[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurological-abnormality\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurological-abnormality":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100606970","turkish-version-of-the-brief-hammersmith-infant-neurological-examination-hine-100606970",false,"NCT07182474","Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE)","Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE) With High-Risk of Infants: A Study of Validity and Reliability","BRIEF-HINE","Inclusion Criteria:\n\n* Infants with high risk of CP: Periventricular hemorrhage, intracranial hemorrhage grade 2, 3, 4, cystic PVL, stage 3 hypoxic ischemic encephalopathy, neonatal bilirubin encephalopathy (kernicterus), perinatal stroke, perinatal asphyxia, respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD) and infants receiving long-term O₂ support, sepsis due to gram-negative bacteria, necrotizing enterocolitis (NEC), infantile apnea, those with a low 5-minute Apgar score (3 and below), those diagnosed with intrauterine growth retardation, multiple births (twins, triplets), preterm infants with retinopathy of prematurity (ROP), infants with prolonged severe hypoglycemia and hypocalcemia, (small for gestational age (SGA), less than the 3rd percentile) or large for gestational age (large for gestational age (LGA), less than the 97th percentile). (large) babies, babies receiving mechanical ventilation for more than 24 hours, babies born at less than 32 weeks of gestation and weighing less than 1500 grams.\n\nExclusion Criteria:\n\n* Infants with any known orthopedic, systemic disease or neurological diagnosis other than CP","ALL","3 Months","12 Months",{"count":21,"type":22},120,"ESTIMATED","1 Year","OBSERVATIONAL","The American Academy of Pediatrics defines high-risk infants as those with preterm birth, special health care needs, family risk factors, and those at risk of early death. Factors such as premature birth, perinatal asphyxia, hypoxic-ischemic encephalopathy (HIE), periventricular leukomalacia (PVL), intraventricular hemorrhage (IVH), chronic lung disease, seizures, meningitis, hyperbilirubinemia, twin\u002Ftriplet pregnancy, and intrauterine growth restriction are risk factors that can result in morbidity and mortality in infants. Regular neurological examinations and neuromotor tests are necessary for at-risk infants to identify developmental problems early and to initiate early intervention programs.In developing countries, regular follow-up and early rehabilitation of at-risk infants are not successfully implemented. 5,6 The lengthy test batteries and busy clinics are among the most significant reasons. Therefore, the development and dissemination of shorter, valid, and reliable tests is of great importance. The Hammersmith Neonatal Neurological Examination (HINE), one of the gold standard methods, consists of 26 items and takes 15-20 minutes to administer.Due to the number of items and the duration, it is not frequently used routinely. In response to this clinical need, the HINE short scale was developed in 2024.The aim of the study is to have a Turkish version of the Abstract-HINE test in Turkey and to study its validity and reliability in high-risk infants.",[27,28,29],"Pediatrics","Neurological Abnormality","Neurodevelopment Outcome","RECRUITING","2025-09-18",{"date":33,"type":34},"2025-09-19","ACTUAL",{"date":36,"type":34},"2025-08-22",{"date":38,"type":22},"2026-10-30",{"name":40,"class":41},"Kahramanmaras Sutcu Imam University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100513888","pilot-study-of-zetafuse-bone-graft-for-the-treatment-of-cervical-degenerative-disc-disease-100513888","NCT05971329","Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease","Inclusion Criteria:\n\n1. Age 22 to 75 years (inclusive) at the time of enrollment.\n2. Diagnosis of radiculopathy and\u002For myelopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:\n\n   * Neck and\u002For arm pain (at least 3 on the 0 - 10 numeric rating scale for pain.\n   * Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.\n   * Abnormal sensation including hyperesthesia or hypoesthesia. and\u002For\n   * Abnormal reflexes.\n3. Symptomatic at one or two contiguous levels from C3 to C7.\n4. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:\n\n   * Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.\n   * Degenerative spondylosis on CT or MRI.\n   * Disc herniation on CT or MRI.\n5. Neck Disability Index Score ≥ 30\u002F100.\n6. Unresponsive to non-operative treatment (e.g., rest, heat, physical therapy, chiropractor, massage, pain medication) for approximately six weeks from the symptom onset; or has the presence of progressive symptoms or signs of nerve root\u002Fspinal cord compression in the face of continued non-operative management.\n7. No previous surgical intervention at the involved levels or any subsequent, planned\u002Fstaged surgical procedure at the involved or adjacent levels.\n8. Appropriate for treatment using an anterior surgical approach.\n9. Skeletally mature at the time of the surgery.\n10. Medically cleared for surgery.\n11. If a female of child-bearing potential, subject is non-pregnant, nonnursing, and agrees not to become pregnant during the study period.\n12. Willing and able to comply with the study plan.\n13. Signed written Patient Informed Consent Form.\n14. Willing to discontinue use of non-steroidal anti-inflammatory drugs (NSAIDs) from one week before the surgery to 3 months after the surgery.\n\nExclusion Criteria:\n\n1. A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved levels.\n2. Documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion\u002Fextension) radiographs showing sagittal plane translation \\>3.5 mm or sagittal plane angulation \\> 20°.\n3. More than two cervical levels requiring surgical treatment.\n4. An immobile or spontaneously fused level adjacent to the levels to be treated.\n5. Severe pathology of the facet joints of the involved vertebral bodies.\n6. Previous surgical intervention at either one or both of the involved levels or at adjacent levels.\n7. History of trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.\n8. Previously diagnosed with osteomalacia;\n9. Any of the following that may be associated with an increased risk osteoporosis (if \"Yes\" to any of the below risk factors, a DEXA Scan is required to determine eligibility). If the level of bone mineral density (BMD) on DEXA scan is a T score of -2.5 or worse (i.e., -2.6, - 2.7, etc.) the subject is ineligible for the study.\n\n   * Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds.\n   * Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture.\n   * Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.\n   * Taking bisphosphonate medication for the treatment of osteoporosis.\n   * Chronic use of high dose steroids.\n10. Reported active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer) unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years.\n11. Overt or active systemic infection, or infection at the operative site.\n12. Insulin dependent diabetes.\n13. A tobacco user who does not agree to suspend smoking prior to surgery.\n14. Chronic or acute renal failure or prior history of renal disease.\n15. Mentally incompetent (If questionable, obtain psychiatric consult).\n16. A prisoner.\n17. An alcohol and\u002For drug abuser currently or recently undergoing treatment for alcohol and\u002For drug abuse.\n18. Involved with current or pending litigation regarding a spinal condition.\n19. Received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate) excluding routine perioperative anti-inflammatory drugs.\n20. A history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers- Danlos Syndrome, or osteogenesis imperfecta).\n21. A condition that requires post-operative medications that interfere with the stability of the implant, such as steroids. (This does not include low dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs).\n22. Received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation with the ZetaFuse™ Bone Graft device.",true,"22 Years","75 Years",{"count":53,"type":22},10,"INTERVENTIONAL",[56],"NA","The goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function.\n\nParticipants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function.",[59,60,28,61,62],"Radiculopathy, Cervical","Myelopathy Cervical","Disc Disease","Disc Degeneration","2025-04-18",{"date":65,"type":34},"2025-04-24",{"date":67,"type":22},"2026-09",{"date":69,"type":22},"2027-09",{"name":71,"class":72},"Zetagen Therapeutics, Inc","INDUSTRY"]