physical activity readiness questionnaire (PAR-Q)\n* Classified as \"moderate\" or \"high\" activity level as defined by the scoring criteria of the International Physical Activity Questionnaire - Short Form (IPAQ)\n* Comfortably fit into combat boots provided by the laboratory (Men's sizes 8, 9, 10, 11, 12 and Women's sizes 6, 7, 8, 9, 10 will be purchased, and so participants with foot lengths of 22.54-29.27.8 cm are expected to fit in the boots provided).\n\nExclusion Criteria:\n\n* Smoking tobacco on a regular basis\n* Previous lower back or lower limb surgery (including the joints of the pelvis and lower limbs)\n* Musculoskeletal injury sustained within the 12-weeks prior to enrollment . A musculoskeletal injury is defined as musculoskeletal pain causing a reduction or stoppage of normal physical activity for at least 3 days within a 7-day period, and have not returned to their normal physical activity and exercise without pain for at least the last 6-weeks.\n* Pregnant (women only)\n* Current or history of an unresolved musculoskeletal, neurological, cardiovascular, pulmonary\u002Frespiratory, metabolic, renal condition, disease, or problem.\n* Torn anterior or posterior cruciate ligament (ACL or PCL).\n* Any other disease or problems that may affect movement or the ability to exercise even at a low intensity.\n* Identification of Functional Ankle Instability (IDFAI) score of \\\u003C11.\n* unable to comfortably perform the drop landing condition.\n* Feet are too large or too small to fit comfortably in the combat boots provided.","40 Years",{"count":241,"type":21},40,[24],"The primary purpose of this study overall is to validate a modified version of a commercially available ankle brace. Inertial measurement unit sensors will be incorporated into an existing ankle brace (\"sXAB\") by TayCo Brace, Inc. In two consecutive studies, gait metrics data collected from the sensor enabled ankle brace will be compared to data collected by the gold-standard equipment that is used in research and clinical settings to determine whether the sXAB performs adequately in terms of measurement or technical feasibility prior to further clinical evaluation. In the Phase 2 protocol, the sXAB will be validated on healthy subjects wearing combat boots performing walking, running, jumping, and stair climbing activities. These movements were selected because they simulate key movements performed during operational activities. All participants experience both conditions: with an ankle brace and without an ankle brace. Comparisons are made within-subject between brace and no-brace conditions. It is hypothesized that the sensor-enabled ankle brace will measure gait metrics with a high degree of accuracy (within 5%) when compared against the gold-standard lab equipment (i.e., motion capture and research-grade inertial measurement units).",[245,246,247,248,249],"Gait","Balance","Biomechanical Data","Postural Control","Locomotion",[251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267],"adult","gait","gait analysis","humans","ankle brace","motion capture","sensor validation","wearable electronic devices","wearable sensors","inertial measurement unit","IMU","locomotion","running","walking","landing","stair ascent","stair descent",{"date":38,"type":41},{"date":270,"type":41},"2026-05-05",{"date":272,"type":21},"2026-09-01",{"name":47,"class":48},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":83,"sex":17,"minAge":281,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":291,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":299,"locationsCount":49},"100622525","foot-strengthening-to-improve-balance-and-gait-in-older-adults-100622525","NCT07384754","Foot Strengthening to Improve Balance and Gait in Older Adults","Evaluation of a Novel Foot Strengthening Device for Improving Fall Risk, Balance, and Gait With Age","Inclusion Criteria:\n\n* Healthy adults: 45 years of age or older\n* Able to walk without an assistive walking device or lower limb prosthesis for at least 6 minutes\n* No history of foot or ankle surgery\n* No history of regular minimalist footwear use\n* No foot or ankle issues for which study activities may be contraindicated\n* BMI \\\u003C= 40\n\nExclusion Criteria:\n\n* Deemed unfit for physical activity by the Physical Activity Readiness Questionnaire (PAR-Q)\n* Current or history of an unresolved musculoskeletal, neurological, cardiovascular, pulmonary\u002Frespiratory, metabolic, renal condition, disease, or problem\n* Use of orthotics in daily (i.e., non-athletic) footwear\n* Pregnancy\n* Any other disease or problems that may affect movement or the ability to exercise even at a low intensity","45 Years",{"count":283,"type":21},160,[24],"The goal of this clinical trial is to learn whether different foot-strengthening strategies can improve foot strength, balance, walking ability, and fall-related outcomes in middle-aged and older adults (ages 45-85 years).\n\nThe main questions it aims to answer are:\n\n* Does foot strength change from baseline after an 8-week foot-strengthening intervention?\n* Do balance, gait, and physical function improve following different foot-strengthening approaches?\n\nResearchers will compare minimalist footwear use, a foot exercise program, a foot-strengthening device (ToePro), and no intervention to see if these interventions lead to greater improvements in foot strength, balance, gait, and fall-related outcomes than no intervention.\n\nParticipants will:\n\n* Complete baseline and post-intervention laboratory testing of foot strength, balance, physical function, and walking gait\n* Perform foot strengthening exercises or wear minimalist footwear (if applicable) five days\u002Fweek for eight weeks\n* Complete daily logs to record intervention compliance",[287,288,289,290],"Minimalist Footwear","Traditional Foot Exercise Program","Foot Strengthening Device (ToePro)","Control Condition",[246,245,292,293,202,294],"Intrinsic Foot Muscles","Minimalist footwear","Fall prevention",{"date":92,"type":41},{"date":297,"type":41},"2025-10-21",{"date":125,"type":21},{"name":47,"class":48},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":83,"sex":17,"minAge":306,"maxAge":18,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},"100502365","phase-4-evaluation-of-fecal-microbiome-changes-after-antegrade-continence-enema-placement-and-initiation-of-bowel-flush-regimen-100502365","NCT05821309","Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen","Inclusion Criteria:\n\n* Recalcitrant chronic functional constipation necessitating a MACE appendicostomy or cecostomy for treatment at Riley Hospital for Children\n* Intact colonic motility as evidenced by CMS studies\n\nExclusion Criteria\n\n* Underlying anatomic or pathologic etiology for constipation\n* History of prior gastrointestinal surgery (excluding placement of G or GJ tubes)\n* Underlying severe GI disease unrelated to the patient's chronic constipation\n* Use within the past month of consent of probiotic supplements, prebiotic supplements or antibiotics","2 Years",{"count":308,"type":21},65,[310],"PHASE4","This study will evaluate changes in the fecal microbiome in constipated pediatric patients before and after antegrade continence enema placement and initiation of antegrade enema flushes. Subjects will have their microbiome sequenced prior to placement by obtaining a fecal sample. Pre-antegrade continence enema placement results will be compared to fecal samples obtained at 0, 4, 8 months after placement of the antegrade continence enema and initiation of miralax or golytely flushes to look for changes in bacterial diversity.",[313],"Constipation",[315,316,317,318,319,320],"Fecal microbiome","Malone Antegrade Continence Enema (MACE)","Miralax","PEG 3350","Antegrade Continence Enema","Chronic Constipation",{"date":151,"type":41},{"date":323,"type":41},"2023-06-08",{"date":325,"type":21},"2027-07",{"name":47,"class":48},2,{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":49},"100474989","leg-heat-therapy-in-peripheral-artery-disease-100474989","NCT05465070","Leg Heat Therapy in Peripheral Artery Disease","Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease","Inclusion Criteria:\n\n* Men and women older than 50 years\n* Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg. Individuals with a resting ABI between 0.91 and 1.00 at baseline will be eligible if their ABI drops by 20% or greater following a heel-rise test.\n\nExclusion Criteria:\n\n* Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)\n* Prior foot or leg amputation\n* Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).\n* Recent (\\\u003C3 months) lower-extremity revascularization or orthopedic surgery\n* Use of walking aid other than a cane\n* Active cancer\n* Chronic kidney disease (eGFR \\\u003C30 by MDRD or Mayo or Cockcroft-Gault formula)\n* Class 2 or 3 obesity (BMI ≥ 35 kg\u002Fm2)\n* Unable to fit into water-circulating trousers\n* A Mini-Mental Status Examination score \\\u003C23\n* Impaired thermal sensation in the leg\n\nAs this study involves MR imaging, patients that have contraindications to MRI will be included in the study but will not be allowed to participate in the MRI experiment. Information about biomedical devices that may pose a risk to patients undergoing MRI is available on the Internet at www.MRIsafety.com. These exclusions include: cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth\u002Ffusion stimulator, cochlear, otologic, or ear implant and history of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner.",{"count":336,"type":21},106,[24],"The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from lower-extremity peripheral artery disease (PAD). We will randomize 106 patients to one of two groups that either receive leg HT or a sham intervention. The primary study outcome is the change in 6-minute walk distance between baseline and the 12-week follow up. Secondary outcomes include changes in the short physical performance battery score, handgrip strength, quality of life (measured by the Walking Impairment Questionnaire and Short-Form (SF)-36 Questionnaire), calf muscle strength (measured using a calf ergometer), size (measured by magnetic resonance imaging) and bioenergetics (assessed using phosphorus-31 magnetic resonance spectroscopy), and physical activity (measured by accelerometer).",[340],"Peripheral Artery Disease",[342,343,344,345],"heat therapy","peripheral artery disease","walking performance","muscle strength","2026-08-14",{"date":154,"type":41},{"date":349,"type":41},"2022-11-07",{"date":351,"type":21},"2026-12-31",{"name":47,"class":48},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":374,"locationsCount":49},"100644977","overground-virtual-reality-vr-gait-rehabilitation-for-stroke-100644977","NCT07676578","Overground Virtual Reality (VR) Gait Rehabilitation for Stroke","Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Stroke Survivors","Inclusion Criteria:\n\n* Diagnosis: Anischemic or hemorrhagic stroke verified by imaging, confirmed by the patient's physician, and 1-6 months post-stroke (subacute phase)\n* Motor Impairment Level: Functional Ambulation Category (FAC) 3-5, showing moderate impairment while still allowing safe participation in gait tasks.\n* Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score \\>= 20, indicating sufficient cognitive function to participate in the study.\n* Exercise Clearance: Approval from a physician for participation in exercise- and VR-based interventions.\n* Rehabilitation Need: 10-Meter Walk Test \\\u003C1.0 m\u002Fs, as timed by a PT during screening, indicating a need for functional rehabilitation.\n* Consent: Must be able to provide informed consent for themselves.\n\nExclusion Criteria:\n\n* Participants with uncontrolled cardiovascular, orthopedic, or metabolic conditions or unstable medication regimens that could interfere with their participation in the study.\n* Any comorbidity that could interfere with walking or gait training.\n* Participation in robot- or VR-assisted gait training within the last 6 months.\n* Intolerance to virtual reality environments or motion simulation.\n* Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.\n* Any other condition deemed unsafe or confounding by investigator, such as pre-existing neurological conditions unrelated to stroke (e.g. Parkinson's, multiple sclerosis), unmanaged pain medications, or acute medical events during the screening period (e.g. recurrent stroke, hospitalization).\n* Individuals who score a 12 or higher on the Disability Rating Scale.\n* Recent Therapy: Participants should not have received physical therapy (PT) within the last month.",{"count":361,"type":21},30,[24],"The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help stroke survivors improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for stroke survivors.",[365],"Stroke",[367,368,365],"Gait Training","Virtual Reality","2026-08-13",{"date":154,"type":41},{"date":372,"type":21},"2026-08",{"date":184,"type":21},{"name":47,"class":48},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":390,"leadSponsor":392,"locationsCount":49},"100595933","overground-virtual-reality-vr-gait-rehabilitation-for-traumatic-brain-injury-tbi-100595933","NCT07038889","Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)","Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)","Inclusion Criteria:\n\n* Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI), confirmed by the referring physician.\n* Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score ≥ 20, indicating sufficient cognitive function to participate in the study.\n* Exercise Clearance: Approval from a physician for participation in exercise-based interventions.\n* Rehabilitation Need: Demonstrates a need for functional rehabilitation.\n* Recent Therapy: Participants should not have received physical therapy (PT) within the last month.\n* Consent: Must be able to provide informed consent for themselves.\n\nExclusion Criteria:\n\n* Participants with unstable medication regimens that could interfere with their participation in the study.\n* Any comorbidity that could interfere with walking or gait training.\n* Participation in VR-assisted gait training within the last 6 months.\n* Intolerance to virtual reality environments or motion simulation.\n* Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.\n* More than 135 kg total body weight.\n* More than 2.00 meters in body height.\n* Presence of open skin lesions or bandages in areas that would come into contact with the harness.\n* Functional Ambulation Category (FAC): Participants with an FAC score of less than 2 indicate they require physical support from more than one person to walk.\n\nClarification:\n\n\\- The diagnosis of TBI can be confirmed by their physician or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a physician to ensure it meets the study's medical criteria.",{"count":361,"type":21},[24],"The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for TBI patients.",[386],"Traumatic Brain Injury",[367,368,386],{"date":154,"type":41},{"date":372,"type":21},{"date":391,"type":21},"2027-06",{"name":47,"class":48},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":83,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":413,"locationsCount":414},"100642586","using-virtual-reality-travel-to-reduce-loneliness-in-older-adults-100642586","NCT07644416","Using Virtual Reality Travel to Reduce Loneliness in Older Adults","Virtual Reality Travel (VRT) as a Loneliness Intervention for Older Adults: A Pilot Randomized Controlled Trial","VRT","Inclusion Criteria:\n\n* Adults aged 65 years or older\n* Express willingness to engage with VR technology\n\nExclusion Criteria:\n\n\\- No self-reported physical, sensory, neurological, or cognitive conditions that would make VR use unsafe or impractical (e.g., uncontrolled seizures, severe vertigo, or significant uncorrected vision\u002Fhearing impairments).",{"count":241,"type":21},[24],"This study aims to investigate whether and how virtual reality travel (VRT) can reduce loneliness among older adults. It will utilize a mixed-methods research design that combines an randomly assigned experiment with follow-up semi-structured interviews.\n\nThis is a pilot study and it is essential to establish the feasibility and acceptability of the protocol, assess the tolerability of VR technology in this population prior to conducting a full-scale RCT, and generate preliminary effect size estimates to inform future sample size calculations.",[405,406,368,407],"Loneliness","Older Adults (65 Years and Older)","Leisure Activities","2026-08-12",{"date":346,"type":41},{"date":411,"type":41},"2026-06-01",{"date":156,"type":21},{"name":47,"class":48},3,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":434,"leadSponsor":436,"locationsCount":49},"100625276","early-phase-1-respiratory-and-real-time-dynamics-in-exercise-induced-paradoxical-vocal-fold-motion-100625276","NCT07420530","Respiratory and Real-time Dynamics in Exercise-Induced Paradoxical Vocal Fold Motion","EILO","Inclusion Criteria for Exercise-Induced Laryngeal Obstruction (EILO):\n\n* Physically active \\>2.5 hours per week\n* Patients with EILO, as diagnosed by routine clinical examination by physician and\u002For speech language pathologist\n* Age range of 18-26 years\n* Greater difficulty breathing inside compared to out and difficulty breathing which is exacerbated at peak exercise and stops 1-5 minutes after exercise\n* Score of 7 or higher on the Dyspnea Index, which is a validated instrument to capture participant self-report of upper airway dyspnea symptoms.\n* Classified as low risk, based on the modified Physical Activity Readiness Questionnaire (PAR-Q) questionnaire, body mass index, and non-smoking status\n* Negative history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure\u002Fepilepsy, claustrophobia, use of beta blockers.\n* No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.\n\nInclusion Criteria for Controls\n\n* Physically active \\>2.5 hours per week\n* Age range of 18-26 years\n* Classified as low risk, based on the modified PAR-Q questionnaire, body mass index, and non-smoking status\n* Negative history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure\u002Fepilepsy, claustrophobia, use of beta blockers.\n* No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.\n\nExclusion Criteria for EILO:\n\n* Individuals older than 26 years and younger than 18 years of age.\n* Women who are pregnant or could possibly be pregnant.\n* BMI \\> 25 kg\u002Fm2\n* A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire\n* Current smoker\n* Positive history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure\u002Fepilepsy, claustrophobia, use of beta blockers.\n* Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.\n* Do not report the following: Greater difficulty breathing inside compared to out and difficulty breathing which is exacerbated at peak exercise and stops 1-5 minutes after exercise\n\nExclusion Criteria for Controls\n\n* Individuals older than 26 years and younger than 18 years of age.\n* Women who are pregnant or could possibly be pregnant.\n* BMI \\> 25 kg\u002Fm2\n* A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire\n* Current smoker\n* Positive history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure\u002Fepilepsy, claustrophobia, use of beta blockers.\n* Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.\n* Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and\u002For compromise the objectives of the study","26 Years",{"count":424,"type":21},130,[426],"PHASE2","The overall objectives of the proposed research are to:\n\n1. Evaluate the diagnostic validity of a novel mechano-acoustic signatures of task-characteristic activity during symptomatic and asymptomatic breathing in Exercise-Induced Laryngeal Obstruction (EILO) patients with the use of a novel miniature, soft wearable skin-mounted device,\n2. Identify the mechanism\u002Fs of paradoxical respiratory control in EILO by quantifying the relationship between pulmonary mechanics, partial pressure of carbon dioxide (PCO2) maintenance, and vocal fold aperture prior to and during symptomatic and asymptomatic exercise ventilation, and\n3. Identify unique biophysiological factors contributing to EILO among exercisers with and without EILO. Findings will be highly novel and clinically significant for early identification and management of EILO.\n\nThe main study will enroll 60 participants with EILO and 60 without EILO to complete three separate visits:\n\n1. Exercise treadmill study\n2. Free running with the device on the neck\n3. Undergoing MRI (Magnetic Resonance Imaging) of the vocal tract.\n\nAn additional substudy limited to the mechanoacoustic device will enroll 10 additional participants (5 healthy and 5 with EILO). These participants will complete a single study visit during which the mechano-acoustic device will be worn during four sequential conditions.",[429,430,431],"Exercise-Induced Vocal Cord Dysfunction","Paradoxical Vocal Fold Motion","Vocal Cord Dysfunction",{"date":346,"type":41},{"date":408,"type":41},{"date":435,"type":21},"2032-01-20",{"name":47,"class":48},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":446,"phases":4,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":49},"100478139","deep-brain-stimulation-for-laryngeal-dystonia-from-mechanism-to-optimal-application-100478139","NCT05506085","Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application","Inclusion Criteria:\n\n* Patients with ADLD and ADLD plus tremor, as diagnosed by routine clinical examination by laryngologist, speech language pathologist, and neurologist.\n* Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) for ADLD with tremor\n* Age range of 18-80 years\n* Native speakers of American English will be recruited since there are known differences in voice and neural signals of native and non-native speakers\n* No evidence for dementia as assessed by neurologist.\n* No evidence for severe untreated mood disorder as assessed by neurologist, or as evident on self-report (Beck Depression Inventory-II score \\> 29, Beck Anxiety Inventory Score \\> 26.\n* At least 3 months since last botulinum toxin injection and the patients would need to be fully symptomatic with no residual effects of botulinum toxin on voice quality.\n\nExclusion Criteria:\n\n* Individuals younger than 18 years and older than 80 years of age.\n* Women who plan to become pregnant during the study period or are currently breastfeeding.\n* Prior history of stroke, brain surgery, or other neurological disorder besides the one under study.\n* Prior laryngeal framework surgeries or other disorders affecting the vocal folds\n* Patients who are asymptomatic due to treatment with botulinum toxin into the vocal folds.\n* Presence of ferromagnetic implants and cardiac implants that would be contraindicated to MRI\n* Gagging or discomfort that would preclude the placement of the endoscope to visualize the larynx\n* Dementia, severe depression or severe anxiety.\n* Any clinical condition or medication judged by the investigators to potentially preclude the patient from safely completing awake brain surgery and research protocols.","70 Years",{"count":445,"type":21},12,"OBSERVATIONAL","Deep Brain Stimulation (DBS) is a neurosurgical procedure used to treat tremors, and dystonia. This study will enroll people who have a form of focal dystonia that affects their vocal cords called Adductor Laryngeal dystonia (ADLD). Participants will undergo Deep Brain Stimulation surgery to treat laryngeal dystonia as part of their clinical care. Before surgery, as part of the study they will have specialized testing to study the movement of the vocal cords, as well as functional magnetic resonance imaging (fMRI). While in the operating room, researchers will examine brain waves to better understand how faulty brain firing patterns lead to dystonia. After surgery, and activation of the deep brain stimulator, participants will repeat speech testing and vocal cord imaging as well as magnetic resonance imaging (MRI).",[449,450],"Laryngeal Dystonia","Adductor Spastic Dysphonia of Dystonia",[452],"deep brain stimulation",{"date":346,"type":41},{"date":455,"type":41},"2022-10-01",{"date":457,"type":21},"2030-08-01",{"name":47,"class":48},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":443,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":327},"100642902","effect-of-gastric-electrical-stimulation-on-serum-insulin-levels-100642902","NCT07635576","Effect of Gastric Electrical Stimulation on Serum Insulin Levels","Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects","Inclusion Criteria:\n\n* • At least 18 years of age.\n\n  * Documented diagnosis of gastroparesis\n  * Not taking diabetic prescribed exogenous insulin.\n  * Patient has a GES device that has been implanted for at least 3 months.\n  * Willing to give up to 8 blood samples.\n  * Willing to lie in a bed for up to 5.5 hours.\n\nExclusion Criteria:\n\n* • Pregnancy\n\n  * History of allergic reaction to EKG lead placement adhesives.\n  * Unable to give informed consent.\n  * Unwilling to give up to 8 5 ml blood samples.\n  * Unwilling to lie in a bed for up to 5.5 hours.",{"count":467,"type":21},32,[24],"The goal of this observational study is to determine how much effect turning the subject's Gastric Electrical Stimulator off for up to four hours will have on levels of insulin, C-peptide, GLP-1 and Glucose levels in patients with gastroparesis who have had a GES for at least three months, who are not taking diabetic prescribed exogenous insulin. EKG recordings will be made and analyzed for Heart Rate Variability and Power Spectral Analysis.",[471],"Gastroparesis Nondiabetic",{"date":369,"type":41},{"date":474,"type":41},"2026-07-23",{"date":476,"type":21},"2028-07-31",{"name":47,"class":48},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":486,"minAge":18,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":490,"conditions":491,"keywords":495,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":49},"100615277","assessing-pain-and-effectiveness-of-carevix-device-for-iud-insertions-100615277","NCT07290517","Assessing Pain and Effectiveness of Carevix Device for IUD Insertions","The Carevix Device: Assessing Pain and Effectiveness of a Suction-based Cervical Stabilizer for IUD Insertions in the Clinic Setting: a Randomized, Controlled Trial (CARE)","CARE","Inclusion Criteria (to be assessed prior to procedure):\n\n* Age 18 years or older\n* Able to consent on their own\n* Scheduled and will undergo an IUD insertion within 90 days of consent\n* Planned use of cervical stabilization device for placement\n* Procedure being performed by a trained provider\n* Provider is willing to use Carevix™ for scheduled procedure\n\nExclusion Criteria (to be assessed by provider at time of procedure):\n\n* Vaginal bleeding of unknown origin\n* Cervix less than 26 mm in diameter\n* Nabothian cyst on anterior lip of cervix\n* Cervical myomas\n* Cervical abnormalities\u002Fshape\n* Pregnant\n* Participants who are not fluent in and\u002For do not fully understand, read, write, or speak the English language\n* Other inability to provide informed consent to participate\n* Initial attempt to place the IUD without any cervical stabilization","FEMALE",{"count":488,"type":21},100,[24],"The goal of this clinical trial is to evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between IUD insertions using a suction cervical stabilizer (new device, FDA approved, atraumatic) and single-tooth tenaculum (standard, traumatic). Our aims are to:\n\n* assess and compare patient-reported pain during IUD insertion between the Carevix device and tenaculum.\n* assess predictors of pain scores including between nulliparous and multiparous patients\n* assess provider-reported ease of use and satisfaction\n\nParticipants (including providers) will:\n\n* be randomized to receive one device to complete the IUD procedure\n* complete a survey following the procedure",[492,493,494],"IUD","Abnormal Uterine Bleeding","Pain, Cervical",[496,497,498,499],"IUD insertion","Cervical Stabilization","Tenaculum","Pain",{"date":369,"type":41},{"date":502,"type":41},"2026-03-11",{"date":504,"type":21},"2027-03",{"name":47,"class":48},{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":513,"maxAge":514,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":521,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":49},"100651786","eye-tracking-and-autism-in-former-preterm-infants-100651786","NCT07764822","Eye Tracking and Autism in Former Preterm Infants","Eye-Tracking Biomarkers for Early Autism Detection in Former Preterm Infants","Inclusion Criteria:\n\n* Children born at \\\u003C37 weeks' gestational age who are 14-48 months old at time of referral\n* Ambulatory (i.e., cruising, walking)\n* Without significant visual impairment\n* Referred for autism testing through EYP (i.e. medium- or high-risk M-CHAT-R\u002FF screening result at 16-22 months corrected age or by referral to Early Years based on caregiver or provider concern for autism)\n\nExclusion Criteria:\n\n* Non-English-speaking participants and families.","14 Months","48 Months",{"count":241,"type":21},[24],"This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.",[519,520],"Autism","Prematurity",[522,523,524],"autism","prematurity","eye tracking biomarkers","2026-08-10",{"date":346,"type":41},{"date":528,"type":21},"2027-01-04",{"date":530,"type":21},"2028-01-03",{"name":47,"class":48},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":22,"phases":541,"briefSummary":542,"conditions":543,"keywords":548,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":556,"locationsCount":49},"100651479","phase-2-prospective-study-on-radiation-induced-cardiotoxicity-assessed-by-pet-ct-for-locally-advanced-non-small-cell-lung-cancer-nsclc-100651479","NCT07761910","Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)","Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 at time of consent\n2. Ability to provide written informed consent and HIPAA authorization\n3. Stage III NSCLC per AJCC 8th edition guideline, confirmed by pathological diagnosis and PET\u002FCT.\n4. To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines.\n5. Tumor estimated to be within 2cm of heart contour or anticipated MHD\\>10Gy per treating physician.\n\nExclusion Criteria:\n\n1. Patients treated with stereotactic body radiotherapy (SBRT).\n2. Prior thoracic radiotherapy.\n\nExclusion for Coronary computed tomography angiography (CCTA)\n\n1. History of a severe anaphylactic reaction to iodinated contrast.\n2. Renal insufficiency (defined as estimated CrCl less than 30 mL\u002Fmin).\n3. Inability to hold breath for more than 5 seconds.\n4. Patients on radioactive iodine therapy.\n\nExclusion for 18F-Flurpiridaz PET\u002FCT Test\n\n1. Second-degree AV block, third-degree AV block, and sinus node disease (such as sick sinus syndrome or symptomatic bradycardia) without a functioning pacemaker.\n\n   Note: Resting 12-lead EKG will be ordered at the time of enrollment to be performed prior to PET\u002FCT stress test.\n2. Patients with bronchospastic diseases including asthma and chronic obstructive pulmonary disease (COPD) who have an acute exacerbation or active wheezing (a high-pitched, musical, adventitious lung sound produced by airflow through the narrowed airways) on the day of PET CT exam.\n3. Patients who are hypotensive (systolic blood pressure less than 90 mm Hg) on the day of the PET\u002FCT scan.",{"count":540,"type":21},10,[426],"Prospective clinical study designed to evaluate damage to the heart after receiving standard of care chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC).",[544,545,546,547],"Non Small Cell Lung Cancer","Cardiotoxicity","Locally Advanced Non-Small Cell Lung Cancer","Radiation Therapy",[549,550,551,545],"PET-CT","Radiation Injury","locally advanced Non-Small Cell Lung Cancer",{"date":408,"type":41},{"date":554,"type":21},"2026-09",{"date":504,"type":21},{"name":47,"class":48},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":49},"100636509","primary-ciliary-dyskinesia-in-adult-bronchiectasis-100636509","NCT07566611","Primary Ciliary Dyskinesia in Adult Bronchiectasis","Novel Use of Combined High-Speed Video Microscopy and Nasal Nitric Oxide Screening for Identification of Primary Ciliary Dyskinesia in Adult Bronchiectasis","Inclusion Criteria:\n\n* Adults (≥18) with CT-confirmed bronchiectasis\n\nExclusion Criteria:\n\n* Pre-existing diagnosis of cystic fibrosis\n* Pre-existing diagnosis of primary ciliary dyskinesia\n* Inability to perform testing\n* Refusal of consent",{"count":86,"type":21},[24],"The purpose of this study is to help determine how often primary ciliary dyskinesia (PCD) is present but undiagnosed in adults with bronchiectasis.",[568],"Idiopathic Bronchiectasis",{"date":408,"type":41},{"date":571,"type":41},"2026-07-17",{"date":573,"type":21},"2028-01-31",{"name":47,"class":48},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":446,"phases":4,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":49},"100416284","the-prevalence-of-hypoesthesia-related-keratitis-in-ocular-graft-vs-host-disease-gvhd-patients-100416284","NCT04700657","The Prevalence of Hypoesthesia Related Keratitis in Ocular Graft Vs. Host Disease (GVHD) Patients","Investigation of the Prevalence of Hypoesthesia Related Neurotrophic Keratitis in Patients With Ocular Graft Versus Host Disease","Inclusion Criteria:\n\n* Chronic GVHD is diagnosed based on the history of allogeneic HSCT (Hematopoietic stem cell transplant) and the presence of systemic GVHD in organs other than the eye. In the ocular GVHD group, dry eye symptoms start after the development of systemic GVHD. If post-HSCT dry eye precedes GVHD clinical signs in other organs, the investigators will use the 2013 diagnostic criteria by International chronic ocular GVHD consensus group.\n* The investigators will recruit patients for the study. The investigators plan to include ocular GVHD patients that are of age 18 years or older who have typical symptoms of dry eye with an Ocular Surface Disease Index (OSDI) score greater than 13 and corneal fluorescein staining (CFS) score of 3 or more (National Eye Institute \\[NEI\\] grading scale, 0-15). Normal age-matched volunteer group will include people whose OSDI less or equal to 13 and CFS score less than 3.\n\nThe patients will continue their current systemic and ocular medications, which may include one or combination of preservative free artificial tears, restasis or xiidra, serum tears, ointment, or scleral contact lens.\n\nExclusion Criteria:\n\n* patients with a history of herpetic simplex or zoster keratitis, ocular or neurologic surgery (including laser or refractive surgical procedure) within 3 months before enrollment, trauma, diabetes with signs of peripheral neuropathy.\n* patients with active corneal thinning or infection.",{"count":361,"type":21},"The Investigators hypothesize that the recalcitrant nature of ocular GVHD may be related to corneal nerve damage and corneal hypoesthesia. The investigators aim to study the prevalence of corneal hypoesthesia in GVHD patients and its correlation with ocular surface changes.",[585],"Ocular GVHD",{"date":408,"type":41},{"date":588,"type":41},"2020-12-17",{"date":590,"type":21},"2028-06",{"name":47,"class":48},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":239,"maxAge":443,"enrollmentInfo":599,"targetDuration":4,"studyType":22,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":608,"leadSponsor":609,"locationsCount":49},"100601067","effects-of-replacing-high-protein-foods-in-people-with-chronic-kidney-disease-100601067","NCT07105670","Effects of Replacing High Protein Foods in People With Chronic Kidney Disease","The Effects of Replacing Red Meat With Alternative Protein Sources on Gut-Derived Metabolites in People With Chronic Kidney Disease","Inclusion Criteria:\n\n* Age 40-70 years\n* Male or postmenopausal female\n* Stage 3 CKD (eGFR between 30-59ml\u002Fmin\u002F1.73m\\^2 by the CKD-EPI equation (without race correction)).\n* If eGFR is greater than or equal to 45ml\u002Fmin\u002F1.73m\\^2 then albuminuria must be greater than 300mg\u002Fg creatinine by spot urine.\n* Willing to consume controlled diet for duration of the study\n* Willing to collect fecal samples at home\n\nExclusion Criteria:\n\n* Hemoglobin A1c greater than 7% within previous six months\n* Treatment with metformin or insulin within previous three months\n* Blood pressure greater than 150\u002F100 mmHg from chart of home on at least two occasions in prior month (can be inclusive of screening visit)\n* Change in cardiovascular and\u002For hypertension medication in the last 30 days\n* History of major gastrointestinal disease (e.g. inflammatory bowel disease, uncontrolled irritable bowel syndrome, C. difficile chronic infection, celiac disease, diverticulitis, stomach or duodenal ulcers)\n* Known HIV disease\n* Hospitalization in the last two months\n* Significant recent unintentional weight loss (5% of weight over past three months)\n* Cancer or received cancer treatment in the last year (except basal cell carcinoma)\n* Prior bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)\n* Treatment with immunosuppressive medications in the past six months or more than one week of treatment with prednisone greater than 10mg per day in the past three months (or equivalent steroid dose of non-prednisone steroids)\n* Recent antibiotic use defined as a single course of antibiotics within the past three months or two or more courses within the past six months\n* Known food allergy that would influence the ability to consume the study diets\n* History of hyperkalemia defined as greater than 5.5mmol\u002FL on at least two occasions\n* Other medical conditions or concerns at the discretion of the investigators",{"count":600,"type":21},15,[24],"The goal of this crossover clinical trial is to explore the effects of red meat intake on serum and fractional urinary excretion of uremic toxins including trimethylamine N-oxide in people with chronic kidney disease.",[604],"Chronic Kidney Disease Stage 3","2026-08-09",{"date":182,"type":41},{"date":272,"type":21},{"date":125,"type":21},{"name":47,"class":48},{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":625,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":327},"100586412","cthpvdna-in-hpv-positive-squamous-cell-carcinoma-of-the-oropharynx-100586412","NCT06915038","ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx","Circulating Tumor HPV DNA Driven Adjuvant Treatment Deintensification After Transoral Surgery for HPV-Positive Squamous Cell Carcinoma of the Oropharynx","Inclusion Criteria:\n\nPre-Surgery\n\n* Subjects ≥ 18 years old at the time of informed consent.\n* Ability to provide written informed consent and HIPAA authorization.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).\n* Histopathologically confirmed squamous cell carcinoma.\n* Detectable ctHPVDNA from blood samples collected prior to treatment.\n* Resectable and accessible tumor with high probability of achieving negative margins.\n* Smokers and non-smokers included.\n* Tumor stage (AJCC 8th edition): T1 or T2, and select T3 tumors that are mobile and do not invade the larynx.\n* Nodal stage (AJCC 8th edition): N0, N1 or N2.\n* HPV+ tumor, as determined by p16, in-situ hybridization, real-time polymerase chain reaction, or ctHPVDNA.\n\nPost-Surgery\n\n• Subjects with unknown primaries included if primary is definitively identified and resectable with negative margins or if the palatine and lingual tonsils are thoroughly resected and pathologically proven to be negative for a primary.\n\nExclusion Criteria:\n\n* Serious medical condition preventing general anesthesia for surgery.\n* History of previous head and neck radiation or previous head and neck cancer within 3 years.\n* Distant metastatic disease present.\n* Subjects with synchronous HPV+ oropharynx primaries\n* Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study.\n* Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test on the day of surgery. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:\n\n  1. Has undergone a hysterectomy or bilateral oophorectomy; or\n  2. Has been naturally amenorrheic for at least 12 consecutive months.",{"count":137,"type":21},[24],"This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.",[621,622,623,624],"Squamous Cell Carcinoma of Oropharynx","HPV Positive Cancer","Throat Cancer","Tonsil Cancer",[626,627,628,629],"NavDX","HPVctDNA","HPV","transoral surgery",{"date":182,"type":41},{"date":632,"type":41},"2025-06-11",{"date":634,"type":21},"2028-12",{"name":47,"class":48},""]