[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"otitis-media-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:otitis-media-recurrent":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100642730","osteopathic-manipulative-treatment-for-children-with-chronic-or-recurrent-otitis-media-100642730",false,"NCT07639775","Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media","The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 6 months to less than 7 years. (All participants)\n* Referred to an otolaryngologist (ENT) for evaluation of chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). (All participants)\n* Planned for tympanostomy tube placement (unilateral or bilateral) pending surgical decision. (All participants)\n* At least 5 weeks between enrollment and anticipated surgical decision point. (All participants)\n\nExclusion Criteria:\n\n* Congenital or developmental conditions associated with increased otitis media risk, including but not limited to Down syndrome, cleft palate, or other craniofacial abnormalities. (All participants)\n* History of prior tympanostomy tube placement or current tympanostomy tubes in place. (All participants)\n* History of tympanic membrane perforation. (All participants)\n* Presence of preauricular pits. (All participants)\n* Patients requiring urgent or expedited surgical intervention, as determined by the treating ENT physician. (All participants)","ALL","6 Months","6 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn whether osteopathic manipulative treatment, or OMT, can reduce the need for tympanostomy tube surgery in children with recurrent or chronic otitis media who have been referred to an Ear, Nose, and Throat surgeon and are being considered for tympanostomy tube placement.\n\nThe main question it aims to answer is:\n\nCan a standardized OMT protocol, given once weekly for 4 weeks before the final surgical decision, reduce the rate of tympanostomy tube surgery in pediatric patients with recurrent or chronic otitis media?\n\nResearchers will compare children who receive the standardized OMT protocol with children who receive a placebo\u002Fcontrol manual treatment protocol to see whether OMT leads to a clinically meaningful reduction in the need for surgery.\n\nParticipants will:\n\n* Attend 4 weekly study visits before their final ENT surgical decision.\n* Receive one of several assigned combinations of standardized OMT intervention procedures and control manual procedures. Each participant's assigned treatment sequence is determined by randomization.\n* Complete study-related assessments and questionnaires related to ear symptoms and quality of life.\n* Continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended.",[27,28,29,30,31,32,33,34],"Otitis Media","Otitis Media Effusion","Otitis Media Recurrent","Otitis Media With Effusion in Children","Otitis Media Chronic","Otitis Media in Children","Tympanostomy Tube Insertion","Osteopathic Manipulative Treatment (OMT)","NOT_YET_RECRUITING","2026-06-06",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":21},"2026-08-01",{"date":43,"type":21},"2028-05-31",{"name":45,"class":46},"Sarah Vidal","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100639335","clikx-tympanostomy-tube-delivery-system-for-the-placement-of-tympanostomy-tubes-100639335","NCT07625657","CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes","A Prospective Clinical Study of the Clikx Tympanostomy Tube Delivery System for Patients Requiring the Placement of Tympanostomy Tubes","Inclusion Criteria:\n\n1. Subject is scheduled to undergo tympanostomy tube insertion.\n2. Subject is ≥ 6 months old at the time of informed consent.\n3. Subject has an ear canal diameter of ≥ 4 mm.\n4. Subject is able and willing to provide informed consent or subject's parent\u002Fguardian is able and willing to provide informed consent and subject is able and willing to provide assent as age appropriate (age 7 years to 21 years old).\n\nExclusion Criteria:\n\n1. Subjects who are pregnant as confirmed by the institution's standard pre- surgery practice.\n2. Subjects with known adverse reaction to anesthesia.\n3. Subjects with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.\n4. Subjects with otitis externa.\n5. Subjects with active acute otitis media.\n6. Subjects with an ear canal diameter \\\u003C 4 mm.\n7. Ear drums that are overly vertical or horizontal\n8. Subjects with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator.\n9. Subjects with any condition that, in the opinion of the investigator, may place the subject at greater risk.\n10. Subjects with suspected middle ear tumors or vascular lesions.\n11. Subjects diagnosed with acute sensorial hearing loss\n12. Subjects with a history of surgery involving the ear drum.\n13. Subjects with hemotympanum.\n14. Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.",{"count":56,"type":21},80,[24],"This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed.\n\nIn this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia.\n\nThe study will also look at how well patients tolerate the procedure by checking for side affects during the procedure.\n\nFinally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..",[27,31,28,29,32],[61,62,63,64,65],"otitis media","Tympanostomy tube","NousQ","CLiKX","myringotomy","2026-06-02",{"date":68,"type":39},"2026-06-04",{"date":70,"type":21},"2026-06",{"date":72,"type":21},"2027-08",{"name":74,"class":75},"ClinQure, Inc.","NETWORK",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":84,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":100,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100635983","the-root-study-scaling-the-standard-of-care-plus-obstetric-nutrition-model-to-optimize-maternal-and-infant-health-100635983","NCT07559773","The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health","The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Integrated Model to Optimize Maternal and Infant Health: a Prospective Interventional Study: Resilient Outcomes Through OB-Nutrition Team Care (ROOT)","ROOT","Inclusion Criteria:\n\n* Pregnant women receiving care at NH Triad OB\u002FGYN\n* ≤20 weeks gestational age at enrollment\n* Age ≥ 18 years (\\\u003C18 years requires parental consent)\n* Ability to provide informed consent\n* Access to smart phone\u002Finternet for digital platform use\n\nExclusion Criteria:\n\n* \\> 20 weeks gestational age\n* High-risk pregnancies requiring specialized care beyond study scope\n* Inability to participate in digital health platform\n* Cognitive impairment preventing informed consent","FEMALE","18 Years",{"count":87,"type":21},500,[24],"The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle recommendations in collaboration with in-person standard obstetric care (SOC).\n\nIn 2014, the investigators demonstrated statistically significant reductions in adverse maternal and infant outcomes using the 'PLUS' model compared to SOC alone. Further study in a 50% Medicaid Oregon 'PLUS' cohort (N=387) demonstrated association with highly significant risk reductions in all primary outcomes (p-value \\\u003C0.001): preterm birth: relative risk (RR) = 0.238 (4.2x less likely), hypertensive disorders of pregnancy: RR = 0.229 (4.4x less likely), gestational diabetes: RR = 0.071 (14x less likely), small for gestational age: RR = 0.252 (4x less likely), and large for gestational age: RR = 0.357 (2.8x less likely). A 100% Medicaid and ethnically diverse Nevada 'PLUS' cohort showed similar trends in all outcomes that were not statistically significant because of small sample size.\n\nStructured as a prospective interventional study, the study evaluates whether the 'PLUS' model can achieve similar outcome improvements within the Novant Health (NH) system in North Carolina. The study will assess both clinical outcomes and digital nutrition platform performance within the existing healthcare infrastructure.\n\nThe primary hypothesis of the ROOT study is that collaborative implementation of the 'PLUS' nutritional care model at NH Triad Obstetrics\u002FGynecology (OB\u002FGYN) Clinic will be associated with reduced maternal and infant adverse outcome rates when compared to historical regional and NH system outcomes in those who received SOC alone.\n\nThe secondary hypothesis of the ROOT Study is that the 'PLUS' model applied during pregnancy will be associated with reduced pediatric adverse outcomes. The 'PLUS' offspring that remain in the NH system will be observed longitudinally over 5 years with chart review at birth through 2 weeks of age, and at 1, 3, and 5 years of life. The outcomes assessed include neonatal intensive care unit (NICU) admission in the first two weeks of life, atopic dermatitis, eczema, asthma, allergies, otitis media, obesity, and autism. The 'PLUS' adverse outcome rates will be compared to adverse outcome rates in children born regionally and nationally under SOC alone.\n\nParticipant compliance with the 'PLUS' model, and participant and nutritionist access to the digital health platform will be studied during each trimester of use, as well as in the postpartum time period. The exploratory hypothesis is that the digital platform will not affect access, compliance, and rates of maternal and neonatal adverse outcomes.",[91,92,93,94,95,96,97,98,29,99],"Preterm Birth","Preeclampsia","Gestational Diabetes Mellitus (GDM)","Small for Gestational Age (SGA)","Large for Gestational Age (LGA)","Asthma Childhood","Atopic Dermatitis","Autism","Obesity",[101,102,103,104,105,106,107,108,109,110],"adverse pregnancy outcomes","prevention","personalized nutrition","nutrigenomics","adverse neonatal outcomes","childhood asthma","childhood allergy","autism","childhood obesity","recurrent otitis media","2026-04-27",{"date":113,"type":39},"2026-04-30",{"date":115,"type":21},"2026-08",{"date":117,"type":21},"2033-12",{"name":119,"class":46},"GrowBaby Life Project"]