[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"All India Institute of Medical Sciences, Jodhpur\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,81],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100622614","a-clinical-trial-to-study-the-effects-on-the-olfaction-capacity-of-an-individual-undergoing-skull-base-surgeries-using-cautery-vs-scalpel--100622614",false,"NCT07385911","A Clinical Trial to Study the Effects on the Olfaction Capacity of an Individual Undergoing Skull Base Surgeries Using Cautery vs Scalpel .","Olfactory Outcomes of Cautery Vs Scalpel in Endoscopic Endonasal Skull Base Surgery- A Prospective Randomised Controlled Study.","Inclusion Criteria:\n\n-Patients undergoing endoscopic endonasal skull base surgeries that require the raising of a nasoseptal flap\n\nExclusion Criteria:\n\n* Patients with preoperative anosmia due to any cause.\n* Patients with a previous history of sino-nasal, pituitary, or skull base surgery.\n* Patients with a medical history of neurodegenerative diseases (for example, Alzheimer's disease or Parkinson's disease), chronic rhinosinusitis","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"NA","Olfaction is a prominent entity that determines a person's quality of life. During human evolution, olfaction has played an essential role in determining safe food, assessing threats, and developing social relationships. Endoscopic endonasal surgeries are widely used today for the removal of brain tumors involving the pituitary and skull base. The minimal invasiveness, rapid recovery, better visualization, and lower occurrence of complication make endonasal endoscopic surgery an ideal approach for tumors involving the pituitary and midline skull base. However, the olfactory epithelium is at risk of injury during endoscopic skull base surgeries due to the orientation of the olfactory epithelium fibers.It has been found that the olfactory neuroepithelium extends from the cribriform plate superiorly to the septum for the superior-most 1 to 2 cm medially and onto the upper half of the superior turbinates laterally.It also extends from the face of the sphenoid posteriorly to the attachment of the middle turbinate anteriorly.This makes the olfactory fibers susceptible to injury during endonasal surgery that requires superior or upper limb septal incisions, such as the pedicled nasoseptal flap (the Hadad-Bassagasteguy flap) and modified nasoseptal rescue flap.It has been debated whether using a scalpel instead of cautery could have a differential effect on the olfaction of an individual, as some surgeons believe that the heat generated by a cautery injures the nearby olfactory mucosa.This study aims at determining the method which is better at preserving the olfactory capacity of an individual undergoing endoscopic endonasal skull base surgery.",[26],"Olfaction","RECRUITING","2026-01-27",{"date":30,"type":31},"2026-02-04","ACTUAL",{"date":33,"type":31},"2025-05-18",{"date":35,"type":20},"2026-08-31",{"name":37,"class":38},"All India Institute of Medical Sciences, Jodhpur","OTHER_GOV",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":5},"100598525","phase-4-early-post-traumatic-seizures-prevention-trial-e-pts-trial-100598525","NCT07072624","Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)","Assessing Phenytoin and Levetiracetam Efficacy, Cost-Effectiveness, and CYP2C9\u002FSV2A Polymorphism in Early Post-Traumatic Seizures: A Multicentric Prospective Randomized Trial","E-PTS","Inclusion Criteria:\n\n1. Patients of severe blunt TBI with GCS score less than 10.\n2. Patients with GCS of more than 10 in the presence of computed tomographic imaging findings consistent with brain injury: subarachnoid hemorrhage \\[SAH\\], subdural hematoma \\[SDH\\], epidural hematoma \\[EDH\\], intracerebral hemorrhage \\[ICH\\], or diffuse axonal injury \\[DAI\\], depressed skull fracture.\n3. Patients with penetrating injury.\n\nExclusion Criteria:\n\n1. Females of childbearing age with urine pregnancy test positive.\n2. Devastating brain injury with expected or confirmed brain death within 48 hours of hospital admission,\n3. Prehospital use of anticonvulsants\n4. Development of seizures before enrolment.","70 Years",{"count":50,"type":20},1260,[52],"PHASE4","Rationale\u002Fgaps in existing knowledge: The prophylaxis for post-traumatic seizures (PTS) remains controversial due to a lack of class I evidence. Investigators plan to conduct a high-quality, prospective, multicentric, randomized study regarding seizure prophylaxis in traumatic brain injury (TBI) with phenytoin, levetiracetam, and the placebo in three respective treatment groups, along with the effect of drug polymorphism on seizure occurrence.\n\nNovelty: Literature is scarce regarding the ideal management of early PTS in traumatic brain injury (TBI), a major public health problem. Further, no study has evaluated the effect of genetic polymorphism on seizure occurrence in traumatic brain injury. This Multicentric study will be the first of its kind, not only in India but also globally.\n\nObjectives: To evaluate the seizure incidence \\& efficacy of the respective anti-epileptic drug in each treatment arm. Assessment of clinical \\& functional outcomes, safety profile, and cost-effectiveness in each group. Effect of genetic polymorphisms on seizure incidence among study participants Methods: A Multicentric prospective randomized placebo-controlled double-blinded clinical trial is planned. After satisfying eligibility criteria and informed consent, TBI patients will be randomly allocated into three arms 'phenytoin arm', 'levetiracetam arm', and 'placebo'. Drug polymorphism will be analyzed in all the patients using quantitative real-time PCR.\n\nExpected outcome: This study will provide high-quality evidence in PTS management and will establish the role of prophylactic anti-epileptics in PTS. This study also opens the plethora of undesignated roles of genetic polymorphism in the efficacy and safety of levetiracetam and phenytoin in traumatic brain injury patients.",[55,56,57],"Seizures","Traumatic Brain Injuries","Traumatic Brain Injury (TBI) Patients",[59,60,61,62,63,64,65,66,67,68,69,70,71,72],"Post Traumatic Seizures","Early Post Traumatic Seizures","Traumatic Brain Injury","Seizure Prophylaxis","Antiepileptic drugs","Phenytoin","Levetiracetam","Placebo","Genetic polymorphism","CYP2C9","SV2A","Randomized Controlled Trial","Cost-effectiveness","Multicentric Trial","2025-08-01",{"date":75,"type":31},"2025-08-06",{"date":77,"type":31},"2025-07-23",{"date":79,"type":20},"2028-03-15",{"name":37,"class":38},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100572788","phase-3-upfront-surgery-vs-induction-chemotherapy-followed-by-surgery-in-oral-cancers-100572788","NCT06737822","Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cancers:","Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cavity Squamous Cell Cancers With Advanced Nodal Disease (SurVIC Trial): A Phase 3 Multicentric Randomized Controlled Trial","SurVIC","Inclusion Criteria:\n\n* Newly diagnosed, treatment naïve, biopsy or cytology proven OSCC\n* Clinical Stage cT1-4a, cN2-N3\\*\\*, M0- as per UICC 2018\n* No evidence of distant metastases on chest x-ray and\u002For CT Thorax\n* ECOG PS 0-2\n* No contraindication to Cisplatin or radiotherapy\\*\\*\\*\n* Patients eligible for definitive curative intent treatment after discussion in multidisciplinary tumour board\n* Adequate organ function at time of participation, defined as Haematological: Haemoglobin \\> 9gm\u002Fdl, ANC ≥ 1500\u002Fcmm3, Platelet ≥100000\u002Fcmm3 Liver Function test: Bilirubin ≤2 x upper limit normal (ULN), AST\u002FALT\u002F ALP ≤ 2.5 x ULN Renal Function test: Creatinine ≤ 1.5 ULN, Creatinine Clearance ≥60 ml\u002Fmin.\n\nExclusion Criteria:\n\n* Pregnant\n* History of moderate to severe hearing loss.\n* History of previous malignancy excluding non-melanoma skin cancers or cervical carcinoma in situ.\n* Documented Weight loss of more than 15% in the last 6 months.\n* Patients with known HIV, hepatitis B or C infection.","75 Years",{"count":91,"type":20},346,[93],"PHASE3","A majority of oral cancer patients in India present in the advanced stage hence tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers but its role in oral cancer is not well defined in curative setting apart from radio sensitization. Attempted trials of neoadjuvant chemotherapy failed to show oncological advantage despite an excellent response rate, in part due to poor patient selection. Patients with a biologically aggressive disease are more likely to benefit, hence we intend to find out the oncological advantage of adding induction chemotherapy to oral squamous cell cancer with advanced nodal disease (N2-N3).\n\nEarlier studies suffered from their heterogeneous patient population- all head and neck subsites together and included a spectrum ranging from early- stage operable cases to inoperable cancer. Due to such patient selection, the intended results were never met. The current study is intended to study the role of chemotherapy in curable patients who are most likely to benefit (biologically aggressive and advanced stage of presentation).\n\nObjective\n\nPrimary:\n\nTo study the 2 year disease free survival by adding induction chemotherapy before surgery in patients of oral cancer with advanced nodal disease as compared to upfront surgery.\n\nSecondary:\n\nTo assess treatment related outcomes between the treatment arms- Response rate; Treatment compliance; treatment related toxicity, postoperative complications and Quality of life.\n\nTo study the overall survival at 2 years. Oral cancer tissue biobanking for future translational research.\n\nStudy population Operable Oral cavity Squamous cell carcinoma with advanced nodal disease (N2-N3) Study Design Open label, Multi centric, randomized controlled trial with allocation ratio of 1:1\n\nSample Size The primary end point is disease-free survival. In order to have 80% power to detect a hazard ratio of 0.67, using a two-sided significance level, a total of 184 events are needed. Assuming an accrual rate of 15 patients a month, 300 patients need to be recruited. The analysis of DFS will take place 32 months after the start of the trial. The follow-up of patients will continue for 5 years. The analysis of OS will be conducted when 184 deaths are observed. taking 10% of withdrawal of consent, a total of 346 patients need to be included.\n\nInclusion Criteria Biopsy proven, operable oral Squamous cell carcinoma cT1-T4; cN2-N3, with adequate organ function, Age- 18-75 years, ECOG-PS:0-2 Treatment Arms\n\nStandard Arm (SURG arm):\n\nSurgery (Wide local Excision\u002Fcomposite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy\n\nExperimental Arm (ICT):\n\n2# TPF or TPX based induction chemotherapy followed by Surgery (Wide local Excision\u002Fcomposite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy\n\nStudy endpoints Primary- Disease free survival Secondary- Overall survival\u002F Quality of life\u002F Toxicity of treatment\u002F Treatment tolerance",[96,97],"Oral Cancer","Head and Neck Neoplasms","2025-03-02",{"date":100,"type":31},"2025-03-04",{"date":102,"type":31},"2024-12-20",{"date":104,"type":20},"2029-10",{"name":37,"class":38},7,""]