[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"subglottic-stenosis-sgs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:subglottic-stenosis-sgs":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641406","phase-1-a-phase-i-evaluation-of-the-safety-and-tolerability-of-pirfenidone-in-idiopathic-subglottic-stenosis-100641406",false,"NCT07654517","A Phase I Evaluation of the Safety and Tolerability of Pirfenidone in Idiopathic Subglottic Stenosis","Inclusion Criteria:\n\n* Adults 18-65 years of age\n* Confirmed diagnosis of idiopathic subglottic stenosis (iSGS)\n* History of at least 2 endoscopic dilations within the past 12 months or -Receiving regular intralesional steroid injections as part of iSGS management (every 3 months)\n* Clinically stable at enrollment (no acute infection or active inflammation)\n* Adequate liver and renal function on screening laboratory tests\n* Willing and able to comply with study procedures, visits, and follow-up\n* Ability to provide written informed consent\n* For participants of childbearing potential: negative pregnancy test and agreement to use effective contraception during treatment and for the protocol-specified period after the last dose\n\nExclusion Criteria:\n\n* Subglottic stenosis due to another identifiable cause (e.g., intubation, granulomatosis with polyangiitis, malignancy)\n* Known hypersensitivity or allergic reaction to pirfenidone or any component of its formulation\n* Severe hepatic impairment or active liver disease (AST or ALT above the upper limit of normal)\n* Severe renal impairment or requirement for dialysis\n* Concurrent use of fluvoxamine\n* Use of high-dose ciprofloxacin or other strong CYP1A2 inhibitors where dose adjustment is not feasible\n* Current smoking or unwillingness to abstain from smoking during treatment\n* Pregnant or breastfeeding individuals\n* Clinically significant comorbid illness that could increase risk or confound results (e.g., advanced cardiac, pulmonary, or autoimmune disease)\n* History of photosensitivity disorders or inability to adhere to sun protection precautions\n* Participation in another investigational clinical trial within the previous 30 days\n* Any condition that, in the investigator's judgment, would interfere with safety monitoring, adherence, or study assessments","FEMALE","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","Idiopathic subglottic stenosis (iSGS) is a rare condition where scar tissue forms just below the vocal cords and in the upper windpipe, making the airway narrow. People with iSGS often feel short of breath, hear noisy breathing, and notice changes in their voice. Many need repeated operations and steroid injections to open the airway, but the narrowing usually comes back, so these treatments are not a cure.\n\nRecent research from a Canadian iSGS registry and biobank has shown that this disease is driven by overactive scarring pathways, similar to those seen in idiopathic pulmonary fibrosis (IPF), a serious lung disease. Pirfenidone is an oral medication already approved for IPF that works by slowing down the cells and signals that cause scarring. Because the same scarring pathways appear to be active in iSGS, pirfenidone may be able to slow or reduce the build-up of scar tissue in the airway.\n\nIn this study, adults with iSGS will be randomly assigned (like flipping a coin) to receive either pirfenidone or a placebo (a look-alike pill with no active drug) for 52 weeks, in addition to their usual intralesional steroid injections. The pirfenidone dose will be increased gradually over the first two weeks up to a regular dose taken three times a day with food, which is the same schedule used in patients with IPF. Participants and their doctors will not know which treatment they are getting until the end of the study, unless this needs to be revealed for safety reasons.\n\nThe main goal of this trial is to see how safe pirfenidone is for people with iSGS and how well they can tolerate taking it for one year. The study team will watch closely for side effects such as stomach upset, skin rash or sensitivity to sunlight, tiredness, and changes in liver blood tests. They will also look for early signs that pirfenidone may help, such as longer time until the next airway dilation, better breathing tests, and improvements in breathlessness and voice-related quality of life scores.\n\nParticipants will be followed for a total of up to two years, including one year on study medication and one year of follow-up. This study may not directly help every person who takes part, but the results will provide important information about whether pirfenidone is safe in iSGS and whether it could become the first medication to slow down this scarring airway disease.",[25,26],"Idiopathic Subglottic Stenosis","Subglottic Stenosis (SGS)",[28,29,30,31],"Subglottic Stenosis","Idiopathic Subglottic stenosis","Airway Fibrosis","Pirfenidone","NOT_YET_RECRUITING","2026-06-12",{"date":35,"type":36},"2026-06-17","ACTUAL",{"date":38,"type":19},"2026-12-01",{"date":40,"type":19},"2029-12-01",{"name":42,"class":43},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100638123","active-vs-passive-vr-during-office-based-ent-procedures-100638123","NCT07599826","Active vs. Passive VR During Office-based ENT Procedures","Active vs. Passive Virtual Reality for Reducing Pain and Anxiety During Office-based ENT Procedures","Inclusion Criteria Active and Passive VR:\n\n* Individuals 18 years old and older are included\n* Individuals undergoing the following common office-based ENT procedures: turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation (Rhineaer\u002FVivaer), nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection\n* Able to consent\n* English speaking\n\nExclusion Criteria Active VR:\n\n* History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, vertigo, or inability to use a handheld controller\n* Any records flagged \"break the glass\" or \"research opt out.\"\n\nExclusion Criteria Passive VR:\n\n* History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, or vertigo\n* Any records flagged \"break the glass\" or \"research opt out.\"","ALL",{"count":54,"type":19},132,[56],"NA","The purpose of this research is to evaluate whether active virtual reality reduces pain and anxiety more effectively than passive virtual reality during office-based ENT procedures. The main procedures include exposure to virtual reality (passive calming scenery or interactive puzzle game) via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures, participant self-report surveys (GAD-7, PHQ-9, PEG, VAS, SUDS, Likert, experience questions), and physician post-procedure survey. The study will enroll individuals 18 years or older who are scheduled to undergo common office-based ENT procedures (turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation, nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection) at Cedars Sinai.",[59,60,61,62,63,64,65,26],"Pain","Anxiety","Chronic Rhinosinusitis (CRS)","Nasal Obstruction","Nasal Polyp","Eustachian Tube Dysfunction","Dysphonia","2026-05-14",{"date":68,"type":36},"2026-05-20",{"date":70,"type":19},"2026-06",{"date":72,"type":19},"2027-12",{"name":74,"class":43},"Cedars-Sinai Medical Center",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":52,"minAge":16,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":44},"100587199","determinants-of-rescue-ventilation-requirement-in-airway-surgery-under-general-anesthesia-with-thrive-100587199","NCT06925282","Determinants of Rescue Ventilation Requirement in Airway Surgery Under General Anesthesia With THRIVE","Determinants of Rescue Ventilation Requirement in Airway Surgery Under General Anesthesia With Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): A Prospective Observational Study","THRIVE","Inclusion Criteria:\n\n* Adult patients undergoing elective airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE)\n* Patients who provide written informed consent\n\nExclusion Criteria:\n\n* Patients who decline to participate in the study",{"count":84,"type":19},80,"1 Day","OBSERVATIONAL","The anesthesia and surgical procedures from the time the patient enters the operating room to discharge from the recovery room are identical to those used in conventional airway surgeries performed under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). The time point at which rescue ventilation is required due to a drop in oxygen saturation below 92% during anesthesia will be recorded, and the predictive factors for this event will be investigated.",[26],"RECRUITING","2026-04-21",{"date":92,"type":36},"2026-04-24",{"date":94,"type":36},"2025-04-25",{"date":96,"type":19},"2028-04",{"name":98,"class":43},"Seoul National University Hospital"]