[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroinflammatory-response\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroinflammatory-response":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,83,109,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100485768","phase-1-minocycline-in-neurocognitive-outcomes---sickle-cell-disease-100485768",false,"NCT05605366","Minocycline In Neurocognitive Outcomes - Sickle Cell Disease","MINO-SCD","Inclusion Criteria:\n\nAdults (age ≥ 18 years old) with SCD (HbSS and HbS-β0thalassemia genotypes only) who are followed at the University of Cincinnati Medical Center's SCD clinic are eligible to participate. As hydroxyurea is the standard-of-care in SCD, individuals on hydroxyurea will be included\n\nExclusion Criteria:\n\n1. adults with other SCD genotypes (HbSC or HbS- β+thalassemia),\n2. individuals with a history of overt stroke or other known neurological disorder,\n3. premature birth before 30 weeks gestation,\n4. monthly therapy with chronic blood transfusions,\n5. coexisting autoimmune condition due to an elevated risk for autoimmune-related complications with tetracyclines,\n6. tetracycline allergy.\n7. Women who are pregnant or breast-feeding","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Sickle cell disease (SCD) is a common, inherited blood disorder that primarily affects people of African Ancestry. It has a lot of complications including neurological complications. The neurological complications of SCD are particularly devastating and lead to cognitive decline even in the absence of overt brain injury. In such cases, it is thought that inflammation in the brain maybe partly responsible for the cognitive decline.\n\nThe main reasons for this research study are to see 1) how safe and 2) how well minocycline works to try to stop\u002Freverse cognitive decline in people with SCD. People with SCD are at risk for changes in their brain over time that can cause problems with learning, memory, and attention. Part of the reason for this is inflammation within the brain. Minocycline may be able to stop these brain changes by stopping this brain inflammation.\n\nMinocycline is a second-generation tetracycline antibiotic that has been shown to both inhibit neuroinflammation and improve cognitive function in a variety of neurodegenerative and psychiatric disorders but has not yet been studied in SCD. We are proposing here, a pilot double-blinded, randomized controlled trial to examine the tolerability and early efficacy of minocycline in adults with SCD at two dosing regimens (200 mg and 300 mg daily) versus placebo over one year. Participants will undergo a neuropsychological exam using the NIH Toolbox Cognition Battery at both study enrollment and exit (after one year) to assess for changes\u002Fstability of cognition. Participants will receive monthly phone calls\u002Ftext messages to assess for adverse events and will be seen every three months for pill counts and routine laboratory monitoring. The primary outcome will be a comparison of adverse events across the two dosing strategies versus placebo. Early evidence for cognitive benefit will also be assessed from the results of the NIH Toolbox.",[26,27,28,29,30,31,32],"Sickle Cell Disease","Cognitive Impairment","Cognitive Decline","Cognitive Change","Cognitive Dysfunction","Cognitive Deficit","Neuroinflammatory Response",[34,35,36,37],"sickle cell disease","benign hematology","cognitive dysfunction","neuroinflammation","NOT_YET_RECRUITING","2026-05-11",{"date":41,"type":42},"2026-05-14","ACTUAL",{"date":44,"type":20},"2026-12-01",{"date":46,"type":20},"2028-06-15",{"name":48,"class":49},"University of Cincinnati","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100478816","phase-2-effects-of-cannabidiol-and-tetrahydrocannabinol-on-microbiome-and-neuroinflammation-in-hiv-100478816","NCT05514899","Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV","Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV","CAMI","1. Aged 21 to 70 years old\n2. Possess the capacity to provide informed consent to a set of neuromedical assessment procedures.\n3. Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope)\n4. No or low cannabis use in the past 2 weeks, defined as no cannabis exposure or use or use limited to only once in the past 2 weeks.\n5. Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention\n6. Individuals with HIV must meet the following criteria\n\n   1. Virally suppressed on stable ART for at least 6 months and have no more than 1 prior event of virologic failure (i.e., required change in ARTs due to virologic failure)\n   2. Stage 1 or 2 infection\n   3. Have a \"normal\" CD4 count defined as ≥350 cells\u002Fmicroliter\n   4. No significant history of ART regimen adherence challenges\n7. Ability to adhere to the study visit schedule.\n\nExclusion Criteria:\n\n1. Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;\n2. Significant cognitive impairment such as Dementia, including Alzheimer's disease\n3. Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial; refusal to maintain highly effective contraceptive methods (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) during the study for persons of child-bearing potential or those with partners of child-bearing potential\n4. Evidence of moderately or worse compromised liver or kidney function, including moderate (Child-Hugh B) or severe (Child-Hugh C) hepatic impairment and AST and ALT above ULN and total bilirubin above ULN;\n5. Evidence of significant cardiovascular risk, resting heart rate \\\u003C50 or \\>110 beats per minute, uncontrolled hypertension (systolic blood pressure \\\u003C80 or \\>140 mmHg; diastolic blood pressure \\\u003C50 or \\>90 mmHg), history of myocardial infarction, congestive heart failure, or arrhythmia);\n6. Evidence of chronic pulmonary disease requiring supplemental oxygen;\n7. Active, recent, or remote medical history of hepatobiliary-related illness, including elevated transaminase levels above 3 times the upper limit of normal accompanied by elevations in total bilirubin above 2 times the upper limit of normal at screening;\n8. Insulin dependent diabetics\n9. Allergy to the study drugs or any of their constituents including sesame\n10. Use of medications with absolute contraindicated or potential significant interactions\n11. Use of sedating medications\n12. Weighing less than 60 kg at screening to minimize the risk of elevated transaminases as a result of exposure to cannabidiol;\n13. Active, uncontrolled psychiatric disorder with psychotic features, severe depression, or suicidality; Participants will be excluded if they have had a history of suicide attempt, recent suicidal ideation or behavior as indexed by their Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression).\n14. Neurologic disorder that could compromise interpretation of study findings, including uncontrolled seizure disorder (active seizures within the past 3 months), multiple sclerosis, Parkinson's disease, Alzheimer's disease, and recent (past 3 months) cerebral infarction or hemorrhage with neurological sequelae.",true,"21 Years","70 Years",{"count":62,"type":20},90,[64],"PHASE2","This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.",[67,68,69,70,32,71],"HIV","Cannabis","THC","Neuroinflammatory Disease","Microbiome","RECRUITING","2026-04-27",{"date":75,"type":42},"2026-05-01",{"date":77,"type":42},"2023-09-01",{"date":79,"type":20},"2027-10-31",{"name":81,"class":49},"University of California, San Diego",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":58,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":82},"100601388","effect-of-boswellia-serrata-on-pain-intensity-central-and-peripheral-sensitization-and-pain-modulation-in-healthy-volunteers-100601388","NCT07109843","Effect of Boswellia Serrata on Pain Intensity, Central and Peripheral Sensitization, and Pain Modulation in Healthy Volunteers","Effect of Boswellia Serrata on Pain Intensity, Central and Peripheral Sensitization, and Pain Modulation in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled, Cross-over Pilot Trial","BSPP","Inclusion Criteria:\n\n* Age: ≥18 years\n\nExclusion Criteria:\n\n* Not pregnant or breastfeeding\n* No renal or liver insufficiency\n* No neurological\u002Fdermatological\u002Fcardiovascular diseases\n* No chronic pain and\u002For use of analgesics\n* No use of anticoagulants\n* No use of antidepressants\n* No use of MAO inhibitors\n* No use of St. John's Wort\n* No use of medications affecting the CYP mechanism\n* No allergies to Boswellia serrata or capsaicin\"",{"count":92,"type":20},12,[94],"NA","This planned study is based on a randomized, placebo-controlled cross-over design.\n\nBoswellic acids, the triterpenes found in the gum resins of Boswellia serrata (family: Burseraceae), are traditionally used in the Indian Ayurvedic medicine system as antioxidants and anti-inflammatory agents for treating conditions such as rheumatoid arthritis, chronic bronchitis, asthma, and chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease). The β-configured pentacyclic triterpenic acids in B. serrata include 3-acetyl-11-keto-β-boswellic acid (AKBBA), 11-keto-β-boswellic acid (KBBA), β-boswellic acid (BBA), and 3-acetyl-β-boswellic acid (ABBA). These compounds, which constitute approximately 14% of the lipophilic fractions of the B. serrata extract, are the major active components. Boswellia serrata is marketed as a food supplement in accordance with EU Directive 2002\u002F46\u002FEC. Several clinical studies have examined the efficacy of B. serrata in chronic pain conditions.\n\nThe data suggest a clinical analgesic efficacy, without, however, allowing conclusions about the underlying mechanisms. These have not yet been investigated in a human experimental pain model. The aim of the study is to investigate the influence of Boswellia serrata in peripheral and central sensitization, as well as descending inhibitory pathways by Quantitative Sensory Testing (QST). These findings are of great relevance for a better understanding of clinical efficacy.\n\nThe 'Capsaicin Pain Model' is a validated method for inducing short-term peripheral and central sensitization. As a non-invasive human pain model, it is therefore well suited for investigating the analgesic and anti-hyperalgesic effects of drugs.\n\nFurthermore, the influence of Boswellia serrata on mood (depression, anxiety), sleep quality and psychological well-being will be investigated by using the psychological questionnaires Becks-Depression-Inventory, Becks-Anxiety-Inventory, Pittsburgh Sleep Quality Index and World Health Organization Well-Being Index (BDI-II, BAI, PSQI and WHO5) as secondary target variables.",[97,98,99,32],"Chronic Pain","Central Sensitisation","Peripheral Sensitization","2025-09-23",{"date":102,"type":42},"2025-09-24",{"date":104,"type":42},"2025-09-01",{"date":106,"type":20},"2025-12-31",{"name":108,"class":49},"Medical University of Graz",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":58,"sex":16,"minAge":17,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":82},"100584781","the-effect-of-griffonia-simplicifolia-on-pain-intensity-central-and-peripheral-sensitization-painmodulation-in-healthy-volunteers-100584781","NCT06893822","The Effect of Griffonia Simplicifolia on Pain Intensity, Central and Peripheral Sensitization, Painmodulation in Healthy Volunteers","The Effect of Griffonia Simplicifolia on Pain Intensity, Central and Peripheral Sensitization, Painmodulation in Healthy Volunteers - A Randomized, Double-blinded, Placebo-controlled, Cross-over Study","Exclusion Criteria:\n\n* pregnancy or breastfeeding.\n* renal or hepatic insufficiency\n* neurological\u002Fdermatological\u002Fcardiovascular diseases\n* chronic pain and\u002For use of analgesics\n* intake of antidepressants\n* intake of MAO inhibitors\n* intake of sleep medication\n* intake of St. John's wort\n* allergy to Griffonia simplicifolia","99 Years",{"count":118,"type":20},20,[94],"This planned study is based on a randomized, placebo-controlled cross-over design.\n\nGriffonia simplicifolia contains the serotonin-precursor 5-hydroxytryptophan (5-HTP), an endogenous amino acid. 5-HTP can cross the blood-brain barrier and is converted to serotonin. Low serotonin levels are associated with depression, anxiety disorders and sleep disorders, among others. Griffonia simplicifolia is marketed as a food supplement in accordance with EU Directive 2002\u002F46\u002FEC. Several clinical studies have examined the efficacy of 5-HTP in chronic pain conditions.\n\nThe data suggest a clinical analgesic efficacy, without, however, allowing conclusions about the underlying mechanisms. These have not yet been investigated in a human experimental pain model. The aim of the study is to investigate the influence of 5-HTP in peripheral and central sensitization, as well as descending inhibitory pathways by Quantitative Sensory Testing (QST). These findings are of great relevance for a better understanding of clinical efficacy.\n\nFor this purpose, \"repetitive phasic heat application\" is a validated method for achieving short-term peripheral and central sensitization. As a non-invasive human pain model, it is therefore well suited for investigating the analgesic and anti-hyperalgesic effects of drugs.\n\nFurthermore, the influence of Griffonia simplicifolia on mood (depression, anxiety), memory, sleep quality and psychological well-being will be investigated by using psychological questionnaires as secondary target variables.",[97,98,99,32],[123,124,125,98],"Griffonia simplicifolia","5-HTP","Peripheral Sensitisation","2025-06-12",{"date":128,"type":42},"2025-06-17",{"date":130,"type":20},"2025-09-12",{"date":132,"type":20},"2025-12-20",{"name":108,"class":49},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":58,"sex":141,"minAge":17,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":147,"conditions":148,"keywords":155,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":82},"100564074","phase-4-immunomodulatory-effects-of-dexamethasone-tocilizumab-and-anakinra-during-experimental-human-endotoxemia-100564074","NCT06624436","Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia","DEDICATE-LPS","Inclusion Criteria:\n\n* Male subjects aged ≥18 and ≤35 years\n* Body mass index (BMI) ≥18 and ≤30 kg\u002Fm2\n* Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine clinical laboratory parameters)\n* Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.\n\nExclusion Criteria:\n\n* Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs\n* Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients\n* History of chronic headache or previous post-dural puncture headache (PDPH)\n* History or signs of severe atopic syndrome (asthma, rhinitis with medication and\u002For eczema)\n* History of any disease associated with immune deficiency\n* History of cancer in the last 5 years (excluding localised skin cancer or carcinoma in situ)\n* History or signs of haematological disease\n* History or signs of thromboembolic disorders\n* History of peptic \u002F gastric ulcer disease\n* History of psychiatric disorders\n* Thrombocytopenia (\\<150\\*109\u002FmL) or anaemia (\\<8.0 mmol\u002FL)\n* History, signs or symptoms of cardiovascular disease, in particular:\n\n  * Prone to vagal collapse\n  * History of atrial or ventricular arrhythmia\n  * Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block\n  * Hypertension (defined as RR systolic \\> 160 or RR diastolic \\> 90 mmHg)\n  * Hypotension (defined as RR systolic \\< 100 or RR diastolic \\< 50 mmHg)\n* Renal impairment (defined as plasma creatinine \\>120 μmol\u002FL)\n* Liver enzyme abnormalities (above 2x the upper limit of normal)\n* Signs of infection (CRP \\> 20 mg\u002FL, white blood cells \\> 12x109\u002FL or\n\n  * lt; 4x109\u002FL)\n* Clinically significant acute illness, including infections or trauma, within 1 month prior to the first LPS challenge\n* Previous (participation in a study with) endotoxin (LPS) administration\n* Participation in an experimental intervention or drug trial within 3 months prior to the first LPS challenge\n* Any vaccination or blood donation within 1 month prior to the first LPS challenge\n* Recent hospital admission or surgery with general anaesthesia within 3 months prior to the first LPS challenge\n* Use of recreational drugs within 2 weeks prior to the first LPS challenge\n* Suspected of not being able to comply with the trial protocol\n* Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and\u002For take part in the study","MALE","35 Years",{"count":144,"type":20},52,[146],"PHASE4","The goal of this clinical trial is to investigate the immunomodulatory effects of the drugs dexamethasone, tocilizumab and anakinra in healthy male subjects aged 18 to 35 undergoing experimental endotoxemia. The main questions it aims to answer are:\n\n* What are the effects of these drugs on the development of immunoparalysis in a repeated human endotoxemia model?\n* What is the extent of the neuroinflammatory response and how do these drugs affect neuroinflammation in a repeated human endotoxemia model?\n\nResearchers will compare these drugs to a placebo (a look-alike substance that contains no drug).\n\nParticipants will visit the Intensive Care research department on two or five occasions (screening included):\n\n* The intervention group will receive an LPS challenge twice, with a week in between. Before the first LPS challenge, one of the described drugs will be administered. Blood, saliva and tear fluid will be collected regularly during the LPS challenge. Cerebrospinal fluid will also be collected through a catheter in the spinal cord.\n* The control group will not receive an LPS challenge or drug administration and will have only one study day. During this day, blood, saliva, tear fluid and cerebrospinal fluid will be collected as regularly as during the LPS challenge of the intervention group.\n\nDuring an LPS challenge, the investigators mimic blood poisoning by giving an endotoxin, also called LPS. This is a small part of the cell wall of a bacteria. This will cause transient flu-like symptoms for 3-4 hours.",[149,32,150,151,152,153,154],"Sepsis","Immunosuppresion","Endotoxemia","Anakinra","Dexamethasone","Tocilizumab",[149,156,157,158,152,153,154,159,160,161],"Immunosuppression","Systemic inflammation","Neuroinflammation","Human endotoxemia","Immunoparalysis","Hyperinflammatory response","2025-04-01",{"date":164,"type":42},"2025-04-04",{"date":166,"type":42},"2024-10-24",{"date":168,"type":20},"2025-12",{"name":170,"class":49},"Radboud University Medical Center"]