[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"encephalitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:encephalitis":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,61,92,126,147,177,200,230,283],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100469490","regulating-emotions-and-behaviors-after-brain-injury-100469490",false,"NCT05393492","Regulating Emotions and Behaviors After Brain Injury","Dialectical Behavior Therapy for Challenging Behaviors and Emotional Distress After Acquired Brain Injury : a Pilot Study","GREMO-LCA","Eligibility Criteria: \\* (Limit: 15,000 characters)\n\nSummary criteria for participant selection.\n\nMain eligibility criteria\n\nGREMO patients :\n\n* Inclusion criteria:\n\n  * Persons with acquired brain injury regardless of the type or location of the injury\n  * Age between 18 and 68\n  * Over 18 months since the acquired brain injury (or 6 month if mild traumatic brain injury)\n  * Challenging behaviors or emotional dysregulation or high level of anxiety \u002F depression or family's complaints about emotional dysregulation\n  * Secondary or exacerbated by an acquired brain injury\n  * Causing important suffering for themselves or their families\n  * Being affiliated to a social security\n  * Fluent in French\n  * Being able to understand goals and risks and to give a dated and signed consent\n* Exclusion criteria:\n\n  * Clinically evident severe lack of insight, lack of abstract reasoning, or severe anosognosia\n  * Patients without any complaints\n  * Severe cognitive impairments, aphasia or intellectual impairments that doesn't allow to understand DBT skills, questionnaires or group intreactions\n  * Non fluent in French\n  * Associated brain degenerative disease\n  * Cancerous brain injury with uncertain progression\n  * Non-stabilized psychotic disorder\n  * Following a third wave cognitive behavioral therapy during the research study (for example : acceptance and commitment therapy)\n\nControls without brain injury\n\n* Inclusion criteria :\n\n  * Being 18 years old or more\n  * Without brain injury\n* Exclusion criteria :\n\n  * Non fluent in French\n  * History of brain injury or brain disease\n  * History of psychiatric disorder\n  * Personality disorder\n  * GREMO patient's family member living together\n  * Psychologist, neuropsychologist or people with an emotional regulation knowledge linked to their profession\n  * Being under guardianship or curatorship\n  * Being pregnant or breastfeeding\n\nGREMO patients' family members\n\n* Inclusion criteria :\n\n  * Being 18 years old or more\n  * GREMO patient's family member\n  * Living with a GREMO patient\n  * Agreeing to rate an emotion-behavior-skills diary cards\n* Exclusion criteria :\n\n  * GREMO patient's refusal for their family member to participate\n  * Non fluent in French\n  * Brain injury or brain disease\n  * Major lack of insight\n  * Being under trusteeship or curatorship\n\nQualitative research ABI patients and families\n\n* Inclusion criteria :\n\n  * Person with ABI attending the same medico-social service as GREMO patients\n  * Ineligible for GREMO patients group (participation refusal, major insight difficulty…)\n  * Agreeing to talk about their free will or spirituality\n* Exclusion criteria :\n\n  * Aphasia or dysarthria not allowing understandable recording\n  * Impossibility to understand oral questions\n  * Non fluent in French",true,"ALL","18 Years",{"count":21,"type":22},77,"ESTIMATED","INTERVENTIONAL",[25],"NA","After acquired brain injury (ABI), persons can experience emotional and behavioral difficulties, that can be painful both for the person and his\u002Fher family. This clinical study aims at measuring the effectiveness of a third wave cognitive behavioral therapy called \"dialectical behavior therapy\" (DBT). DBT aims at teaching persons emotion regulation skills, interpersonal effectiveness skills, mindfulness and distress tolerance skills through group and individual sessions.\n\nThe study's hypothesis is that DBT, in an adapted format for persons with ABI can lead to\n\n* a better quality of life, emotional and behavioral regulation, and self-esteem\n* decrease in problematic behaviors\n* progress in life goals\n* increase post traumatic growth and spirituality\n* better family functioning and lesser burden for care givers\n* experiencing more emotions and more free will\n\n  45 persons with an ABI sustained more than 18 month back, will follow a 3 phases, follow-up with care as usual for 5 months, followed by 5 months of DBT, followed by 5 months of care as usual + DBT monthly sessions.\n\nSelf- and family-questionnaire will explore quality of life, emotional regulation, self-esteem, stress, anxiety, cognitive difficulties, family functioning and coping, post traumatic growth and spirituality and will be compared across the 3 phases. Results will be analyzed at a group level but also at an individual level (each patient separately) to test for decrease in unwanted behaviors and at a dyadic level (the person and his\u002Fher spouse) to test for the mutual effect of regulating emotions. Persons' memories will by analyzed at 3 time points by a linguistic analysis, and experience of free will after ABI will be analyzed by transcribed narratives of participants.",[28,29,30,31,32,33],"Acquired Brain Injury","Stroke\u002F Cerebrovascular Accident (Ischemic or Hemorrhagic)","Brain Tumor (After Recovery)","Encephalitis","Cerebral Anoxia","Meningitis",[35,36,37,38,39,40,41,42,43,44,45,46,47],"brain injury","dialectical behavior therapy","emotions","emotional dysregulation","behavioral disorders","spirituality","challenging behaviors","linguistic markers","emotional distress","family burden","free will","interpretative phenomenological analysis","single-case experimental design","RECRUITING","2026-06-05",{"date":51,"type":52},"2026-06-09","ACTUAL",{"date":54,"type":52},"2022-05-19",{"date":56,"type":22},"2028-12",{"name":58,"class":59},"University Hospital, Strasbourg, France","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":69,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":60},"100626167","prediction-of-infectious-agents-in-the-biofire-filmarray-biomrieux-meningitisencephalitis-panel-based-on-clinical-syndrome-and-cerebrospinal-fluid-parameters-a-diagnostic-stewardship-proposal-100626167","NCT07432113","Prediction of Infectious Agents in the Biofire® FilmArray bioMérieux Meningitis\u002FEncephalitis Panel Based on Clinical Syndrome and Cerebrospinal Fluid Parameters: a Diagnostic Stewardship Proposal.","Inclusion Criteria:\n\nPatients aged 18 years or older, of any gender.\n\nPresence of at least two of the following symptoms: fever, lethargy, altered level of consciousness, seizures, acute focal deficit, signs of meningeal irritation, or headache.\n\nSymptoms must have started within the last 30 days.\n\nObligatory presence of pleocytosis (CSF white blood cell count ≥ 5 cells\u002Fmm³).\n\nProvision of written Informed Consent (TCLE) by the patient or their legal representative.\n\nExclusion Criteria:\n\n* Failure to sign the Informed Consent Form.\n\nClinical manifestations lasting more than 30 days.\n\nPatients under 18 years of age.\n\nPatients who have undergone neurosurgery within 30 days prior to the onset of symptoms (applies to both prospective and control groups).",{"count":68,"type":22},182,[25],"Background: Infections of the central nervous system (CNS) are associated with high morbidity, mortality, and high resource consumption. The BioFire FilmArray is a molecular diagnostic panel capable of identifying 14 pathogens in approximately one hour, including bacteria, viruses, and fungi. However, it is not yet widely available in the Brazilian public health system.\n\nObjective: The primary objective of this study is to evaluate the pre-test probability of positivity of the Biofire FilmArray bioMérieux Meningitis\u002FEncephalitis panel in patients with clinical syndrome of meningitis and\u002For encephalitis and pleocytosis (CSF ≥ 5 cells).\n\nAs secondary objectives, the study aims to:\n\nDetermine the clinical impact of using the panel through variables such as total hospital stay and length of stay in the intensive care unit.\n\nCompare the duration of antibiotic use in non-bacterial cases between groups. Compare the time to reduction of acyclovir use in etiologies without proven benefit.\n\nCompare the time for identification of the causative pathogen and mortality rates between the study groups.\n\nPerform a cost-effectiveness analysis of the test. Compare the request for imaging exams, such as brain MRI and CT scan, between the groups.\n\nMethods: This is a prospective, transversal, and multicenter study conducted at Santa Casa de Porto Alegre and Hospital Dom João Becker. Patients will be compared with a retrospective cohort used as a control group.",[33,72,31,73,74,75],"Encephalitic Infection","Meningitis, Fungal","Meningitis, Viral","Meningitis, Bacterial",[77,78,79,80,81],"filmarray","biofire","biofire filmarray","meningits","encephalitis","NOT_YET_RECRUITING","2026-02-18",{"date":85,"type":52},"2026-02-25",{"date":87,"type":22},"2026-03-16",{"date":89,"type":22},"2029-10-31",{"name":91,"class":59},"Federal University of Health Science of Porto Alegre",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":103,"conditions":104,"keywords":113,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100544420","comind-early-feasibility-study-100544420","NCT06368648","CoMind Early Feasibility Study","An Early Feasibility Study for the Development of a Model to Non-Invasively Estimate Intracranial Pressure (ICP) and New Metrics of Cerebral Autoregulation (CAR) Using the CoMind One EFS Device","CoMind EFS","Inclusion Criteria:\n\n1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.\n2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.\n3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.\n4. Receiving continuous invasive ABP monitoring as part of standard care.\n\nExclusion Criteria:\n\n1. Presence of any implant (cosmetic or otherwise) in the frontal bone in such proximity to the CoMind One EFS Sensor that they might physically touch.\n2. Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin\n3. Presenting with radiographic evidence of a non-intact skull at the recording site on admission.\n4. If patient is enrolled in an intervention\u002Fstudy that may interfere with SoC ICP measurements or the CoMind One EFS device measurement then the patient is ineligible.\n5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.",{"count":101,"type":22},581,"OBSERVATIONAL","The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.\n\nRecent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.\n\nThrough collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.",[105,106,107,108,31,109,110,111,112],"Intracranial Pressure","Intracranial Pressure Changes","Traumatic Brain Injury","Intracerebral Hemorrhage","Encephalopathy","Hydrocephalus","Stroke","Autoregulation",[105,107,114],"Cerebral Autoregulation","2026-02-12",{"date":117,"type":52},"2026-02-13",{"date":119,"type":52},"2024-11-27",{"date":121,"type":22},"2026-11",{"name":123,"class":124},"CoMind Technologies Limited","INDUSTRY",14,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":81,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":18,"minAge":132,"maxAge":19,"enrollmentInfo":133,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":60},"100611536","clinicolaboratory-predictors-of-outcome-in-children-with-encephalitis-100611536","NCT07241858","Clinicolaboratory Predictors of Outcome in Children With Encephalitis","Inclusion Criteria:\n\n* 1\\. Pediatric population aged 1month to 18 years.\n\n  * Decreased level of consciousness, personality change, or psychiatric manifestations lasting \\>24 h (in toddlers and infants, may present as increased irritability or lethargy)\n  * No alternative diagnosis to explain presentation\n  * Seizure (new onset)\n  * Fever (≥38.0°C)\n  * Focal neurologic findings (new onset)\n  * CSF WBC ≥5\u002Fmm3\n\nExclusion Criteria:\n\n* 1\\. Neonates and adults ( \\\u003C1 month or \\>18 years) 2. If they had a diagnosis of delirium or encephalopathy secondary to sepsis, toxins,renal ,hepatic or metabolic causes (hypoglycemia, electrolyte disturbances","1 Month",{"count":134,"type":22},90,". A glycolytic enzyme called enolase is primarily found in neurons. A dimeric isoform of enolase called neuron-specific enolase (NSE) exists. It can be found in neurons, platelets, erythrocytes, and other neuroectodermal cells.It is one of the laboratory biomarkers that could be investigated in cases of encephalopathy, which can be found in both blood and cerebrospinal fluid, might be a helpful biomarker for determining brain injury prognosis and neuronal damage.(4) High S-100beta levels were associated with higher intensive care unit mortality and represented the strongest independent predictor of intensive care unit survival, whereas neuron-specific enolase (NSE) and the Glasgow Coma Scale failed to predict fatal outcome.(5) (NSE) and S100B are important as a diagnostic and a prognostic value in pediatric encephalopathy which is common and is potentially life threatening, previous studies were done worldwide to detect its diagnostic and prognostic value in acute encephalopathy among adult and pediatric age groups.(4) ,so we asses (NSE) and S100B to detect the the out come of acute encephalopathy",[137,31],"Encephalitis in Children","2025-11-17",{"date":140,"type":52},"2025-11-21",{"date":142,"type":22},"2026-01-01",{"date":144,"type":22},"2028-01-01",{"name":146,"class":59},"Assiut University",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":18,"minAge":155,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100391102","phase-2-the-extinguish-trial-of-inebilizumab-in-nmdar-encephalitis-100391102","NCT04372615","The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis","A Phase-2b, Double-Blind, Randomized Controlled Trial to Evaluate the Activity and Safety of Inebilizumab in Anti-Nmda Receptor Encephalitis and Assess Markers of Disease","ExTINGUISH","Inclusion Criteria\n\n1. Diagnosis of NMDAR encephalitis, defined by both a and b:\n\n   1. A subacute onset of change in mental status consistent with autoimmune encephalitis,\n   2. A positive cell-based assay for anti-NMDA receptor IgG antibody in the CSF confirmed in study-specified laboratories.\n2. Participants, ≥ 12 years of age at the time of informed consent. Participants under 18 years of age must weigh ≥40 kilograms.\n3. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \\[HIPAA\\] in the United States of America \\[USA\\], European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the participant\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n4. Non-sterilized participants who are sexually active with a partner capable of becoming pregnant must use a condom with spermicide from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. A recommendation will be made that the partners (capable of becoming pregnant) of study participants (capable of getting their partner pregnant) should use a highly effective method of contraception other than a physical method.\n\n   Participants of childbearing potential who are sexually active with a non-sterilized partner capable of getting their partner pregnant must agree to use a highly effective method of contraception beginning at screening or upon discharge from hospitalization\u002Finpatient rehabilitation (for participants who were incapacitated at the time of screening), and to continue precautions for 12 months after the final dose of IP.\n   1. Participants of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not postmenopausal (per ICH M3 (R2) 11.2: defined as 12 months with no menses without an alternative medical cause).\n   2. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Periodic abstinence, the rhythm method, and the withdrawal method do not qualify as \"highly effective\" or acceptable methods of contraception for study purposes. Acceptable methods of contraception are listed in the table below:\n\n      Physical Methods Hormonal Methods e\n\n      • Intrauterine device (IUD)\n\n      • Intrauterine hormone-releasing system, also known as drug-eluting IUD a\n\n      • Bilateral tubal occlusion\n\n      • Vasectomized partner b\n\n      • Sexual abstinence c • Combined (estrogen and progestogen-containing hormonal contraception)\n      * Oral (combined pill)\n      * Injectable\n      * Transdermal (patch)\n      * Progestogen-only hormonal contraception associated with inhibition of ovulation d\n      * Implantable\n      * Intravaginal a This is also considered to be a hormonal method. b With appropriate post-vasectomy documentation of surgical success (absence of sperm in ejaculate).\n\n      c Sexual abstinence is considered to be a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of the study and if it is the preferred and usual lifestyle of the participant.\n\n      d Progestogen-only hormonal contraception, where inhibition of ovulation is not the primary mode of action (minipill) is not accepted as a highly effective method.\n\n      e These methods are only considered highly effective and therefore acceptable when used in conjunction with a barrier method (i.e., diaphragm with spermicide, sponge with spermicide, cervical cap with spermicide, condoms, spermicide alone.)\n5. Willing to forgo other immunomodulatory therapies (investigational or otherwise) for NMDAR encephalitis during the study.\n6. Participant must have received at least 3 days of methylprednisolone 1000 mg IV or equivalent corticosteroid within 90 days prior to randomization (Day 1). In addition, participants must have received EITHER of the following treatments within 90 days before randomization.\n\n   1. IVIg, at a dose range between 1.2 and 2 g\u002Fkg\n   2. Plasma exchange or plasmapheresis, (defined as 5 to 6 exchanges).\n\n   NOTE: These treatments may be provided during the screening period but must be completed prior to randomization. Participants who receive methylprednisolone and BOTH IVIg and plasma exchange are not excluded from participating in the trial, however, this treatment course with both IVIg and plasma exchange is not encouraged, and enrollment and randomization should not be delayed in order to complete additional first line treatments.\n7. Modified Rankin Score of ≥3 at the screening visit, indicating at least moderate disability. The baseline mRS must be confirmed by Site Investigators at screening and confirmed \u002F adjudicated before randomization.\n8. Ability and willingness to attend study visits and complete the study. \\*All inclusion criteria must be met during the screening period, prior to randomization, except where noted.\n\nExclusion Criteria\n\nAny of the following excludes an individual from participation in the study:\n\n1. Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the IP, interpretation of participant safety or study results, or would make participation in the study an unacceptable risk. This specifically includes recent history (last 5 years) of herpes simplex virus encephalitis or known central nervous system demyelinating disease (e.g., multiple sclerosis).\n2. Presence of an active or chronic infection that is serious in the opinion of the Investigator.\n3. History of solid organ or cell-based transplantation.\n\n\u003C!-- -->\n\n1. Concurrent\u002Fprevious enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is longer, prior to randomization.\n2. Lactating or pregnant individuals, or individuals who intend to become pregnant anytime from study enrollment to 12 months following last dose of investigational agent.\n3. Known history of allergy or reaction to any component of the investigational agent formulation or history of anaphylaxis following any biologic therapy.\n4. Receipt of the following at any time prior to randomization:\n\n   a. Alemtuzumab b. Total lymphoid irradiation c. Bone marrow transplant d. T-cell vaccination therapy\n5. Receipt of any biologic B cell-depleting therapy (e.g., rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) in the 6 months prior to screening. Receipt of such a B cell-depleting agent in the period 6-12 months prior to screening is exclusionary unless B cell counts have returned to ≥ age-based LLN by central laboratory. For EU participants, B cell counts at screening will be determined by the laboratories of the participating sites. Receipt of non-depleting B cell-directed therapy (e.g., belimumab), abatacept, or other biologic immunomodulatory agent within 6 months prior screening.\n6. Treatment at therapeutic doses\u002Fdurations with any of the following within 3 months prior to randomization\n\n   a. Natalizumab (Tysabri®) b. Cyclosporine c. Methotrexate d. Mitoxantrone e. Cyclophosphamide\\* f. Azathioprine g. Mycophenolate mofetil\n\n   \\*Cyclophosphamide is only permitted as rescue therapy to be administered as outlined in Section 5.4.1 no earlier than the week 6 visit.\n7. Severe drug allergic history or anaphylaxis to two or more food products or medicines (including known sensitivity to acetaminophen\u002Fparacetamol, diphenhydramine (cetirizine in EU) or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid).\n8. Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the participant to infection.\n9. Active malignancy or history of malignancy that was active within the last 10 years, apart from ovarian or extra-ovarian teratoma (also known as a dermoid cyst) or germ cell tumor, or squamous cell carcinoma of the skin or basal cell carcinoma of the skin, that in the opinion of the Medical Safety Monitor (MSM) would preclude enrollment due to safety concerns. Squamous cell and basal cell carcinomas should be treated with documented success of curative therapy \\> 3 months prior to randomization.\n10. At screening (repeat testing may be conducted to confirm results within the same screening period, prior to randomization), any of the following:\n\n    a. Total white blood count \\\u003C2,500 cells\u002Fmm3 (or \\\u003C 2.5 × 109\u002FL) b. Total immunoglobulin \\\u003C 600 mg\u002FdL (or 6 µmol\u002FL; 400 mg\u002FdL for participants \\\u003C18 years)\\* c. Absolute neutrophil count \\\u003C 1200 cells\u002FμL (or \\\u003C 1.2 × 109\u002FL) d. CD4 T lymphocyte count \\\u003C 300 cells\u002FµL (or \\\u003C 0.3 × 109\u002FL)\n\n    \\*Baseline levels of IgG prior to first line treatments (methylprednisolone, plasmapheresis\u002Fplasma exchange) should be used to determine eligibility.\n11. Active hepatitis B or C established with positive hepatitis B serology (hepatitis B surface antigen and core antigen) and\u002For positive hepatitis C PCR testing and confirmed by the MSM\n12. Any live or attenuated vaccine within 4 weeks prior to Day 1 (administration of killed vaccines is acceptable).\n13. Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of enrollment.\n14. History of alcohol or drug abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits or interfere with safety or other study assessments.\n15. Recurrence of previously treated NMDAR encephalitis within the last 5 years, or suspicion of symptomatic untreated NMDAR encephalitis of greater than 3 months duration at the time of screening.\n16. Evidence of active tuberculosis\\* (TB) or being at high risk for TB based on:\n\n    a. History of active TB or untreated\u002Fincompletely treated latent TB. Participants with a history of active or latent TB who have documentation of completion of treatment according to local guidelines may be enrolled.\n\n    b. History of recent (≤ 12 weeks of screening) close contact with someone with active TB (close contact is defined as ≥ 4 hours\u002Fweek OR living in the same household OR in a house where a person with active TB is a frequent visitor).\n\n    c. Signs or symptoms that could represent active TB by medical history or physical examination.\n\n    d. Positive, indeterminate, or invalid interferon-gamma release assay test result at screening, unless previously treated for TB. Participants with an indeterminate test result can repeat the test once, but if the repeat test is also indeterminate, the participant is excluded.\n\n    e. Chest radiograph, chest computed tomography or MRI scan that suggests a possible diagnosis of TB or suggests that a work-up for TB should be considered; all participants must have had lung imaging with an acceptable reading within 6 months prior to consent, or during screening.\n17. Active, clinically significant (CS) infection at the time of randomization (IP administration may be delayed until recovery, if within 14-day screening window, otherwise participant may be rescreened).\n\nExclusion criteria are applied at time of screening and are applicable throughout the study.\n\n* Participants will undergo QuantiFERON®-TB Gold testing or equivalent TB testing during screening as standard of care. A positive result will not exclude patients from participation; thus, enrollment should not be delayed awaiting this result. If positive, an appropriate course of anti-TB treatment will need to be documented. If results are in indeterminate, participants may still be eligible for randomization if history is not suggestive of active \u002F latent TB and a chest x-ray shows no evidence of active or latent TB.\n\n1.1 Additional Eligibility Considerations\n\nThe following criteria are not necessarily exclusionary but require review from the MSM to determine if a participant should be excluded due to safety concerns:\n\n1. At screening (out of range lab values may be reviewed with the MSM to determine whether a potential participant should be excluded for safety reasons; repeat testing may be conducted to confirm results within the same screening period, prior to randomization), any of the following:\n\n   1. Aspartate transaminase (AST) \\> 2.5 × age-based upper limit of normal (ULN)\n   2. Alanine transaminase (ALT) \\> 2.5 × age-based ULN\n   3. Total bilirubin \\> 1.5 × age-based ULN (unless due to Gilbert's syndrome)\n   4. Platelet count \\\u003C 75,000\u002FμL (or \\\u003C 75 × 109\u002FL)\n   5. Hemoglobin \\\u003C 8 g\u002FdL (or \\\u003C 80 g\u002FL or 5 mmol\u002FL)\n2. History of untreated hepatitis C infection. Participants who are considered cured following antiviral therapy with an HCV load below the limit of detection may be enrolled pending confirmation from the MSM that there are no safety concerns for inclusion.\n3. Patients with coexistent autoantibodies should not immediately be excluded but should be reviewed with the MSM to determine eligibility.","12 Years",{"count":157,"type":22},116,[159],"PHASE2","Determine the difference in the modified Rankin score at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with \"first-line\" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo.",[162,31],"Autoimmune Encephalitis",[164,165,162,166],"Inebilizumab","NMDAR encephalitis","Rare Disease","2025-06-30",{"date":169,"type":52},"2025-07-01",{"date":171,"type":52},"2022-03-30",{"date":173,"type":22},"2028-09-30",{"name":175,"class":59},"University of Utah",39,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":60},"100560968","efficacy-and-safety-of-calculus-bovis-sativus-cbs-for-adult-encephalitis-cbsinencephalitis-100560968","NCT06584045","Efficacy and Safety of Calculus Bovis Sativus (CBS) for Adult Encephalitis (CBSinEncephalitis)","An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Adult Encephalitis","Inclusion Criteria:\n\n* Subjects must meet the following eligibility criteria at screening to participate in this study.\n\n1.1 Inclusion criteria for subjects with autoimmune encephalitis (hereinafter referred to as AE) of all subtypes 1.1.1 Subjects are able to understand the purpose and risks of the study, provide informed consent, and authorize the use of confidential health information in accordance with national and local privacy regulations.\n\n1.1.2. Tumors or malignancies can be reasonably excluded before the baseline visit (randomization), and screening guidelines for thymoma, teratoma, and malignant tumors should be followed.\n\n1.1.3. Both men and women are welcome, and the age at the time of providing informed consent is 18-80 years old (inclusive).\n\n1.1.4. Meet the diagnosis of AE (according to the Chinese Autoimmune Encephalitis Diagnosis and Treatment Expert Consensus 2022 Edition): A. Clinical manifestations: acute or subacute onset (\\\u003C3 months), with one or more of the following neurological and psychiatric symptoms or clinical syndromes.\n\n* a. Limbic system symptoms: recent memory loss, epileptic seizures, mental and behavioral abnormalities, one or more of the three symptoms.\n* b. Encephalitis syndrome: clinical manifestations of diffuse or multifocal brain damage.\n* c. Clinical manifestations of involvement of the basal ganglia and\u002For diencephalon\u002Fhypothalamus.\n* d. Mental disorder, and the psychiatric specialist believes that it does not meet the non-organic disease.\n\nB. Auxiliary examination: one or more of the following auxiliary examination findings, or combined with related tumors.\n\n* a. Abnormal cerebrospinal fluid: cerebrospinal fluid leukocytosis (\\>5×106\u002FL), or cerebrospinal fluid cytology shows lymphocytic inflammation, or specific oligoclonal bands are positive.\n* b. Neuroimaging or electrophysiological abnormalities: MRI limbic system T2 or FLAIR abnormal signals, unilateral or bilateral, or other areas of T2 or FLAIR abnormal signals (excluding nonspecific white matter changes and stroke); or PET imaging limbic system hypermetabolism changes, or multiple cortical and\u002For basal ganglia hypermetabolism. Figure 1 shows the typical neuroimaging manifestations of AE patients. Abnormal electroencephalogram, manifested as focal epilepsy or epileptiform discharge (located in the temporal lobe or outside the temporal lobe), or diffuse or multifocal slow wave rhythm. In adult patients with anti-NMDAR encephalitis, abnormal delta brush waves (extreme delta brush) often correspond to prolonged hospitalization and poor prognosis.\n* c. Specific types of tumors associated with AE, such as limbic encephalitis combined with small cell lung cancer, anti-NMDAR encephalitis combined with ovarian teratoma.\n\nC. Confirmatory experiments: positive anti-neuronal antibodies. Including NMDA-R, LGI-1, CASPR2, IgLON5, GABAA\u002FBR, GlyR, AMPAR and axonal protein-3α and intracellular substance antibodies anti-Hu, anti-Ma2, anti-CRMP5, anti-Yo, anti-double carrier protein, anti-GAD, etc.\n\nD. Reasonably exclude other causes (refer to the differential diagnosis section of the consensus).\n\nDiagnostic criteria: including possible AEs and confirmed AEs:\n\n1. Possible AEs: meet the three diagnostic criteria of A, B and D.\n2. Confirmed AEs: meet the four diagnostic criteria of A, B, C and D. 1.1.5. AE symptoms occurred ≤9 months before randomization 1.1.6. Subjects meet new AEs\n\n   \\- New onset: defined as subjects with NMDA-R or LGI-1 AEs and meeting the following criteria:\n   * The mRS score measured at baseline is stable (at least 24 hours) and is ≥2 points.\n   * Received the first acute first-line treatment within 6 weeks before randomization (baseline visit).\n\n   1.1.7. All females of childbearing potential and all males must use contraception during the study and for at least 30 days after the last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 30 days after the last dose of study treatment.\n\n   1.1.8. Stable neurological examination within 30 days before baseline (Visit 1).\n\n   1.2 Additional inclusion criteria for the NMDA-R AE cohort\n\n   In addition to the criteria outlined in Section 1.1, only subjects who met all of the following criteria were eligible for inclusion in the NMDA-R AE cohort:\n   * Age ≥ 18 years at the time of informed consent\n   * Informed consent, as appropriate based on patient age, specific site, and national criteria\n   * Suspected or definite NMDAR AE diagnosis as follows:\n\n   1.2.1. Suspected NMDAR encephalitis was diagnosed when all three of the following criteria were met: 1.2.1.1 Rapid onset (less than 3 months) of at least four of the following six cardinal symptoms:\n   * Abnormal (psychiatric) behavior or cognitive dysfunction\n   * Speech dysfunction (rushing speech, hypospeech, mutism)\n   * Seizures\n   * Ataxia, dyskinesia, or rigid\u002Fabnormal posture\n   * Decreased level of consciousness\n   * Autonomic dysfunction or central hypoventilation 1.2.1.2. At least one of the following laboratory results:\n   * Abnormal EEG (focal or diffuse slow or disorganized activity, epileptic activity, or extreme delta brushes)\n   * CSF with pleocytosis or oligoclonal bands 1.2.1.3. Reasonable exclusion of other etiologies and other clear encephalitis syndromes: for example, Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary angiitis of the central nervous system (CNS), Rasmussen encephalitis.\n\n   Note: If the above three groups of symptoms in criterion 1.2.1.1 are present and accompanied by systemic teratoma, suspected NMDAR encephalitis can also be diagnosed.\n\n   1.2.2 Definite NMDAR encephalitis can be diagnosed when the following three criteria are met at the same time: 1.2.2.1. The presence of one or more of the six main symptoms described in criterion 1.2.1.1 for suspected NMDAR encephalitis.\n\n   1.2.2.2. History of anti-NMDAR (GluN1) IgG antibodies detected in CSF using a cell-based assay.\n\n   1.2.3. Reasonable exclusion of other etiologies and other well-defined encephalitis syndromes: e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary angiitis of the central nervous system (CNS), Rasmussen encephalitis.\n\n   1.3 Other inclusion criteria for the LGI-1 AE cohort\n\n   In addition to the criteria outlined in Section 1.1, only subjects who meet all of the following criteria are eligible for inclusion in the LGI1 AE cohort:\n\n   1.3.1 Age ≥ 18 years at the time of signing the informed consent For subjects who are unable to provide informed consent due to the severity of their illness, the informed consent may be signed by their legally authorized representative at the time of obtaining the subject's consent, according to local requirements.\n\n   1.3.2 Diagnosis of LGI-1 AE\n\n   The diagnosis of LGI-1 encephalitis can be made when both of the following criteria are met:\n\n   1.3.2.1 Documented history of anti-LGI-1 IgG antibodies (in serum or CSF) using a cell-based assay.\n\n   1.3.2.2 Subacute onset (less than 4 months of development) of working memory deficits, seizures (including faciobrachial dystonic seizures), or psychiatric symptoms suggestive of limbic system involvement.\n\n   1.3.2.3 Diagnosis of LGI1 AE is reasonable when other etiologies and other well-defined encephalitis syndromes are excluded: e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary CNS vasculitis, Rasmussen encephalitis.\n\n   1.4 Other inclusion criteria for the AA AE cohort\n\n   In addition to the criteria outlined in Section 1.1, only subjects who meet all of the following criteria are eligible for inclusion in the AA AE cohort:\n   * Aged ≥ 18 years at the time of signing the informed consent form For subjects who are unable to provide informed consent due to the severity of their illness, the informed consent form may be signed by their legally authorized representative when the subject agrees, according to local requirements.\n   * Diagnosis of AA AE Meet the diagnosis of AE in 1.1, negative for anti-NMDA antibodies and anti-LGI-1 antibodies, and positive for at least one of the other anti-neuronal antibodies.\n\n   1.5 Inclusion criteria for viral encephalitis (hereinafter referred to as VE) cohort\n\n   The following four conditions must be met simultaneously for diagnosis of VE:\n   * Primary condition: altered mental status, including decreased level of consciousness, drowsiness, or abnormal mental behavior lasting ≥24 h; or new onset of epileptic seizure\n   * Secondary condition: fever ≥38 °C (before or within 72 h after onset), or new focal manifestations of the nervous system, or cerebrospinal fluid leukocytes ≥5×10\\^6\u002FL, or cerebrospinal fluid cytology showing lymphocytic inflammation, or imaging showing brain parenchymal lesions consistent with encephalitis, or abnormal electroencephalogram consistent with encephalitis\n   * Confirmatory laboratory test: positive cerebrospinal fluid viral nucleic acid (polymerase chain reaction or metagenomic next-generation sequencing), or positive cerebrospinal fluid and\u002For serum antiviral antibody IgM\n   * Reasonable exclusion of other causes\n\n   1.6 Healthy cohort:\n   * Age ≥ 18 years old when signing the informed consent form\n   * Healthy adult subjects without underlying diseases\n\n     * Exclusion Criteria:\n\n       * Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the investigator determines would preclude participation in the clinical trial.\n       * Any untreated teratoma or thymoma at the baseline visit (randomization)\n       * Other causes of symptoms, including central nervous system infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatic disease, Reyes syndrome, or inborn errors of metabolism.\n       * History of herpes simplex encephalitis within the previous 24 weeks. 1.5. Any surgical procedure within 4 weeks prior to baseline, except laparoscopic surgery or minor surgery (defined as surgery requiring only local anesthesia or conscious sedation, i.e., surgery that does not require general, neuraxial, or regional anesthesia and can be performed on an outpatient basis; e.g., toenail surgery, mole surgery, wisdom tooth extraction), excluding thymoma or teratoma removal.\n       * Planned surgery during the study (except minor surgery).\n       * History of severe allergic or anaphylactic reactions, or any allergic reaction that the investigator believes may be exacerbated by any component of study treatment.\n       * Current or history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma and squamous cell carcinoma that have been completely resected and considered cured for at least 12 months prior to Day -1). Subjects with cancer remission for more than 5 years prior to baseline (Visit 1) may be included after discussion with the sponsor\u002Fsponsor approval.\n       * A history of gastrointestinal surgery (except appendectomy or cholecystectomy performed more than 6 months before screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant active gastrointestinal diseases in the opinion of the investigator.\n       * A history of clinically significant recurrent or active gastrointestinal symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days before screening, including the need to start symptomatic treatment (e.g., start medication for gastroesophageal reflux disease) or a change in symptomatic treatment within 90 days before screening (e.g., dose increase).\n       * A history of diverticulitis or concurrent severe gastrointestinal (GI) abnormalities (e.g., symptomatic diverticular disease) because the investigator believes that this may lead to an increased risk of complications such as GI perforation.\n       * A history of blood donation (1 unit or more), plasma donation, or platelet donation within 90 days before screening.\n       * Active suicidal ideation within 6 months before screening, or a history of suicide attempt within 3 years before screening.\n       * Based on the investigator's judgment, there are serious diseases or abnormalities in the clinical laboratory test results that prevent the patient from completing the study or participating in the study safely.\n       * Pregnant or lactating, or planning to become pregnant during the study or within 3 months after the last dose of the study drug; women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the start of the study.\n       * The subject's mental or physical condition will hinder the evaluation of efficacy and safety.\n       * Systolic blood pressure \\>150 mmHg or \\\u003C90 mmHg after sitting still for 5 minutes or before dosing at screening. If out of range, it can be measured again at screening and before dosing. If the repeated measurement value is still out of range, the subject shall not receive the drug.\n       * Subjects with second or third degree atrioventricular block or sick sinus syndrome, poorly controlled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction, or significant ECG abnormalities, including corrected QT interval \\>450 msec (male) or 470 msec (female), where corrected QT interval is determined based on the Fridericia correction method, within 3 months prior to the screening visit.\n       * Planned elective procedures or surgeries at any time after signing the Informed Consent Form by follow-up visit.\n       * Any condition that affects the absorption of study treatment (e.g., gastrectomy).\n       * History of hypersensitivity to heparin or history of heparin-induced thrombocytopenia.\n       * Subjects with abnormalities in medical history, physical examination, ECG, or diagnostic laboratory tests that the investigator considers to be clinically relevant.\n       * History of human immunodeficiency virus (HIV) or positive test results at screening.\n       * Current infection with hepatitis C (defined as positive hepatitis C virus (HCV) antibodies and detectable HCV RNA). Subjects with positive HCV antibodies and HCV RNA below the limit of detection are eligible to participate in the study.\n       * Current infection with hepatitis B (defined as positive HBsAg and\u002For positive total anti-HBc).\n       * Chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) within 90 days prior to baseline (visit 1).\n       * History of tuberculosis (TB) diagnosis or positive latent TB test result.\n       * Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 28 days prior to baseline (visit 1). Subjects with localized fungal infection (e.g., candidiasis, tinea) are eligible for rescreening after successful treatment of the infection.\n       * Infection requiring hospitalization or IV anti-infective medication within 4 weeks prior to baseline visit.\n       * Any live or live attenuated vaccine within 28 days prior to baseline (visit 1) or planned during the study.\n       * Contraindications to all of the following salvage therapies: rituximab, intravenous immunoglobulin, high-dose corticosteroids, or IV cyclophosphamide.\n       * History of or receipt of the following treatments: Total lymphoid irradiation, cladribine, T-cell or T Cell recipient vaccination, total body irradiation, or total lymphoid irradiation at any time. Stem cell transplantation at any time.\n       * Abnormal laboratory values determined by the investigator to be clinically significant at Screening or Baseline (Visit 1).\n       * Any of the following blood test abnormalities at Screening: a. White blood cell count \\\u003C 3.0 × 10\\^3\u002FµL. b. Absolute neutrophil count \\\u003C 2.0 × 10\\^3\u002FµL. c. Absolute lymphocyte count \\\u003C 0.5 × 10\\^3\u002FµL. d. Platelet count \\\u003C × 10 × 10\\^4\u002FµL. e. glutamic-pyruvic transaminase, glutamic oxaloacetic transaminase, or γ-glutamyl transpeptidase ≥ 3 x upper limit of normal (ULN) or bilirubin \\> 2 x ULN. f. glomerular filtration rate ≤ 60 mL\u002Fmin\u002F1.73 m2. g. Lymphocyte count \\\u003C lower limit of normal\n       * Any of the following urine test abnormalities at Screening: a. β-2-microglobulin\\>0.3 μg\u002FmL. b. Albumin\u002Fcreatinine ratio\\>22.6 mg\u002Fmmol.\n       * Previous participation in this study.\n       * Blood donation (1 unit or more) within 90 days before screening, plasma donation within 1 week before screening, and platelet donation within 6 weeks before screening.\n       * History of alcohol or drug abuse in the past year (determined by the investigator).\n       * Pregnant or lactating subjects, as well as subjects planning to become pregnant or start breastfeeding at any time during the study and within 30 days after completion of study treatment.\n       * Participating in a clinical trial or having participated in a clinical trial within 90 days before screening.\n       * History of clinically significant suicidal thoughts or behaviors in the past 12 months as assessed by Columbia-Suicide Severity Rating Scale at screening.\n       * Unwilling or unable to comply with protocol requirements.\n       * The patient has obvious hearing or vision impairment, language barriers, claustrophobia, etc., which makes the patient unable to cooperate with the neuropsychological scale assessment and MRI examination.\n       * The researcher or sponsor believes that there are other unknown reasons that make the subject unsuitable for inclusion.",{"count":185,"type":22},250,[25],"Based on the records of traditional Chinese medicine, CBS has the functions of purifying the heart, eliminating phlegm, stimulating bile secretion, and soothing the nerves. It has the ability to alleviate fever, coma, delirium, epilepsy, convulsions in youngsters, dental caries, throat swelling, mouth ulcers, carbuncle, and furuncle.\n\nEncephalitis is a neurological condition characterized by widespread or multiple inflammation of brain tissue. The causes of encephalitis are many and can stem from infectious organisms or be induced by autoimmune reactions, the latter being referred to as autoimmune encephalitis (AE). The yearly occurrence rate of encephalitis is 12.6 per 100,000 individuals. Among these cases, approximately 40-50% are caused by infectious factors, whereas 20-30% are attributed to autoimmune encephalitis (AE). The development of viral encephalitis involves the direct invasion of brain tissue by the virus and the immune response of the body to viral antigens. The virus multiplies extensively, leading to the degeneration of neurons, necrosis, the proliferation of glial cells, and the infiltration of inflammatory cells. These severe tissue reactions can result in the formation of demyelinating lesions and damage to blood vessels and the areas surrounding them. Additionally, vascular lesions affect the circulation in the brain and worsen the damage to brain tissue. The development of AE involves several factors, including molecular mimicry, the activation of latent antigen epitopes, the spread of antigen epitopes, and the disruption of the innate immune system caused by persistent pathogen infection.\n\nThe mechanisms that are clearer can be summarized as follows: (1) Decrease in the number of receptors on the surface due to cross-linking and internalization: Anti-NMDAR antibodies have the ability to attach to NMDAR on the postsynaptic membrane, resulting in a reduction of NMDAR surface density through cross-linking and internalization. This reduction leads to a decrease in NMDAR-mediated current, which in turn causes learning and memory defects. (2) Protein-protein interaction disruption: Anti-LGI1 antibodies can disrupt the binding between LGI1 and ADAM23 on the presynaptic membrane and ADAM22 on the postsynaptic membrane. This disruption leads to a decrease in the density of anti-α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPAR).\n\nAccording to the aforementioned background processes, along with the most recent research, there was a decrease in the abundance of gut flora in patients with AE. Transplanting the fecal bacteria of individuals with anti-NMDAR encephalitis into mice's intestines resulted in cognitive impairment in the animals. This indicates that the brain-gut axis may have a significant role in the development of anti-NMDAR encephalitis. From a clinical perspective, patients consume CBS orally in order to achieve its therapeutic benefits. The primary constituents, bilirubin and bile acid, have been documented to possess regulatory effects on the gut microbiota. Thus, we hypothesize that CBS is probable to have neuroprotective and anti-inflammatory impacts on the brain through alterations in the intestinal microbiota and regulation of the brain-gut connection. CBS is expected to decrease the occurrence of symptomatic seizures and enhance the patient's level of consciousness and cognitive abilities.",[31,189,190,162],"Encephalitis, Viral","Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody","2025-04-06",{"date":193,"type":52},"2025-04-08",{"date":195,"type":52},"2024-09-30",{"date":197,"type":22},"2029-12",{"name":199,"class":59},"Tongji Hospital",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100581338","inflammatory-and-metabolic-prognostic-assessment-in-critically-ill-neurological-patients-100581338","NCT06849011","Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients","Development and Validation of a Prognostic Prediction Model for Adverse Outcomes in Neurocritical Patients Receiving Enteral Nutrition Based on Key Inflammatory and Metabolic Markers","IMPACT-NEURO","Inclusion Criteria:\n\n1. Age between 18 and 80 years, no gender restrictions.\n2. Within 7 days of disease onset and expected NICU stay of at least 7 days.\n3. Eligible for enrollment within 24 hours of NICU admission, with enteral nutrition (EN) initiated and continued for at least 7 days.\n4. Non-traumatic severe brain injury patients (including cerebrovascular disease and encephalitis) with a Glasgow Coma Scale (GCS) score ≤12.\n5. NRS 2002 score ≥3.\n6. Kuwata drinking test ≥ grade 3.\n7. Acute Gastrointestinal Injury (AGI) grade 1 or 2.\n8. Signed informed consent obtained from the patient or their legal representative.\n\nExclusion Criteria:\n\n1. Severe malnutrition prior to admission, defined as BMI \\\u003C 16 kg\u002Fm².\n2. Pregnant or lactating women.\n3. Receiving hypothermia treatment or core body temperature \\\u003C 36°C.\n4. End-stage disease with an expected survival time of \\\u003C 48 hours, or severe dysfunction of the heart, lungs, or other vital organs, leading to hemodynamic instability.\n5. Malignant tumors.","80 Years",{"count":210,"type":22},1185,"The study aims to develop and validate a prognostic prediction model for adverse outcomes in neurocritical patients receiving enteral nutrition based on key inflammatory and metabolic markers. This model will serve as a clinical tool to help physicians identify high-risk patients and guide individualized nutritional support strategies.",[213,31,214],"Stroke Acute","Non-traumatic Brain Injury",[216,217,218,219],"enteral nutrition","adverse prognosis","prediction model","non-traumatic severe brain injury","2025-02-23",{"date":222,"type":52},"2025-02-27",{"date":224,"type":22},"2025-03-01",{"date":226,"type":22},"2027-03-31",{"name":228,"class":59},"Yan Zhang",19,{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":240,"conditions":241,"keywords":256,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100284234","fosfomycin-iv-for-treatment-of-severely-infected-patients-100284234","NCT02979951","Fosfomycin I.v. for Treatment of Severely Infected Patients","An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.","FORTRESS","Inclusion Criteria:\n\n* Male or female patients aged ≥ 18 years\n* Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.\n* Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC\n* Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)\n\nExclusion Criteria:\n\n* Previous documentation of the patient in the present study\n* Patients participating in an interventional clinical trial\n* Patients with known hypersensitivity to fosfomycin or any of the excipients\n* Terminally ill patients\n* Patients with \"do not resuscitate order\"\n* Palliative treatment approach\n* Failure of \\> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney\n* Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)\n* Fosfomycin treatment as 4th line treatment or at later stage\n* Patients with involvement of fungi or mycobacteria in the targeted infection",{"count":239,"type":22},1000,"The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.",[242,243,244,245,75,31,246,247,248,249,250,251,252,253,254,255],"Bacterial Infections","Bone Diseases, Infectious","Osteomyelitis","Central Nervous System Bacterial Infections","Brain Abscess","Urinary Tract Infections","Respiratory Tract Infections","Pneumonia, Bacterial","Skin Diseases, Bacterial","Soft Tissue Infections","Intraabdominal Infections","Sepsis","Bacteremia","Endocarditis, Bacterial",[257,258,259,260,261,262,263,264,265,266,242,267,268,243,244,245,75,31,246,247,248,249,250,251,252,253,254,255,269,270,271,272],"Observational Study","Non-Interventional Study","Registries","Prospective","Monitored","Multicentric","International","Fosfomycin","Infectofos","Fomicyt","Gram-Negative Bacterial Infections","Gram-Positive Bacterial Infections","Treatment Outcome","Clinical Efficacy","Microbiological Efficacy","Safety","2024-09-27",{"date":275,"type":52},"2024-10-01",{"date":277,"type":4},"2016-12",{"date":279,"type":22},"2030-12",{"name":281,"class":124},"Infectopharm Arzneimittel GmbH",50,{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":293,"conditions":294,"keywords":304,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":319},"100317883","central-nervous-system-infections-in-denmark-100317883","NCT03418441","Central Nervous System Infections in Denmark","Danish Study Group of Infections of the Brain: A Nationwide Prospective Observational Cohort Study of All Central Nervous System Infections in Adults at Departments of Infectious Diseases in Denmark","DASGIB","Definitions of central nervous system infections:\n\nFor all cases with unproven aetiologies no alternative diagnosis than CNS infection is thought more likely after completed multidisciplinary diagnostic work-up.\n\nViral meningitis inclusion criteria\n\n\\- All patients have to have a clinical presentation consistent with non-bacterial meningitis (e.g. headache, neck stiffness, photo- or phonophobia, fever)\n\nand\n\nCerebrospinal fluid leukocytes\\>10 cells\u002Fml\n\nPatients with viral meningitis with undetermined pathogen have to have:\n\n* CSF leukocytes\\> 10\u002FmL and no other more probable diagnosis assessed by the local investigator.\n\nIn case of doubt, patients are discussed with the DASGIB secretary and chair or at meetings.\n\nBacterial meningitis inclusion criteria - All patients have to have a clinical presentation consistent with bacterial meningitis (e.g. headache, neck stiffness, fever, altered mental status)\n\nand\n\nProven bacterial aetiology (CSF or blood culture\u002FDNA based technology or antigen tests)\n\nPatients with bacterial meningitis in whom the bacteria cannot not be cultured or identified by DNA-based technologies have to have:\n\n\\- CSF leukocytes\\> 10\u002FmL and no other more probable diagnosis assessed by the local investigator.\n\nIn case of doubt, patients are discussed with the DASGIB secretary and chair or at meetings.\n\nEncephalitis inclusion criteria - All patients have to have a clinical presentation consistent with encephalitis (e.g. headache, fever, focal neurological deficit, altered mental status \\>24 hours) as defined by the International Encephalitis Consortium (Venkatesan A et al., Clin Infect Dis 2013; doi:10.1093\u002Fcid\u002Fcit458.).\n\nEncephalitis exclusion criteria\n\n\\- We exclude cases of proven or suspected autoimmune encephalitis.\n\nPrimary brain abscess inclusion criteria\n\n\\- All patient have a clinical presentation consistent with brain abscess (e.g. headache, focal neurological deficit, mass lesion on cranial imaging)\n\nand\n\n\\- Proven microbiological aetiology by culture\u002FDNA-based technology from pus from brain abscess or blood or CSF\n\nor\n\n\\- Aspiration of pus from the brain abscess\n\nor\n\n\\- Response to antimicrobial treatment\n\nor\n\n\\- Tumour ruled out\n\nor\n\n\\- Tumour thought less probable than abscess on MRI using diffusion weighted imaging (DWI) and apparent diffusion coefficient (ADC) sequences.\n\nLyme neuroborreliosis inclusion criteria\n\n\\- A clinical presentation consistent with neuroborreliosis (e.g. radiculopathy)\n\nand\n\n\\- CSF pleocytosis\\>10 leukocytes\u002FmL\n\nand\n\n\\- Positive intrathecal B.burgdorferi antibody production index.\n\nNeurosyphilis inclusion criteria - A clinical presentation consistent with neurosyphilis (e.g. 'encephalitis-like symptoms', dementia, ocular or otogenic syphilis)\n\nand either\n\n\\- Positive syphilis serology in serum combined with CSF leukocytes\\>10\u002FmL\n\nor\n\n\\- CSF syphilis antibodies.",{"count":292,"type":22},1900,"The Danish Study Group of Infections of the Brain is a collaboration between all departments of infectious diseases in Denmark. The investigators aim to monitor epidemiological trends in central nervous system (CNS) infections by a prospective registration of clinical characteristics and outcome of all adult (\\>17 years of age) patients with community-acquired CNS infections diagnosed and\u002For treated at departments of infectious diseases in Denmark since 1st of January 2015.",[295,296,297,298,31,246,299,300,301,302,303,33],"Central Nervous System Infections","Bacterial Meningitis","Viral Meningitis","Aseptic Meningitis","Neuroborreliosis","Neurosyphilis","Lyme Disease","Tertiary Syphilis","Cerebral Abscess",[305,306,295,33,31,307,308,299,300,309],"Nationwide prospective observational cohort study","Epidemiology","Brain abscess","Lyme disease","Tertiary syphilis","2024-05-15",{"date":312,"type":52},"2024-05-16",{"date":314,"type":52},"2015-01-01",{"date":316,"type":22},"2030-01-01",{"name":318,"class":59},"Aalborg University Hospital",8]