[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Iowa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":651},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,44,76,100,122,150,181,200,225,248,275,300,326,347,370,397,418,446,478,503,525,545,570,600,626],{"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":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100372848","carbon-dioxide-co2-chemosensitivity-and-sudep-100372848",false,"NCT04134754","Carbon Dioxide (CO2) Chemosensitivity and SUDEP","The Role of Central CO2 Chemosensitivity in Postictal Respiratory Depression and SUDEP","Inclusion Criteria:\n\n1. The subject is between 18 and 99 years of age.\n2. Confirmed or suspected epilepsy.\n3. Admission to the EMU for spell characterization (EMU group) or undergoing care in the University of Iowa Health Care Epilepsy Clinic.\n\nExclusion Criteria:\n\n1. History of uncontrolled cardiac, pulmonary, or hepatic disease.\n2. Progressive or uncontrolled neurologic disease unrelated to epilepsy.\n3. Current opioid use.\n4. Women of child-bearing potential who are pregnant or capable of becoming pregnant (e.g. sexual activity within the past 21 days without a highly effective form of birth control or positive urine pregnancy test).\n5. Other comorbid condition that may influence the safety or feasibility of HCVR testing.\n6. Limited decision-making capacity and absence of a qualified representative.","ALL","18 Years","99 Years",{"count":21,"type":22},335,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this research study is to better understand what causes Sudden Unexpected Death in Epilepsy (SUDEP). This study will enroll subjects from the University of Iowa Hospitals and Clinics (UIHC) Epilepsy Monitoring Unit (EMU) and Epilepsy Clinics. The investigators will analyze the effects of seizures on breathing, on the cardiovascular system, and on arousal. The investigators are studying these effects because some cases of SUDEP might be due, in part, to an inability to wake up or sense elevated carbon dioxide (CO2) levels when breathing is impaired. Subjects will be followed for ten years after enrollment to monitor their health.",[28,29],"Epilepsy","SUDEP",[28],"RECRUITING","2026-06-18",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":35},"2019-12-12",{"date":39,"type":22},"2029-10-01",{"name":41,"class":42},"University of Iowa","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100457664","phase-2-single-arm-study-of-neoadjuvant-dostarlimab-in-stage-ii-and-iii-deficient-mismatch-repair-colon-cancers-100457664","NCT05239546","Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers","Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers","NAIO","Inclusion Criteria:\n\n* Capable of understanding and complying with the protocol requirements and have signed the informed consent document. Patients with mild cognitive impairment may be considered for enrollment in the study if their legally authorized representative provides written informed consent for the patient.\n* 18 years or older in age\n* Biopsy proven dMMR (by IHC), Stage II or III colon cancer per CT imaging correlation with AJCC 8th edition, 2017, amendable to en block surgical resection as determined by colorectal surgeon.\n* Biopsy specimen for diagnosis of dMMR Colon cancer should have enough tissue for minimum 4 and max 6 adjacent unstained FFPE slides (4µm each) as determined by Protocol Pathologist Dr. Anthony Snow for CD3+ and CD8+ analysis. If there is not enough tissue present in original sample, a repeat colonoscopy and biopsy may be performed; otherwise patient is not eligible.\n* Potentially surgically resectable Stage II or III patients who are willing to forgo surgical resection if study endpoints are met. Patient with easily manageable bowel changes amenable to laxatives or stool softeners as outpatient per assessment by colorectal surgery are allowed. (See exclusion criteria #2)\n* ECOG performance status less than or equal to 1\n* Absence of metastatic disease on CT CAP with Contrast within 28 days from treatment start\n* Absolute neutrophil count greater than or equal to 1,500\u002FµL\n* Platelets greater than or equal to 100,000\u002FµL\n* Hemoglobin greater than or equal to 9 g\u002FdL\n* Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) or calculated creatinine clearance 60mL\u002Fmin using the Cockcroft-Gault equation\n* Total bilirubin less than or equal to 1.5 x ULN (less than or equal to 2.0 in patients with known Gilberts syndrome) OR direct bilirubin less than or equal to 1 x ULN\n* Aspartate aminotransferase and alanine aminotransferase less than or equal to 3.0 x ULN\n* International normalized ratio (INR) or prothrombin time (PT) less than or equal to 1.5× ULN unless patient is receiving anticoagulant therapy if PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) less than or equal to 1.5× ULN unless patient is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulants\n* Participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to taking study treatment and agree to use an adequate method of contraception from screening through 180 days after the last dose of study treatment. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner starting with first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n\nExclusion Criteria:\n\n* Synchronous primary tumor (i.e. more than 1)\n* Obstruction or perforation requiring diverting ostomy or immediate resection, or bright red blood per rectum requiring urgent blood transfusion, from their primary tumor.\n* Clinical T4b tumors\n* Known hypersensitivity to dostarlimab components or excipients.\n* Major surgery less than or equal to 3 weeks prior to initiating protocol therapy\n* Received investigational therapy less than or equal to 3 months, or within a time interval less than at least 5 half- lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.\n* Heavy bleeding from the colon cancer tumors requiring PRBC transfusions that would require palliative surgical resection\n* Concurrent, clinically significant, active malignancies within two years of study enrollment.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, glucocorticoids, or immunosuppressive drugs). Other than Replacement hormone therapy with thyroxine for hypothyroidism , insulin for T1 diabetes mellitus , or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.)\n* Diagnosis of immunodeficiency or has received any systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.\n* History of greater than or equal to Grade 3 immune-related AE with prior immunotherapy, except for non-clinically significant lab abnormalities.\n* Patients with known HIV (Human Immunodeficiency Virus) infection on effective retroviral therapy regardless of CD4 count who have had an opportunistic infection within the past 12 months.\n* Organ transplant recipients on immunosuppressive medications\n* Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy but not on suppressive antiviral therapy prior to initiation of treatment of this protocol are excluded. Also, patients with history of HCV infection that have not completed curative antiviral treatment and the HCV viral load is not below the limit of quantification areexcluded.(e.g. a patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution is eligible.)\n* Prior history of interstitial lung disease.\n* Received a live vaccine within 30 days of initiating protocol therapy.\n* Not enough tissue for confirming dMMR status and CD3+ \u002FCD8+ testing\n* 19\\. Patients with severe cognitive impairment.",{"count":7,"type":22},[54],"PHASE2","This is a Phase II, single arm study looking at the rate of major clinical response and non-operative management in Stage II and III colon cancer after 18 weeks (up to 6 cycles) of neoadjuvant dostarlimab.",[57,58],"Colon Cancer","dMMR Colorectal Cancer",[60,61,62,63,64,65,66],"Colon cancer","dMMR","Deficient mismatch repair colon cancer","MSI-High","MSI-H","Non-operative management","No surgery","2026-06-10",{"date":69,"type":35},"2026-06-12",{"date":71,"type":35},"2023-03-24",{"date":73,"type":22},"2029-06-30",{"name":41,"class":42},2,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":43},"100579962","aquagenic-wrinkling-prediction-100579962","NCT06831110","Aquagenic Wrinkling Prediction","Using Aquagenic Wrinkling to Predict CF Carrier State","Inclusion Criteria:\n\n* Interested in participating in other CF Carrier-related research studies.\n\nExclusion Criteria:\n\n* CF patient status\n* Unable to speak English\n* Unable to provide written informed consent\n* Prisoner status\n* An open wound on either hand\n* A tattoo on either hand\n* Missing any portion of either hand\n* Diagnosis of Diabetes\n* Diagnosis of Hyperhidrosis\n* Diagnosis of Raynaud's Disease\n* Diagnosis of Atopic Dermatitis\n* Regularly taking ACE inhibitors or angiotensin receptor blockers",true,"24 Years",{"count":86,"type":22},2000,"OBSERVATIONAL","The goal of this observational study is to determine whether an aquagenic wrinkling procedure (i.e., soaking hands in a water bath for up to 20 minutes) can be used as a screening tool for cystic fibrosis carrier status.\n\nParticipants will complete one visit where they will undergo an aquagenic wrinkling procedure to see how their hands respond.",[90,91],"Aquagenic Wrinkling of Palms","Carrier State","2026-06-02",{"date":94,"type":35},"2026-06-04",{"date":96,"type":35},"2025-03-06",{"date":98,"type":22},"2026-12",{"name":41,"class":42},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":107,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100542048","use-of-allied-health-professionals-to-improve-treatment-of-disease-100542048","NCT06337799","Use of Allied-health Professionals to Improve Treatment of Disease","Use of Non-physician Allied-health Professionals to Recruit (and Follow) Research Participants, Sustain Engagement, and Improve and Diagnose Treatment of Diseases by Facilitating Transitions of Care","Inclusion Criteria:\n\n* Biological mothers delivering at UIHC or attending a well-child visit for an infant between 1 month and 9 months\n* Preeclampsia during pregnancy\n* Preceived prenatal care at UIHC\n* Owns a smartphone\n\nExclusion Criteria:\n\n* Arm circumference greater than 17 inches\n* Prisoner status\n* Unable to provide own written informed consent","FEMALE","55 Years",{"count":110,"type":22},200,[25],"The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care.\n\nParticipants will:\n\nTake their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months.",[114],"Preeclampsia","NOT_YET_RECRUITING",{"date":94,"type":35},{"date":118,"type":22},"2026-10",{"date":120,"type":22},"2030-03",{"name":41,"class":42},{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":130,"enrollmentInfo":131,"targetDuration":133,"studyType":87,"phases":4,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":43},"100599597","perceptions-of-diltiazem-versus-adenosine-for-treatment-of-supraventricular-tachycardia-in-the-emergency-department-100599597","NCT07086560","PERceptions of Diltiazem Versus ADEnosine for Treatment of Supraventricular Tachycardia in the Emergency Department","PERceptions of Diltiazem Versus ADEnosine for Treatment of Supraventricular Tachycardia in the Emergency Department: PERVADE-ED Study","PERVADE-ED","Inclusion Criteria:\n\n1. ED encounter for acute SVT\n2. Age \\>\u002F= 18 years\n3. Receipt of IV adenosine and\u002For IV diltiazem for SVT in the ED or prehospital setting\n\nExclusion Criteria:\n\n1. Neurologic status precluding survey participation due to medical instability\n2. Pregnant\n3. Incarcerated\n4. Non-English speaking","100 Years",{"count":132,"type":22},20,"1 Day","Supraventricular tachycardia (SVT) is a dysrhythmia characterized rapid heart rate, typically with rapid onset. SVT accounts for over 50,000 emergency department visits per year. Of patients with regular, narrow-complex SVT, the mainstay of therapy includes adenosine and diltiazem. Adenosine is recommend by American and European guidelines as first-line therapy, however adenosine carries unique side effects that are potentially distressing to patients, including: \"feeling of impending death or doom\", flushing, anxiety, shortness of breath, and chest discomfort. Diltiazem does not carry this side effect profile, but has typically been reserved as second-line treatment due to side effects of low blood pressure associated with this class of medications. Diltiazem and adenosine have not been well studied head-to-head to compare safety and efficacy of their treatment for SVT. The purpose of this study is to evaluate safety and efficacy of adenosine and diltiazem for SVT in the ED (as completed through chart review of specific patient-level outcomes) and capture patient and clinician perspectives of medication satisfaction (through administration of questionnaires).",[136],"Supraventricular Tachycardia (SVT)",[138,139,140,141],"diltiazem","adenosine","emergency medicine","supraventricular tachycardia","2026-05-26",{"date":144,"type":35},"2026-05-28",{"date":146,"type":35},"2025-04-04",{"date":148,"type":22},"2027-12",{"name":41,"class":42},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":43},"100559118","phase-2-iv-vs-epidural-opioids--epidural-local-anesthetic-for-laparotomy-analgesia-100559118","NCT06559969","IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia","Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia","Inclusion Criteria:\n\n1. Age including and between 18 to 85 years old\n2. Planned open abdominal procedure with an incision that is or includes above the umbilicus, where epidural would normally be offered and epidural would be maintained for an average of 4 to 5 days\n3. Patient has consented for an epidural\n4. Patient is able to converse in English\n5. Patient is able to use a patient controlled pump\n\nExclusion Criteria:\n\n1. Has a known contraindication for an epidural\n2. Known mental or cognitive disability\n3. History of chronic opioid use or substance abuse disorder\n4. Pre-operative use of opioids\n5. History of chronic pain\n6. Routine use of marijuana\n7. Incarcerated\n8. Unable to converse in English\n9. Planned to remain intubated post-operatively\n10. Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter\n11. End stage renal disease or dialysis\n12. Hepatic disease that affects metabolism of drugs\n13. Known contraindication to any of the study drugs\n14. Known pregnancy or positive pre-operative pregnancy test\n15. Known neurological condition that may affect motor or sensory systems","85 Years",{"count":159,"type":22},80,[54,161],"PHASE3","The purpose of this research study is to determine if the two common ways of administering additional opioids (morphine like substance, narcotic) with an epidural, either mixed in the epidural solution or given separately through the intravenous, are equally effective in controlling post-operative pain",[164],"Laparotomy",[166,167,168,169,170,171,172],"Epidural","PCEA","PCA","Hydromorphone","bupivacaine","analgesia","laparotomy","2026-04-27",{"date":175,"type":35},"2026-04-28",{"date":177,"type":35},"2024-09-17",{"date":179,"type":22},"2027-03-30",{"name":41,"class":42},{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":199,"locationsCount":43},"100581203","genetic-risk-factor-for-heat-stroke-100581203","NCT06847256","Genetic Risk Factor for Heat Stroke","Exploring a Common Genetic Risk Factor for Heat Stroke and Dehydration","Inclusion Criteria:\n\n* Previously genotyped as a CF carrier or control\n* Comfortable speaking\u002Freading English\n\nExclusion Criteria:\n\n* Previously genotyped as a CF patient\n* Diagnosis of Type 1 or Type 2 diabetes\n* History of heart attack, stroke, heart failure, or atherosclerosis\n* Currently pregnant\n* Currently taking beta blockers or diuretics\n* Prisoner status\n* Unable to provide own written informed consent","60 Years",{"count":110,"type":22},"The goal of this observational study is to examine the effect of the Cystic Fibrosis (CF) Carrier state on the risk for dehydration and other CF-specific fluid-and-electrolyte disorders in male and female adults.\n\nThe primary aim of the study is to estimate the risk of electrolyte disorders attributable to the CF carrier state in a genotyped cohort.\n\nThis will be accomplished with two smaller projects- Aim 1 and Aim 2.\n\nAim 1 will consist of 100 CF Carriers and 100 age- and sex-matched controls. Participants in this aim will be asked to complete a Participant Info and Temperature Survey consisting of questions about race, ethnicity, medical history, and how they experience heat.\n\nAim 2 will consist of a subset of 25 CF Carriers and 25 age- and sex-matched controls from Aim 1. Participants in this aim will be scheduled for a visit to complete a heat challenge. At this visit, they will also complete the Participant Info and Temperature Survey. They will also sit in a sauna at 62 - 63 degrees Celsius for 45 minutes.",[91,192,193],"Heat Stroke","Dehydration","2026-04-21",{"date":173,"type":35},{"date":197,"type":35},"2025-11-19",{"date":98,"type":22},{"name":41,"class":42},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":17,"minAge":207,"maxAge":19,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":43},"100401198","phase-2-mmp-9-inhibition-for-recalcitrant-wet-amd-100401198","NCT04504123","MMP-9 Inhibition for Recalcitrant Wet AMD","MMP-9 Inhibition for Recalcitrant Wet Age-Related Macular Degeneration (AMD)","Inclusion Criteria:\n\n* Wet age-related macular degeneration (wAMD);\n* Solely treated with anti-VEGF IVI for active CNV due to wAMD. However, enrolled patients can have other retinal pathologies such as diabetic retinopathy or vein occlusion for which they are not being treated with anti-VEGF IVI;\n* Must have persistent sub-retinal with or without intra-retinal fluid due to active CNV from wAMD despite receiving at least three consecutive injections with any anti-VEGF agent;\n* Must not have encountered previous side effects from tetracycline medications.\n\nExclusion Criteria - Ocular:\n\n* History of uveitis (including endophthalmitis) or presence of intraocular inflammation;\n* Presence of significant epiretinal membrane or macular hole causing distortion of macular anatomy;\n* Presence of media opacity preventing discerning of fluid on OCT;\n* Any prior ophthalmic surgery (including YAG or retinal laser) within the previous 3 months or anticipated need for any ophthalmic surgery (including cataract extraction) for 9 months following randomization;\n* History of peribulbar corticosteroid injection to the studied eye or the fellow eye within the past 6 months;\n* History of intravitreal triamcinolone acetonide injection to the studied eye within the past 4 months;\n* An ocular condition (other than AMD) is present in the studied eye that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, and Irvine-Gass syndrome);\n* CNV due to causes other than wAMD;\n* Inability to follow up at the 6th and 9th months time points after recruitment;\n* Missing two or more consecutive injections during the six months treatment period;\n* Patient requiring imminent need for IVI anti-VEGF medication switch or another treatment intervention, such as photodynamic therapy, during the 9 months trial period;\n* Presence of fluid associated with geographic atrophy or disciform scar;\n* Any patient with sub-retinal and\u002For intra-retinal fluid that is not due to CNV (eg, overlying areas of geographic atrophy;\n* Any patient actively being actively treated for Irvine-Gass Syndrome.\n\nExclusion Criteria - Systemic:\n\n* Patient with and\u002For who developed an unstable medical status (e.g., glycemic control, blood pressure, cardiovascular disease, individuals who are unlikely or unable to complete the 9 months trial period) in the opinion of the investigator;\n* Significant renal disease (defined as a serum creatinine \\>2.5 mg\u002FdL);\n* Systolic blood pressure \\>180 mm Hg or diastolic blood pressure \\>110 mm Hg;\n* History of headaches associated with tetracycline therapy\n* History of pseudotumor cerebri;\n* History of tetracycline therapy within the past 6 months;\n* Pregnancy or patient intending to become pregnant within the 9 months of the trial period. For women of child-bearing potential, a pregnancy test will be performed;\n* Sexually active women of child-bearing potential not actively practicing birth control by using a medically accepted device or therapy (i.e., intrauterine device, hormonal contraceptive, or barrier device) during the study period (at least 24 months). This is important as doxycycline may interfere with the effectiveness of hormonal contraceptives. Hence, sexually active women of child-bearing potential who use a hormonal contraceptive will be required to use a second form of contraception to safeguard against contraceptive failure while participating in the study;\n* Known allergy\u002Fintolerance to doxycycline, tetracyclines, or any ingredient in the study drug or placebo;\n* Patients receiving phenytoin, barbiturates, carbamazepine, digoxin, or isotretinoin; patients with gastroparesis; patients with a history of gastrectomy, gastric bypass surgery, or otherwise deemed achlorhydric should all be excluded due to altered doxycycline pharmacokinetics and\u002For bioavailability;\n* Patients taking strontium, acitretin, or tretinoin should excluded due to the potential for serious interactions with doxycycline;\n* Patients with abnormal ALT or AST at baseline will be referred to their primary care physician for medical clearance for participation in this study.","50 Years",{"count":209,"type":22},50,[54],"Wet (or neovascular) form of age-related macular degeneration (wAMD) is the most common cause of blindness in the Western world. Currently, anti-vascular endothelial growth factor (VEGF) intravitreal injections (IVI) remain the standard-of-care treatment for wAMD. Previous studies show that about 90% of treated patients lose minimal visual function after 2 years of follow-up. There is still, a subset of 15% patients, incomplete responders, that do not improve and possibly worsen due to the persistence of sub-retinal fluid (with or without intra-retinal fluid) with chronic treatment.\n\nThe investigators plan to evaluate the effect of oral doxycycline versus placebo on the anatomic and functional outcomes in persistent sub-retinal eye fluid in neovascular wet age-related macular degeneration. This subset are incomplete or non-responders to current anti-VEGF intravitreal therapy.",[213,214],"Exudative Macular Degeneration","Wet Age-related Macular Degeneration",[216],"Active choroidal neovascularization (CNV)","2026-03-27",{"date":219,"type":35},"2026-04-02",{"date":221,"type":35},"2020-11-04",{"date":223,"type":22},"2027-03-01",{"name":41,"class":42},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":231,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":43},"100474683","early-phase-1-regional-nerve-blocks-to-improve-analgesia-and-recovery-in-older-adults-undergoing-spinal-fusion-100474683","NCT05461092","Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion","Inclusion Criteria:\n\n* Are 65 or older\n* Indicated for lumbar spinal fusion of less than or equal to 3 levels\n* Undergoing elective surgery\n* no contraindications to local anesthetic or procedures\n* no severe cardiac or respiratory disease\n* no preexisting cognitive dysfunction\u002Fdementia\n\nExclusion Criteria:\n\n* 64 years old and younger\n* emergency treatment\n* pathologic fractures\n* seeking revision surgery\n* major liver or kidney dysfunction\n* coexisting hematological disorder or irreversible abnormal coagulation\n* patients with previous diagnosis of dementia or SLUMS score \\\u003C20\n* patient unable to communicate\u002Fcooperate\u002Flanguage barrier\n* BMI\\>40\n* allergy to study medications\n* opioid tolerant (oral opioid intake morphine equivalent =\\\u003C 60 mg\u002Fday)\n* other sources of chronic pain like fibromyalgia\n* patients with associated significant CNS or respiratory disease (home oxygen requirements)\n* incarcerated patients\n* psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions\n* pregnant or breast feeding","65 Years",{"count":209,"type":22},[234],"EARLY_PHASE1","This initial study is a feasibility study for implementing thoracolumbar interfascial plane, or TLIP, blocks in older adults undergoing spinal fusion. TLIP blocks are done by using anesthesia. In this case, it will be done to either side of the back where surgery will be performed. This has been shown to decrease pain the patients have post-operatively in previous research. In this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing TLIP. Further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. The ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of TLIP blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.",[237,238,239,240],"Delirium","Pain, Back","Spinal Fusion","Thoracolumbar Interfascial Plane Block","2026-03-24",{"date":217,"type":35},{"date":244,"type":35},"2024-01-01",{"date":246,"type":22},"2026-12-31",{"name":41,"class":42},{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":259,"conditions":260,"keywords":263,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":43},"100610183","early-phase-1-effect-of-terazosin-on-atp-levels-in-people-with-amyotrophic-lateral-sclerosis-100610183","NCT07224269","Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis","A Pilot Study of the Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis","TZ-ALS","INCLUSION CRITERIA\n\n* Ages 18 - 80 years old\n* Diagnosed with ALS based on Gold Coast Criteria\n* ALS symptom onset within 36 months at enrollment\n* Slow vital capacity (SVC) \\> 65%\n* Riluzole use-Never taken or taking a stable dose for at least 4 weeks prior to screening visit or will refrain from starting for the duration of the study\n* Edaravone use-Never taken or completed at least one cycle (typically 14 days) prior to screening visit or will refrain from starting for the duration of the study\n* Must have the ability to swallow pills at the time of the screening visit, and in the principle investigator's opinion, have the ability to swallow pills for the duration of the study\n* Willing to use highly effective contraception for the duration of the trial treatment and for a duration of 80 days after the last dose.\n\nEXCLUSION CRITERIA\n\n* Orthostatic hypotension at screening is defined as decrease in BP \\> 20 mmHg systolic or \\> 10 mmHg diastolic and HR increase \\\u003C20 bpm on transition from supine to sitting or from sitting to standing\n* Known allergy or previous adverse reaction to terazosin or related compound\n* Current use of terazosin or concurrent use of doxazosin, alfuzosin, prazosin, or tamsulosin at the time of screening visit or within the 3 months prior to baseline visit\n* Pregnancy or breastfeeding women\n* Taking therapeutic anticoagulant medication (i.e. warfarin, DOAC's, full dose Lovenox or heparin)\n* Liver function blood tests (ALT or AST) more than twice the upper limit of normal\n* Hemoglobin \\\u003C 11.0 g\u002FdL\n* Traumatic brain injury or post-traumatic stress disorder\n* Presence of a confounding acute or unstable medical, psychiatric, or orthopedic condition\n* Noncompliant or sporadic use of medications that modulate the central nervous system\n* Uncontrolled major depression or bipolar affective disorder, or other mental health disorders that are, in the opinion of the PI, sufficiently severe to increase risk of experiencing an Adverse Drug Reaction (ADR)\n* Current suicidal ideation as measured by question 2 of the Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Participants with insufficient decisional capacity to provide written informed consent determined by the primary investigator.\n* Noncompliant or sporadic use of antihypertensive medications\n* Unable to lie supine and still for 60 minutes for the duration of the study\n* Currently taking part in another clinical trial with an investigational medicinal product or having taken part in one in the three months prior to screening visit\n* Current diagnosis of diabetes (type 1 or type 2) or healthcare professional-recommended treatment (medication, exercise or diet) of diabetes mellitus\n* Screening visit glucose \\>140 mg\u002Fdl","80 Years",{"count":132,"type":22},[234],"This will be a single center, randomized, double-blind, placebo-controlled pilot study to assess the safety and tolerability of terazosin (TZ) at a dose of 5 milligrams (mg) per os (PO) daily for patients with amyotrophic lateral sclerosis (ALS). The primary outcome of this study is to determine whether TZ increases adenosine triphosphate (ATP) levels in ALS. The investigators will measure adverse outcomes, safety, and tolerability of taking TZ. Procedures include blood draws, spirometry, fluorodeoxyglucose-positron emission tomography (FDG-PET) scans, questionnaires, and physical examinations. TZ will be titrated up to 5 mg PO daily. This is a pilot study and is not powered to assess efficacy of this medication. The investigators' hope is that this study will guide future studies of this (and similar) medications for the disease modification of ALS. This study also aims to learn more about how patients produce and use energy and if TZ can help to reverse energy deficits that appear in ALS.",[261,262],"Amyotrophic Lateral Sclerosis","Adenosine Triphosphate Activities",[264,265,266],"amyotrophic lateral sclerosis","terazosin","clinical trial","2026-03-06",{"date":269,"type":35},"2026-03-10",{"date":271,"type":22},"2026-05-01",{"date":273,"type":22},"2027-05-31",{"name":41,"class":42},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":43},"100525867","the-effects-of-heel-distraction-height-on-foot-loading-with-carbon-fiber-custom-dynamic-orthoses-100525867","NCT06127316","The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses","CDODistract","Inclusion Criteria:\n\n1. Ages 18-65 years\n2. Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)\n3. Mechanical pain with limb loading (\\>=4\u002F10 on Numerical Pain Rating Scale)\n4. Ability to walk 50 feet at a slow to moderate pace\n5. Ability to walk without a cane or crutch\n6. Ability to read and write in English and provide written informed consent\n\nExclusion Criteria:\n\n1. Diagnosis with a moderate or severe brain injury\n2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g., cardiac condition, clotting disorder, pulmonary condition, etc.\n3. Ankle weakness resulting from spinal cord injury or central nervous system pathology\n4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity\n5. Rheumatoid or inflammatory arthritis\n6. Necrosis of any bones in the foot or ankle\n7. Pain of 8\u002F10 or greater during walking\n8. Uncorrected visual or hearing impairments\n9. Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)\n10. Pregnancy\n11. Body mass index greater than 40 kg\u002Fm2",{"count":132,"type":22},[25],"Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.",[286],"Traumatic Lower Limb Injury",[288,289,290,291],"Plantar Force","Ankle Foot Orthosis","Carbon Fiber Orthosis","Biomechanics","2026-01-13",{"date":294,"type":35},"2026-01-15",{"date":296,"type":35},"2024-08-16",{"date":298,"type":22},"2026-06-01",{"name":41,"class":42},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":75},"100570659","effect-of-custom-dynamic-orthoses-on-forefoot-loading-100570659","NCT06710119","Effect of Custom Dynamic Orthoses on Forefoot Loading","LoadsolCP","Patient Inclusion criteria\n\n* Ages: 18-65\n* Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis\n* Shoe size between women's 8 and 13.5 or men's 6.5 and 13\n* Any of the following: weakness of ankle plantarflexors (\\\u003C4\u002F5 on MMT), limited pain free ankle motion (DF\\\u003C10deg or PF\\\u003C20deg), mechanical pain with loading onto hindfoot\u002Fmidfoot\u002Fforefoot (\\>4\u002F10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle\u002Ffoot impairment\n* Ability to walk 25 feet without using a cane or crutch\n* Ability to walk at a slow to moderate pace\n* Able to read and write in English and provide written informed consent\n\nPatient Exclusion criteria\n\n* Pain \\> 9\u002F10 while walking\n* Ankle weakness as a result of spinal cord injury or central nervous system pathology\n* AFO or CDO prescription that includes a knee brace or goes up to thigh\n* Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)\n* Nerve, muscle, bone, or other condition limiting function of the contralateral extremity\n* BMI greater than 40\n* Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing\n* Pregnancy",{"count":308,"type":22},60,[25],"The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.",[312],"Lower Extremity Injuries",[314,289,315,291,316,317],"Gait Analysis","Carbon Fiber","Visual Feedback","Foot Loading","2025-12-29",{"date":320,"type":35},"2025-12-31",{"date":322,"type":35},"2025-06-18",{"date":324,"type":22},"2027-12-31",{"name":41,"class":42},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":341,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":346,"locationsCount":43},"100525863","reliability-of-force-measurement-within-the-carbon-fiber-orthosis-proximal-cuff-100525863","NCT06127264","Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff","CuffForce","Group 1 - Able Bodied Participants\n\nInclusion Criteria\n\n* Between the ages of 18 and 65\n* Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months\n* Able to hop without pain\n* Able to perform a full squat without pain\n* Ability to read and write in English and provide written informed consent\n* Ability to fit in a generic sized CDO\n\nExclusion Criteria\n\n* Diagnosed with a moderate or severe brain injury\n* Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks\n* Injuries that would limit performance in this study\n* Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)\n* Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing\n* Require use of an assistive device\n* Unhealed wounds (cuts\u002Fabrasions) that would prevent AFO use\n* BMI \\> 40\n* Pregnancy\n\nGroup 2 - AFO Users without Peripheral Neuropathy\n\nInclusion Criteria:\n\n* Between the ages of 18 and 90\n* Use an AFO(s) for daily activities\n* The AFO(s) proximal cuff is compatible with loadpad sensors\n* Have used their AFO(s) for a minimum of 2 weeks\n* Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)\n* Ability to read and write in English and provide written informed consent\n\nExclusion Criteria\n\n* Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments\n* Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)\n* Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities\n* Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing\n* BMI \\> 40\n* Pregnancy\n\nGroup 3 - AFO Users with Peripheral Neuropathy\n\nInclusion Criteria:\n\n* Between the ages of 18 and 90\n* Use an AFO(s) for daily activities\n* The AFO(s) proximal cuff is compatible with loadpad sensors\n* Have used their AFO(s) for a minimum of 2 weeks\n* Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)\n* Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments\n* Ability to read and write in English and provide written informed consent\n\nExclusion Criteria\n\n* Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)\n* Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities\n* Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing\n* BMI \\> 40\n* Pregnancy","90 Years",{"count":308,"type":22},[25],"The primary purpose of this research study is to determine if forces within carbon fiber custom dynamic orthoses (CDOs) can be reliability assessed using Loadpad and Loadsol force measuring sensors (Novel GMBH, St. Paul, MN). An improved understanding of the forces acting within orthoses may help to guide future orthosis related research studies, provision methods, and patient education.\n\nStudy participants will consist of three groups; 1) healthy, able-bodied adult participants using generic sized CDOs, which consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that runs the length of the leg and bends to store and return energy, and a semi-rigid footplate that acts as a lever arm to bend the posterior strut, 2) individuals without peripheral neuropathy who use AFO(s) regularly, and 3) individuals with peripheral neuropathy who use AFO(s) regularly. .\n\nGroup 1 participants will be asked to fasten the proximal cuff to a self-selected cuff tightness 'SSCT', as well as three different predefined force levels; 'Loose' where the proximal cuff is loosely fastened around the participants leg, 'Moderate' where the proximal cuff is fastened with moderate tightness, and 'Tight' where the proximal cuff is tightly fastened around the participants leg. Testing in the predetermined force levels (Loose, Moderate, Tight) will occur in a randomized order. Group 2 and Group 3 participants will be asked to fasten their AFO(s) to a self-selected 'SSCT' tightness.\n\nFor all groups, forces acting on the leg, within the proximal cuff, will be measured using wireless Loadpad sensors and forces acting on the foot will be measured using wireless Loadsol insoles. Testing will include collection of force data as participants sit quietly, stand quietly, and walk and completion of questionnaires.",[338,339,340],"Healthy","Ankle Foot Orthosis (AFO)","Peripheral Neuropathy",[289,290,288],{"date":320,"type":35},{"date":344,"type":35},"2024-03-01",{"date":246,"type":22},{"name":41,"class":42},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":354,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":363,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":43},"100423945","the-effects-of-afo-heel-height-and-stiffness-on-gait-100423945","NCT04800484","The Effects of AFO Heel Height and Stiffness on Gait","AFOHeel","GROUP 1 Patient Inclusion criteria\n\n* Ages: 18-70\n* Daily AFO use to address unilateral, below knee functional deficits that result from limb injury or musculoskeletal disease (e.g. fracture, muscle and\u002For nerve injury, ankle arthritis)\n* Greater than 2 weeks using their current AFO\n* Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)\n* Ability to walk at a slow to moderate pace\n* AFO fits into traditional footwear\n* Able to read and write in English and provide written informed consent\n\nGROUP 1 Patient Exclusion criteria\n\n* Pain \\> 6\u002F10 while walking during testing or an increase in pain during testing of \\> 2\u002F10.\n* Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity).\n* Disorder or disease that affects peripheral nerve function (e.g. diabetes, Charcot Marie Tooth).\n* Limited contralateral lower limb function due to injury or neurological\u002Fmusculoskeletal disorder.\n* Use of a hinged\u002Farticulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist\u002Fstop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.\n* Use of an AFO that crosses the knee (Knee brace)\n* Insufficient space in shoe to accommodate the tallest heel wedge and their AFO\n* Visual or hearing impairments that limit walking ability or could limit the ability to comply with instructions given during testing\n* Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.\n* Body Mass index \\> 40.\n\nGROUP 2 Patient Inclusion Criteria\n\n* Ages: 18-70\n* Daily AFO use to address below knee functional deficits that result from disease involving the peripheral nervous system (e.g. Charcot Marie Tooth, Multiple Sclerosis, diabetes)\n* Greater than 2 weeks using their current AFO (unilateral or bilateral)\n* Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)\n* AFO fits into traditional footwear\n* Ability to walk at a slow to moderate pace\n* Able to read and write in English and provide written informed consent\n\nGROUP 2 Patient Exclusion Criteria\n\n* Pain \\> 6\u002F10 while walking or an increase in pain during testing of \\> 2\u002F10\n* Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity)\n* Limited function due to limb injury (e.g. fracture, muscle and\u002For nerve injury)\n* Use of a hinged\u002Farticulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist\u002Fstop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.\n* Use of an AFO that crosses the knee (Knee brace)\n* Insufficient space in shoe to accommodate the tallest heel wedge and their AFO\n* Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing\n* Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study\n* Body Mass index \\> 40.","70 Years",{"count":356,"type":22},40,[25],"The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited. In this study, heel cushions with different height and stiffness's (4 conditions) will be placed in participants shoes and they will walk at controlled and self-selected speeds. Participants will also walk with their AFO as configured prior to enrollment, and with no AFO if possible. The proposed study will provide evidence that can be used by clinicians and researchers to align braces that most effectively improve function during every-day walking.",[360,361,362],"Musculoskeletal Injury","Musculoskeletal Diseases","Peripheral Nervous System Diseases",[314,289,291],{"date":320,"type":35},{"date":366,"type":35},"2019-11-07",{"date":368,"type":22},"2027-01-01",{"name":41,"class":42},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":83,"sex":17,"minAge":378,"maxAge":231,"enrollmentInfo":379,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":75},"100542123","cognitive-control-to-boost-physical-activity-adherence-100542123","NCT06338774","Cognitive Control to Boost Physical Activity Adherence","Targeting Cognitive Control to Improve Physical Activity Adherence in Midlife for Alzheimer's Risk Reduction","BOOST","Inclusion Criteria:\n\n* Between the ages of 40 and 65 years old\n* Full-time working status of an average of 35 hrs.\u002Fweek or more\n* Scoring as \"Low Active\" by the short form of the International Physical Activity Questionnaire (IPAQ)\n* Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire\n* Approval from their Primary Care Physician for approval to participate in the prescribed training program\n* Corrected vision of 20\u002F40\n* Fluent in English to ensure instructions for cognitive assessments and training are understood clearly\n\nExclusion Criteria:\n\n* Impairments in hearing inhibiting the ability to discuss study instructions or directions\n* Visual impairments that prevent the perception of color, or loss of sight in the visual field\n* Qualify as \"high risk\" for exercise-induced adverse events by American College of Sports Medicine criteria will be excluded, which includes known or symptomatic chronic cardiovascular or metabolic disease\n* Not fluent in English\n* Inability to comply with experimental instructions or access a tablet or computer to complete computerized training\n* Previous diagnosis of a neurological or psychiatric condition, including diagnosis with any of the following: major depression, Attention Deficit Disorder or attention-deficit\u002Fhyperactivity disorder (ADHD), schizophrenia or bipolar disorder, multiple sclerosis, epilepsy, meningitis, Parkinson's disease, stroke, Transient Ischemic Attack (TIA), or brain aneurysm surgery.\n* Previous diagnosis of a heart condition, cardiovascular disease, or a recent cardiovascular event (such as high blood pressure or cholesterol) that would increase the risk for an adverse event in response to vigorous exercise, Chronic obstructive pulmonary disease (COPD), uncontrolled asthma (this includes anyone who has asthma but is not on medication.\n* Previous diagnosis of a chronic condition such as cystic fibrosis, unregulated thyroid disorder (this includes anyone with thyroid disease that is not on medication), untreated diabetes, renal or liver disease, heart murmur, arrhythmia, or irregular heartbeat.\n* Previous brain surgery or injury associated with concussion or loss of consciousness that required rehabilitation or caregiver assistance to regain function (i.e., dressing\u002Fpersonal hygiene)\n* Previous diagnosis of Alzheimer\\'s or related dementias\n* Current or previous cancer treatments within the last 6 months\n* Pregnant or trying to get pregnant","40 Years",{"count":380,"type":22},264,[25],"This trial is designed to develop and test the efficacy of cognitive training strategies to improve self-regulatory capacities for middle-aged adults to adopt and sustain a physically active lifestyle. The main questions it aims to answer are:\n\n* Can cognitive training designed to improve cognitive control improve physical activity adherence?\n* What are the psychological, physiological, cognitive, and sociodemographic factors that affect the impact of cognitive control on physical activity adherence?\n\nParticipants will\n\n* Complete a 6-week home-based, computerized cognitive training program\n* Complete a 6-week home-based, aerobic exercise training program with supervision of a health coach and trainer\n* Complete a 6-week home-based, aerobic exercise training program prescribed by a health coach and trainer\n* Visit the laboratory before and after cognitive training, and before and after physical training, to complete assessments of cognition and aerobic fitness",[384],"Physical Inactivity",[386,387,388],"health behavior change","physical activity adherence","exercse","2025-12-09",{"date":391,"type":35},"2025-12-11",{"date":393,"type":35},"2024-09-01",{"date":395,"type":22},"2027-11-30",{"name":41,"class":42},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":417,"locationsCount":75},"100553681","early-phase-1-role-of-inflammation-in-vascular-phenotype-associated-with-e-cigarette-use-100553681","NCT06489249","Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use","Inclusion Criteria:\n\n* 18 - 24 years of age\n* no history of e-cigarette use (control) OR current with 6 months or more history of e-cigarette use (chronic use).\n\nExclusion Criteria:\n\n* tobacco cigarette use (current or history of)\n* use of stimulant drugs\n* skin diseases\n* cardiovascular disease\n* diagnosed or suspected hepatic or metabolic disease including diabetes\n* statin or other cholesterol-lowering medication\n* antihypertensive medication\n* current pregnancy or breastfeeding\n* blood pressure greater than or equal to 140mmHg systolic and\u002For greater than or equal to 90mmHg diastolic\n* allergy to materials used during the experiment\n* known allergies to salsalate or other study drugs",{"count":404,"type":22},24,[234],"The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as \"vaping\" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored. The purpose of this study is to directly asses the mechanistic role of inflammation in this dysfunction.",[408,409,410],"Electronic Cigarette Use","Endothelial Dysfunction","Inflammation","2025-12-08",{"date":413,"type":35},"2025-12-15",{"date":415,"type":35},"2024-08-15",{"date":118,"type":22},{"name":41,"class":42},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":426,"maxAge":231,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":428,"briefSummary":429,"conditions":430,"keywords":434,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":43},"100547256","phase-2-psilocybin-or-ketamine-for-alcohol-use-disorder-an-active-comparator-trial-100547256","NCT06405607","Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial","Psilocybin vs Ketamine for Alcohol Use Disorder","Psi or Ket","Inclusion criteria:\n\n* Weight between 50kg and 150kg\n* No known allergies to rescue medication\n* For people capable of becoming pregnant, not pregnant and using contraception\n* Not currently breastfeeding\n* Meets criteria for DSM-V moderate to severe AUD.\n* Have at least 4 heavy drinking days (5 or more standard drinks in a day) in the past 30 days.\n* Not currently participating in formal treatment for AUD.\n* No history of a of cerebrovascular accident, asthma, or significant alcohol withdrawal history\n* No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes, pancreatitis, liver disease\n* No hallucinogen or ketamine use in past 12 months\n* No self-reported, personal, or familial history of specific psychotic disorders\u002Fepisodes.\n* No serious traumatic brain injury (TBI) in the past 2 years\n* No substance use disorder other than AUD over the past 12 months\n* If taking a GLP-1 agonist, stable dosage for past 3 months\n* Family member\u002Ffriend for pick-up, overnight post-drug session monitoring.\n* No MRI contraindications\n\nExclusion Criteria:\n\nDrug\u002Fmedication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the study investigators), medically unstable, current medication use that has significant potential to interact with study drug (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents, lithium, anticonvulsants, or benzodiazepines).\n\nPsychiatric assessment that yields:1) history of severe suicide attempt, 2) current suicidality 3) first-degree relative with schizophrenia or schizoaffective disorder, 4) comorbid substance use disorder including cocaine, psychostimulant, or opioid use disorder within past 12 months 5) history of co-occurring psychotic episode\u002Fdiagnosis including schizophrenia, schizoaffective disorder, schizophreniform, substance-induced psychosis, delusional disorder, or psychosis not otherwise specified, 6) high risk of adverse emotional or behavioral reaction based on the medical monitor's clinical evaluation that may also yield evidence of serious current stressors, a lack of meaningful social support, antisocial behavior, and\u002For serious personality disorders amongst other conditions.\n\nMedical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation \\[QTc \\> .045\\]), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation (significantly impaired liver function), or pregnancy.\n\nMRI contraindication (pacemaker, etc.)","21 Years",{"count":159,"type":22},[54],"This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg\u002Fkg dose of ketamine.",[431,432,433],"Alcohol Use Disorder","Alcohol Dependence","Alcohol Abuse",[435,436,437],"psychedelic","psilocybin","ketamine","2025-11-21",{"date":440,"type":35},"2025-11-28",{"date":442,"type":35},"2025-06-12",{"date":444,"type":22},"2028-04",{"name":41,"class":42},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":465,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":477,"locationsCount":43},"100611763","probing-the-role-of-mitochondrial-oxidative-stress-in-impaired-vascular-function-among-young-adults-with-early-life-adversity-100611763","NCT07244809","Probing the Role of Mitochondrial Oxidative Stress in Impaired Vascular Function Among Young Adults With Early Life Adversity","PROMISE","Inclusion Criteria:\n\n* 18-29 years\n* ACE score \\>=4\n\nExclusion Criteria:\n\n* Resting arterial blood pressure \\>140\u002F90 mmHg\n* BMI \\\u003C=17 or \\>= 35\n* Are on a weight-loss diet or involved in a formal weight-loss program or are not intentionally weight stable for 6 months (+\u002F- 5 kg) prior to the study.\n* Cardiovascular or metabolic prescription drug use\n* Vasoactive antidepressant drug use (SSRIs and clonidine)\n* Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)\n* Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)\n* Current tobacco or nicotine use\n* Vaping\n* Regular vigorous (\\>6 METs) aerobic exercise (\\>4 bouts\u002Fweek, \\>30 min\u002Fbout)\n* dietary supplementation with antioxidants or habitual use of NSAIDs\n* Currently pregnant or breastfeeding","29 Years",{"count":455,"type":22},300,[25],"Adverse childhood experiences (ACEs) represent highly stressful events in the first 18 years of life that include abuse, neglect, and household and community-level dysfunction. Greater exposure to ACEs are associated with greater increases in the risk of cardiovascular diseases and death. Our laboratory has previously observed that vascular function is disrupted in young adults with prior ACE exposure, even though these individuals appear to be healthy clinically (i.e., no classic clinical cardiovascular disease risk factors). There is a need to identify and understand the biological mechanisms underlying these vascular impairments to inform effective interventions to reduce cardiovascular risks the millions of individuals affected by ACEs.\n\nThe body's response to stress is coordinated across various systems, all of which depend on energy supplied by mitochondria (often referred to as the \"powerhouse of cells\"). Based on new evidence across multiple physiological systems from our team, our overarching hypothesis is that disruption of mitochondrial function contributes to cardiovascular impairments among young adults with ACEs. Here we propose the initial pilot work necessary to begin to understand these associations, which will directly inform identification of individuals who may be most vulnerable to stress-related cardiovascular risk and the development of interventions to promote cardiovascular-stress resilience.\n\nOur aims are to:\n\n1. Determine whether mitochondrial oxidative stress contributes to impaired vascular function among young adults who experienced early life adversity.\n2. Determine whether reducing mitochondrial oxidative stress improves the cellular stress and integrated cardiovascular response to laboratory-based psychosocial stress among young adults who experienced early life adversity.",[459,460,461,462,463,464],"Adverse Childhood Experience","Endothelial Function (FMD)","Endothelial Injury","Mitochondrial Function","Oxidative Stress","Psychosocial Influence on Cardiovascular Disease",[466,467,468,469,470],"flow mediated dilation","mitoquinone mesylate","placebo","early life adversity","trier social stress test","2025-11-17",{"date":473,"type":35},"2025-11-24",{"date":475,"type":35},"2025-10-13",{"date":246,"type":22},{"name":41,"class":42},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":83,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":502},"100147630","genetics-of-charcot-marie-tooth-cmt---modifiers-of-cmt1a-new-causes-of-cmt2-100147630","NCT01193088","Genetics of Charcot Marie Tooth (CMT) - Modifiers of CMT1A, New Causes of CMT2","Genetics of Charcot Marie Tooth Disease (CMT) - Modifiers of CMT1A, New Causes of CMT","INC-6602","Inclusion Criteria:\n\nAll patients must agree to take part in the study and sign a consent form. A teenager (age 13-17 years) considering enrolling must agree to take part in the study and sign an assent form (depending on local ethics committee requirements).\n\nAdditional inclusion criteria are described below.\n\nInclusion Criteria: CMT1A Gene Modifier Study\n\nPatients must have at least one of the following:\n\n1. Patient has a documented PMP22 duplication. AND\u002FOR\n2. Patient has a first or second degree relative (parent, child, sibling, half- sibling, aunt, uncle, grandparent, grandchild, niece, or nephew) with a documented PMP22 duplication AND a clear link between that family member and the affected patient AND a phenotype consistent with CMT1A.\n\ni. A clear link is necessary for a second-degree relative. For example, if a grandparent is affected and has a PMP22 duplication, and the parent does not have any signs, symptoms, or electrophysiology consistent with CMT1A, there is no clear link.\n\nii. In cases where clear links are not available, genetic testing is required for the patient or the first degree family member who is not clearly affected.\n\nInclusion Criteria - Patients for CMT Exome Project\n\na. Patient has demonstrated neuropathy on nerve conduction studies or clinically diagnosed genetic neuropathy, in the opinion of the investigator or genetic counsellor.\n\nInclusion Criteria - Controls for CMT Exome Project\n\n1. Person is a family member of a CMT patient who is enrolled in the CMT Exome Project.\n\n   AND one of the following:\n2. Person does not have a peripheral neuropathy, in the opinion of the investigator or genetic counsellor.\n\n   OR\n3. Person is suspected to have a peripheral neuropathy, but has not been examined at an INC site.\n\nExclusion Criteria\n\n1. Patient does not wish to participate or does not sign a consent form.\n2. For CMT Exome Project, patient has a genetically confirmed form of CMT (i.e. mutation in MFN2 causing CMT2A, mutation in GARS causing CMT2D, etc.).\n3. Patients with known neuropathy from a non-genetic source, such as chemotherapies (i.e. Vincristine, Taxol, Cisplatin), diabetes, alcoholism will be evaluated independently so that genetic contributions to their effects on CMT1A phenotypes can also be analyzed.",{"count":487,"type":22},1050,"This project includes two projects. One is looking for new genes that cause Charcot Marie Tooth disease (CMT). The other is looking for genes that do not cause CMT, but may modify the symptoms a person has.",[490,491],"Charcot-Marie-Tooth Disease, Type Ia (Disorder)","HMSN",[493,494],"CMT","CMT1A","2025-10-01",{"date":497,"type":35},"2025-10-07",{"date":499,"type":35},"2010-05",{"date":98,"type":22},{"name":41,"class":42},22,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":510,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":43},"100554496","early-phase-1-comparing-approaches-to-assess-nitric-oxide-dependent-cutaneous-vasodilation-100554496","NCT06499844","Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation","CAP NOVA","Inclusion Criteria:\n\n* men and women\n* 18-30 years of age\n\nExclusion Criteria:\n\n* Current or recent (within 8 wks) use of medication that could conceivably alter microvascular function \\[including (but not limited to) stimulants, antihypertensives, HMG-CoA reductase inhibitors\\]\n* Changes or alterations in medication status (starting a new, additional, or different medication or changing the dose of a current medication)\n* Unstable or diagnosed chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease (e.g., hypertension, heart disease, diabetes, hyperlipidemia, psoriasis)\n* Body mass index \\\u003C18.5 or \\>35 kg\u002Fm2\n* Pregnancy (including a positive urine pregnancy test) or breast-feeding\n* Known allergies to pharmacological agents or study drugs\n* Non-English-speaking. Participants need to understand English to follow instructions and comply with procedures conducted during the screening and experimental visits.","30 Years",{"count":512,"type":22},56,[234],"The increase in skin blood flow in response to rapid local heating of the skin (i.e., cutaneous vasodilation) is commonly used to assess nitric oxide (NO)-dependent dilation and overall microvascular function. Historically, rapid local heating to 42°C was considered the standard approach for these assessments. More recently, many investigators have adopted rapid local to 39°C instead, based on its larger dependency on NO and therefore improved ability to quantify NO-dependent dilation without the use of pharmacological techniques. However, to date, only one direct methodological comparison between these protocols has been performed.\n\nIn this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a nickel-sized area of the skin in young adults ages 18 - 30 years old. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, the investigators also have participants fill out a variety of surveys to assess things such as sleep quality, physical activity, daily stressors, etc.",[516],"Endothelial Function","2025-08-19",{"date":519,"type":35},"2025-08-24",{"date":521,"type":35},"2024-08-01",{"date":523,"type":22},"2026-09",{"name":41,"class":42},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":532,"enrollmentInfo":533,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":43},"100491817","dimensional-changes-randomized-clinical-trial-100491817","NCT05684068","Dimensional Changes: Randomized Clinical Trial","Dimensional Changes of Autogenous Free Epithelialized Gingival Grafts on Different Bed Preparations Among Dental Patients With Thin Tissue Phenotypes: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients 18-95 years of age\n* Inactive periodontal disease\n* Lack of, or an insufficient (less than 2 millimeters) band of keratinized tissue width on the buccal site (closest to the cheek)\n* Shallow vestibule depth (the space between the soft tissue (lips and cheeks), and the teeth and gums)\n* Thin gingival phenotype (less than 1.5mm of gum tissue depth).\n* Aberrant frenum attachment in need of free-epithelized gingival grafts.\n* At least one RT1, 2, or 3 (Cairo's classification) gingival recession defect on the mandibular anterior sextant (Teeth #22-27).\n* Non-smokers or past smokers (those who have stopped at minimum 6 months ago).\n* Patient willing and able to follow instruction related to the study procedures.\n\nExclusion Criteria:\n\n* Previous soft tissue augmentation procedures at the area of interest.\n* Current smokers (Light smokers meaning less than 10 cigarettes\u002Fday, heavy smokers meaning more than 10 cigarettes\u002Fday, or social smokers)\n* Uncontrolled systemic disease (uncontrolled diabetes defined by blood sugar HbA1c greater than 7%)\n* Any active local or systemic infections\n* Any diseases or medications that may compromise normal wound healing\n* Currently receiving chemotherapy or radiotherapy or a history of radiotherapy in head and neck area.\n* Severe hematologic (blood) disorders\n* Pregnancy or nursing mother\n* Patients undergoing orthodontic therapy\n* Patients taking antibiotics in the past 3 months","95 Years",{"count":209,"type":22},[25],"The goal of this clinical trial is to evaluate the dimensional changes in the short and long-term in patients with thin gum tissues who have gum grafts placed on either denuded bone or gum grafts placed on a bone with some tissues remaining.\n\nThe main question this study aims to answer is:\n\n\\- Does the placement of free-epithelized gingival grafts (gum grafts) on full thickness bed preparation (having all of the tissue removed from the bone) lead to similar clinical, digital, and patient-related outcomes and measurements over a period of 12 months versus split thickness bed preparation (where a small layer of tissue is left over the bone) in patients with thin gum tissue phenotypes (gum tissue is generally less than 1.5 millimeters) who are in need of soft tissue augmentation procedures?\n\nParticipants will be asked to attend 8 visits, which include: (i) screening visit, (ii) prophylaxis visit, (iii) random assignment to Group A or Group B along with surgery and digital data collection, (iv) 2-week post-operative visit, (v) 6-week post-operative visit, (vi) 3-month follow-up visit, (vii) 6-month follow-up visit, (viii) 12-month follow-up visit. Also, Group A will have a free epithelialized gingival\u002Fmucosal graft (gum graft) placed on full thickness periosteal bed preparation where all of the tissue was removed (test group). Group B will have a free epithelialized gingival\u002Fmucosal graft (gum graft) on split thickness periosteal bed preparation where only a portion of the tissue was removed (control group). Researchers will compare Group A and Group B to see if there is a difference in clinical, digital, and patient-related outcomes and measurements over a period of 12 months.",[537],"Gingival Recession","2025-08-13",{"date":517,"type":35},{"date":541,"type":22},"2028-08",{"date":543,"type":22},"2031-03",{"name":41,"class":42},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":256,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":554,"briefSummary":555,"conditions":556,"keywords":559,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":43},"100532016","acceptance-and-commitment-therapy-for-patients-undergoing-coronary-artery-bypass-graft-surgery-100532016","NCT06207318","Acceptance and Commitment Therapy for Patients Undergoing Coronary Artery Bypass Graft Surgery","Acceptance and Commitment Therapy for the Perioperative Period of Coronary Artery Bypass Graft Surgery: a Randomized Controlled Feasibility Trial","ACT for CABG","Inclusion Criteria:\n\n* admission to the Heart and Vascular Center at University of Iowa Hospitals and Clinics (UIHC) for urgent or elective CABG\n* access to a personal phone or device with video or audio capabilities\n* ability to provide informed consent\n* English fluency.\n\nExclusion Criteria:\n\n* life-threatening comorbid (noncardiac) medical condition(s)\n* active suicidal ideation or intent\n* psychotropic medication use lasting less than four weeks\n* inability to provide informed consent and comply with study procedures\n* those undergoing repeat revascularization",{"count":5,"type":22},[25],"Heart disease is the leading cause of death globally, accounting for 16% of the world's total deaths. The number of cases is expected to increase as our population ages. Heart disease also results in large economic burden. It costs the United States about $219 billion per year. Some patients have symptoms that aren't helped by drugs or other medical treatments. These patients will need a surgery that is called cardiac artery bypass graft (CABG) surgery. CABG helps to improve chest pain which is one of the most common complaints of heart disease, and has life-prolonging potential. A limitation of CABG is that it results in increased inflammation. These patients also report high levels of anxiety and depression. Depression and anxiety in the several days surrounding surgery are related to several important things. These include worse health outcomes, worse quality of life, increased risk of death, and increased health care cost. Acceptance and Commitment Therapy (ACT) is a kind of therapy. ACT is adaptable, easy to access, and effective in brief formats. ACT has been gaining evidence for its use in many patient samples. Few studies have used ACT with heart disease patients. No known studies currently exist that have used ACT within the few days surrounding CABG surgery. To address this need, the investigators will conduct a two-arm feasibility randomized control trial (RCT). Patients will be randomized to one of two groups. The first group will complete a brief, 2-session telehealth ACT intervention. The second group will be a control group. The control will consist of treatment as usual. The investigators will evaluate the feasibility of this brief ACT intervention delivered in the peri-operative period. The investigators will also examine preliminary efficacy of the ACT intervention. The investigators will examine anxiety, depression, psychological inflexibility, well-being, and cardiovascular health-related quality of life. The investigators will also examine the intervention's impact on inflammation by measuring two inflammatory markers. The results from this study will also lay the groundwork for larger or multiple site RCT studies.",[557,558],"Coronary Artery Disease","Vascularization",[560,561],"ACT","CABG","2025-08-07",{"date":564,"type":35},"2025-08-08",{"date":566,"type":35},"2024-02-12",{"date":568,"type":22},"2025-12",{"name":41,"class":42},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":578,"maxAge":579,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":581,"briefSummary":582,"conditions":583,"keywords":587,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":43},"100600474","paediatric-post-tb-pulmonary-rehab-study-100600474","NCT07097961","Paediatric Post-TB Pulmonary Rehab Study","Paediatric Post-TB Home-based Pulmonary Rehabilitation Feasibility Study","PPT Rehab","Inclusion Criteria:\n\n* Aged 6-17 years\n* Previously diagnosed with post-TB lung disease,\n* Willing to remain in the study catchment area during the study period\n* Able to participate in mild-to-moderate physical activity (late inclusion criterion)\n\nExclusion Criteria:\n\n* Currently participating in another rehabilitation program\n* Residence outside the Kampala metropolitan area\n* Active respiratory infection (late exclusion criterion)","6 Years","17 Years",{"count":356,"type":22},[25],"The goal of this clinical trial is to learn if a home-based pulmonary rehabilitation program is feasible and acceptable for children ages 6-15 who have recently completed treatment for pulmonary tuberculosis. The main questions it aims to answer are:\n\nCan children and caregivers follow a 6-week rehabilitation program?\n\nIs the program acceptable and feasible for children and caregivers?\n\nResearchers will also explore preliminary changes in walking distance and quality of life.\n\nParticipants will:\n\nAttend a clinic visit for baseline testing, including a 6-minute walk test (6MWT) and the St. George's Respiratory Questionnaire (SGRQ)\n\nReceive exercise instructions and a pedometer\n\nComplete home-based walking and wall sit exercises twice per week for 6 weeks\n\nReceive weekly follow-up from study staff (by phone or home visit)\n\nReturn to clinic at 6 weeks for follow-up testing",[584,585,586],"Tuberculosis in Children","Chronic Lung Disease","Post Tuberculosis",[588,589,590,591],"Post-TB lung disease","Uganda","Pulmonary rehabilitation","pediatric tuberculosis","2025-08-06",{"date":594,"type":35},"2025-08-11",{"date":596,"type":35},"2025-07-29",{"date":598,"type":22},"2026-02-23",{"name":41,"class":42},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":23,"phases":609,"briefSummary":610,"conditions":611,"keywords":615,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":43},"100546474","phase-2-177lu-dotatate-modified-delivery-based-on-individualized-dosimetry-100546474","NCT06395402","177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry","LUMOD-ID","In order to be eligible to participate in this study, an individual must meet all of the following criteria. A physical, with vital signs, concomitant medication review, and medical history must be completed within 60 calendar days to confirm appropriateness of Lutathera treatment as well as to foundation for listed criteria.\n\nInclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Aged ≥ 18 years at time of consent.\n* Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with the primary tumor location known or believed to be gastroenteropancreatic origin (GEP-NET)\n* Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST that shows uptake \\> liver background on sstr2 PET\u002FCT with any FDA approved sstr2 imaging agent. SSTR2 PET\u002FCT must have been obtained within 90 days prior to scheduled C1D1 of Lutathera.\n* Recommended to receive LUTATHERA® therapy for unresectable and\u002For metastatic neuroendocrine disease.\n* Adequate performance status (ECOG of 0 or 1; or Karnofsky performance status of ≥70).\n* Agrees to contraception during therapy.\n* Neutrophil count within normal limits within 28 days of treatment day 1.\n* Platelet count within normal limits within 28 days of treatment day 1.\n* Ability to take oral medication and be willing to adhere to the treatment regimen\n* For individuals of reproductive potential: agreement to use effective birth control\n* Agreement to adhere to Lifestyle Considerations throughout study duration: abstain from caffeine or xanthine-containing products as well as alcohol before the start of cycle dosing and through the cycle's final blood sample; minimize social interactions during low blood counts.\n\nExclusion Criteria:\n\n* Individuals who are pregnant or lactating (note: potential participants should not engage in 'pump \\& dump' strategy; lactation must be discontinued).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring inpatient admission or a delay to start of therapy), fever, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1 (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).\n* Prior peptide-receptor radiotherapy (PRRT).\n* Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable).\n* A concurrent malignancy that, in the opinion of the investigator, would cause a safety risk by delaying therapy or confound\u002Fnegatively impact study objectives (documentation of the rationale must be provided)\n* Prior external beam radiation dose to the kidneys of \\>10 Gy (mean dose to functional renal volume).\n* Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of ≤ 5 Gy) as estimated by a radiation oncologist.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Octreoscan® or Netspot™.",{"count":608,"type":22},120,[54],"The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will:\n\n* Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET\u002FCT scan\n* Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry)\n* Undergo blood tests for 4 to 8 weeks after each Lutathera treatment\n* Complete patient reported outcome questionnaires\n* Visit the clinic for follow-up about every 8 weeks.",[612,613,614],"Neuroendocrine Tumors","Neuroendocrine Tumor Grade 1","Neuroendocrine Tumor Grade 2",[616,617],"lutetium Lu 177 dotatate","Radiotherapy Planning, Computer-Assisted","2025-07-17",{"date":620,"type":35},"2025-07-22",{"date":622,"type":35},"2024-05-03",{"date":624,"type":22},"2029-12-31",{"name":41,"class":42},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":256,"enrollmentInfo":633,"targetDuration":4,"studyType":23,"phases":635,"briefSummary":636,"conditions":637,"keywords":640,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":43},"100589221","robotic-assisted-versus-manual-electrode-array-insertion-100589221","NCT06951594","Robotic-Assisted Versus Manual Electrode Array Insertion","Iowa Cochlear Implant Clinical Research Center Study on Robotic-Assisted Versus Manual Electrode Array Insertion","Inclusion Criteria:\n\n* Candidate for a cochlear implant according to CMS guidelines\n* Willingness to comply with all study requirements\n* Patent cochlea and normal cochlear anatomy, as confirmed by preoperative imaging\n* English speaking\n\nExclusion Criteria:\n\n* Medical or psychological conditions that contraindicate undergoing surgery\n* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.\n* Unrealistic expectations on the part of the candidate and\u002For candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.",{"count":634,"type":22},100,[25],"Robotics-assisted electrode insertion overcomes many surgeon-related kinetic limitations such as insertion speed, tremor, drift, and lack of accurate force control. In human cadaveric cochleae, robotics-assisted electrode insertion causes less intracochlear trauma compared to manual insertion. Whether this technical advance results in functional benefits in CI patients remains unknown. To address this critical knowledge gap, the investigators will compare cochlear trauma assessed using CT scans, cochlear and AN function assessed using ECochG and\u002For the eCAP, and clinical outcomes quantified by postoperative residual acoustic hearing and speech perception scores between participants randomized to either manual or robotics-assisted electrode array insertion.",[638,639],"Cochlear Implantation","Robotics",[641,642,643],"cochlear implantation","robotics","hearing preservation","2025-07-15",{"date":618,"type":35},{"date":647,"type":35},"2025-06-30",{"date":649,"type":22},"2028-08-31",{"name":41,"class":42},""]