[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spondylosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spondylosis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,74,106,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100549778","phase-1-novel-soluble-epoxide-hydrolase-inhibitor-for-neuropathic-pain-in-patients-with-spinal-cord-injury-100549778",false,"NCT06438471","Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury","Development of a Novel Soluble Epoxide Hydrolase Inhibitor as a Strategy for Treating Neuropathic Pain in Patients With SCI","Inclusion Criteria:\n\nEach subject must meet all of the following criteria to be enrolled in this study:\n\n1. Male and female subjects must be 18 and older.\n2. Subjects must be willing to provide written informed consent to participate in the study.\n3. Subjects must be able to provide own transportation to study site every day for the duration of the study.\n4. Subjects with either a traumatic or a non-traumatic SCI may be eligible to enroll in this study. For subjects with complete or incomplete traumatic spinal cord injuries (tSCI), or complete non-traumatic spinal cord injury: Subjects must have a complete or incomplete T6 or below tSCI, or complete non-traumatic SCI of at least 12 months duration, with below-level neuropathic pain identified by the International Spinal Cord Injury Pain (ISCIP) classification criteria. Importantly, subjects must not be ventilator-dependent as detailed in Exclusion Criteria 1. For subjects with degenerative partial spinal cord injuries (pSCI): Subjects must have an incomplete, non-traumatic, SCI at any level secondary to degenerative spinal disorders such as disc degeneration, spinal stenosis, or spondylosis, with associated chronic neuropathic pain. The injury and the associated pain must be of at least 12 months duration. Neuropathic pain should meet the ISCIP classification criteria. Importantly, subjects must not be ventilator-dependent as detailed in Exclusion Criteria 1.\n5. Subjects must have completed a minimum of 6 of the 7 daily assessments for average and worst daily pain prior to final screening, using an 11-point numerical rating scale (NRS) for average daily pain intensity, and the arithmetic average daily SCI neuropathic pain score must be ≥4 and ≤9, with a standard deviation less than or equal to 1.2. Daily pain assessment screenings will be done over the phone with the study coordinator after informed consent is obtained.\n6. Subjects must have failed at least 2 classes of medications for their neuropathic pain due to SCI (classes may include antidepressants, antiepileptics, opioids, anti-inflammatories, topical treatments, etc.).\n7. Subjects must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements\n8. Subjects must have normal or not clinically significant clinical laboratory test results, as determined by the study investigator, including coagulation panel, blood cell counts, comprehensive metabolic panel analytes, and creatinine clearance (60 cm3\u002Fmin or greater). Clinical laboratory tests results that are consistent with known, stable comorbidities will be allowed as long as the comorbidities do not represent an exclusion criteria per se.\n9. Subjects must have a negative screening for HIV, Hepatitis C, and Hepatitis B within 30 days of randomization.\n10. Subjects must have a normal hypothalamic-pituitary-adrenal and hypothalamic-pituitary-gonadal axes screening study.\n11. Subjects must have a negative urinary drug screen (UDS) for illicit drugs (marihuana\u002FTHC are allowed) and serum ethanol level \\\u003C80 mg\u002FdL.\n12. Male subjects who are not surgically sterile (vasectomized) and their female sexual partners must agree to use contraception during the study period and for 2 months afterward.\n13. Male subjects must not donate sperm during the study and for 12 months after receiving the last dose of study drug.\n14. Female subjects must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation ('clipping or tying tubes' or hysterectomy) for at least 3 months, or they must agree to use two forms of highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), from 28 days and\u002For their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after clinic discharge. Postmenopausal status will be defined as follow: minimum 1 year; amenorrhea duration of 12 consecutive months and a serum FSH value \\>40 IU\u002FL; postmenopausal status must be confirmed by an FSH test at Screening). Highly effective contraception methods include: Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g., Mirena®), and\u002For barrier methods of contraception, including condoms (external or internal) and diaphragm ('cap'). Hormonal methods of contraception (with the exception of hormonal IUD) are not permitted within this study. Female participants will refrain from using hormonal contraceptives for at least 28 days prior to study entry until the end of the study period. Participants\u002FParticipant's partner(s) must also use a barrier form of contraception, from the first dose of study drug through until 2 months after the last dose. For all females of childbearing potential, the pregnancy test result must be negative at Screening and Pre-Study Baseline (Day -1).\n15. Subjects must be able to speak, read, and understand English sufficiently to allow comprehension and completion of all study assessments.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded from the study:\n\n1. Ventilator-dependent subjects, with the exception of nocturnal use of CPAP or BiPAP.\n2. Subjects with pain that is not present every day (chronic) or where the pain description does not have a classic neuropathic phenotype.\n3. Subjects with other chronic neuropathic pain conditions, including painful diabetic neuropathy, HIV-associated neuropathic pain, chemotherapy or ethanol-associated neuropathy.\n4. Subjects with other pain syndromes that may confound assessment or self-evaluation of the SCI neuropathic pain.\n5. Subjects with only negative symptoms, defined as numbness without clear evidence of spontaneous pain, either constant or episodic.\n6. Non-opioid pain medications will be allowed if at a fixed stable dose for more than 1 month prior to Screening with no anticipation of the dose changing during the study, and if they do not interfere with the subject's ability to rate pain as per Investigator's discretion. Allowed non-opioid medications include gabapentin, pregabalin, duloxetine, acetaminophen, ibuprofen, celecoxib, meloxicam, other antidepressants including amitriptyline and other antiepileptics, as well as topical capsaicin and topical lidocaine.\n7. Subjects using opioid medications will be required to be on a dose of 60 morphine milligrams equivalents (MME) per day or less, and with a stable dose for at least four (4) weeks prior to consent, with no anticipation of dose changing during the study.\n8. Subjects with active Hepatitis A, Hepatitis B and\u002For Hepatitis C.\n9. Subjects with any clinically unstable or significant cardiovascular (including acute coronary syndrome within the prior year to Screening), renal, hepatic, respiratory, gastrointestinal, hematological, endocrine, or infectious disease (including HIV infection).\n10. Subjects with clinically significant abnormalities on screening vital signs, laboratory tests, and\u002For ECG. Subjects with poor venous access will also be excluded.\n11. Subjects with a history of disorders of the hypothalamic-pituitary-adrenal axis, including adrenal insufficiency and Cushing's, or with a history of disorders of the hypothalamic-pituitary-gonadal axis, including hypogonadism.\n12. Subjects who have used any topical, oral, or intravenous exogenous corticosteroids within 12 weeks and\u002For intra-articular exogenous corticosteroids within 6 months prior to the start of the trial, or who plan on using them during the study.\n13. Subjects who have used fludrocortisone or exogenous testosterone products within 12 weeks prior to the start of the trial or who plan on using them during the study.\n14. Subjects who have used (within 14 of randomization) or plan on using during the duration of the study any renin-angiotensin system (RAS)-acting drugs (including angiotensin-receptor blockers, or ARBs; angiotensin-converting enzyme inhibitors, or ACE-inhibitors; and direct renin inhibitors) or mineralocorticoid receptor antagonists (such as spironolactone and eplerenone)\n15. Subjects who have used chemotherapy agents, or who have a personal history of cancer or cancer in first degree relatives suggestive of elevated cancer risk, other than nonmetastatic skin cancer that has been completely excised, within 5 years prior to Screening.\n16. Subjects with a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to randomization.\n17. Subjects who have used (within 14 days of randomization) or plan on using during the duration of the study any prescription or over-the-counter drugs that are moderate-strong CYP3A4 inducers or inhibitors.\n18. Subjects who have used (within 14 days of randomization) or plan on using during the duration of the study any dietary aids, supplements, or foods that are moderate-strong CYP3A4 inhibitors (e.g., grapefruit juice).\n19. Subjects with difficulty in swallowing oral medications.\n20. Subjects with serious psychosocial comorbidities as determined by the Investigator.\n21. Subjects with current cognitive or major psychiatric disorders, or any other condition that could interfere with compliance with study procedures.\n22. Subjects with a positive drug or alcohol test (\\>80 mg\u002FdL) during Screening and\u002For admission (a positive THC test will be allowed as long as it consists of minimal social use, per discretion of Investigator), or with a recent history of binge drinking within 1 week of randomization.\n23. Subjects who have used any other investigational drug within 1 month prior to enrollment. If the investigational drug is known to have a long half-life, a longer washout period will be done.\n24. Subjects with a presence or history of active gastrointestinal disorder, including esophageal or gastroduodenal ulceration, or renal, hepatic, or coagulant disorder within 1 month prior to enrollment.\n25. Subjects with a family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction before the age of 50).\n26. Subjects with confirmed COVID-19, or suspected COVID-19 (e.g., developed symptoms of a respiratory infection such as cough, sore throat, shortness of breath, or fever, but did not get tested for COVID 19) within 30 days of randomization.\n27. Subjects who have received a COVID-19 vaccine within 30 days of randomization or are planning on receiving it during the study duration.\n28. Exclude subjects with spinal cord injury at T6 or higher with a history of neurogenic bladder.\n29. Exclude subjects with documented autonomic dysreflexia (AD) or a history of episodes consistent with undiagnosed AD as determined by an experienced clinician.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain.\n\nResearchers will compare EC5026 to placebo.\n\nParticipants will be asked to:\n\n* Take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days.\n* Undergo physical exams, vital signs assessments, ECGs, and blood draws\n* Complete assessments of pain, sleep, functional status, and perception of change",[26,27,28,29,30],"Spinal Cord Injuries","Neuropathic Pain","Degenerative Disc Disease","Spinal Stenosis","Spondylosis","RECRUITING","2026-02-13",{"date":34,"type":35},"2026-02-17","ACTUAL",{"date":37,"type":20},"2026-02-28",{"date":39,"type":20},"2027-06",{"name":41,"class":42},"EicOsis Human Health Inc.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100457603","comparison-of-radiographic-fusion-rate-and-clinical-outcome-of-alif-and-xlif-performed-with-either-recombinant-human-bone-morphogenetic-protein-2-or-vivigen-100457603","NCT05238740","Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®","Comparison of Radiographic Fusion Rate and Clinical Outcome of Anterior Lumbar and Extreme Lateral Interbody Fusion Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen® Cellular Bone Matrix, a Prospective Randomised Assessor Blind, Monocentric Trial","Inclusion criteria:\n\nPatients who have an indication for a monosegmental ALIF procedure on the L5\u002FS1 segment or a monosegmental XLIF procedure on L4\u002F5 (both ALIF and XLIF procedure with or without an additional pedicular stabilisation), e.g., treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and\u002For leg pain\n\n* Patients must be 18 - 70 years of age\n* Patients must have understood and signed the study information and the informed consent form\n* Patients are willing and able to complete scheduled follow-up evaluations \u002F questionnaires as described in the Informed Consent\n\nExclusion criteria:\n\n* Patients under 18 years and over 70 years of age\n* Patients with tumour \u002F spine trauma \u002F known bone disease \u002F Parkinson's disease and similar CNS disorders \u002F diseases or injuries of the peripheral nerves\n* Other procedures or segment than mentioned in the inclusion citeriaAdditional planed spine surgeries after index surgery\n* Current smoking\n* Pregnant or breastfeeding patients (or patient planning a pregnancy within one year after surgery)\n* Insufficient language skills in German\n* Inability to give informed consent\n* Refusal to participate in the study, unsigned study consent\n* Participation in another interventional study within the 30 days preceding and during the present study","70 Years",{"count":53,"type":20},168,[55],"NA","The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5\u002FS1 and in monosegmental XLIF procedure L4\u002F5",[30,58,28],"Spondylolisthesis",[60,61,62,63,30,58,28,64],"ViviGen","Radiographic fusion rate","Anterior lumbar interbody fusion","Recombinant human bone morphogenetic protein-2","Extreme lateral interbody fusion","2025-06-04",{"date":67,"type":35},"2025-06-08",{"date":69,"type":35},"2022-10-27",{"date":71,"type":20},"2027-12",{"name":73,"class":42},"Lindenhofgruppe AG",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":103,"locationsCount":105},"100430310","cem-plate-and-cem-cage-first-in-human-use-efficacy-study-100430310","NCT04883411","CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study","First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate","Inclusion Criteria:\n\n1. Males and females aged 22-79 years.\n2. Documented diagnosis of cervical spine radiculopathy or myelopathy.\n3. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.\n4. Baseline NDI score ≥30 and\u002For baseline mJOA score ≤16.\n5. Pathology at the level to be treated correlating to the primary symptoms confirmed by imaging (computed tomography (CT), CT myelography, magnetic resonance imaging (MRI), or plain radiography).\n6. Unresponsive to non-operative, conservative treatment for at least 6 weeks from symptom onset or presence of progressive cervical myelopathy or signs of nerve root\u002Fspinal cord compression despite continued non-operative treatment.\n7. Ability to speak, read, and understand the IRB approved Informed Consent document.\n8. Willingness to give informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.\n2. Fewer than 2 or more than 2 vertebral levels requiring treatment.\n3. Anatomy that is non-conducive to receiving investigational device.\n4. More than one immobile vertebral level between C-1 to C-7 from any cause, including but not limited to congenital abnormalities and osteoarthritic \"spontaneous\" fusions.\n5. Known diagnosis of osteoporosis, current pharmacological treatment for osteoporosis or bone density which in the medical opinion of the surgeon precludes operation or contraindicates instrumentation.\n6. Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis.\n7. Active malignancy that includes a history of any invasive malignancy (except nonmelanoma skin cancer), unless previously treated with curative intent and with no clinical signs or symptoms of the malignancy for \\> 5 years.\n8. Severe cervical instability based on radiographic exam (whereby an anterior and posterior reconstructive procedure is indicated).\n9. Decompression requiring corpectomy at one or more levels.\n10. Active systemic infection or an infection localized to the site of the proposed implantation.\n11. Open wounds.\n12. Signs of local inflammation.\n13. Fever.\n14. Any diseases or conditions that would preclude accurate clinical evaluation.\n15. Daily, high-dose oral and\u002For inhaled steroids or a history of chronic use of high-dose steroids.\n16. BMI \\> 40.\n17. Use of any other investigational drug or medical device within 30 days prior to surgery.\n18. Smoking more than 1 pack of cigarettes\u002Fday.\n19. Mental illness that, in the opinion of the investigator, would preclude patient's ability to participate in the study.\n20. Current or recent history of substance abuse (alcoholism and\u002For narcotic addiction) requiring intervention.\n21. Litigation relating to spinal injury\u002Fworker's compensation.\n22. Reported to have a history of or anticipated treatment for active systemic infection, including human immunodeficiency virus (HIV) or Hepatitis C.\n23. Previous trauma to the C2 to T1 levels resulting in significant bony or disco-ligamentous cervical spine injury.\n24. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy or myelopathy justifying the need for surgical intervention.\n25. Pregnancy.\n26. Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.\n27. Suspected or documented metal allergy or intolerance.\n28. Inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.\n29. Any patient unwilling to cooperate with the post-operative instructions.\n30. Any time implant utilization would interfere with anatomical structures or expected physiological performance.","22 Years","79 Years",{"count":84,"type":20},50,[55],"The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.",[88,30,89,90,91,92],"Neck Pain","Spondylosis With Myelopathy","Spondylosis With Radiculopathy","Spondylosis With Radiculopathy Cervical Region","Intervertebral Disc Disorder Cervical",[94,95,96,88],"Cervical Spondylosis","Cervical Myelopathy","Cervical Radiculopathy","2025-04-15",{"date":99,"type":35},"2025-04-18",{"date":101,"type":35},"2022-03-07",{"date":71,"type":20},{"name":104,"class":42},"ReVivo Medical, Corp.",4,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":43},"100466634","recording-of-intraoperative-spinal-cord-stimulation-and-monitoring-100466634","NCT05356286","Recording of Intraoperative Spinal Cord Stimulation and Monitoring","Inclusion Criteria:\n\n* Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.\n\nExclusion Criteria:\n\n* none",{"count":113,"type":20},150,[55],"Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.",[117,118,30],"Cervical Stenosis","Disk, Herniated","2025-03-07",{"date":121,"type":35},"2025-03-10",{"date":123,"type":35},"2011-01-21",{"date":125,"type":20},"2027-01-22",{"name":127,"class":128},"University of California, Los Angeles","OTHER",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":43},"100462821","preventing-pain-after-surgery-100462821","NCT05306665","PREventing Pain After Surgery","PREventing Pain After Surgery: a Feasibility and Acceptability Study of Acceptance and Commitment Therapy for the Prevention of Chronic Post-surgical Pain (PREPS)","PREPS","Inclusion Criteria:\n\n* scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy\n* age 22 and older\n* able to communicate fluently in English\n\nExclusion Criteria:\n\n* inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment\n* have a history of severe neurologic movement disorder\n* are pregnant or intent to become pregnant during study\n* have undergone previous spinal surgery\n* have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery\n* have undergone Acceptance and Commitment Therapy in last 2 years",{"count":138,"type":20},140,[55],"The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.",[142,29,143,30,58,144],"Pain, Back","Disc Herniation","Back Injuries",[146,147,148,149,150],"Chronic pain","Surgery","opioid","acceptance and commitment therapy","Prevention","2024-10-25",{"date":153,"type":35},"2024-10-28",{"date":155,"type":35},"2023-01-13",{"date":157,"type":20},"2026-08-01",{"name":159,"class":128},"Brigham and Women's Hospital"]