[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Michigan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":660},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,182,0,25,[9,45,75,94,123,144,171,195,222,252,277,302,324,350,370,400,426,452,470,506,535,562,583,606,629],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053897","understanding-metabolism-and-inflammation-risks-for-diabetes-in-adolescents-100053897",false,"NCT06007404","Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents","The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance","Inclusion Criteria:\n\n* Between 14 and 18 years of age\n* Tanner stage 4 or 5 (mature adult stage of puberty)\n* Normal weight (BMI ≥ 5th percentile \\& \\\u003C 85th percentile), overweight (BMI \\> 86th percentile) \\& \\\u003C 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and\u002For pre-diabetes (HbA1c \\> 5.7%)\n* For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes\n\nExclusion Criteria:\n\n* Currently pregnant\n* Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management\n* Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff\n* Allergies or intolerance to milk, soy, or palm oil",true,"ALL","14 Years","18 Years",{"count":22,"type":23},175,"ESTIMATED","OBSERVATIONAL","This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.",[27,28,29,30,31],"Type 2 Diabetes","Insulin Resistance","Obesity","Metabolic Disease","PreDiabetes","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2023-09-06",{"date":40,"type":23},"2027-09",{"name":42,"class":43},"University of Michigan","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100054239","pediatric-influence-of-cooling-duration-on-efficacy-in-cardiac-arrest-patients-p-icecap-100054239","NCT05376267","Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)","Inclusion criteria:\n\n* Age 2 days to \\\u003C 18 years with corrected gestational age of at least 38 weeks\n* Chest compressions for at least 2 minutes\n* Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)\n* Requires continuous mechanical ventilation through endotracheal tube or tracheostomy\n* Definitive temperature control device initiated\n* Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)\n* Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours\n\nExclusion criteria:\n\n* Glasgow Coma Motor Score (GCMS) = 6\n* LAR does not speak English or Spanish\n* Duration of Cardiopulmonary Resuscitation (CPR) \\> 60 minutes\n* Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg\u002Fkg\u002Fminute) or initiation of Extracorporeal membrane oxygenation (ECMO)\n* Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy\n* Pre-existing terminal illness, unlikely to survive to one year\n* Cardiac arrest associated with brain, thoracic, or abdominal trauma\n* Active and refractory severe bleeding prior to randomization\n* Extensive burns or skin lesions incompatible with surface cooling\n* Planned early withdrawal of life support before 120 hours\n* Sickle cell anemia\n* Pre-existing cryoglobulinemia\n* Non-fatal drowning in ice covered water\n* Central nervous system tumor with ongoing chemotherapy\n* Previous enrollment in P-ICECAP trial\n* Prisoner\n* Chronic hypothermia\n* New post-cardiac arrest diabetes insipidus\n* Pregnancy","2 Days","17 Years",{"count":54,"type":23},900,"INTERVENTIONAL",[57],"NA","This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest.\n\nThe study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.",[60,61,62],"Cardiac Arrest, Out-Of-Hospital","Hypothermia, Induced","Hypoxia-Ischemia, Brain",[64,65,66,67],"Bayesian Adaptive Clinical Trial","Hypothermia, therapeutic","Coma","Pediatric",{"date":35,"type":36},{"date":70,"type":36},"2022-08-05",{"date":72,"type":23},"2028-03-31",{"name":42,"class":43},62,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":17,"sex":18,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100053428","identification-of-phenotypic-factors-that-predict-success-for-weight-loss-and-long-term-weight-maintenance-100053428","NCT02043457","Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance","Inclusion Criteria:\n\n* Obese males and females: age \\>20 years; Obese population defined as BMI \\> or = 27 kg\u002Fm2\n* Lean population BMI \\\u003C 27 but \\> 17 kg\u002Fm2\n* Able and willing to provide written informed consent for the trial\n\nExclusion Criteria:\n\n* Evidence of inherited disorders of lipid metabolism.\n* History of Cancer within the last 5 years\n* Human immunodeficiency virus (HIV) antibody positive.\n* Patients with solid organ transplants.\n* Participation in any other clinical trial within 90 days of entry into this trial.\n* Pregnant or lactating females.\n* Uncontrolled thyroid disease\n* Unstable angina or NY heart association class II failure or above\n* Gastrointestinal disease specifically GI motility disorders\n* Unstable neuropsychiatric disease including major depression\u002Fanxiety, eating disorder such as binge eating, bulimia or anorexia\n* End stage renal or hepatic disease\n* Autoimmune disorders (e.g. SLE)\n* Body weight fluctuation of more than 5 kg in the previous 3 months\n* Prior bariatric surgery\n* A history or current alcohol\u002Fsubstance abuse and change in smoking habits or cessation in the past 6 months.\n* Women of childbearing age must use a reliable form of contraception.\n* Any medical condition, which in the opinion of the investigator would make the patient unsuitable for recruitment, or could interfere with the patient participating in or completing the protocol.\n* Unwilling or unable to consent for the study.","15 Years","75 Years",{"count":84,"type":23},3200,"The Investigational Weight Management Clinic now entitled the Weight Management Program at the University of Michigan was created to identify strategies that will result in cost-effective, long term weight management for overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size fits all' philosophy is untenable with a complex disease such as obesity. The clinic will serve as a portal for patients to choose standard clinical care or to explore alternatives from a variety of clinical studies offered through the clinic. These studies will include further investigations into nutrition, the biological basis of weight and weight management and protocols using approved and experimental pharmaceuticals as well as technologies that aid in self-management of weight.",[29],"2026-07-09",{"date":35,"type":36},{"date":90,"type":4},"2009-08",{"date":92,"type":23},"2030-12",{"name":42,"class":43},{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":55,"phases":103,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":44},"100628048","developing-a-self-management-intervention-to-improve-health-outcomes-for-patients-with-inflammatory-bowel-disease-100628048","NCT07456566","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial","Inclusion Criteria:\n\n* Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD\n* Impaired health-related quality of life\n* Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC)\n* Fecal calprotectin \\> 250 microgram (ug\u002Fg)\n* Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60\n\nExclusion Criteria:\n\n* Unable to speak and read English\n* Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components\n* Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses\n* Are planned for imminent surgery\n* Have short bowel syndrome\n* Uncontrolled medical or psychiatric disease",{"count":102,"type":23},40,[57],"This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease.\n\nThe study team hypothesizes:\n\n* the study will achieve a recruitment rate of 10 participants every 3 months\n* 70% participant retention at 24 weeks\n* 70% outcome data collection\n* 70% intervention completion\n* high acceptability",[106,107,108],"Inflammatory Bowel Diseases","Ulcerative Colitis","Crohn Disease",[110,111,112,113],"Digital self-management program","Standard of care","Randomization","Questionnaires","NOT_YET_RECRUITING","2026-06-30",{"date":117,"type":36},"2026-07-02",{"date":119,"type":23},"2026-07",{"date":121,"type":23},"2028-03",{"name":42,"class":43},{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":55,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":44},"100623868","systemic-sclerosis-diet-for-gastrointestinal-symptoms-100623868","NCT07402226","Systemic Sclerosis DIet for GastrointESTinal Symptoms","SSc-DIGEST Trial: Systemic Sclerosis DIet for GastrointESTinal Symptoms Randomized Controlled Trial of Low FODMAP, CDED, and NICE Diets for Gastrointestinal Symptoms in Systemic Sclerosis","DIGEST","Inclusion Criteria:\n\n* Diagnosis of systemic sclerosis (SSc) as per ACR\u002FEULAR classification criteria\n\n  .• Self-reported moderate to severe gastrointestinal bloating or distension, with a UCLA SCTC-GIT 2.0 bloating Scale score ≥2.00 on (0.00-3.00 scale) at screening.\n* Willingness and ability to comply with dietary intervention and study procedures.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease.\n* Use of systemic antibiotics within 4 weeks prior to baseline.\n* History of gastrointestinal surgery (other than cholecystectomy or appendectomy unless in the last 3 months).\n* Severe cognitive impairment or psychiatric illness that would limit ability to follow dietary instructions.\n* Known allergy or intolerance to major components of any of the study diets (e.g., lactose, gluten) unless manageable within diet framework.\n* Current or recent (within 3 months) dietary intervention for managing GI symptoms (e.g. gluten-free diet, low FODMAP diet, etc.).\n* Clinically significant self-reported (≥10 percent weight loss) in the last 3 months\n* BMI less than 20\n* Ongoing tube feeds or TPN\n* Participating in another interventional trial\n* Pregnancy or lactation, or planning pregnancy in the next 6 months",{"count":132,"type":23},60,[57],"This research will evaluate the effect of diets on bloating\u002Fdistention, assess changes in abdominal pain, and overall gastrointestinal symptom burden in Systemic Sclerosis. The researchers will do this by comparing outcomes of people assigned to 3 different diets. Following the research specifics of the diets will be available upon contact with the details listed below.",[136],"Systemic Sclerosis (SSc)",{"date":138,"type":36},"2026-07-01",{"date":140,"type":36},"2026-03-16",{"date":142,"type":23},"2027-04",{"name":42,"class":43},{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":17,"sex":18,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":55,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":44},"100644305","the-bottle-optimization-testing-tiny-little-eaters-study-100644305","NCT07665983","The Bottle Optimization Testing Tiny Little Eaters Study","Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions","BOTTLE","Inclusion Criteria:\n\n1. Mother-infant dyad: The biological mother is the legal guardian of the infant and has custody for ≥5 days per week (in cases of joint custody).\n2. Maternal age: Mother is ≥18 years old.\n3. Language: Mother understands spoken and written English sufficiently to provide informed consent, answer questionnaires and follow study instructions.\n4. Gestational age: Infant was born at 37.0-42.0 weeks gestation.\n5. Birthweight: Infant's birthweight was appropriate for gestational age.\n6. Bottle feeding: Infant currently receives at least one bottle feeding of ≥2 ounces at least once per week.\n7. Residence: Family lives within approximately one hours driving distance of Ann Arbor, Michigan to participate in an at- home appointment or is willing to drive to the U-M North Campus research site.\n8. Infant age: Infant is 4.0-6.0 months old at enrollment.\n\nExclusion Criteria:\n\n1. Current maternal depression or anxiety, as assessed by screening questionnaires, or any cognitive impairment that would limit ability to follow study instructions.\n2. Infant developmental delay, genetic condition, or medical problems or diagnosis affecting current or future eating, growth, or development.\n3. History of significant sucking or feeding difficulties or breastfeeding difficulties requiring significant medical intervention or support.\n4. Current weight-for-age below the 10th percentile or significant history of poor weight gain.\n5. Infant already typically uses a slower-flow nipple (flow rate \\\u003C 5 mL\u002Fmin).","4 Months",{"count":154,"type":23},440,[57],"The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep.",[158],"Childhood Obesity",[160,161,162,163],"Infant growth","Responsive feeding","Satiation cues","Milk intake","2026-06-29",{"date":138,"type":36},{"date":167,"type":36},"2026-06-26",{"date":169,"type":23},"2028-08",{"name":42,"class":43},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":55,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":192,"leadSponsor":194,"locationsCount":44},"100644914","leveraging-interventions-for-needs-and-knowledge-in-diabetes-linkd-100644914","NCT07676188","Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD)","Improving Diabetes Outcomes and Health Disparities by Addressing Unmet Resource Needs- A Sequential Multiple Assignment, Randomized Trial","LINKD","Inclusion Criteria:\n\nParticipants:\n\n* Age: 18 years of age or older\n* Diabetes diagnosis: Documented diagnosis of diabetes (Type 1 or Type 2) with prescribed anti-hyperglycemic medication\n* Glycemic control: Most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.0% for individuals between 70-75 years of age Prior study participation: Did not participate in the CareAvenue trial (R01DK116715)\n* Financial burden and\u002For social needs (meeting ONE or more of the following):\n\nPositive report of financial burden using validated screening questions; Medicaid or dual Medicare\u002FMedicaid coverage; Income ≤250% of the federal poverty level; Self-identified as ALICE (Asset-Limited, Income-Constrained, Employed): income above Medicaid threshold but reporting difficulty affording basic needs; Underinsured: high-deductible plan (≥$1,500 individual\u002F$3,000 family) with self-reported difficulty affording healthcare costs; Positive screen for one or more social risk factors on PRAPARE or equivalent (food insecurity, housing instability, transportation barriers, utility insecurity);\n\n* Financial decision-making: Self-identifies as primarily responsible for making own healthcare financial decisions (to address concerns about young adults dependent on family support).\n* Interest in assistance: Expresses interest in receiving assistance with unmet social needs.\n* Ability to participate: Able to complete the screening process in English (or Spanish\u002FArabic if materials available) on behalf of self.\n* Healthcare access: Receives or is able to receive care at Michigan Medicine (required for potential social worker referral).\n\nPeer Supporters:\n\n* Age: 18 years of age or older\n* Diabetes diagnosis: Self-reported diagnosis of diabetes (Type 1 or Type 2)\n* Glycemic control: Within the past 12 months, have had at least one hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.5% for individuals ≥71 years of age, but have since had at least one A1c (HbA1c) level, including their most recent test, of: \\\u003C7.5% for individuals ≤70 years of age and \\\u003C8.5% for individuals ≥71 years of age\n* Experience navigating social or financial resources: Self-reported success in navigating financial assistance or social services resources\n* Ability to participate: Able to provide peer support in English (option to additionally provide support in Spanish and\u002For Arabic); Able to complete training; Able to make calls every other week with assigned participants; Able to submit call logs; Able to complete a brief survey about experience throughout participation.\n* Confidence in diabetes self-management: Self-reported confidence in ability to manage diabetes\n\nExclusion Criteria:\n\nParticipants:\n\n* Serious psychiatric disorder: Active diagnosis of schizophrenia, active psychosis, or other serious mental illness that would impair ability to engage in intervention (as determined by medical record review)\n* Cognitive impairment: Documented moderate to severe cognitive impairment that would prevent meaningful participation in study activities (as determined by medical record review)\n* Active substance use: Current active illicit drug use that would interfere with study participation (as determined by medical record review)\n* Pregnancy: Currently pregnant or planning pregnancy during the study period (due to expected A1c changes) (as determined by medical record review)\n* Glucose-altering medications: Currently taking medications that alter glucose metabolism as a side effect rather than for diabetes management, including: Chronic oral corticosteroids (≥2 weeks continuous use); Antipsychotic medications known to affect glucose; Other medications affecting glucose when NOT prescribed for diabetes management Note: GLP-1 agonists, SGLT2 inhibitors, and other diabetes medications are NOT excluded, regardless of whether they are also used for weight management\n* Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years\n* Concurrent diabetes study participation: Currently enrolled in another diabetes intervention study\n* Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own behalf\n\nPeer Supporters:\n\n* Cognitive impairment: Self-reported cognitive impairment that would prevent meaningful participation in study activities\n* Participation Concerns or Barriers: Self-reported concerns that would prevent meaningful participation in study activities\n* Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years\n* Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own",{"count":180,"type":23},694,[57],"Unmet social needs and economic burden persist as key reasons why one-third of people with diabetes have poor disease control. The purpose of this study is to learn whether different tools and types of support may help people manage diabetes and related challenges. The study will compare several approaches to understand how they affect people's experiences and health over time. Completion of the study aims will lead to an optimized intervention to improve the health and social well-being of people with diabetes.\n\nParticipants will be randomly assigned to one or more interventions aimed at addressing social and financial needs and will complete multiple surveys over the course of a year. The study team will collect information about their blood pressure and HbA1c (blood glucose).\n\nFindings will advance the field by determining the effectiveness of supportive interventions to address both social needs and diabetes self-care, and by informing protocols for the optimal sequencing of these strategies, a critical evidence gap in healthcare settings.",[184],"Diabetes",[184,186,187,188,189],"Intervention Strategies","Social Support","Financial Support","Disease Management",{"date":138,"type":36},{"date":119,"type":23},{"date":193,"type":23},"2030-07-31",{"name":42,"class":43},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":55,"phases":204,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":219,"leadSponsor":221,"locationsCount":44},"100630622","phase-4-mechanistic-clinical-trial-comparing-the-pharmacokineticspharmacodynamics-of-metoprolol-in-heart-failure-with-reduced-ejection-fraction-patients-with-low-vs-high-polygenic-score-100630622","NCT07490067","Mechanistic Clinical Trial Comparing the Pharmacokinetics\u002FPharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score","Personalizing Heart Failure Treatment With Genomics: A Clinical Trial to Understand the Mechanisms and Validate a Polygenic Risk Score for Beta-Blocker Response","Inclusion Criteria:\n\n* Heart Failure with Reduced Ejection Fraction (HFrEF)\n* Has not taken a beta-blocker within the past 6 months (preferred), or if needed to meet enrollment target, patients that have not taken a beta-blocker in the past 3 months, or only taken a low dose of beta-blocker within the past 6 months (i.e., \\\u003C 50% of the guideline-recommended HFrEF target dose, or for beta-blockers that are not approved for HFrEF, \\\u003C50% of the maximum dose)\n* Genetic data already available to calculate the polygenic score (e.g., through participation in the Michigan Genomics Initiative (MGI) or other genetic tests) or willingness to provide a deoxyribonucleic acid (DNA) sample for genetic analysis\n* White race\n* Has been prescribed a stable dose (including no dose) of angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), ARB-neprilysin inhibitor (ARNI), sodium-glucose cotransporter 2 (SGLT-2) inhibitor, or mineralocorticoid receptor antagonist (MRA) for at least the past 4 weeks\n* Has been prescribed a stable dose (including no dose) of diuretic(s) for at least the past 2 weeks\n* For women of child-bearing potential: the participant is willing to perform a pregnancy test and use a highly effective contraceptive method for at least 4 weeks prior to the start of metoprolol treatment, during the entire metoprolol treatment period, and for at least 5 days after the discontinuation of metoprolol treatment\n* Ability to understand and willing to sign a written informed consent\n\nExclusion Criteria:\n\n* Prior heart transplant or left ventricular assist device (LVAD) or planned within treatment period\n* Planned implantation of a pacemaker or Cardiac Resynchronization Therapy (CRT) during treatment period\n* Patients with a pacemaker that does not allow their heart rate to change in response to exercise per protocol\n* Pregnant\n* Systolic blood pressure \\\u003C 95 millimeters of mercury (mmHg)\n* Heart rate \\\u003C 60 beats per minute\n* Second (Mobitz II)- or third-degree heart block\n* Cardiogenic shock\n* Patients with acute decompensated heart failure requiring current hospitalization or immediate medical intervention.\n* Sick sinus syndrome\n* Pheochromocytoma\n* Known hypersensitivity to the metoprolol succinate oral tablet used in the trial\n* Hypertrophic obstructive cardiomyopathy\n* Active myocarditis\n* Acute coronary syndrome within the past month\n* Active or uncorrected severe mitral or aortic valvular dysfunction\n* Patients with known severe congenital heart disease per protocol\n* Child-Pugh Class C liver disease\n* Patients with end-stage renal disease (ESRD) requiring hemodialysis\n* Concomitant disease that prohibits participating in Cardiopulmonary Exercise Test (CPET) per protocol\n* Concomitant disease with expected survival less than the duration of the study (e.g., metastatic cancer)\n* Current or planned treatment with cardiotoxic medications, including interferons and the cancer therapies per protocol\n* Concurrent participation in another clinical trial that may affect participant safety or validity of data collected in this clinical trial\n* Inability to take oral medication\n* Unwilling or unlikely to adhere to the study procedures, as determined at the discretion of the study team, including but not limited to the following reasons:\n\n  1. Psychiatric illness or other comorbidities\n  2. Substance abuse\n  3. Social or logistical circumstances",{"count":203,"type":23},100,[205],"PHASE4","The purpose of this trial is to better understand how the beta-blocker metoprolol works in people with Heart Failure with Reduced Ejection Fraction (HFrEF) according to participants genetics. Participants will have the beta-blocker (BB) polygenic score calculated from genotype data. The score will be used to stratify the patients in the low and high polygenic score groups in the study.\n\nThe hypotheses for this trial are:\n\n* HFrEF patients with high polygenic score will have weaker cardiovascular responses to metoprolol succinate than HFrEF patients with low polygenic score.\n* HFrEF patients with high polygenic score have lower steady-state plasma concentrations of metoprolol succinate than HFrEF patients with low polygenic score.\n* HFrEF patients with high polygenic score require higher metoprolol succinate plasma concentrations to achieve similar cardiovascular effects as those with low polygenic score.",[208],"Heart Failure With Reduced Ejection Fraction",[210,211,212,213,214,215,216],"Beta-blocker","Polygenic Risk Score","Pharmacokinetic","Pharmacogenomics","Pharmacodynamics","Pharmacogenetic","Cardiac testing",{"date":115,"type":36},{"date":119,"type":23},{"date":220,"type":23},"2029-07",{"name":42,"class":43},{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":18,"minAge":230,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":55,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":44},"100607651","testing-personalized-high-definition-transcranial-direct-current-stimulation-hd-tdcs-as-a-treatment-of-posterior-cortical-atrophy-100607651","NCT07191327","Testing Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) as a Treatment of Posterior Cortical Atrophy","Testing Personalized High Definition Transcranial Direct Current Stimulation (HD-tDCS) as a Treatment of Posterior Cortical Atrophy","PCA","Inclusion Criteria:\n\n* Diagnosis or symptoms consistent with PCA\n* Fluent in English\n* HD-tDCS compatible\n* Stable on relevant medications for at least approximately 4 weeks prior to study enrollment\n* If completing any additional, optional, long-term study visits in a remote location (i.e., not our office), a study partner is required in order to administer HD-tDCS. Those choosing to return to our office may have, but are not required to have, a study partner.\n\nExclusion Criteria:\n\n* Other relevant neurological disease (e.g., epilepsy) or injuries (e.g., large vessel stroke, moderate-severe traumatic brain injury) viewed as primary to deficits since these could interfere with etiologic considerations and confound study results\n* Active, relevant psychiatric conditions (e.g., bipolar disorder, schizophrenia) since the symptoms of these conditions may confound study participation.\n* A recent (e.g., within the past 2 years) significant history of, or current, alcohol or drug abuse\u002Fdependence. Remote history of abuse\u002Fdependence is not exclusionary as long as it is not considered to be the primary etiology for visuospatial deficits.\n* Women that are lactating\u002Fbreastfeeding, pregnant, or may potentially be pregnant will be excluded from the study.","50 Years",{"count":232,"type":23},50,[57],"This study is being completed to learn if high-definition transcranial direct current stimulation (HD-tDCS) has an effect on visual and thinking abilities in persons with posterior cortical atrophy (PCA). Participants will be randomized to receive real or sham HD-tDCS (8 sessions over 4 days).\n\nFollowing the randomized treatment, participants will have optional open-label phase with real HD-tDCS up to 26 weeks and other possible testing.",[236],"Posterior Cortical Atrophy",[238,239,240,241,242,113,243,244,245],"HD-tDCS","Functional Magnetic resonance imaging (fMRI)","Positron emission tomography\u002Fcomputerized tomography","Memory and thinking testing","Computerized tests","Blood draws","Eye tracking and vision tests","Functional Near Infrared Spectroscopy",{"date":115,"type":36},{"date":248,"type":36},"2026-01-28",{"date":250,"type":23},"2029-07-31",{"name":42,"class":43},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":55,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},"100496994","reducing-posttraumatic-stress-disorder-ptsd-symptoms-in-first-responders-and-frontline-health-care-workers-100496994","NCT05751473","Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers","Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs","Inclusion Criteria:\n\n* Are employees at an orginization served by a participating EAP\n* Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33\n* Have had psychotropic medication stability for at least 4 weeks\n\nInclusion criteria for the qualitative portion of the study:\n\n\\- Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder\n\nExclusion Criteria:\n\n* Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)\n* High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: found in protocol)\n* Need for detoxification\n* Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment\n* Currently engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).\n* Patients who do not speak English will be excluded for logistical reasons.",{"count":260,"type":23},410,[57],"This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs).\n\nThe central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).",[264],"Post Traumatic Stress Disorder",[266,267,268,269],"Employee Assistance Programs","Frontline Healthcare Workers","Prolonged Exposure for Primary Care","First Responders",{"date":138,"type":36},{"date":272,"type":36},"2023-05-16",{"date":274,"type":23},"2027-07-30",{"name":42,"class":43},14,{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":55,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},"100474444","testing-adaptive-interventions-to-improve-posttraumatic-stress-disorder-treatment-outcomes-in-federally-qualified-health-centers-100474444","NCT05457985","Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers","Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers","Inclusion Criteria:\n\n* Receive care at a participating federally qualified health center (FQHC)\n* Have a Posttraumatic Stress Disorder checklist (PCL-5) score greater or equal (≥) to 33\n* Own a mobile device that can be used for the PTSD Coach App\n* Have had psychotropic medication stability for at least 4 weeks\n\nExclusion Criteria:\n\n* Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)\n* High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form\n* Severe alcohol or substance use disorder (moderate-severe alcohol use disorder on Alcohol Use Disorders Identification Test (AUDIT) (scores ≥ 15) or high risk on National Institute on Drug Abuse Quick Screen (scores ≥ 27))\n* Active psychosis or unmanaged bipolar disorder\n* Unstable housing\n* Current engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).\n* Patients who do not speak English will be excluded for logistical reasons.",{"count":285,"type":23},430,[57],"This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working.\n\nThe central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.",[289],"PTSD",[268,291,292,293,294],"Mobile device","Clinician Supported PTSD Coach App","PTSD symptoms","Prolonged Exposure\u002FPE",{"date":138,"type":36},{"date":297,"type":36},"2022-06-23",{"date":299,"type":23},"2027-09-30",{"name":42,"class":43},13,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":17,"sex":18,"minAge":20,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":55,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":44},"100644751","enhancing-voluntary-motion-in-broad-patient-populations-with-modular-powered-orthoses-renewal-100644751","NCT07673328","Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal","Inclusion Criteria:\n\nInclusion criteria for able-bodied, young participants will be:\n\n* Aged between 18 to 65 years\n* Weigh less than 300 lbs (due to challenges in bracing heavier participants)\n* BMI \\\u003C 40 (due to challenges in bracing heavier participants)\n\nInclusion criteria for knee osteoarthritis participants will be:\n\n* Aged between 30 to 85 years\n* Medical diagnosis of patellofemoral and tibiofemoral osteoarthritis\n* Patient reported pain ≥ 4 out of 10 during activities of daily life (to avoid floor effects)\n* Weigh less than 300 lbs (due to challenges in bracing heavier participants)\n* BMI \\\u003C 40 (due to challenges in bracing heavier participants)\n* Ability to walk 6 minutes without assistance from a person (may use walking aid)\n* Ability to ascend\u002Fdescend ramps and stairs with or without the use of handrails\n\nExclusion Criteria:\n\nExclusion criteria for able-bodied, young adult participants will be:\n\n* Pregnant (self-report)\n* Any significant neuromuscular or musculoskeletal disorder that would interfere with the study\n* Unable to walk for 20 minutes\n* History of any cardiovascular, vestibular, or visual diseases and\u002For impairments that may interfere with the study\n* Cognitive deficits that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments. Cognitive deficits will be determined by a Mini-Mental State Examination (MMSE) score of \\\u003C22.\n* Adults with a known allergy to medical grade tape\n\nExclusion criteria for knee osteoarthritis participants will be:\n\n* Pregnant (self-report)\n* Any recent lower-extremity fracture (within 6 months)\n* Significant limitation on knee joint range of motion\n* Significant neurological (e.g., stroke) or cardiovascular disorder that may affect the ability to walk\n* Advised by a physician not to walk or exercise\n* Uncontrolled hypertension or diabetes\n* Use of opioids\n* Cognitive deficits or visual impairment that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments. Cognitive deficits will be determined by a Mini-Mental State Examination (MMSE) score of \\\u003C22.\n* Adults with a known allergy to medical grade tape","85 Years",{"count":310,"type":23},65,[57],"The overall goal of this project is to establish a novel design and control paradigm for modular, partial-assist powered orthoses (exoskeletons) to enhance voluntary lower-limb motion and manage pain in broad patient populations. Building upon a previous study period that addressed weakness from advanced age or muscle fatigue, this current period extends the technology to novel powered unloader orthoses designed to manage knee osteoarthritis (OA) pain. The investigators hypothesize that by providing 15-30% of biological joint torque, these motorized devices can reduce muscular contributions to painful loads on the joint's surfaces during activities of daily living (ADLs). The project aims to develop a task-agnostic, neural network-based controller and establish the feasibility of reducing knee pain and muscle effort in individuals with multi-compartment knee osteoarthritis.",[314,315,316],"Lower-limb Orthoses","Osteoarthritic Knee Pain","Osteoarthritis (OA) of the Knee","2026-06-22",{"date":164,"type":36},{"date":320,"type":36},"2025-07-18",{"date":322,"type":23},"2030-03-31",{"name":42,"class":43},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":55,"phases":333,"briefSummary":334,"conditions":335,"keywords":338,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":44},"100643967","noninvasive-thalamocortical-neuromodulation-with-low-intensity-focused-ultrasound-for-persistent-developmental-stuttering-100643967","NCT07668882","Noninvasive Thalamocortical Neuromodulation With Low-Intensity Focused Ultrasound for Persistent Developmental Stuttering","Inclusion Criteria:\n\n* have normal language, hearing and cognition\n* speak English as their primary language\n* currently stutter\n* score at least 10 (very mild) on the Stuttering Severity Instrument (SSI-4) or exhibit greater than 3% stuttered syllables during at least one of the first 3 speech samples\n* have not receive any treatment for stuttering within the past year\n\nExclusion Criteria:\n\n* History of seizures\n* Major medical or neurological illness (e.g., stroke, serious head trauma, brain infection, Parkinson's disease, etc.)\n* History of closed head injury with loss of consciousness (e.g., concussion)\n* Metal or electronic implants such as cochlear implants and pacemakers\n* Braids or other hair styling that prevents direct access to the scalp (if removal not possible)\n* Current or planned pregnancy\n\nNote: participants who cannot undergo MRI may complete the other portions of the study.","65 Years",{"count":332,"type":23},20,[57],"This research is studying the use of low-intensity focused ultrasound (LIFU; a mild, noninvasive acoustic stimulation technique) in a small number of people to learn about its safety as a treatment for stuttering. LIFU is a small, safe sound signal that produces a gentle, pulsing flow of acoustic waves to help different parts of the brain communicate with each other. Researchers want to understand how the mild, non-invasive brain stimulation affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.",[336,337],"Stuttering","Developmental Stuttering",[339,340,341],"Low Intensity Focused Ultrasound","Thalamus","Neuromodulation","2026-06-19",{"date":344,"type":36},"2026-06-25",{"date":346,"type":23},"2026-06",{"date":348,"type":23},"2027-06",{"name":42,"class":43},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":330,"enrollmentInfo":357,"targetDuration":4,"studyType":55,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":44},"100630999","defining-objective-markers-of-compliance-for-dietary-therapies-in-ibs-100630999","NCT07494968","Defining Objective Markers of Compliance for Dietary Therapies in IBS","Defining Objective Markers of Compliance for Dietary Therapies in Irritable Bowel Syndrome (IBS) Using a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients with IBS ( including diarrhea, mixed or constipation type) and without unexplained alarm features (rectal bleeding, weight loss, nocturnal pain, nocturnal diarrhea). In presence of alarm symptoms, if they have had evaluation with colonoscopy or fecal calprotectin or serum C-reactive protein (CRP) since onset of alarm symptoms with normal results, they will be included.\n2. Aged 18-65 years at the time of screening\n3. IBS-SSS of at least 175 at baseline\n\nExclusion Criteria:\n\n1. Subjects adhering to a dietary treatment such as the low-fat diet, low FODMAP diet, or gluten-free diet, within the past 6 months. Those who are lactose intolerant will not be excluded from the study and will be allowed to limit lactose intake as previously.\n2. Subjects who are predicted to make changes to their baseline IBS medication(s), over-the-counter (OTC) therapy, exercise, diet (beyond what is advised), or initiate\u002Fmake changes to other complementary therapy that could affect IBS symptoms (e.g. yoga, acupuncture, etc.) during the four weeks study period.\n3. Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis\n4. Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.\n5. BMI \\\u003C 18.5\n6. Subjects with prior small bowel or colonic surgery (other than appendectomy or cholecystectomy).\n7. History of appendectomy or cholecystectomy in the last 6 months.\n8. Oral antibiotic use in the past 3 months\n9. Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.\n10. Currently pregnant or breastfeeding.",{"count":358,"type":23},94,[57],"This research will investigate if a specific marker in your stool or urine can be used to track changes in your carbohydrate intake including fructo-oligosaccharide and mannitol intake",[362],"Irritable Bowel Syndrome","2026-06-18",{"date":317,"type":36},{"date":366,"type":36},"2026-05-11",{"date":368,"type":23},"2027-12",{"name":42,"class":43},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":18,"minAge":377,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":55,"phases":380,"briefSummary":381,"conditions":382,"keywords":387,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":399},"100563444","training-community-members-to-be-coaches-to-deliver-the-healthylifetime-program-100563444","NCT06616246","Training Community Members to be Coaches to Deliver the HealthyLifetime Program","Evaluating the Use of Community Members Trained as Health Coaches to Deliver the HealthyLifetimeTM Program","Inclusion Criteria:\n\n* Be at least 30 years of age, with no more than three, uncomplicated chronic conditions and want to learn to take better care of their health.\n* Independent Living Index (ILI) greater than 35. ILI is derived by averaging the outcome measures scores.\n* A score of less than 4 on items related to anxiety and depressive symptoms\n* Have Medicare and\u002For Medicaid insurance.\n* Be able to read, speak, and hear English - but may use glasses or hearing aids, if needed;\n* Tell us their age, date of birth, address, and phone number, and explain their health problems;\n* Have a computer, iPad (Tablet), or Smartphone with an Internet connection, email address, a working camera, and microphone;\n* Be able to use their computer\u002Ftablet to connect to video chat sessions like Zoom in a private space in their home or a private room\n* Are not currently participating in any other studies involving diet, weight management, exercise and\u002For coaching at the current time; and\n* Reside in Michigan.\n\nExclusion Criteria:\n\n* ● Are less than 30 years of age.\n\n  * Have more than three, uncomplicated chronic conditions.\n  * A score of more than 4 on items related to anxiety and depressive symptoms\n  * Do not have Medicare and\u002For Medicaid insurance.\n  * Do not reside in Michigan.\n  * Have a new acute health problem that requires seeing a doctor more than once a month for acute medical treatment.\n  * Have been told their illness is not curable.\n  * Need help remembering their name, date of birth, or health problems.\n  * Cannot use glasses or a hearing aid to see or hear well enough to read materials on the computer or talk to the nurse easily.\n  * Are currently participating in any other studies involving diet, weight management, exercise and\u002For coaching at the current time; and\n  * Do not have, or cannot use, a computer, iPad, or another device with the Internet at home to use Zoom (e.g., internet streaming).","30 Years",{"count":379,"type":23},300,[57],"The goal of this randomized controlled study is to learn if, in addition to nurses, community members can be trained as health coaches to deliver the HealthyLifetime (HL) program to people without complex chronic health conditions, an intervention that provides a short-term and effective health coaching intervention delivered through a virtual platform to improve health, resiliency, and independent self-care to participants who are without complex chronic conditions. The main question it aims to answer is:\n\n• Can Community Health Coaches achieve the same level of competency and outcome as Nurse Health Coaches in participants without complex chronic conditions?",[383,384,385,386],"Health Behaviors","Functional Decline","Chronic Disease","Risk Factors",[388,389,390,391,392],"health coach","health resiliency","independent self-care","community health workers","independent aging",{"date":317,"type":36},{"date":395,"type":36},"2025-05-15",{"date":397,"type":23},"2028-12",{"name":42,"class":43},2,{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":17,"sex":18,"minAge":20,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":55,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":44},"100477533","identification-of-biomarkers-for-stress-vulnerability-and-resilience-100477533","NCT05498207","Identification of Biomarkers for Stress Vulnerability and Resilience","Inclusion Criteria:\n\n* Incoming Freshmen Students at the University of Michigan\n\nExclusion Criteria:\n\n* Suicidal Ideation","22 Years",{"count":408,"type":23},500,[57],"The purpose of this research study is to understand the biological mechanisms of stress vulnerability (being susceptible to stress) and stress resilience (being able to recover readily from stress), obtain biomarkers (a biological indicator) for stress resilience and to devise strategies for prevention and treatment of stress-related disorders.",[412],"Healthy",[414,415,416,417,418],"Mental Health","Mobile application","Cognitive Behavioral Therapy (CBT)","Stress","Fitbit",{"date":420,"type":36},"2026-06-23",{"date":422,"type":36},"2022-08-23",{"date":424,"type":23},"2029-12",{"name":42,"class":43},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":432,"maxAge":330,"enrollmentInfo":433,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":451},"100428158","the-biomarkers-in-the-hyperbaric-oxygen-brain-injury-treatment-trial-biohobit-100428158","NCT04855396","The Biomarkers in the Hyperbaric Oxygen Brain Injury Treatment Trial (BioHOBIT)","Inclusion Criteria:\n\n* Enrolled in HOBIT (this is an ancillary study to the HOBIT Trial)\n\nExclusion Criteria:\n\n* Profoundly anemic (subjects who are profoundly anemic require blood transfusion)\n* Blood samples cannot be obtained","16 Years",{"count":434,"type":23},150,"There are no therapeutic agents that have been shown to improve outcomes from severe traumatic brain injury (TBI). Critical barriers to progress in developing treatments for severe TBI are the lack of: 1) monitoring biomarkers for assessing individual patient response to treatment; 2) predictive biomarkers for identifying patients likely to benefit from a promising intervention. Currently, clinical examination remains the fundamental tool for monitoring severe TBI patients and for subject selection in clinical trials. However, these patients are typically intubated and sedated, limiting the utility of clinical examinations. Validated monitoring and predictive biomarkers will allow titration of the dose of promising therapeutics to individual subject response, as well as make clinical trials more efficient by enabling the enrollment of subjects likely to benefit. Glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL) and high sensitivity c-reactive protein (hsCRP) are promising biomarkers that may be useful as 1) monitoring biomarkers; 2) predictive biomarkers in severe TBI trials. Although the biological rationale supporting their use is strong, significant knowledge gaps remain. To address these gaps in knowledge, we propose an ancillary observational study leveraging an ongoing severe TBI clinical trial that is not funded to collect biospecimen. The Hyperbaric Oxygen in Brain Injury Treatment (HOBIT) trial, a phase II randomized control clinical trial that seeks to determine the dose of hyperbaric oxygen therapy (HBOT) that that has the highest likelihood of demonstrating efficacy in a phase III trial. The proposed study will: 1) validate the accuracy of candidate monitoring biomarkers for predicting clinical outcome; 2) determine the treatment effect of different doses of HBOT on candidate monitoring biomarkers; and 3) determine whether there is a biomarker defined subset of severe TBI that responds favorably to HBOT. This proposal will: 1) inform a go\u002Fno-go decision for a phase III trial of HBOT by providing adjunctive evidence of the effect of HBOT on key biological pathways through which HBOT is hypothesized to affect outcome; 2) provide evidence to support further study of the first monitoring biomarkers of severe TBI; 3) increase the likelihood of success of a phase III trial by identifying the sub-population of severe TBI likely to benefit from HBOT; 4) create a repository of TBI biospecimen which may be accessed by other investigators.\n\nThis study is related to NCT04565119",[437],"Traumatic Brain Injury",[439,440,441,442,443],"Monitoring Biomarkers","Predictive Biomarkers","Glial Fibrillary Acidic Protein","Neurofilament Light Chain","High Sensitivity C-Reactive Protein","2026-06-17",{"date":317,"type":36},{"date":447,"type":36},"2021-01-19",{"date":449,"type":23},"2027-08-31",{"name":42,"class":43},11,{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":469,"locationsCount":44},"100644402","development-of-pain-management-jitai-content-in-multiple-sclerosis-and-spinal-cord-injury-100644402","NCT07663266","Development of Pain Management JITAI Content in Multiple Sclerosis and Spinal Cord Injury","Development of Pain Management Just-In-Time Adaptive Interventions (JITAI) Content in Multiple Sclerosis and Spinal Cord Injury","Inclusion Criteria:\n\n* Able to read and converse fluently in English\n* Multiple sclerosis (MS) or Spinal Cord Injury (SCI) diagnosis\n* Chronic pain ( ≥ 4 on average using a 0-10 NRS for 3-month duration)\n* Access to an internet connected device with a camera and microphone for participating in virtual interview\u002Ffocus group.\n\nExclusion Criteria:\n\n* Cognitive or other impairment (e.g., hearing) that precludes study participation.",{"count":276,"type":23},"Just-In-Time Adaptive Interventions (JITAIs) offer a framework for delivering personalized behavioral support using time-varying data to optimize the timing and type of intervention content. This project will develop the foundational components of a JITAI tailored to adults with chronic pain and either MS or SCI by drawing on symptom self-management content from existing programs (PainGuide, MyMSToolkit, and MySCIToolkit). Intervention content and delivery parameters will be refined through stakeholder engagement via structured interviews to ensure relevance, acceptability, and feasibility.",[462,463],"Multiple Sclerosis","Spinal Cord Injury","2026-06-16",{"date":420,"type":36},{"date":467,"type":36},"2026-05-25",{"date":119,"type":23},{"name":42,"class":43},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":478,"minAge":479,"maxAge":480,"enrollmentInfo":481,"targetDuration":4,"studyType":55,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":44},"100594660","hemodynamics-after-resistance-training-100594660","NCT07022340","Hemodynamics After Resistance Training","Investigating Resistance Training for Vascular Function and Quality of Life in Perimenopausal Women","HeART","* Are between 40-60 years old\n* Have had menstrual irregularities in the last 12 months\n* Do not currently complete more than two 30-min sessions of structured exercise per week and do not do any resistance training exercise;\n* Are not currently pregnant\n* Do not smoke or vape nicotine or marijuana\n* Have not had an oophorectomy, hysterectomy, or surgical menopause\n* Are not currently taking hormone replacement therapy\n* Have not taken hormone replacement therapy in the last 6 months\n* Are not taking steroidal medication or medication to treat diabetes, cholesterol, or high blood pressure\n* Are able to exercise - your doctor has not told you that you cannot exercise\n* Can attend a morning study visit at the University of Michigan's School of Kinesiology Building\n* Are willing to avoid food 2 hours prior to the morning study visit\n* Are willing to avoid strenuous exercise, caffeine, and alcohol, 8 hours prior to the morning study visit\n* Are willing to participate in an exercise training program or health education program for 16 weeks","FEMALE","40 Years","60 Years",{"count":232,"type":23},[57],"Women's blood vessel health gets worse after menopause, or \"the change of life\". Some women exercise less during menopause. Exercise can improve blood vessel health. The investigators want to know if resistance exercise, like lifting weights, can improve blood vessel health in women who are just starting menopause. The investigators also want to know if lifting weights can improve mood, sleep, and quality of life in women going through menopause. The investigators will have two groups of women for this study. One group will lift weights (do resistance exercise) twice per week, and the other group will get emails with information about menopause. The investigators will measure blood vessel health, sleep, mood, and menopause symptoms at the start and the end of this study and compare women who did and did not exercise.",[485],"Perimenopause",[487,488,489,490,491,492,493,494,495,496,497,498,499],"menopause","perimenopause","vascular function","arterial stiffness","endothelial function","resistance exercise training","strength training","mood","sleep","quality of life","cardiovascular disease","estrogen deficiency","exercise",{"date":363,"type":36},{"date":502,"type":36},"2025-06-06",{"date":504,"type":23},"2026-12",{"name":42,"class":43},{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":330,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":55,"phases":515,"briefSummary":516,"conditions":517,"keywords":522,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":4},"100641983","home-based-monitoring--enabled-medication-independence-with-new-digital-tools-100641983","NCT07659548","Home-based Monitoring & Enabled Medication Independence With New Digital Tools","Technological Innovation to Support Medication Safety and Optimization in Older Adults Living Alone With Cognitive Decline","HOME-MIND","Inclusion Criteria:\n\n* Older adults (≥ 65 years old)\n* Living alone (in a non-institutional setting without others)\n* With subjective or mild cognitive decline (a screening test to confirm)\n* Taking at least five prescribed medications concurrently\n* With suboptimal self-reported medication adherence (a screening test to confirm)\n* Having access to a computer or mobile device and internet service\n* Able to read and speak English\n\nExclusion Criteria:\n\n* Having severe cognitive, vision, hearing, or other impairment\n* Unable to use computers or mobile devices\n* Relying on someone else to manage medications",{"count":132,"type":23},[57],"This clinical trial is studying an online tool that may help older adults safely manage their medications at home. The study focuses on older adults who live alone and have memory concerns or mild changes in thinking. Many people in this group take several medications, which can make it hard to keep track of when and how to take them, notice side effects, or know when to ask for help.\n\nIn this study, participants use an online self-monitoring platform to record any problems, symptoms, or concerns they have while taking their medications. The platform also provides helpful education and suggestions for managing medications and symptoms. Participants can share summaries from the platform with their health care team, which may help improve communication and support.\n\nThe goal of the study is to see whether this tool can help older adults feel more confident, informed, and prepared to manage their medications safely while living at home.",[518,519,520,521],"Older Adults (65 Years and Older)","Living Alone","Mild Cognitive Decline","Polypharmacy (People Under Treatment With 5 or More Drugs)",[523,524,525,526,527],"older adults","mild cognitive decline","medication self-management","symptom self-tracking","online digital tool","2026-06-15",{"date":317,"type":36},{"date":531,"type":23},"2026-08-01",{"date":533,"type":23},"2028-05-31",{"name":42,"class":43},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":542,"enrollmentInfo":543,"targetDuration":4,"studyType":55,"phases":545,"briefSummary":546,"conditions":547,"keywords":550,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":4},"100540003","exploring-ptsd-symptoms-barriers-and-facilitators-to-mindfulness-100540003","NCT06311188","Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness","Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness-based Stress Reduction for Justice-Involved Black\u002FAfrican American Female Adolescents and Parents\u002FCaregivers","Inclusion Criteria:\n\n* Black girls aged 14-18\n* Black girls with a misdemeanor and\u002For felony charge in their lifetime\n* Positive PTSD screen (PC-PTSD score of 2 or more; if more than one JI BAFA are from the same family, the investigators will recruit the girl with the highest PTSD score)\n* Black girls report juvenile justice involvement within 12 months prior\n* Black girls live with a P\u002FC (mothers, fathers, and other caregivers\u002Flegal guardians) who will also participate in the study\n* Parents\u002FCaregivers nominated by the girls to participate in the study who are between the ages of 18 and 90 years of age\n* Legal\u002F social services providers \u002F educators who work with the population.\n\nExclusion Criteria:\n\n* Prisoners per the IRB definition\n* Black girls who are younger than 14 and older than 18\n* Severe cognitive delay so the youth cannot complete the assessment instruments, as measured using the Montreal Cognitive Assessment (MoCA)\n* Active psychosis requiring a greater level of care \\[Structured Clinical Interview for DSM Disorders (SCID)\\]. Screening for the study will take place prior to consent\u002Fassent of the study participants\n* Parents\u002FCaregivers who are not nominated by the girls to participate in the study who are not between the ages of 18 and 90 years of age\n* Legal\u002F social services providers \u002F educators who have been working with the population for less than three years.","90 Years",{"count":544,"type":23},90,[57],"The purpose of this study is to investigate justice-involved Black\u002FAfrican American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents\u002Fcaregivers' (P\u002FCs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention.",[417,548,289,549],"Trauma","HPA",[551,552,553,554],"Nonrandomized trial","Black girls","Legal system involvement","Cortisol Biomarker","2026-06-12",{"date":464,"type":36},{"date":558,"type":23},"2026-07-08",{"date":560,"type":23},"2027-01-31",{"name":42,"class":43},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":82,"enrollmentInfo":569,"targetDuration":4,"studyType":55,"phases":570,"briefSummary":571,"conditions":572,"keywords":573,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":44},"100628722","michigan-weight-navigation-program-miweigh-study-100628722","NCT07465341","Michigan Weight Navigation Program (MiWeigh) Study","The Michigan Weight Navigation Program (MiWeigh) Study","Inclusion Criteria:\n\n* Body Mass index (BMI) 30 kilogram per square meter or higher\n* Diagnosed with one or more of the following weight-related conditions:\n\n  * Type 2 Diabetes\n  * Prediabetes Mellitus\n  * Hyperlipidemia (HLP)\n  * Hypertension (HTN)\n  * Polycystic Ovary Syndrome (PCOS)\n  * Obstructive Sleep Apnea (OSA) and\u002For\n  * Metabolic dysfunction-associated steatotic liver disease (MASLD)\n* Speaks English\n* Interest in losing weight\n* Willingness to complete assessments per study protocol\n* Willing and able to use the Electronic health records patient portal to respond to messages\n* Willing to report weight weekly by text if randomized to intervention arm\n* Able to see provider virtually at certain days\u002Ftimes up to four times in a year\n\nExclusion Criteria:\n\n* ≥ 5% weight loss within the prior 12 months\n* Has had a Weight Navigation Program visit in past\n* Pregnant, planning a pregnancy, or breastfeeding in the next year\n* Ongoing participation in another weight-loss program\n* Taking an anti-obesity medication\n* Ever diagnosed with Type 1 Diabetes Mellitus (per protocol)\n* Dementia\n* Serious uncontrolled mental health conditions as indicated (per protocol)\n* Chronic kidney disease, Stage 4 or higher\n* Alcohol dependence and opioid dependence (per protocol)\n* History of anorexia or bulimia\n* Bariatric\u002F gastric bypass surgery, gastric sleeve surgery, or gastric balloon procedure in last year\n* Currently enrolled in an interventional research study that is examining how a diet, program, or drug might: promote physical exercise, healthy eating habits, or weight loss; lower blood pressure; or lower blood sugar\n* Not planning to live in local area over the next year\n* Intensive cancer treatment such as bone marrow transplant, chemotherapy, radiation, or cancer related surgery (not including hormonal chemotherapy like Tamoxifen) in last six months or next 12 months\n* Other serious health issues or personal concerns that could prevent participant from completing study",{"count":408,"type":23},[57],"The main purpose of this study is to determine whether people who participate in MiWeigh lose more weight than people who receive information about weight loss strategies and programs. The researchers also want to learn what parts of the program do and do not work and why. If the program is effective, the researchers want to learn how other health care systems could offer this program.\n\nThe overarching aim of the MiWeigh Study is to better help patients prevent, manage, or reverse obesity-related chronic conditions.",[29],[574,575,113,243],"Weight loss program","Related Chronic health condition","2026-06-10",{"date":555,"type":36},{"date":579,"type":36},"2026-04-09",{"date":581,"type":23},"2028-09-30",{"name":42,"class":43},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":591,"minAge":20,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":55,"phases":594,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":44},"100560199","michigan-mens-diabetes-project-iiimendiii-mind-and-motion-100560199","NCT06574035","Michigan Men's Diabetes Project III(MenDIII): Mind and Motion","Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion","MenDIII","Inclusion Criteria:\n\n* African American\u002FBlack males\n* age 18 years or older\n* ambulatory status\n* diagnosis of Type 2 Diabetes (T2D) for one year duration or longer\n* be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year\n* be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments)\n* have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet\u002Fphone\u002Fcomputer to complete study related tasks\n* live in the Wayne or Washtenaw County\\\\\n* have reliable transportation to in-person events\n\nExclusion Criteria:\n\n* stage 2 hypertension as defined by Joint National Committee (JNC) VIII\n* recent cardiac events\n* recent laser surgery for proliferative retinopathy\n* history of stroke\n* lower limb amputation\n* peripheral neuropathy\n* severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)\n* class III or IV heart failure\n* medical instability.\n\nPer American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing:\n\n* ongoing unstable angina\n* uncontrolled cardiac arrhythmia with hemodynamic compromise\n* active endocarditis\n* symptomatic severe aortic stenosis\n* acute myocarditis or pericarditis\n* acute aortic dissection\n* acute pulmonary embolism\n* pulmonary infarction\n* deep venous thrombosis\n* physical disability that precludes safe and adequate testing\n* chest discomfort with exertion\n* unreasonable breathlessness, or dizziness, fainting, or blackouts.\n\nAs part of the screening process, the investigators will ask the participant to self-report on these conditions. Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health provider will be excluded. Participants who are currently receiving only medication management from a psychiatrist will be included.\n\nIf you are interested in the study, please complete our screening survey: https:\u002F\u002Fredcapproduction.umms.med.umich.edu\u002Fsurveys\u002F?s=JNPPEDANX7KLPPF9. Thank you so much!","MALE",{"count":593,"type":23},80,[57],"The Michigan Men's Diabetes Project III: Mind \\& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet\u002Fphone\u002Fcomputer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours\u002Fsessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.",[597,598,599],"Diabetes Mellitus, Type 2","Depressive Symptoms","Depression",{"date":555,"type":36},{"date":602,"type":36},"2025-01-13",{"date":604,"type":23},"2026-09",{"name":42,"class":43},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":55,"phases":615,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":626,"leadSponsor":628,"locationsCount":44},"100642087","artificial-intelligence-ai-for-proximal-caries-detection-and-its-impact-on-treatment-threshold-100642087","NCT07648212","Artificial Intelligence (AI) for Proximal Caries Detection and Its Impact on Treatment Threshold","Artificial Intelligence for Proximal Caries Detection and Its Impact on Treatment Threshold: Randomized Trial","Early learner Inclusion Criteria:\n\n* Provide informed consent\n* Willing to comply with all study procedures and be available for the duration of the study\n* Dental student in second, third, or fourth year of dental school at University of Michigan School of Dentistry\n\nLate learner Inclusion Criteria:\n\n* Provide informed consent\n* Willing to comply with all study procedures and be available for the duration of the study\n* Dental resident or junior faculty having at least 2 years of clinical experience outside of a dental education setting\n\nExclusion Criteria for participants:\n\n* Dental students who do not have previous experience with caries detection (such as first year dental students)\n* Residents that do not have frequent exposure to caries detection, such as orthodontic, periodontic, oral surgery graduate residents.","99 Years",{"count":132,"type":23},[57],"The purpose of this study is to assess the impact of artificial intelligence on proximal caries detection and subsequent treatment decisions of early learners and compare those with outcomes of experienced learners.",[618],"Caries,Dental",[620,621,622],"Artificial intelligence","Dental students (years 2-4)","Dental resident or junior faculty","2026-06-09",{"date":528,"type":36},{"date":346,"type":23},{"date":627,"type":23},"2027-05",{"name":42,"class":43},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":636,"enrollmentInfo":637,"targetDuration":4,"studyType":55,"phases":638,"briefSummary":639,"conditions":640,"keywords":642,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":44},"100538462","phase-4-mechanism-of-sglt2-inhibition-in-the-kidney-100538462","NCT06291155","Mechanism of SGLT2 Inhibition in the Kidney","Molecular Mechanisms of SGLT2 Inhibition in Diabetic Kidney Disease","Inclusion Criteria:\n\n* Aged 18-80 years.\n\n  * The lower age limit was set so renal function test results would not reflect changes associated with growth.\n* Diagnosis of type 2 diabetes for ≥ 3 years.\n* Estimated GFR \\>45 and \\\u003C 90 ml\u002Fmin\u002F1.73m2 as determined from the CKD-EPI equation using serum creatinine (Levey et al., 2009)\n* A screening urinary albumin-to-creatinine ratio \\\u003C3000 mg\u002Fg.\n* Willingness to participate after receiving a thorough explanation of the study.\n* Participants receiving a RAAS inhibitor must have been receiving the drug at maximum tolerable dose for at least 3 months prior to the study baseline examination.\n* Participants receiving a GLP-1 receptor agonist must have been receiving the drug for at least 3 months prior to the study baseline examination.\n* Participants must meet the current clinical guidelines for prescribing SGLT2 inhibitors, to maintain FDA-approved standards\n\nExclusion Criteria:\n\n* Clinically significant disorders of the liver \\[cirrhosis, portal hypertension, hepatitis, increased bilirubin (≥1.5 mg\u002Fdl), active or uncontrolled cardiovascular disease, symptomatic peripheral vascular disease, (i.e. intermittent claudication), pulmonary diseases (including uncontrolled asthma and restrictive or obstructive lung disease requiring therapy), renal-urinary disorders (calculi, urinary tract obstruction, glomerulonephritis, chronic infection), gastrointestinal disorders (nausea, vomiting, diarrhea or anorexia sufficient to cause weight loss or wasting), or hematocrit levels ≤30 percent in women or ≤35 percent in men.\n* Prior and ongoing treatment with SGLT2 inhibitors\n* Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure ≥150 or diastolic ≥90 mm Hg)\n* Hematuria of unknown etiology.\n\n  * Prior to entry into the study, any participant with hematuria should be evaluated, the etiology established and documented, and treatment rendered as appropriate.\n* Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus \\[SLE\\], cancer, amyloidosis, and chronic infection) that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate the efficacy of treatment.\n* Currently receiving a drug regimen that includes steroids, immunosuppressants, or investigational new drugs not associated with this trial.\n* Pregnancy.\n\n  * SGLT2 inhibitors are not recommended during the second or third trimester of pregnancy. Moreover, we do not wish to expose pregnant women to conscious sedation that is used during the kidney biopsies.. Women of childbearing potential must have a negative pregnancy test prior to entry and every 2 months during the study and agree to using an effective form of contraception throughout the study, such as the oral contraceptive pill or an intrauterine device. Women who are planning a pregnancy in the next three years will be excluded.\n* Known hypersensitivity to canagliflozin or iodine.\n* Bleeding disorders or requirements for anticoagulation or platelet inhibitors which cannot be safely interrupted since kidney biopsies cannot be performed safely in these individuals.\n* Massive obesity with body mass index ≥45 kg\u002Fm².\n\n  * Kidney biopsies are more technically difficult with massive obesity.\n* Allergy to iodine-containing contrast material or shellfish.\n* Non-diabetic kidney disease - based on clinical history or kidney biopsy examination.\n* History of osteoporotic fracture.\n* History of lower-limb amputation irrespective of etiology\n* Conditions likely to interfere with informed consent or compliance with the protocol.\n* Known solitary kidney\n* Size of one or both kidneys on ultrasound \\\u003C 9 cm (small kidney size is concerning for renal atrophy due to underlying kidney disease) or \\> 2 cm discrepancy between left and right kidney sizes based on largest longitudinal diameter\n* Current use of UGT enzyme inducters, lithium, and digoxin\n* Blood urea nitrogen (BUN) \\> 80 gm\u002FdL\n* INR \\> 1.4 (a)\n* PTT \\> 35 seconds (a)\n* Platelet count \\\u003C 100,000 uL (a)\n* Hemoglobin (Hgb) \\\u003C 10 mg\u002FdL (a)\n* Hydronephrosis or other important renal ultrasound findings such as significant stone disease\n\n  1. Inclusion possible after this has been obtained within range","80 Years",{"count":332,"type":23},[205],"The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years.\n\nParticipants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study:\n\nConsent and Screening:\n\n* Laboratory tests to determine baseline health\n* Ultrasound to measure kidney size and ensure presence of 2 functioning kidneys\n\nMonth 0:\n\n* Study entry kidney MRI (day 0)\n* Study entry kidney biopsy (within 30 days of MRI)\n* Study entry visit for dispensing 100 mg\u002Fdaily Canagliflozin medication 3 month supply\n\nMonth 3:\n\n* Study visit to dispense remaining 3 months of 100 mg\u002Fdaily Canagliflozin medication\n* Review of systems\n\nMonth 6:\n\n* Follow-up kidney MRI\n* Follow-up kidney biopsy\n\nStudy participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs).\n\nParticipants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples.",[27,641],"Diabetic Kidney Disease",[643,644,645,646,647,648,649,650,651,652],"Kidney biopsy","Kidney MRI","SGLT2 inhibitor","SGLT2i","FDA-approved","Renal biopsy","Renal MRI","Type 2 diabetes","Canagliflozin","INVOKANA",{"date":654,"type":36},"2026-06-11",{"date":656,"type":36},"2024-01-01",{"date":658,"type":23},"2028-02-28",{"name":42,"class":43},""]