[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Minnesota\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":551},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,198,0,25,[9,42,59,86,108,130,153,172,194,214,237,254,272,292,315,342,365,384,406,432,450,466,484,514,533],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100054061","oxidative-stress-and-inflammatory-biomarkers-in-gaucher-disease-100054061",false,"NCT02437396","Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease","Novel Inflammatory Biomarkers Complement 5A and Hepcidin in Patients With Gaucher Disease (GD)","Inclusion criteria:\n\n1. All participants must be 18 years or older.\n2. All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.\n3. Individuals with Gaucher disease who are medically stable for participation in study in the opinion of the investigator.\n4. GD subjects must be stable on a specific ERT and\u002For SRT therapy at a specific dose (for e.g. on a units\u002Fkg basis) for at least 2 years or be naïve to these therapies (no therapy for 2 years).\n5. GD1 patients, who have had a change in therapy i.e. a change in dose or switch from one drug to another, can be enrolled after at least 6 months have elapsed since the change and is considered stable in the opinion of the clinician providing care to the patient.\n6. All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study.\n\nExclusion Criteria:\n\n1. Medically unstable conditions in any group as determined by the investigators\n2. Concurrent disease; medical condition; or an extenuating circumstance that, in the opinion of the investigator, might compromise subject safety, study compliance, completion of the study, or the integrity of the data collected for the study.\n3. Females who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception\n4. History of asthma that is presently being treated\n5. Subjects who cannot or are unwilling to have blood drawn\n6. Unable to adhere to study protocol for whatever reason","ALL","18 Years","75 Years",{"count":21,"type":22},34,"ESTIMATED","OBSERVATIONAL","The objective of this study is to evaluate oxidative stress and\u002For inflammation in patients with Gaucher disease type I using a series of biomarkers and correlate with measurements of currently used diagnostic biomarkers.",[26,27,28],"Gaucher Disease Type I","Oxidative Stress","Inflammation","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2015-10",{"date":37,"type":22},"2026-10-30",{"name":39,"class":40},"University of Minnesota","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":53,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":41},"100053973","deciphering-circulating-signatures-of-infected-pancreatic-necrosis-100053973","NCT06899087","DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis","Inclusion Criteria:\n\n* Adults aged \\>18 years.\n* Diagnosis of NP based on CECT.\n\nExclusion Criteria:\n\n* recurrent AP\n* pancreatic cancer\n* pregnancy, lactation\n* solid organ transplant\n* immunodeficiency disorders like AIDS.",{"count":49,"type":22},45,"The purpose of the study is to identify novel blood-based biomarkers for prediction and diagnosis of infected pancreatic necrosis (IPN) in patients with necrotizing pancreatitis (NP).\n\nAcute pancreatitis (AP) is the leading cause of gastrointestinal hospital admissions, accounting for over 300,000 emergency department visits annually and imposing a significant socio-economic burden. It is an acute inflammatory condition of the pancreas characterized by damage to the acinar cells, which triggers an inflammatory response and causes widespread systemic damage. In about 20% of cases, the disease progresses to necrotizing pancreatitis (NP), a severe form characterized by tissue necrosis. NP poses serious health risks, especially when the necrotic tissue becomes infected, leading to infected (peri-)pancreatic necrosis (IPN), which is associated with secondary organ failure (OF), sepsis, and mortality rates as high as 40%. While patients with sterile (peri-)pancreatic necrosis (SPN) can often be managed conservatively, those with IPN typically require antibiotics and therapeutic interventions such as endoscopic drainage or surgery.\n\nTimely recognition and treatment of IPN are crucial for improving patient outcomes, yet current diagnostic methods based on clinical symptoms and routine lab markers lack the specificity to reliably distinguish SPN from IPN in the early stages. Furthermore, while multifactorial scoring systems like Ranson, Imrie, and APACHE II predict necrosis and overall severity in AP, they are not accurate for identifying IPN or predicting mortality in NP. The diagnostic gap delays appropriate treatment, allowing the infection to advance and limiting available therapeutic options. The growing incidence and significant impact of AP and NP in the general population underscore the urgent need to better understand IPN pathophysiology and to develop specific diagnostic biomarkers that can improve prognosis, guide therapeutic decisions, and enhance patient outcomes.",[52],"Acute Pancreatitis",{"date":32,"type":33},{"date":55,"type":33},"2025-07-01",{"date":57,"type":22},"2026-12-01",{"name":39,"class":40},{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":41},"100053998","phase-2-dora-and-lp-in-alzheimers-disease-biomarkers-100053998","NCT06274528","DORA and LP in Alzheimer's Disease Biomarkers","Effect of a Dual Orexin Receptor Antagonist on CSF Alzheimer's Disease Biomarkers","Inclusion Criteria:\n\n* Male or female.\n* Any race or ethnicity.\n* Participants must be age ≥ 65 years and able to sign informed consent.\n* Global Clinical Dementia Rating (CDR) 0.\n* Willing and able to undergo study procedures.\n\nExclusion Criteria:\n\n* History or reported symptoms suggestive of restless legs syndrome, narcolepsy, or parasomnia.\n* STOP-Bang score \\>6 for participants without PAP.\n* Untreated sleep apnea AHI\\>15\n* Poorly treated sleep apnea due to noncompliance or an AHI ≥ 10.\n\n  \\- PAP compliance is defined as ≥ 4 hours per night \\>70% of the nights.\n* Plasma p-Tau217\u002Fnp-Tau217% \\\u003C2.5\n* Stroke.\n* History of renal impairment\n\n  * Defined as older adult patients with markers of kidney damage or eGFR \\\u003C 45.0 ml\u002Fmin\u002F1.73m2.\n  * Normal Limits ≥ 45.0 mL\u002Fmin\u002F1.73m2\n* History of hepatic impairment\n\n  * AST and\u002For ALT ≥ 2X upper limit of normal (ULN).\n  * Normal Limits: AST 11-47 IU\u002FL and ALT 6-53 IU\u002FL\n* HIV\u002FAIDS.\n* History of substance abuse or alcohol abuse in the preceding 6 months.\n* Regular alcohol consumption 3 or more days a week over the last 6 months. Regular alcohol consumption is defined as having more than 2 alcoholic beverages within 3 hours of bedtime. Participants that agree to reduce alcohol consumption during the study may not be excluded.\n* History of presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or participant report that could affect the safety of the participant or interfere with study assessments or in the judgement of the Principal-Investigator (PI) if participant is not a good candidate.\n* Has any medical condition that, in the PI's or study team investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection\u002Fanalysis of the data. Potential medical conditions that will be exclusionary at the PI's or study team investigator's discretion:\n\n  * Cardiovascular disease requiring medication except for controlled hypertension.\n  * Pulmonary disease.\n  * Type I diabetes.\n  * Neurologic or psychiatric disorder requiring medication.\n  * Untreated depression\n  * Tobacco use.\n  * Use of sedating medications.\n  * Use of medications that interact with lemborexant (if cannot be discontinued).\n  * Abnormal safety labs.\n* History of current suicidal ideations.\n* Inability to speak and understand English.\n* Currently pregnant or breast-feeding.\n* In the opinion of the PI, the participant should be excluded due to an abnormal physical examination.\n* Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment.\n* Must not participate in another drug or device study prior to the end of this study participation.\n\nOptional assessment exclusion criteria:\n\n• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).",true,"65 Years",{"count":69,"type":22},201,"INTERVENTIONAL",[72],"PHASE2","The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the blood. Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease.",[75],"Alzheimer Disease",[77,78,79],"Sleep","Older Adults","DORA",{"date":32,"type":33},{"date":82,"type":33},"2024-03-11",{"date":84,"type":22},"2030-03-31",{"name":39,"class":40},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":66,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":70,"phases":95,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":41},"100053331","phase-2-sleep-trial-to-prevent-alzheimers-disease-100053331","NCT04629547","Sleep Trial to Prevent Alzheimer's Disease","SToP-AD","Inclusion Criteria:\n\n* Male or female.\n* Any race or ethnicity.\n* Participants must be age ≥65 years and able to sign informed consent.\n* Global Clinical Dementia Rating (CDR) 0.\n* Willing and able to undergo study procedures.\n\nExclusion Criteria:\n\n* History of reported symptoms suggestive of restless legs syndrome, narcolepsy or other central disorder of hypersomnolence, or parasomnia\n* STOP-Bang score \\>6 for participants without PAP\n* Untreated OSA with AHI ≥15 on home sleep test\n* Treated sleep apnea with PAP non-compliance\n\n  * PAP compliance is defined as \\>= 4 hours per night \\>70% of the nights\n* Plasma A-beta and tau test with a plasma p-tau 217% ≤ 1.19\n* Stroke.\n* Chronic kidney disease defined as patients with markers of kidney damage or eGFR of \\\u003C 45 ml\u002Fmin\u002F1.73m2.\n* Hepatic impairment defined as AST and\u002For ALT \\> 2x upper limit of normal (normal limits AST: 11-47 IU\u002FL, ALT: 6-53 IU\u002FL).\n* HIV\u002FAIDS.\n* History of substance abuse or alcohol abuse in the proceeding 6 months.\n* Regular alcohol consumption 3 or more days a week over the last 6 months. Regular alcohol consumption is defined as having more than 2 alcoholic beverages within 3 hours of bedtime. Participants that agree to reduce alcohol consumption during the study may not be excluded.\n* History of presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or participant report that could affect the safety of the participant or interfere with study assessments or in the judgement of the Principal-Investigator (PI) if participant is not a good candidate.\n* Has any medical condition that, in the PI's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection\u002Fanalysis of the data. Potential medical conditions that will be exclusionary at the PI's discretion:\n\n  * Cardiovascular disease requiring medication except for controlled hypertension.\n  * Pulmonary disease.\n  * Type I diabetes.\n  * Neurologic or psychiatric disorder requiring medication.\n  * Tobacco use.\n  * Use of sedating medications.\n  * Use of medications that interact with suvorexant (if cannot be discontinued)\n  * Abnormal safety labs\n* History of current suicidal ideations.\n* Currently pregnant or breast-feeding.\n* In the opinion of the PI, the participant should be excluded due to an abnormal physical examination.\n* Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment.\n* Must not participate in another drug or device study prior to the end of this study participation.\n\nExclusion criteria for optional lumbar punctures\n\n-• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).",{"count":94,"type":22},120,[72],"The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.",[77,75],[99,100,101],"poor sleep","Amyloid-Beta","Insomnia",{"date":32,"type":33},{"date":104,"type":33},"2022-05-25",{"date":106,"type":22},"2028-05",{"name":39,"class":40},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":70,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":41},"100053487","fast-her-fasting-effects-on-breast-cancer-treatment-100053487","NCT07624617","Fast-Her: Fasting Effects on Breast Cancer Treatment","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed metastatic breast cancer\n* Menopausal or medically ovarian suppressed\n* Currently receiving capivasertib therapy (2 tablets twice daily, 4 days per week)\n* Stable on current capivasertib regimen for at least 2 weeks\n* an ECOG performance status of 0-1\n* BMI ≥25kg\u002Fm2\n* Able to provide informed consent\n* Willing to comply with study procedures including CGM wear, food tracking by mCC app and dietary modifications\n* Access to smartphone or tablet for mobile application use\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Uncontrolled type 2 diabetes (HbA1c \\>9.0%)\n* History of severe hypoglycemia\n* Eating disorders or contraindications to fasting\n* Pregnancy or breastfeeding\n* Significant gastrointestinal disorders affecting food absorption\n* Unable to fast for medical reasons\n* Concurrent participation in other dietary intervention studies\n* A history of significantly abnormal lab results within 4 weeks of consent date, such as hematologic (Hgb \\\u003C 10.0, platelets \\\u003C 100), hepatic (LFTs \\> 2X nl), renal (Cr \\> 1.5)",{"count":115,"type":22},15,[117],"NA","We hypothesize that promoting a fasting state will strengthen the anti-cancer effects of PI3K inhibitors in metastatic breast cancer (MBC) treatment. The primary objective of this study is to assess acceptability of prolonged fasting in this population.",[120],"Metastatic Breast Cancer",[122],"capivasertib","2026-07-09",{"date":32,"type":33},{"date":126,"type":33},"2026-05-18",{"date":128,"type":22},"2027-07-01",{"name":39,"class":40},{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":136,"minAge":18,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":70,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":41},"100053612","phase-4-modifying-progesterone-and-estradiol-levels-to-prevent-postpartum-cigarette-smoking-relapse-and-reduce-secondhand-smoke-exposure-in-infants-and-children-100053612","NCT04783857","Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children","Inclusion Criteria:\n\n* Ability to provide informed consent,\n* Aged 18 to 45 years old\n* Self-reported stable physical and mental health\n\n  1. self-report uncomplicated pregnancy at gestational week 30 or beyond, or\n  2. self-report the birth of a child within the past 6 months\n* History of ≥ 4 cigarettes per month during the six months prior to pregnancy\n* At enrollment, self-report of motivation to become and\u002For remain abstinent after delivery ≥ 6 on a 10 point Likert-type scale\n* Willingness to protect against pregnancy following day 0 to week 12 of the study\n* Participants must live in the continental US and have a device to fully participate in the protocol\n\nExclusion Criteria:\n\n* Current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes\n* Current major depressive disorder based on the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory\n* Contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy),\n* Current or within the past 3 months treatment for illicit drug use or alcohol use\n* Any condition or issue that, in the opinion of the clinical team, precludes participation in the trial.","FEMALE","45 Years",{"count":139,"type":22},171,[141],"PHASE4","The investigators aim to address the following specific aims:\n\n* Determine the efficacy of Prog in preventing postpartum smoking relapse and reducing smoking relapse risk factors.\n* Examine the effects of this maternal smoking intervention on infant health.\n* Examine racial and ethnic differences in intervention outcomes.",[144,145,146],"Smoking","Smoking Cessation","Smoking Reduction",{"date":32,"type":33},{"date":149,"type":33},"2022-04-14",{"date":151,"type":22},"2027-06-02",{"name":39,"class":40},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":41},"100642578","mri-as-noninvasive-innovative-approach-in-detection-and-monitoring-of-malignant-oral-lesions-in-fanconi-anemia-patients-100642578","NCT07649031","MRI as Noninvasive Innovative Approach in Detection and Monitoring of Malignant Oral Lesions in Fanconi Anemia Patients","Inclusion Criteria:\n\n* Patients with a diagnosis of Fanconi Anemia who are willing to participate and willing to have MRIs\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Patient without diagnosis of FA\n* Patients with FA who are under the age of 18\n* Unable to tolerate any MRI due to claustrophobia\n* Any contraindication for the MRI\n* Unable to provide informed consent or comply with the study protocol",{"count":160,"type":22},80,"This study being done to learn more about the use of medical Magnetic Resonance Imaging (mMRI) and dedicated dental MRI (ddMRI) as a non-invasive diagnosing tool when evaluating potential oral cancerous and precancerous lesions in Fanconi Anemia patients.",[163],"Fanconi Anemia","2026-06-30",{"date":166,"type":33},"2026-07-02",{"date":168,"type":33},"2026-06-23",{"date":170,"type":22},"2030-05-31",{"name":39,"class":40},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":67,"enrollmentInfo":178,"targetDuration":4,"studyType":70,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":41},"100616093","myofunctional-therapy-for-obstructive-sleep-apnea-100616093","NCT07301125","Myofunctional Therapy for Obstructive Sleep Apnea","Inclusion Criteria:\n\n* Adults aged 18-65\n* New diagnosis of OSA (AHI ≥ 5) or failure of first-line OSA treatment\n* Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months\n\nExclusion Criteria:\n\n* Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia)\n* Severe nasal obstruction\n* Severe ankyloglossia\n* Craniofacial abnormality\n* Severe pulmonary disease\n* Severe post-traumatic stress disorder (PCL-5 \\> 33)\n* Very severe insomnia (ISI \\> 22)\n* Body mass index (BMI) ≥30 kg\u002Fm2.\n* History of TBI\n* Known oropharyngeal or esophageal dysphagia\n* Pregnancy\n* Allergy to topical anesthetic\n* Inability to fast for 6 hours\n* Recent facial trauma\n* Recent nasal, pharyngeal, laryngeal, or esophageal surgery\n* Known nasal, pharyngeal or esophageal obstruction\n* Current upper respiratory infection\n* Insufficient internet\u002Fcomputer access to participate in remote study visit\n* Severe excessive daytime sleepiness (risk of motor vehicle accidents)\n* Heart failure, recent stroke, heart attack, etc.\n* Nasal Obstruction Symptom Evaluation (NOSE) Scale \\>15",{"count":179,"type":22},30,[117],"The purpose of this study is to explore a new way to examine the function of the muscles using a technique called high-resolution manometry. The study will enroll 30 adults with OSA, all of whom will use the myofunctional therapy (MFT) devices for 3 months. High-resolution manometry will be used to measure the amount of pressure generated by the muscles of the throat when drinking water or breathing air, both with and without the MFT devices, and before and after the MFT intervention. If successful, this method can help us understand why sleep improves after MFT.",[183],"Obstructive Sleep Apnea",[183,185,186],"Myofunctional Therapy","High-Resolution Manometry",{"date":188,"type":33},"2026-07-01",{"date":190,"type":22},"2026-07-15",{"date":192,"type":22},"2027-09-30",{"name":39,"class":40},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":200,"targetDuration":4,"studyType":70,"phases":202,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":41},"100569279","phase-1-an-open-label-pilot-clinical-trial-to-test-the-safety-and-feasibility-of-a-suspension-of-freeze-dried-microbiota-in-patients-undergoing-colon-resection-100569279","NCT06692179","An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection","Inclusion Criteria:\n\n* Able\u002Fwilling to provide informed consent\n* Between 18-75 years of age\n* Undergoing surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) not predicted based on pre-operative National Comprehensive Cancer Network guidelines to meet criteria for adjuvant chemotherapy, or a history of diverticulitis.\n* Able to provide fecal samples.\n* Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and\u002For video visits or correspondence\n\nExclusion Criteria:\n\n* Any history of inflammatory bowel disease\n* Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child-bearing potential on the proposed day of MTP-101P (prior to its administration). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive MTP-101P.\n* Life expectancy of \\\u003C 6 months\n* Presence of ileostomy or colostomy\n* Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)\n* Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg\u002Fday, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).\n* Patients with neutropenia (an absolute neutrophil count \\\u003C0.5 x 10\\^9 cells\u002FL) obtained on a complete blood count with differential at screening.\n* History of solid organ or bone marrow transplant.\n* Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis).\n* History of severe anaphylactic food allergy.\n* History of celiac disease.\n* Patients receiving cancer chemotherapy, immunotherapy, or radiation.\n* Subjects who, in the opinion of the Investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.",{"count":201,"type":22},40,[203],"PHASE1","This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. We plan to enroll male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. We will recruit 40 patients total to receive the investigational product. This trial will inform development of future trials in treatment of colon and rectal surgery. Active drug is composed of highly purified, freeze-dried, fecal microbiota from healthy donors. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment. The exploratory objective is to evaluate engraftment of donor microbiota with this preparation and compare the results with data generated with the data generally from microbiota transplantation (IND28152). Stool samples may be returned via mail rather than clinic visit.",[206,207],"Recurrent Clostridioides Difficile Infection","Colonic Surgery",{"date":166,"type":33},{"date":210,"type":33},"2025-02-18",{"date":212,"type":22},"2027-02-18",{"name":39,"class":40},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":66,"sex":17,"minAge":137,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":41},"100551741","pathways-mediating-impaired-postural-control-in-parkinsons-disease-100551741","NCT06464029","Pathways Mediating Impaired Postural Control in Parkinson's Disease","Inclusion Criteria:\n\nParticipants with Parkinson's disease\n\n* Diagnosis of idiopathic PD or dystonia as determined by a movement disorders neurologist in accordance with the UK Society Brain Bank diagnostic criteria.\n* Age 45-80 years.\n* Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters.\n\nHealthy Older Adults (Control participants)\n\n* Age 45-80 years (this group will be age and sex-matched to the PD group)\n* Able to ambulate independently without the use of an assistive device (cane or walker)\n\nHealthy Young Adults\n\n* Age 21-44 years (this group will be age and sex-matched to the PD group)\n* Able to ambulate independently without the use of an assistive device (cane or walker)\n\nExclusion Criteria:\n\n* Subjects who describe a history of a frequent vasovagal syncope (fainting) in response to blood, emotional stress, or sensory triggers.\n* Subjects who are on anti-coagulant medications.\n* Any musculoskeletal disorder that affects the ability to stand.\n* History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury.\n* Intracranial metallic or magnetic devices.\n* Pacemaker or any implanted device.\n* History of surgery on blood vessels, brain or heart.\n* Unexplained, recurring headaches or concussion within the last six months.\n* Moderate to severe hearing impairment.\n* Subjects who are pregnant.\n* Dementia diagnosis\n* Other significant neurological disorders that may affect participation or performance in the study\n* Implanted deep brain stimulator or other neurosurgeries to treat PD.","80 Years",{"count":222,"type":22},160,"The purpose of this project is to use transcranial magnetic stimulation (TMS) to explore the state of excitability of corticocortical and corticofugal (cortex to spinal cord, cortex to brainstem to spinal cord) pathways that project to muscles that control the legs and trunk in people with Parkinson's disease. The outcome variables will be further analyzed to understand their relationship to quantitative measures of postural instability and gait dysfunction. As such, the project can be classified as basic physiologic research. The protocol is not designed to determine if measures of corticocortical or corticofugal excitability can be used as a biomarker to predict disease progression.",[225],"Parkinson Disease",[227,228,229,230],"gait","posture","transcranial magnetic stimulation","Parkinson's disease",{"date":166,"type":33},{"date":233,"type":33},"2024-06-01",{"date":235,"type":22},"2027-06-10",{"name":39,"class":40},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":244,"targetDuration":4,"studyType":70,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":41},"100544591","phase-1-intestinal-microbiota-transplantation-in-patients-undergoing-colon-resection-100544591","NCT06370884","Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection","An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection","Inclusion Criteria:\n\n* Able\u002Fwilling to provide informed consent\n* Between 18-75 years of age\n* Undergoing surgery for a history of diverticulitis or sigmoid colon cancer.\n* Able to provide fecal samples\n* Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and\u002For video visits or correspondence\n\nExclusion Criteria:\n\n* Any history of inflammatory bowel disease\n* Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child- bearing potential on the proposed day of IMT (prior to the receipt of IMT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive IMT treatment.\n* Life expectancy of \\\u003C 6 months\n* Presence of ileostomy or colostomy\n* Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)\n* Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg\u002Fday, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors)\n* Patients with neutropenia (an absolute neutrophil count \\\u003C 0.5 x 109 cells\u002FL) obtained on a complete blood count with differential at screening.\n* History of solid organ or bone marrow transplant.\n* Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis).\n* History of severe anaphylactic food allergy.\n* History of celiac disease.\n* Patients receiving cancer chemotherapy, immunotherapy, or radiation.",{"count":201,"type":22},[203],"This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive IMT solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT, recipients will be screened for inclusion\u002Fexclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43\" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics).",[206,207],{"date":166,"type":33},{"date":250,"type":33},"2024-02-01",{"date":252,"type":22},"2026-09-01",{"name":39,"class":40},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":70,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":41},"100605156","phase-1-combined-tdcs-and-cognitive-training-as-an-adjunctive-treatment-in-opioid-use-disorder-100605156","NCT07158853","Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder","Inclusion Criteria:\n\n* Ability to provide consent and comply with study procedures\n* Diagnostic and Statistical Manual of Mental Disorders criteria for OUD\n* Undergoing medication treatment for OUD. Participants may have current comorbid drug use, but primary diagnosis must be OUD\n* Intention to remain in the study until intervention completion.\n\nExclusion Criteria:\n\n* Any medical condition with neurological sequelae\n* Head injury resulting in skull fracture or loss of consciousness of \\>30 minutes\n* Any tDCS or MRI contraindication (tDCS: history of seizures, metallic cranial plates\u002Fscrews or implanted device, history of eczema on scalp. MRI: unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, or claustrophobia)\n* Any psychotic disorder (participants with other treated and stable psychiatric disorders will be included)\n* Presence of a condition that would render study measures impossible to administer or interpret\n* Age younger than 18\n* Primary current substance use disorder on a substance other than opioids except for caffeine or nicotine\n* In treatment instead of jail\n* Pregnancy\n* Disrespectful behavior towards the investigators and staff.",{"count":201,"type":22},[203],"The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals taking medication for treatment for Opioid Use Disorder(OUD).",[264],"Opioid Use Disorder","2026-06-26",{"date":164,"type":33},{"date":268,"type":33},"2026-02-04",{"date":270,"type":22},"2027-08-31",{"name":39,"class":40},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":278,"targetDuration":4,"studyType":70,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":41},"100573540","phase-2-evaluation-of-microbiota-transplant-therapy-in-patients-with-alopecia-areata-100573540","NCT06747611","Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata","Inclusion Criteria:\n\n* Patients 18 to 75 years of age with moderate to severe alopecia areata (SALT score \\>30%).\n* Patients with a diagnosis of patch type alopecia areata, totalis, or universalis..\n* Duration of hair loss \\>=3 months..\n* No evidence of active, ongoing regrowth present at baseline.\n* Females of childbearing potential must have a negative urine or serum pregnancy test at screening and immediately prior to MTT.\n* Females of childbearing potential must agree to use an effective form of contraception from 14 days prior to study antibiotics through at least 30 days after MTT. Acceptable forms of contraception include oral or intramuscular contraceptives, intrauterine devices, surgical sterilization.\n* Participants are not enrolled in another clinical study.\n* If undergoing treatment with a JAK inhibitor, participant is willing to discontinue treatment for 1 month prior to enrollment and throughout the duration of the study.\n\nExclusion Criteria:\n\n* Active gastrointestinal infection at time of enrollment.\n* Having been administered antibiotics in the last 48 hours.\n* Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to treatment..\n* Requires continued antibiotic use\n* Allergy to study antibiotics (vancomycin, neomycin).\n* Known or suspected severe gastrointestinal dysmotility disorder, e.g., gastroparesis, pseudo-obstruction, scleroderma with gastrointestinal involvement\n* Ileus or small bowel obstruction.\n* Major gastrointestinal surgery (e.g., significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.\n* History of total colectomy.\n* Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy.\n* Unable or unwilling to comply with protocol requirements.\n* Expected life expectancy \\< 6 months.\n* Previous MTT or microbiome-based products at any time excluding this study.\n* History of severe anaphylactic or anaphylactoid food allergy.\n* Solid organ transplant recipients 90 days post-transplant or on active treatment for rejection.\n* A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.\n* History of or existing skin diseases affecting the scalp such as psoriasis or seborrheic dermatitis and patients with evidence of infection or skin cancer in the treated areas.\n* Patients in whom the diagnosis of alopecia areata is questionable.\n* Patients in whom regrowth is present\u002Fevident at baseline in the areas to be treated.\n* Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma of the skin) which in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections.\n* Patients unwilling or unable to discontinue treatments known to affect hair regrowth in alopecia areata.\n* Patients who have been treated with intralesional steroids, systemic steroids, anthralin, squaric acid, DPCP (diphenylcycloprophenone), protopic, minoxidil, JAK inhibitors or other medication which in the opinion of the investigator may affect hair regrowth, within one month of the baseline visit..\n* Patients determined by the investigator to have extreme diets..\n* Pregnant and breastfeeding females..",{"count":201,"type":22},[72],"Alopecia Areata (AA) is among the most highly prevalent human autoimmune diseases, leading to disfiguring hair loss due to the collapse of immune privilege of the hair follicle and subsequent autoimmune attack. AA affects about 5.3 million people in the United States alone, including males and females across all ethnic groups, with a lifetime risk of 2.1%. Autoimmunity develops against the hair follicle, resulting in non-scarring hair loss that may begin as patches that can coalesce and progress to cover the entire scalp (alopecia totalis) or eventually the entire body (alopecia universalis). In AA, there is no permanent destruction of the hair follicle, and regrowth remains possible. Treatment options for AA include intralesional steroids, topical anthralin, allergic contact dermatitis with diphencyprone (DPCP), dinitrochlorobenzene (DNCB), or squaric acid dibutyl ester (SADBE), and recently janus kinase ( JAK) inhibitors. Despite the recent approval of JAKs for the treatment of extensive alopecia areata, some patients are treatment resistant, suffer relapses, or cannot take an oral immunosuppressive medication.\n\nThis study will attempt to elucidate the pre-treatment and post treatment skin and gut microbiome composition to determine whether specific bacterial species may correlate with disease or treatment response. To determine the effects of MTT on immune cell composition and activation systemically and locally in the skin, we will analyze major immune cell populations in peripheral blood samples and collect skin biopsies for histopathology and next generation sequencing analyses. Further, to determine if changes in immune cell populations affect the inflammatory response, we will profile inflammatory cytokines. To identify if changes in the gut microbiota influence the metabolic signature in AA, we will also perform untargeted metabolomics in stool gut microbiome samples and in plasma. Altogether, this comprehensive approach aims to identify the pathogenic immunological mechanisms associated with microbiome composition correlated to pre-treatment disease, post-treatment response, and any non-responders to treatment.",[282,283,284],"Alopecia Areata","Alopecia Totalis","Alopecia Universalis","2026-06-25",{"date":265,"type":33},{"date":288,"type":33},"2025-08-21",{"date":290,"type":22},"2028-03-15",{"name":39,"class":40},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":299,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":70,"phases":301,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":41},"100616095","pascal-feasibility-study-100616095","NCT07301151","PASCAL Feasibility Study","Feasibility of Using a Conversational Agent for Promoting Smoking Cessation Treatment Utilization","Inclusion Criteria:\n\n* Identify as Black or African American\n* Be at least 21 years of age\n* Meet a minimum smoking amount\n* Be willing to make a quit attempt in the next 30 days\n* Have a smartphone capable of downloading and running the study app\n* Be able to upload data from the app\n* Agree to receive text message reminders about study activities\n* Be a native English speaker\n* Reside in Minnesota.\n\nExclusion Criteria:\n\n* Medicinal nicotine use would require careful monitoring by a healthcare professional\n* Medical condition or medication used likely to significantly interfere with study outcomes or to be significantly affected by changes in smoking behavior\n* Are pregnant or breastfeeding","21 Years",{"count":94,"type":22},[117],"The goal of this randomized study is to assess if a conversational agent (or chatbot) that the investigators have developed to help with quitting smoking is acceptable to people trying to quit smoking and to also collect initial information regarding its effectiveness.\n\nIn this study, some participants trying to quit smoking will be provided with this chatbot while other participants will not be",[145,304],"Smoking (Tobacco) Addiction",[306,307],"cigarette smoking","chatbot",{"date":309,"type":33},"2026-06-24",{"date":311,"type":33},"2026-06-11",{"date":313,"type":22},"2027-06-30",{"name":39,"class":40},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":321,"maxAge":299,"enrollmentInfo":322,"targetDuration":4,"studyType":70,"phases":323,"briefSummary":324,"conditions":325,"keywords":331,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":41},"100489364","inhibitory-mechanisms-of-negative-urgency-in-adolescent-suicidal-behavior-100489364","NCT05652153","Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior","Inclusion Criteria:\n\n* Ages 13-21 years (inclusive)\n* Any sex, gender, race, or ethnicity\n* For participants 18 years of age or older, ability to provide written informed consent\n* For participants under 18 years of age, ability to provide written assent, with legal guardian's ability to provide written informed consent\n* Ability of participant (and parent\u002Fguardian, if applicable) to read and to communicate verbally and in writing in English (in order to permit comprehensive assessment of suicide risk by study team, and to facilitate safety planning and mitigation of suicide-related risks as necessary)\n* Current diagnosis of a unipolar depressive episode (major depressive episode, unspecified depressive disorder, or adjustment disorder with depressed mood), confirmed on the structured diagnostic interview (MINI or MINI-Kid)\n* For participants in the Dep\u002FSI group:\n\n  * Any lifetime history of suicidal ideation, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)\n  * No prior history of suicidal behavior (interrupted attempt, aborted attempt, or suicide attempt) as assessed by the C-SSRS\n* For participants in the Dep\u002FSB group:\n\n  \\-- Any lifetime history of suicidal behavior (interrupted attempt, aborted attempt, or suicide attempt) as assessed by the C-SSRS\n* If the study participant will be completing any of the assessments remotely through the use of video teleconferencing, access to a reliable internet connection will be required\n\nExclusion Criteria:\n\n* Imminent suicide risk as determined by the PI or other study board-certified child and adolescent psychiatrist (based on review of C-SSRS and SSI scales and clinical assessment of participant)\n* Current substance use meeting diagnostic criteria for a substance use disorder within the last month on the MINI or MINI-KID diagnostic interview (with the exceptions of caffeine and nicotine)\n* Lifetime history of psychosis, hypomania, or mania\n* Historical diagnosis of autism spectrum disorder or intellectual disability\n* Antiepileptic medication use or chronic benzodiazepine use (as-needed benzodiazepine use will be permitted if it can be held on day of study visit with TMS-EEG testing)\n* Pregnancy or suspected pregnancy in participants capable of becoming pregnant (assessed with urine pregnancy test)\n* Medical\u002Fneurologic history that would pose increased risks for transcranial magnetic stimulation (TMS) or magnetic resonance imaging (MRI), or factors that would impede completion of study procedures, including:\n\n  * Neurological disorders including seizure disorder, history of anoxia, history of head injuries with loss of consciousness for greater than 5 minutes\n  * Suicide attempt by hanging or strangulation (asphyxiation) leading to anoxia\n  * Any personal history of seizure or family history of epilepsy\n  * Any metallic implants, fragments, or devices\n  * Any cardiac pacemaker, medication pump, neural stimulator, or other implanted medical device\n  * Risk for increased intracranial pressure (e.g., history of intracranial mass)\n  * History of intracranial surgical procedure\n  * Any contraindication to TMS determined by the TMS Adult Safety Screen (TASS)\n  * Any contraindication to MRI identified on imaging center screening form\n* Any non-removable hair, head, or neck body modifications that would impede TMS and proper EEG recording","13 Years",{"count":160,"type":22},[117],"The goal of this study is to understand why some people act more impulsively when feeling negative emotions, which is called negative urgency. The researchers hope to understand how negative urgency relates to the way networks of brain cells communicate with one another. The researchers will measure negative urgency and brain signals in adolescents aged 13-21 years with depression and suicidal thoughts and behaviors.\n\nThe main questions it aims to answer are:\n\n* Whether a type of brain signaling called cortical inhibition is related to negative urgency\n* Whether depressed adolescents with suicidal behavior have more problems with cortical inhibition than depressed adolescents with suicidal thoughts only\n* Whether the relationship between negative urgency and cortical inhibition changes over time\n\nAdolescents who participate in the study will complete the following activities at the time they join the study, as well as 6 months and 12 months later:\n\n* Interviews with researchers and questionnaires to learn about their thoughts, emotions, and symptoms\n* A questionnaire about impulsive behaviors and negative urgency\n* Computerized games that measure brain functions\n* An MRI scan of the brain\n* Transcranial magnetic stimulation with electroencephalography (TMS-EEG), a way to measure how brain cells communicate (cortical inhibition) using a magnet placed outside of the head and recording brain signals",[326,327,328,329,330],"Suicidal Behavior","Suicidal Ideation","Negative Urgency","Cortical Inhibition","Depression",[326,327,328,329,330,332,333,334],"Adolescent","Transcranial Magnetic Stimulation","Electroencephalography","2026-06-18",{"date":168,"type":33},{"date":338,"type":33},"2024-05-25",{"date":340,"type":22},"2028-01",{"name":39,"class":40},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":70,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":355,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":364},"100610453","phase-2-b-palmz-for-tb-meningitis-100610453","NCT07227779","B-PaLMZ for TB Meningitis","A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS","Inclusion Criteria:\n\n* First Episode definite or probable TBM with physician intent to treat\n* Age ≥18 years\n* Provision of Informed Consent by participant or surrogate\n* Living with HIV\n* Weight \\> 35kg, estimate or measured\n\nExclusion Criteria:\n\n* Additional active and confirmed CNS infection\n* Known rifampicin-resistant TB\n* Allergy or contraindication to a study medicine\n* More than 5 doses of any TB therapy received within the previous 14 days\n* Presence of jaundice, known liver cirrhosis, elevated ALT or AST \\>3x ULN, or total bilirubin \\>2x ULN\n* Estimated Glomerular Filtration Rate \\\u003C30 ml\u002Fmin\u002F1.73m2\n* Significant cardiac comorbidity, heart failure, arrhythmia, or QTc \\>450 ms\n* Pregnancy or Breastfeeding\n* Cryptococcal antigen positivity in blood\n* Condition which makes participation not in the participant's best interest",{"count":350,"type":22},240,[72],"This two-stage study will compare consented research participants with tuberculous meningitis receiving BPaLMZ to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE.",[354],"Tuberculous Meningitis","NOT_YET_RECRUITING","2026-06-17",{"date":358,"type":33},"2026-06-22",{"date":360,"type":22},"2026-07-20",{"date":362,"type":22},"2030-08-31",{"name":39,"class":40},3,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":70,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},"100564623","phase-2-standardized-microbiota-transplant-therapy-in-crohns-disease-100564623","NCT06631586","Standardized Microbiota Transplant Therapy in Crohn's Disease","Inclusion Criteria:\n\n* Able and willing to provide informed consent.\n* 18-89 years of age.\n* English speaking.\n* Diagnosis of CD based on typical clinical and histologic features.\n* Active disease on endoscopy:\n\n  * SES-CD \\>= 6\n  * SES-CD \\>= 4 for isolated ileal disease\n* Current CD therapies are in the maintenance phase of dosing at the time of randomization.\n* Any ongoing CD therapy (apart from steroid use) must be at stable doses for 4 weeks prior to randomization and remain stable over study course.\n* Steroid use 20mg or less by 5 days prior to randomization.\n* Steroid use stipulations:\n* Prednisone must be tapered below 20mg after 7 days.\n* Any use of budesonide over the study period is allowed although tapering is encouraged.\n* Rescue medications: Steroid courses (up to 40mg for two weeks with a planned taper) are allowed at the discretion of the treating provider. Study drug therapy will be stopped on a case-by-case basis on discussion with the participant and treating provider.\n* Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g., absence of ovaries and\u002For uterus) must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device).\n\n  o Periodic abstinence and early withdraw are not acceptable methods.\n* Able to comply with study measures in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern.\n* Documented gastroparesis\n* History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.\n* Symptomatic stricture defined as a stricture that:\n\n  * Cannot be traversed by the colonoscope,\n  * Requires intervention to be traversed,\n  * Is otherwise responsible for the predominant clinical picture, in the opinion of the investigator.\n* Presence of ileostomy or colostomy.\n* Entero-vesicular fistula (i.e., fistula from bowel to bladder).\n* Suspicion of ischemic colitis, radiation colitis or microscopic colitis.\n* Diagnosis of ulcerative colitis.\n* Active or untreated infection.\n* Adenomatous polyps that have not been removed.\n* Use of antibiotics within 14-days of randomization.\n* Current pregnancy.\n* Current breastfeeding or planning to breastfeed over the study period.\n* History of anaphylactic food allergies.\n* End stage liver disease or cirrhosis.\n* Anticipated need for antibiotics over the study period.\n* Anticipated surgical procedure over the study period.\n* An absolute neutrophil count \\\u003C500 cell\u002FµL.\n* Diagnosis of a primary immunodeficiency.\n* Active malignancy requiring the use of chemotherapeutic agent (except for localized non-melanomatous skin cancers).\n* Patients receiving active cytotoxic therapy for solid tumors and hematologic malignancies.\n* Any solid organ transplant within 6 months of randomization.\n* Use of chimeric antigen receptor T-cell therapy or hematopoietic cell transplant within the past 12 months\n* Life expectancy \\\u003C=6 months.","89 Years",{"count":94,"type":22},[72],"Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.",[376],"Crohn Disease",{"date":358,"type":33},{"date":379,"type":33},"2025-01-15",{"date":381,"type":22},"2029-06-15",{"name":39,"class":40},2,{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":70,"phases":394,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":383},"100567294","phase-2-platform-trial-for-cryptococcal-meningitis-platform-cm-100567294","NCT06666322","Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)","Platform Trial For Cryptococcal Meningitis","PLATFORM-CM","Inclusion Criteria:\n\n* CSF cryptococcal antigen (CrAg) positive meningitis\n* Living with HIV\n* Ability and willingness to provide informed consent\n* Willing to receive protocol-specified lumbar punctures\n* Age \\>= 18 years\n* Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use reliable forms of contraception (duration will be indicated in each Trial Appendix).\n\nExclusion Criteria:\n\n* Received 3 or more doses of antifungal therapy for meningitis within last 30 days\n* Inability to take enteral (oral or nasogastric) medicine\n* Cannot or unlikely to attend regular clinic visits\n* Receiving chemotherapy or corticosteroids\n* Receiving hemodialysis or known liver cirrhosis\n* Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)\n* Pregnancy or breastfeeding\n* Previous administration of investigational study drug\n* Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments\n* Trial Appendix study-drug specific eligibility criteria",{"count":393,"type":22},2000,[72,395],"PHASE3","Cryptococcal meningitis is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy. Even with antifungal therapy, mortality rates remain high, especially in low and middle income countries where the ongoing HIV\u002FAIDS pandemic increases the risk of cryptococcosis among persons living with HIV infection. The combination of amphotericin and flucytosine (5-FC) has been the mainstay of therapy for the initial management of cryptococcal meningitis for 4 decades. Indeed, the effective delivery of these first line therapy in Africa can lower mortality to 25%. However, several challenges exist. First, even while 5-FC is included on the WHO list of essential medicines, the availability of 5-FC worldwide is limited. Second, liposomal amphotericin (Ambisome ®) is currently available from a single source supplier, creating risk. Third, current therapies have substantial toxicity. Lastly, with widespread agricultural fungicide use of azoles, the median fluconazole minimum inhibitory concentration (MIC50 ) for Cryptococcus has doubled since 2013. Globally, new or improved antifungals are needed for cryptococcal meningitis, particularly those which have less toxicity, greater efficacy, a prolonged half-life, and minimal drug-drug interactions. As multiple new antifungal medicines are on the horizon, this platform trial utilizes a master protocol to investigate, multiple regimens using standardized eligibility criteria, standardized study schedule of events, and standardized contemporary endpoints.",[398,399],"Hiv","Cryptococcal Meningitis",{"date":358,"type":33},{"date":402,"type":33},"2025-05-28",{"date":404,"type":22},"2032-04-21",{"name":39,"class":40},{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":70,"phases":416,"briefSummary":417,"conditions":418,"keywords":422,"overallStatus":355,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":429,"leadSponsor":431,"locationsCount":4},"100641099","feasibility-of-a-remotely-delivered-step-count-intervention-in-chronic-stroke-100641099","NCT07649135","Feasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke","Feasibility of Engaging Stroke Survivors in a Brief Step Count Intervention During Chronic Stroke","PA-ChatS","Inclusion Criteria:\n\n* Stroke diagnosis confirmed by imaging\n* Stroke occurred 6 or more months before study enrollment\n* Meet criteria for \"inactive\" on the International Physical Activity Questionnaire-Short Form\n* Able to identify a support person that they interact with in-person at least once per week\n* Able and willing to participate fully in the study and provide informed consent or proxy consent with participant assent\n\nExclusion Criteria:\n\n* Currently receiving care in a transitional care unit, skilled nursing facility, or other institutional care setting\n* Currently receiving outpatient neurorehabilitation services (e.g., physical therapy, occupational therapy, speech therapy)\n* Severe cognitive or communication impairments (inability to respond accurately to complete study screening questions or to provide informed consent or assent)\n* Currently pregnant or expecting to become pregnant in the next 8 weeks Comorbid neurological disorder (Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma, spinal cord injury, cerebral palsy)\n* Comorbid cancer, currently undergoing chemotherapy or radiation treatment\n* Received inpatient treatment or was hospitalized for a psychiatric condition and\u002For alcohol or substance abuse within the past 12 months\n* Current diagnosis of a terminal illness and\u002For currently receiving hospice care\n* History of allergic reaction to adhesives that precludes the use of an adhesive necessary for adherence to activPAL measurement\n* Uses wheelchair as primary mobility aid outside of home setting\n* Inability to speak, read, or understand English\n* Concurrent participation in another rehabilitation intervention research study\n* Resides more than 50 miles outside of the Twin Cities, Minnesota metropolitan area\n* Investigator discretion for safety or adherence reasons",{"count":415,"type":22},24,[117],"The goal of this study is to explore the feasibility of a new approach to rehabilitation that focuses on step count. Participants will complete 6 telephone or Zoom-based sessions with an occupational therapist over 6 weeks and use a step count tracker during that time. They will also complete questionnaires, assessments, surveys, and physical activity measurements during study weeks 0 (baseline), 3 (mid-point), 7 (post-intervention) and 12 (follow-up).",[419,420,421],"Stroke","Ischemic Stroke","Hemorrhagic Stroke",[423,424,425],"physical activity","behavior change","rehabilitation","2026-06-16",{"date":335,"type":33},{"date":358,"type":22},{"date":430,"type":22},"2027-01",{"name":39,"class":40},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":70,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":355,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":447,"leadSponsor":449,"locationsCount":4},"100604894","phase-3-perioperative-nutrition-optimization-for-reducing-complications-after-surgical-fracture-fixation-100604894","NCT07155447","Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation","Inclusion Criteria:\n\n1. Adults age 18-55 years\n2. Open or closed fracture of the lower extremity including femur, tibia and\u002For fibula, calcaneus, talus, Lisfranc joint (OTA\u002FAO 31, 32, 33, 41, 42, 43, 44, 4F, 81, 82, 83, 85)\n3. Ability to begin supplementation within 72 hours of injury\n\nExclusion Criteria:\n\n1. BMI \\\u003C18.5 kg\u002Fm 2 (underweight) or BMI \\> 45 kg\u002Fm 2 (severe obesity) to exclude patients with severely increased baseline risk of adverse outcome due to preoperative poor nutrition\n2. Non-ambulatory prior to injury\n3. Currently pregnant\n4. Medical contraindication to CEAA supplementation (e.g., phenylketonuria)\n5. Inability to provide informed consent due to intellectual disability\n6. Protected populations (e.g., prisoners)\n7. Inability to follow up (e.g., homeless at time of surgery, home address out of state of treating facility)\n8. Documented dementia, mild or moderate traumatic brain injury\n9. Inability to consume supplement or placebo due to head or neck trauma\n10. Low-energy fragility fracture (i.e. ground level falls)\n11. Pathologic fracture (i.e. fracture through site of compromised bone due to infection, neoplasm, documented osteoporosis, metabolic bone disease from conditions such as end stage renal disease, osteomalacia, hypophosphatemic rickets, renal osteodystrophy, osteofibrous dysplasia)","55 Years",{"count":440,"type":22},1000,[395],"The objective of this multi-center, prospective, placebo-controlled, randomized study is to compare oral conditionally essential amino acid (CEAA) supplementation for decreasing the key postoperative complications of fracture-related infection, fracture nonunion, and skeletal muscle wasting with a placebo control (PC) after lower extremity fracture fixation. Investigators hypothesize that perioperative oral supplementation with an investigational CEAA supplement (ICS) will reduce postoperative fracture-related infections, fracture nonunion rates, and skeletal muscle wasting in patients with traumatic lower extremity fractures. This is supported by strong pilot data. Conducting a randomized controlled trial at five civilian tertiary referral centers and one military treatment facility will further study the potential benefits of oral CEAA supplementation for preventing the stated key postoperative complications in patients following high energy lower extremity orthopedic trauma. This low cost, low risk intervention has demonstrated potential to expedite Warfighter return to duty as well as potentially reducing delayed limb amputations and mortality in severely injured patients.",[444],"Lower Extremity Fracture",{"date":335,"type":33},{"date":252,"type":22},{"date":448,"type":22},"2027-12-31",{"name":39,"class":40},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":66,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":41},"100595234","development-of-a-novel-evaluation-scale-of-mental-body-representation-mbr-for-adults-with-spinal-cord-injury-100595234","NCT07029802","Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury","Inclusion Criteria:\n\nControl group\n\n* Uninjured adults (from the contact list with the Brain Body Mind lab or through fliers or StudyFinder)\n* 18+ years old adults\n\nSCI group\n\n* 18+ years old, participants with an incomplete or complete SCI of ≥ 1 year\n* medically stable\n* able to read and understand English\n* having access to the internet\u002FiPad\u002Fcomputer\u002Fphone and willing to come in for an in-person testing at the University of Minnesota.\n\nExclusion Criteria:\n\nSCI group\n\n* Uncontrolled seizure disorder;\n* cognitive impairment and\u002For communicative disability (e.g., due to brain injury) preventing them from following directions or from learning;\n* ventilator dependency;\n* major medical complications;\n* pressure ulcers hindering prolonged sitting or lying down.",{"count":160,"type":22},"The purpose of this study is twofold: (1) Develop a new evaluation scale for mental body representations (MBR, i.e., body awareness and visuospatial body maps) for adults with spinal cord injury (SCI) with and without neuropathic pain. (2) Assess the psychometric properties of usability, reliability, and validity of the new evaluation scale This is a cross-sectional observational study design. For Aim 1, this study will involve initial item generation for a novel MBR evaluation scale for SCI through email communication, and individual interviews proctored remotely through Zoom, or, if preferred by the participant, in-person. For Aim 2, the study will include a Zoom call for consenting and questionnaires, as well as an in-person visit where participants will be tested with the new SCI-BodyMap evaluation scale, and a questionnaire asking about the usability and satisfaction of the new evaluation scale.",[459],"Spinal Cord Injuries",{"date":335,"type":33},{"date":462,"type":33},"2024-11-18",{"date":464,"type":22},"2027-06-15",{"name":39,"class":40},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":472,"enrollmentInfo":473,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":41},"100570328","cognitive-function-in-rett-syndrome-during-trofinetide-treatment-100570328","NCT06705816","Cognitive Function in Rett Syndrome During Trofinetide Treatment","Inclusion Criteria:\n\n* Any individuals who are initiating trofinetide treatment for RTT through the physicians associated with the Gillette Children's RTT clinic will be potentially eligible for participation, regardless of age. To enroll, participants must meet the following criteria:\n\n  1. Provision of signed and dated informed consent form by the individual\\'s parent\u002Flegal guardian\n  2. Stated willingness to comply with all study procedures and availability for the duration of the study\n  3. Documented diagnosis of Rett syndrome\n  4. Participant is not showing active signs of developmental regression, defined as: no loss or degradation of ambulation within the past 6 months; no loss or degradation of hand function within the past 6 months; and no loss or degradation of verbal or non-verbal communication or social skills in the past 6 months.\n  5. Participant's current pharmacological treatment regimen has been stable for at least 4 weeks.\n  6. Seeking prescription for trofinetide through the Gillette Children's Rett syndrome clinic\n\nExclusion Criteria:\n\n1. Diagnosis of a progressive medical or neurological condition that in the opinion of the investigator would interfere with the conduct of the study.\n2. Current clinically significant systemic illness that is likely to result in the deterioration of the participant\\'s condition during the study.\n3. Participants taking any other investigational drug currently or within the past 30 days.\n4. Known, uncorrected visual impairment that would limit the ability to view images during eye-tracking tasks.\n5. Severe behavioral problems (i.e., aggression, property destruction, extreme hyperactivity) that would interfere with participation in study activities.","99 Years",{"count":474,"type":22},20,"Assessing cognitive functions among individuals with severe intellectual and developmental disabilities (IDD), including RTT, is often challenging due to floor effects of many standardized assessment batteries in this population. In addition, deficits in motor function and verbal ability may obscure certain abilities in this population when using standard IQ measures. Remote eye-tracking tasks have been proposed as an alternative approach for assessing cognitive functions among individuals with severe IDD, because eye-tracking tasks can be designed to minimize the influence of gross motor and receptive language deficits on performance. Although several types of eye-tracking tasks have been evaluated in RTT, most have been implemented only at a single time-point. As a result, it is unclear whether these measures are stable over time, or sensitive to developmental changes or alterations to health status that occur in RTT (e.g., developmental regression, development of seizures, change in medication, etc.). With the recent FDA approval of trofinetide for the treatment of RTT, we have a novel opportunity to test the sensitivity of eye-tracking and other psychophysiological measures to treatment changes. Anecdotally, parents and clinicians have reported improvements in attention and alertness during trofinetide treatment, but currently available outcome measures do not capture these types of effects. Therefore, we propose to conduct a pilot trial of changes in measures of attention, oculomotor function, learning, and autonomic function, all collected using non-invasive measures, during trofinetide treatment. This is an observational within-subject design with a 4-week post-treatment assessment compared to two pre-treatment assessments. Additional optional follow-up assessments will be performed with families who are interested and returning for standard-of-care visits to Gillette or who are willing to travel for a research-only visit.",[477],"Rett Syndrome",{"date":335,"type":33},{"date":480,"type":33},"2024-12-01",{"date":482,"type":22},"2027-06",{"name":39,"class":40},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":490,"maxAge":491,"enrollmentInfo":492,"targetDuration":4,"studyType":70,"phases":494,"briefSummary":495,"conditions":496,"keywords":501,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":364},"100544195","effects-of-walking-in-greenspace-and-the-built-environment-in-adults-with-prediabetes-a-randomized-crossover-trial-100544195","NCT06365723","Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial","Inclusion Criteria:\n\n* 25-64 years old.\n* Classified as overweight or obese with BMI 20.0-39.9 kg\u002Fm2 per self-report and a BMI of 20.0- 41.9 kg\u002Fm2 upon actual measure.\n* Documentation\\* of a PreD diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg\u002FdL, a 2-hour oral glucose tolerance test of 140-199 mg\u002FdL, or an HbA1c level of 5.7%-6.49%271; OR a study screening lab value of HbA1C within the aforementioned range.\n* Currently engaged in ≤100 min\u002Fweek of moderate to vigorous exercise -confirmed via a 7-day activity recall.\n* No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) -this Questionnaire involves seven \"yes\" or \"no\" questions regarding an individual's health status. Answering \"yes\" to any one of these questions may require a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention. The participant would not be enrolled until this doctor's note is received.\n* Stable weight over the last 3 months (less than 10% change).\n* Not currently pregnant, planning to become pregnant, or currently breastfeeding.\n* Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.\n* Must own a smartphone and be willing and able to download the Garmin Connect app\n* Ability to speak and understand English.\n* Any level of income\n* Any race\u002Fethnicity\n\nExclusion Criteria:\n\n* Individuals \\\u003C25 or \\>64: younger individuals may have not yet reached physiological maturity and in whom PreD prevalence is low; older individuals are more likely to have contraindications to PA and other comorbidities.\n* BMI \\\u003C20 or ≥42.\n* Individuals with an HbA1c level \\\u003C5.7% or \\>6.4%.\n* Currently engaged in \\>100 min\u002Fwk of PA.\n* Individuals with contraindications to exercise participation as indicated by the PAR-Q.\n* A self-reported physical\u002Fmental disability that would prevent them from being able to adhere to the intervention.\n* Past or current diagnosis of Diabetes (Type 1, 1.5 or 2) or use of diabetic medications (e.g. medications to control blood sugar)\n* Any history of a cardiovascular disease event (e.g. heart attack, ablation, pacemaker, stroke)\n* Current treatment for cancer or heart disease (lipid and hypertensive medications acceptable but will be tracked closely).\n* Any change within the last 3 months, or anticipated changes, of any medications that would affect study outcomes (e.g. medications for lipids, blood pressure, anxiety, depression)\n* The use of any medication that significantly interferes with the autonomic nervous system\n* Current tobacco or nicotine users, or those who have quit within the last six months\n* Excessive alcohol (on average\\>1 drinks\u002Fday for women and \\>2 drinks\u002Fday for men) or excessive recreational drug use (reported usage of once a week or more).\n* Unstable weight over the last three months (\\>10% change).\n* Those with major surgery planned or recent history of bariatric surgery (within last 2 years) or a history of other medical interventions that would interfere with study outcomes\n* Currently within one-year postpartum, currently pregnant, or planning to become pregnant during the study period.\n* Currently breastfeeding.\n* Unwilling to comply with study randomization procedures.\n* Unwilling to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.\n* Current participation in another interventional clinical trial.\n* Previous randomization in this study.","25 Years","64 Years",{"count":493,"type":22},216,[117],"The goal of this randomized crossover trial is to compare the differences in psychological and physiological effects of walking in two different outdoor environments (urban\u002Fsuburban commercial environments vs. urban\u002Fsuburban nature areas\u002Fpreserves) in adults with prediabetes. The main questions it aims to answer are:\n\n* Do psychological measures of stress, anxiety, and affect improve more in one type of outdoor environment over the other?\n* Do physiological measures of stress improve more in one type of outdoor environment over the other?\n\nAs this is a crossover trial, participants will serve as their own controls. Researchers will compare both the psychological and physiological effects walking in the two types of outdoor environments.\n\nParticipants will:\n\n* Walk 150-minutes per week for six weeks in each of the two outdoor conditions.\n* Visit the clinic four times, including before and after each six-week walking period.\n* Collect saliva samples immediately proceeding or following the four clinic visits.\n* Return to their pre-study level of physical activity for a 5-week washout period between each of the two walking interventions.",[497,498,499,500],"PreDiabetes","Heart Rate Variability (HRV)","Stress and Anxiety","Stress Biomarkers",[502,503,504,505,506,507],"walking intervention","built environment","outdoor environment","prediabetes","stress","urban",{"date":335,"type":33},{"date":510,"type":33},"2024-06-06",{"date":512,"type":22},"2028-11-30",{"name":39,"class":40},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":66,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":70,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":530,"leadSponsor":532,"locationsCount":41},"100609905","cognition-and-ultrasound-100609905","NCT07220655","Cognition and Ultrasound","Inclusion Criteria:\n\n* 18 years of age or older\n* Speak English (as assessed by their ability to read\u002Fanswer survey questions)\n* May be required to score in the appropriate range on self-report measures\n\nExclusion Criteria:\n\n* They have a neurological disorder which may impact their fMRI scan or cause their reaction to LIFU to differ from that of healthy adults.\n* They take any psychoactive medication.\n* They are unable to undergo fMRI scanning due to a contraindication such as claustrophobia, unremovable piercings, pregnancy, the presence of medical devices such as pacemakers, or a movement or sleep disorder.\n* Are pregnant, or may have reason to believe that they are pregnant.\n* They have a diagnosis of a psychiatric condition other than depression or anxiety",{"count":521,"type":22},100,[117],"Our primary goal is to investigate the role of Low-Intensity Focused Ultrasound (LIFU) neuromodulation on deep brain targets, and its potential to improve cognition",[525],"Healthy Participants","2026-06-12",{"date":528,"type":33},"2026-06-15",{"date":233,"type":33},{"date":531,"type":22},"2028-07-01",{"name":39,"class":40},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":550},"100598277","an-international-observational-study-of-adults-with-acute-infection-100598277","NCT07069400","An International Observational Study of Adults With Acute Infection","Inclusion Criteria:\n\n* Age ≥18 years old\n* Admitted to hospital (or in an emergency department with anticipated hospital admission) for the management of a suspected or confirmed acute infectious disease.\n* Onset of symptoms of an infectious disease within the past 30 days.\n* Informed consent for study participation by the participant or a surrogate decision maker if the participant lacks capacity for consent.\n\nExclusion Criteria:\n\n* Current imprisonment (this does not include quarantine for an infectious disease).\n* Patient undergoing comfort care measures only such that treatment focuses on end- of-life symptom management over prolongation of life.\n* Expected inability or unwillingness to participate in study procedures.\n* In the opinion of the investigator, participation in the study is not in the best interest of the patient.",{"count":540,"type":22},1500,"Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.",[543],"Infectious Disease",{"date":528,"type":33},{"date":546,"type":33},"2025-08-25",{"date":548,"type":22},"2027-06-08",{"name":39,"class":40},50,""]