[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sensation-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sensation-disorders":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,60,104,139,156,200,230],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100584599","phase-3-study-to-evaluate-sepofarsen-in-subjects-with-leber-congenital-amaurosis-lca-type-10-hyperion-100584599",false,"NCT06891443","Study to Evaluate Sepofarsen in Subjects With Leber Congenital Amaurosis (LCA) Type 10 (HYPERION)","A Double-Masked, Randomized, Placebo-Controlled, Paired-Eye Study to Evaluate the Efficacy, Safety and Tolerability of Sepofarsen in Subjects With Leber Congenital Amaurosis (LCA) Due to the c.2991+1655A>G (p.Cys998X) Mutation in the CEP290 Gene","HYPERION","Inclusion Criteria:\n\n1. Confirmed clinical diagnosis of LCA10 and a molecular diagnosis of homozygosity or compound heterozygosity for the c.2991+1655A\\>G mutation in CEP290.\n2. Adults: \\>=18 years \u002F Minors: 6 to \\\u003C18 years.\n3. BCVA (FrACT) equal to or worse than logMAR +0.4 (approximate Snellen equivalent 20\u002F50) to +2.9 logMAR based on quantifiable, reliable FrACT. LP subjects with documented evidence of prior better vision eligible.\n4. Symmetrical disease between the two eyes as defined by a BCVA (FrACT) within 0.2 logMAR at baseline.\n5. Detectable ONL in the macular area as determined by the CRC at Screening.\n\nExclusion Criteria:\n\n1. Mutations in genes other than the CEP290 gene associated with other IRD diseases or syndromes.\n2. Presence of any ocular pathology in either eye that may make comparison of the eyes not feasible.\n3. Presence of unstable concurrent CME, or subject started on (or changed dose of) topical or systemic carbonic anhydrase inhibitor treatment in the 3 months prior to enrollment. CME is allowed if stable for 3 months (with or without treatment).\n4. Presence of any clinically significant lens opacities\u002Fcataracts based on the AREDS lens grading scale.\n5. Any prior receipt of genetic (RNA or DNA therapy) or stem-cell therapy for ocular or non-ocular disease, including sepofarsen.","ALL","6 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this double-masked, randomized, placebo-controlled, paired-eye study is to evaluate the efficacy, safety and tolerability of Sepofarsen in subjects with Leber Congenital Amaurosis (LCA) due to the c.2991+1655A\\>G (p.Cys998X) mutation in the CEP290.",[27,28,29,30,31,32,33,34,35,36],"Leber Congenital Amaurosis 10","Blindness","Leber Congenital Amaurosis","Sensation Disorders","Vision Disorder","Neurological Manifestations","Eye Diseases, Hereditary","Eye Diseases","Eye Disorders Congenital","Retinal Disease",[38,39,40,41,42,43,44,45,46],"LCA10","p.Cys998X","Antisense oligonucleotides","RNA therapy","QR-110","sepofarsen","CEP290","Leber's Congenital Amaurosis","c.2991+1655A>G","RECRUITING","2026-06-24",{"date":50,"type":51},"2026-06-25","ACTUAL",{"date":53,"type":51},"2025-06-04",{"date":55,"type":21},"2028-10",{"name":57,"class":58},"Laboratoires Thea","INDUSTRY",17,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":71,"conditions":72,"keywords":81,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100554583","long-term-outcomes-after-vestibular-implantation-100554583","NCT06500975","Long Term Outcomes After Vestibular Implantation","Inclusion Criteria\n\n* Adults older than 22 years old who\n* have previously been enrolled in Johns Hopkins University Institutional Review Board protocol NA\\_00051349, IRB00335294 or IRB00346924 and\n* have previously been implanted with a vestibular implant under FDA IDE G150198","22 Years","90 Years",{"count":20,"type":21},[70],"NA","Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.",[73,74,75,76,77,78,30,79,80],"Bilateral Vestibular Hypofunction","Bilateral Vestibular Deficiency","Bilateral Vestibulopathy","Gentamicin Ototoxicity","Aminoglycoside Toxicity","Vestibular Diseases","Labyrinth Diseases","Other Disorders of Vestibular Function",[82,83,84,85,86,87,88,89,90,91,92],"Vestibular","Implant","Prosthesis","Labyrinth","Ototoxicity","Gentamicin","Oscillopsia","Disequilibrium","Dizziness","Vestibulopathy","Inner Ear","2026-03-05",{"date":95,"type":51},"2026-03-09",{"date":97,"type":51},"2024-12-01",{"date":99,"type":21},"2029-12",{"name":101,"class":102},"Johns Hopkins University","OTHER",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":67,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":103},"100491270","vestibular-implantation-in-older-adults-100491270","NCT05676944","Vestibular Implantation in Older Adults","Inclusion Criteria:\n\n1. Adults age 65-90 years diagnosed with ototoxic, idiopathic or non-ototoxic\u002Fnon-central bilateral vestibular hypofunction inadequately responsive to vestibular rehabilitation for greater than 1 year as determined by pre-inclusion history, vestibular testing and clinical examination conducted by a board-certified neurotologist, neurologist or other physician skilled in diagnosis of vestibular disorders\n2. Hearing status: (1) Hearing in the candidate ear for implantation is equivalent to or worse than that in the contralateral ear; and (2) hearing in the contralateral ear is good enough to allow functional communication in case hearing in the implanted ear is lost after implantation. Specifically, the contralateral ear must satisfy all of the following criteria:\n\n   1. 0.5\u002F1\u002F2\u002F4 kHz pure-tone-average threshold (PTA) hearing better than (i.e., less than) 70 dB HL; and\n   2. ear-specific sentence recognition score using the recorded AzBio Sentence Test presented at 60 dB SPL-A in quiet must be \\>60% when tested under either the unaided condition or, if 0.5\u002F1\u002F2\u002F4 kHz PTA\\>50 dB, the best-aided condition; and\n   3. ear-specific word recognition score using the recorded Consonant-Nucleus-Consonant (CNC) Word Recognition Test presented at 60 dBHL in quiet must be \\>60% when tested under either the unaided condition or, if 0.5\u002F1\u002F2\u002F4 kHz PTA\\>50 dB, the best-aided condition\n3. Caloric responses consistent with severe or profound bilateral loss of labyrinthine function, as indicated by one or more of the following: (a) summed speed of caloric responses to warm and cool supine caloric stimuli totaling \\\u003C10°\u002Fsec per ear for each of both ears; (b) summed speed of ice water caloric responses during supine and prone head orientation tests totaling \\\u003C10°\u002Fsec per ear for each of both ears; or (c) speed of ice water caloric responses during supine head orientation tests \\\u003C5°\u002Fsec per ear for each of both ears, with a lack of nystagmus reversal on quickly flipping from supine to prone\n4. Prior MRI imaging of the brain, internal auditory canals and cerebellopontine (CP) angle showing a patent labyrinth, present vestibular nerve, patent cochlea, present cochlear nerve, and absence of internal auditory canal\u002Fcerebellopontine angle tumors or other central causes of vestibulo-ocular reflex dysfunction or sensorineural hearing loss\n5. Prior CT imaging of the temporal bones showing a facial nerve canal with normal caliber and course, middle ear without evidence of chronic otitis media or tympani membrane perforation or cholesteatoma, a mastoid cavity with adequate aeration for surgical access to each semicircular canal, skull thickness ≥3 mm at the planned well site, and scalp soft tissue thickness ≤7 mm. This criterion may be satisfied without additional imaging if an existing head CT or MRI already demonstrates those findings\n6. Vaccinations as recommended per Johns Hopkins Cochlear Implant Center and United States Centers for Disease Control and Prevention protocols to reduce the risk of meningitis in subjects undergoing cochlear implantation, as described at this site: https:\u002F\u002Fwww.cdc.gov\u002Fvaccines\u002Fvpd\u002Fmening\u002Fpublic\u002Fdis-cochlear-faq-gen.html\n7. Motivated to travel to the study center, to undergo testing and examinations required for the investigational study, and to participate actively in a vestibular rehabilitation exercise regimen\n8. The participant must agree not to swim or to use or operate vehicles, heavy machinery, powered tools or other devices that could pose a threat to the participant, to others, or to property throughout the duration of participation in the study and until at least 1 month after final deactivation of the MVI Implant\n\nExclusion Criteria:\n\n1. Inability to understand the procedures and the potential risks involved as determined by study staff\n2. Inability to participate in study procedures due to blindness, ≤ ±10° neck range of motion, cervical spine instability, ear canal stenosis or malformation sufficient to prevent caloric testing\n3. Diagnosis of acoustic neuroma\u002Fvestibular schwannoma, chronic middle ear disease, cholesteatoma, or central nervous system causes of vestibulo-ocular reflex dysfunction, including chronic and continuing use of medications, drugs or alcohol at doses sufficiently great to interfere with vestibular compensation\n4. Vestibular dysfunction known to be caused by reasons other than labyrinthine injury due to ototoxicity, ischemia, trauma, infection, Meniere's disease, or genetic defects known to act on hair cells\n5. Lack of labyrinth patency or vestibular nerve as determined by MRI of the brain with attention to the internal acoustic meatus\n6. Any contraindication to the planned surgery, anesthesia, device activation and deactivation, or participation in study assessments, as determined by the surgeon, anesthesiologist, or designee, including known intolerance of any materials used in any component of the investigational devices that will come in contact with the subject\n7. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening\n8. Orthopedic, neurologic or other nonvestibular pathologic conditions of sufficient severity to confound posture and gait testing or other tests used in the study to assay vestibular function.\n9. Subjects with estimated glomerular filtration rate (GFR) \\\u003C 30 ml\u002Fmin (MDRD formula) at screening\n10. Subjects with heart failure NYHA class III or IV\n11. Subjects with Child-Pugh class C cirrhosis\n12. Inadequately treated or unstable depression, suicidality as indicated by any affirmative answer to the 6-question screener version of the Columbia Suicide Severity Rating Scale (C-SSRS), or any other psychiatric disease or substance abuse history likely to interfere with protocol compliance\n13. Contraindications to scleral coil eye movement testing, including monocular blindness and a history of fainting vagal reactions to prior eye manipulations would exclude subjects from eye coil testing\n14. Inability to tolerate baseline testing protocols\n15. Recent corneal injury\n16. A history of cervical spine disease preventing head rotation\n17. A history of fainting or vagal reactions prior to eye manipulations that would preclude 3D eye movement coil testing\n18. Pregnancy, positive urine or serum pregnancy test at any time during study participation,\n19. Ability to become pregnant combined with failure or refusal to consistently use a highly effective method of contraception from at least 1 month prior to implantation to not before 1 month after both device deactivation and conclusion of study participation. Highly effective contraception methods include:\n\n    Total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception for purposes of defining exclusion criteria for this study Female sterilization (surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before entering the study. A woman who has undergone oophorectomy without hysterectomy may participate in the study only after her reproductive status has been confirmed by subsequent hormone level assessment For female subjects of child-bearing potential, study participation is not excluded if the study candidate's male partner is the sole partner of the study candidate and has been vasectomized.\n\n    Combination of any two of the following:\n\n    Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example, hormone vaginal ring or transdermal hormone contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository In case of use of oral contraception, women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.\n20. Women who are nursing\u002Flactating\n21. Any medical condition, judged by the investigator team, that is likely to interfere with a study candidate's participation in the study or likely to cause serious adverse events during the study.","65 Years",{"count":112,"type":21},15,[70],"Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to fifteen older adults (age 65-90 years at time of enrollment) with ototoxic or non-ototoxic bilateral vestibular hypofunction.",[116,117,76,79,78,30,73,75,118,119],"Other Disorders of Vestibular Function, Bilateral","Bilateral Vestibular Deficiency (BVD)","Presbyvestibulopathy","Aminoglycoside Ototoxicity",[82,121,122,123,124,125,126,127,128,129,130],"implant","prosthesis","labyrinth","ototoxicity","gentamicin","oscillopsia","disequilibrium","dizziness","vestibulopathy","inner ear","2026-01-09",{"date":133,"type":51},"2026-01-12",{"date":135,"type":51},"2023-04-11",{"date":137,"type":21},"2028-01-31",{"name":101,"class":102},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":67,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":71,"conditions":148,"keywords":149,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":103},"100491104","vestibular-implantation-to-treat-adult-onset-bilateral-vestibular-hypofunction-100491104","NCT05674786","Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction","Inclusion Criteria:\n\n1. Adults age 22-90 years diagnosed with ototoxic, idiopathic or non-ototoxic\u002Fnon-central bilateral vestibular hypofunction inadequately responsive to vestibular rehabilitation for greater than 1 year as determined by pre-inclusion history, vestibular testing and clinical examination conducted by a board-certified neurotologist, neurologist or other physician skilled in diagnosis of vestibular disorders\n2. Hearing status: (1) Hearing in the candidate ear for implantation is equivalent to or worse than that in the contralateral ear; and (2) hearing in the contralateral ear is good enough to allow functional communication in case hearing in the implanted ear is lost after implantation. Specifically, the contralateral ear must satisfy all of the following criteria:\n\n   1. 0.5\u002F1\u002F2\u002F4 kHz pure-tone-average threshold (PTA) hearing better than (i.e., less than) 70 dB HL; and\n   2. ear-specific sentence recognition score using the recorded AzBio Sentence Test presented at 60 dB SPL-A in quiet must be \\>60% when tested under either the unaided condition or, if 0.5\u002F1\u002F2\u002F4 kHz PTA\\>50 dB, the best-aided condition; and\n   3. ear-specific word recognition score using the recorded Consonant-Nucleus-Consonant (CNC) Word Recognition Test presented at 60 dBHL in quiet must be \\>60% when tested under either the unaided condition or, if 0.5\u002F1\u002F2\u002F4 kHz PTA\\>50 dB, the best-aided condition\n3. Caloric responses consistent with severe or profound bilateral loss of labyrinthine function, as indicated by one or more of the following: (a) summed speed of caloric responses to warm and cool supine caloric stimuli totaling \\\u003C10°\u002Fsec per ear for each of both ears; (b) summed speed of ice water caloric responses during supine and prone head orientation tests totaling \\\u003C10°\u002Fsec per ear for each of both ears; or (c) speed of ice water caloric responses during supine head orientation tests \\\u003C5°\u002Fsec per ear for each of both ears, with a lack of nystagmus reversal on quickly flipping from supine to prone\n4. Prior MRI imaging of the brain, internal auditory canals and cerebellopontine (CP) angle showing a patent labyrinth, present vestibular nerve, patent cochlea, present cochlear nerve, and absence of internal auditory canal\u002Fcerebellopontine angle tumors or other central causes of vestibulo-ocular reflex dysfunction or sensorineural hearing loss\n5. Prior CT imaging of the temporal bones showing a facial nerve canal with normal caliber and course, middle ear without evidence of chronic otitis media or tympani membrane perforation or cholesteatoma, a mastoid cavity with adequate aeration for surgical access to each semicircular canal, skull thickness ≥3 mm at the planned well site, and scalp soft tissue thickness ≤7 mm. This criterion may be satisfied without additional imaging if an existing head CT or MRI already demonstrates those findings\n6. Vaccinations as recommended per Johns Hopkins Cochlear Implant Center and United States Centers for Disease Control and Prevention protocols to reduce the risk of meningitis in subjects undergoing cochlear implantation, as described at this site: https:\u002F\u002Fwww.cdc.gov\u002Fvaccines\u002Fvpd\u002Fmening\u002Fpublic\u002Fdis-cochlear-faq-gen.html\n7. Motivated to travel to the study center, to undergo testing and examinations required for the investigational study, and to participate actively in a vestibular rehabilitation exercise regimen\n8. The participant must agree not to swim or to use or operate vehicles, heavy machinery, powered tools or other devices that could pose a threat to the participant, to others, or to property throughout the duration of participation in the study and until at least 1 month after final deactivation of the MVI Implant\n\nExclusion Criteria:\n\n1. Inability to understand the procedures and the potential risks involved as determined by study staff\n2. Inability to participate in study procedures due to blindness, ≤ ±10° neck range of motion, cervical spine instability, ear canal stenosis or malformation sufficient to prevent caloric testing\n3. Diagnosis of acoustic neuroma\u002Fvestibular schwannoma, chronic middle ear disease, cholesteatoma, or central nervous system causes of vestibulo-ocular reflex dysfunction, including chronic and continuing use of medications, drugs or alcohol at doses sufficiently great to interfere with vestibular compensation\n4. Vestibular dysfunction known to be caused by reasons other than labyrinthine injury due to ototoxicity, ischemia, trauma, infection, Meniere's disease, or genetic defects known to act on hair cells\n5. Lack of labyrinth patency or vestibular nerve as determined by MRI of the brain with attention to the internal acoustic meatus\n6. Any contraindication to the planned surgery, anesthesia, device activation and deactivation, or participation in study assessments, as determined by the surgeon, anesthesiologist, or designee, including known intolerance of any materials used in any component of the investigational devices that will come in contact with the subject\n7. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening\n8. Orthopedic, neurologic or other nonvestibular pathologic conditions of sufficient severity to confound posture and gait testing or other tests used in the study to assay vestibular function.\n9. Subjects with estimated glomerular filtration rate (GFR) \\\u003C 30 ml\u002Fmin (MDRD formula) at screening\n10. Subjects with heart failure NYHA class III or IV\n11. Subjects with Child-Pugh class C cirrhosis\n12. Inadequately treated or unstable depression, suicidality as indicated by any affirmative answer to the 6-question screener version of the Columbia Suicide Severity Rating Scale (C-SSRS), or any other psychiatric disease or substance abuse history likely to interfere with protocol compliance\n13. Contraindications to scleral coil eye movement testing, including monocular blindness and a history of fainting vagal reactions to prior eye manipulations would exclude subjects from eye coil testing\n14. Inability to tolerate baseline testing protocols\n15. Recent corneal injury\n16. A history of cervical spine disease preventing head rotation\n17. A history of fainting or vagal reactions prior to eye manipulations that would preclude 3D eye movement coil testing\n18. Pregnancy, positive urine or serum pregnancy test at any time during study participation,\n19. Ability to become pregnant combined with failure or refusal to consistently use a highly effective method of contraception from at least 1 month prior to implantation to not before 1 month after both device deactivation and conclusion of study participation. Highly effective contraception methods include:\n\n    Total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception for purposes of defining exclusion criteria for this study Female sterilization (surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before entering the study. A woman who has undergone oophorectomy without hysterectomy may participate in the study only after her reproductive status has been confirmed by subsequent hormone level assessment For female subjects of child-bearing potential, study participation is not excluded if the study candidate's male partner is the sole partner of the study candidate and has been vasectomized.\n\n    Combination of any two of the following:\n\n    Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example, hormone vaginal ring or transdermal hormone contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository In case of use of oral contraception, women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.\n20. Women who are nursing\u002Flactating\n21. Any medical condition, judged by the investigator team, that is likely to interfere with a study candidate's participation in the study or likely to cause serious adverse events during the study.",{"count":146,"type":21},8,[70],[116,117,76,79,78,30,73,75,119],[82,121,122,123,124,125,126,127,128,129,130],{"date":133,"type":51},{"date":152,"type":51},"2023-02-28",{"date":154,"type":21},"2027-03-31",{"name":101,"class":102},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":163,"sex":17,"minAge":164,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":168,"conditions":169,"keywords":178,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100523328","prospective-study-of-sensation-and-satisfaction-in-cancer-and-transgender-mastectomy-patients-100523328","NCT06094257","Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients","Prospective Cohort Study Comparing Sensory Outcome, Development of Chronic Pain and Phantom Pain, as Well as Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation.","Inclusion Criteria:\n\n* Age over 18\n* Patient is scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft) or NSM with breast implant or autologous reconstruction\n* Patient is capable and willing to provide informed consent\n\nExclusion Criteria:\n\n* Patient has a nerve condition that does not allow for assessment of sensation\n* Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule\n* Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy\n* Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)",true,"18 Years",{"count":166,"type":21},400,"OBSERVATIONAL","During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively.",[30,170,171,172,173,174,175,176,177],"Sensation, Phantom","Pain, Postoperative","Pain, Chronic","Numbness","Sensory Disorder","Sensory Defect","Phantom Pain","Phantom Sensation",[179,180,181,182,183,184,185,186,187,188,189],"Sensation","Reinnervation","Peripheral nerve","Reconstruction","Breast reinnervation","Chest reinnervation","Gender-affirming mastectomy","Breast reconstruction","Peripheral nerve repair","Targeted nipple areolar complex","Targeted nipple areolar complex reinnervation","2025-08-26",{"date":192,"type":51},"2025-08-27",{"date":194,"type":51},"2022-02-09",{"date":196,"type":21},"2033-03",{"name":198,"class":102},"Weill Medical College of Cornell University",2,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":163,"sex":17,"minAge":164,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":220,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":4},"100570197","phase-4-meloxicam-versus-ibuprofen-for-pain-control-after-third-molar-exodontia-in-adult-patients-100570197","NCT06704113","Meloxicam Versus Ibuprofen for Pain Control After Third Molar Exodontia in Adult Patients","Analgesic Efficacy of Meloxicam Versus Ibuprofen for Pain Control After Third Molar Extraction in Adult Patients: Randomized Clinical Trial","Inclusion Criteria:\n\nMaxillary or mandibular third molar with semi or fully erupted crown.\n\nExclusion Criteria:\n\nPatients with Systemic pathologies. Presence of third molar localized infection. Completely included third molar crown. Periodontal compromise. Pregnant or breastfeeding women. Patients with hypersensitivity to NSAIDs. Patients with a history of drug abuse. Patients who had taken any drug in the previous 24 hours. Intervention (exodontia) time longer than 45 minutes.","59 Years",{"count":209,"type":21},68,[211],"PHASE4","Third molar extraction is a common dental procedure, offently related with pain and swelling. The purpose of this study is to evaluate if Meloxicam has a better effect relieving pain after the extraction than Ibuprofen, one of the most common pain relieving drugs administered after this procedure.",[214,30],"Dental Pain",[216,217,218,219],"Tooth Extraction","Molar, Third","Meloxicam","Ibuprofen","NOT_YET_RECRUITING","2024-11-22",{"date":223,"type":51},"2024-11-25",{"date":225,"type":21},"2024-12-15",{"date":227,"type":21},"2025-01-20",{"name":229,"class":102},"Universidad Austral de Chile",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":164,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":241,"conditions":242,"keywords":250,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":103},"100550753","early-phase-1-novel-antisense-oligonucleotide-eye-drops-for-treating-antibiotic-resistant-bacterial-keratitis-100550753","NCT06451172","Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis","ASOTARI","Inclusion Criteria:\n\n* The results of antimicrobial susceptibility testing in patients with bacterial keratitis showed multidrug-resistant bacterial infections, and the existing commercial antibiotics could not effectively control the disease.\n* Age over 18 years.\n* No systemic immune eye disease.\n* Good eyelid structure and blink function.\n* Exists the potential of visual recovery by evaluation of ocular structure and function.\n* Subjects or their legal guardians voluntarily participate in this study, sign informed consent, good compliance and cooperation with follow-up visits.\n\nExclusion Criteria:\n\n* Lacrimal coating and blink function loss.\n* Schirmer's test result is less than 2mm for severe dry eye disease.\n* Pregnant and lactating women (pregnancy defined in this study as positive urine pregnancy test).\n* Currently is involved in clinical trials of other drugs or medical devices.\n* Active eye infection (including but not limited to: blepharitis, infectious conjunctivitis, sclerotitis, endophthalmitis) in target eye or contralateral eye within 30 days prior to enrollment.\n* Ocular surface malignant tumor.\n* A history of allergic reaction or allergy to sodium luciferin, allergy to protein products used for treatment or diagnosis, allergy to ≥ 2 drugs or non-drug factors, or current allergic disease.\n* current in an infectious disease requiring oral, intramuscular or intravenous administration.\n* Patients with systemic immune diseases.\n* Any uncontrolled clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant neoplasms).\n* Not effective contraception.\n* In uncontrolled hypertension, systolic is no less than 160 mmhg, diastolic is no less than 100 mmhg.\n* In uncontrolled diabetes, fasting glucose is no less than 10.0umol\u002FL.\n* Renal insufficiency, serum creatinine is more than 133umol\u002FL.\n* Arrhythmia, myocardial ischemia, myocardial infarction (diagnosed by electrocardiogram).\n* Liver dysfunction, al ANINE aminotransferase and aspartate aminotransferase levels are higher than 80 IU\u002FL.\n* Platelet level is below 100,000 \u002FuL or above 450,000 \u002FuL.\n* Hemoglobin level is below 10.0g\u002FdL (male) or 9.0g\u002FdL (female).\n* No anticoagulant was used, prothrombin time is higher than 16s, and thrombin time of activated part is higher than 50s.\n* HIV infection (HIV-positive).\n* Subjects lack compliance with the study or the ability to sign informed consent.\n* There are currently signs of systemic infection, including fever and ongoing antibiotic treatment (in this study, systemic infection was defined as deviation from normal values of white blood cells, lymphocytes, and neutrophils on routine blood tests).\n* Administration of Glucocorticoids and other systemic immunosuppressive drugs.\n* The investigator judges other conditions unsuitable for the trial",{"count":238,"type":21},20,[240],"EARLY_PHASE1","The purpose of this study is to evaluate the safety and efficacy of GP-asPNA for in vivo treatment of severe antibiotic resistant bacterial keratitis.",[243,244,245,246,34,247,30,28,248,249],"Bacterial Keratitis","Antibiotic-resistant Bacteria","Infections, Bacterial","Corneal Diseases","Vision Disorders","Antisense Peptide Nucleic Acid","Antibacterial Therapy",[243,245,246,34],"2024-06-08",{"date":253,"type":51},"2024-06-11",{"date":255,"type":51},"2023-10-11",{"date":257,"type":21},"2026-10-31",{"name":259,"class":102},"Eye & ENT Hospital of Fudan University"]