[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"physiological-effects-of-drugs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:physiological-effects-of-drugs":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,63,98,132,190,227],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":45,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100551600","natural-history-of-depression-bipolar-disorder-and-suicide-risk-100551600",false,"NCT06462196","Natural History of Depression, Bipolar Disorder and Suicide Risk","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\n* Age 18 years or older\n* Able to provide informed consent\n* Able to read and write English\n\nEXCLUSION CRITERIA:\n\n* Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.\n* Pregnancy\n* Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.\n* Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.","ALL","18 Years","120 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.\n\nPeople 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.\n\nThis study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.\n\nParticipants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Behavioral Symptoms","Suicide","Self-Injurious Behavior","Sensory System Agents","Analgesics","Peripheral Nervous System Agents","Physiological Effects of Drugs","Anesthetics, Dissociative","Anesthetics, General","Anesthetics","Central Nervous System Depressants","Excitatory Amino Acid Antagonists","Excitatory Amino Acid Agents","Neurotransmitter Agents","Molecular Mechanisms of Pharmacological Action","Ketamine","Depression, Unipolar","Depressive Symptoms","Treatment Resistant Depression","Major Depressive Disorder","Depression, Bipolar",[46,25,43,47,48,49,42],"Neurobiology","Bipolar Disorder","Biomarkers","Suicide Risk","RECRUITING","2026-06-26",{"date":53,"type":54},"2026-06-29","ACTUAL",{"date":56,"type":54},"2024-09-09",{"date":58,"type":20},"2030-06-01",{"name":60,"class":61},"National Institute of Mental Health (NIMH)","NIH",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":84,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":62},"100555424","phase-2-investigation-of-the-antidepressant-effects-of-2r6r-hnk-an-enhancer-of-synaptic-glutamate-release-in-treatment-resistant-depression-100555424","NCT06511908","Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","An Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Ability of participant to understand and willingness to sign a written informed consent document. To verify this, participants must score \\>= 80% on the consent quiz.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. 18 to 70 years of age.\n4. All participants must have undergone a screening assessment under protocol 01-M-0254.\n5. Participants must fulfill DSM-IV or DSM-5 criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Participants must be experiencing a current major depressive episode lasting at least two weeks.\n6. Participants must have an initial score of \\>= 20 on the MADRS and a YMRS score of \\\u003C12 within one week of study entry and upon entry into Phase II.\n7. Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen.\n8. Participants must have a current or past history of lack of response to at least one adequate antidepressant trial (may be from the same chemical class), with at least one in the current major depressive episode, operationally defined using the modified Antidepressant Treatment History Form (ATHF); non-response to an adequate trial of ECT or TMS would count as an adequate antidepressant trial.\n9. For individuals of reproductive potential: use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after the end of Study Phase II.\n10. For males of reproductive potential: use of condoms or other methods from the time of enrollment to ensure effective contraception with partner, and for an additional 90 days after the end of Phase II.\n11. Agreement to adhere to Lifestyle Considerations throughout study duration.\n12. Medically healthy, or with stable, treated, chronic medical conditions (provided any medications are not excluded)\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current use of disallowed concomitant medications or transcranial magnetic stimulation (TMS) two weeks prior to the start of Phase II.\n2. Treatment with a reversible monoamine oxidase inhibitor (MAOI) four weeks prior to the start of Phase II.\n3. Treatment with fluoxetine, aripiprazole, or brexpiprazole five weeks prior to the start of Phase II.\n4. Treatment with clozapine or electroconvulsive therapy (ECT) four weeks prior to the start of Phase II.\n5. Ongoing treatment with moderate or strong CYP3A4\u002F5 inhibitors or inducers\n6. Lifetime history of deep brain stimulation.\n7. Previous antidepressant non-response to ketamine or esketamine (full course).\n8. No structured psychotherapy will be permitted during the total duration of the study. Participants unable or unwilling to stop psychotherapy will be unable to participate in the study.\n9. Pregnancy or lactation.\n10. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n11. Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to screen and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to starting Phase II. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician. Due to the interactions between cannabis and SSRIs, frequent cannabis use during previous antidepressant treatment will result in that treatment being considered a failed trial for eligibility purposes.\n12. Participants with a DSM-IV or DSM-5 Axis II diagnosis of borderline or antisocial personality disorder.\n13. Participants with a history of head injury that resulted in loss of consciousness exceeding five minutes (for the imaging component of the study).\n14. No serious, unstable medical illnesses including but not limited to the following body systems and organs or those that in the judgment of the Principal Investigator pose a risk to the participant's ability to safely participate in the study: Hepatic diseases (e.g. active viral hepatitis infection or cirrhosis of the liver, any liver disease with Child-Pugh score \\>=5), cardiovascular disease (including ischemic heart disease, coronary artery disease, congestive heart failure, poorly controlled hypertension due to risk of further blood pressure elevation and increase in demand on cardiac function from study drug), renal\u002Furologic (e.g chronic kidney disease or acute kidney injury, history of bladder dysfunction due to theoretical risk of ketamine-induced cystitis, moderate to severe renal impairment of any etiology), endocrinologic (including uncontrolled diabetes due to association with progressive abnormality of the microvasculature and nervous system), or neurologic disease (e.g. elevated intraocular pressure or history of or presence of diseases that are associated with elevated intracranial pressure).\n15. Participants with unstable clinical hyperthyroidism or hypothyroidism.\n16. Participants with one or more seizures without a clear and resolved etiology.\n17. Clinically significant abnormal laboratory tests specifically defined by:\n\n    * Alkaline phosphatase (Alk Phos) \\> 150 U\u002FL\n    * Alanine aminotransferase (ALT) \\> 55 U\u002FL\n    * Aspartate aminotransferase (AST) \\> 34 U\u002FL\n    * Total bilirubin (TB) \\> 1.2 mg\u002FdL\n    * Direct bilirubin (DB) \\> 0.5 mg\u002FdL\n    * 25-hydroxyvitamin D \\\u003C 20 ng\u002FmL\n    * Folate \\\u003C 2ng\u002FmL\n    * Vitamin B12 \\\u003C 200 pg\u002FmL\n18. Moderate to severe renal impairment with body surface area corrected eGFR \\\u003C60mL\u002Fmin.\n19. Participants who, in the Principal Investigator's judgment, pose a current serious suicidal or homicidal risk.\n20. Positive HIV test.\n21. Contraindications to MRS (metal in body, claustrophobia, etc. for imaging)\n22. Participants with COVID-19 or suspected COVID-19\n23. Inability to read and understand English. Non- English speakers will not be eligible as most of the required monitoring and rating instruments are not validated in languages other than English.","70 Years",{"count":72,"type":20},50,"INTERVENTIONAL",[75],"PHASE2","Background:\n\nMajor depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD.\n\nObjective:\n\nTo test a study drug (HNK) in people with MDD.\n\nEligibility:\n\nPeople aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254.\n\nDesign:\n\nParticipants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity.\n\nHNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule:\n\nThey will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study.\n\nThey will receive no drugs for 2 to 3 weeks.\n\nThey will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study.\n\nOne set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo.\n\n...",[25,78,39,38,37,36,30,79,80,81,82,83,24],"Depressive Disorder, Treatment-Resistant","Depressive Disorder, Major","Depressive Disorder","Depression","Mental Disorders","Mood Disorders",[43,39,48,85,86,87,46,88,89],"Neuropharmacology","Magnetic Resonance Imaging","Magnetoencephalography","Glutamate","Hydroxynorketamine","2026-06-13",{"date":92,"type":54},"2026-06-16",{"date":94,"type":54},"2024-11-06",{"date":96,"type":20},"2027-07-01",{"name":60,"class":61},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":73,"phases":109,"briefSummary":111,"conditions":112,"keywords":119,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":131},"100609123","phase-3-a-study-of-nt-201-in-adults-with-moderate-to-severe-platysma-prominence-in-europe-platinum-eu-100609123","NCT07210463","A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)","A Phase 3, Randomized, Parallel-group, Double-blind, Multicenter Study Investigating the Safety and Efficacy of NT 201 Compared With Placebo in Adult Participants With Moderate to Severe Platysma Prominence in Europe","PLATINUM EU","Inclusion Criteria:\n\n* Presence of four (medial and lateral, left and right) platysmal bands assessed at screening and baseline.\n* A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPSD at maximum contraction by the investigator AND participant.\n\nExclusion Criteria:\n\n* Hypersensitivity or a history of allergic reaction to botulinum toxin of any serotype or any of their formulation ingredients.\n* Any medical condition that may put the participant at increased risk with exposure to botulinum toxin of any serotype, or any disorders that might interfere with neuromuscular function.\n* Any serious disease or disorder that could interfere with the safe completion of treatment or with study outcome assessments, or compromise participant safety.\n* Botulinum toxin treatment in the face (below the lower orbital rim), jawline, or neck within the last seven months.\n* History of lower face surgery, neck or chest surgery, and aesthetic procedures in the past 12 months and\u002For orthodontic procedures in the past 6 months.\n* Planned surgery or aesthetic procedures to the lower face, neck, or chest during the study period.\n* Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study products).","65 Years",{"count":108,"type":20},300,[110],"PHASE3","The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence. The study will be conducted in two periods: Main Period (MP) and Open label Extension Period (OLEX).",[113,29,30,114,115,38,116,37,117,118],"Neuromuscular Agents","Acetylcholine Release Inhibitors","Membrane Transport Modulators","Cholinergic Agents","incobotulinumtoxinA","Botulinum Toxins, Type A",[120],"Platysma prominence","2026-06-10",{"date":123,"type":54},"2026-06-12",{"date":125,"type":54},"2025-10-01",{"date":127,"type":20},"2027-11",{"name":129,"class":130},"Merz Aesthetics GmbH","INDUSTRY",26,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":73,"phases":142,"briefSummary":144,"conditions":145,"keywords":169,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":62},"100557242","single-vs-dual-antiplatelet-therapy-in-elderly-or-hbr-patients-undergoing-percutaneous-intervention-with-dcb-piccoleto-iv-epic-38-100557242","NCT06535568","Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)","International, Multicenter, Investigator-driven Randomized Clinical Trial to Assess the Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (PICCOLETO IV-EPIC 38)","PIV-EPIC","Inclusion Criteria:\n\nMale and female patients who meet the following criteria:\n\n* Age ≥ 75 years or age ≥ 18 years at high bleeding risk;\n* Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels;\n* Stable or unstable coronary syndromes;\n* De novo coronary lesions in vessels with diameter ≥2.0 and ≤4.0 mm (visual estimation);\n* Informed consent to participate in the study given by the patient or impartial witness.\n\nExclusion Criteria:\n\n* Stent implantation during index or recent (\\\u003C6 months) procedure;\n* Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated;\n* Pregnancy at the time of hospitalization;\n* Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer;\n* ST-elevation myocardial infarction;\n* Life expectancy \\\u003C12 months;\n* Left ventricular ejection fraction \\\u003C30%;\n* Visible thrombus at lesion site;\n* Target lesion\u002Fvessel with any of the following characteristics:\n\n  * severe and\u002For \\>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory);\n  * left main stem stenosis \\>50%;\n  * target lesion is in the left main stem;\n  * chronic total occlusion with anticipated necessity of retrograde approach;\n  * lesion is in a bypass graft.\n* History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs);\n* History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage;\n* Acute gastrointestinal ulcers;\n* Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding);\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin);\n* Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT\u002FAST \\> 2 x ULN or total bilirubin \\>1.5 x ULN);\n* Severe cardiac failure (NYHA grade III or IV);\n* Combination with methotrexate at doses of 15 mg\u002Fweek or more;\n* Patients with baseline neutrophil counts \\\u003C 1500 cells\u002Fmm³;\n* Breastfeeding women;\n* Full-blown thyrotoxicosis;\n* Patients with a very high risk of thrombosis.",{"count":141,"type":20},576,[143],"NA","This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.",[146,147,148,149,150,151,152,153,154,155,38,156,157,158,30,159,160,161,162,163,164,165,166,167,168],"Coronary Disease","Heart Diseases","Cardiovascular Diseases","Myocardial Ischemia","Atherosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Coronary Artery Disease","Acute Coronary Syndrome","Coronary Stenosis","Enzyme Inhibitors","MTOR Inhibitors","Protein Kinase Inhibitors","Immunosuppressive Agents","Antineoplastic Agents","High Bleeding Risk","Single Antiplatelet Therapy","Dual Antiplatelet Therapy","Cyclooxygenase Inhibitors","P2Y12 Inhibitor","Platelet Aggregation Inhibitors","Aspirin","Clopidogrel",[170,171,172,173,174,175,176,177,178,179],"DCB","Angioplasty","Paclitaxel","Antiplatelet treatment","Single antiplatelet therapy (SAPT)","Dual antiplatelet therapy (DAPT)","High bleeding risk (HBR)","MACE","Native CAD","stable or unstable coronary syndromes","2026-01-21",{"date":182,"type":54},"2026-01-22",{"date":184,"type":54},"2026-01-10",{"date":186,"type":20},"2028-02-20",{"name":188,"class":189},"Fondazione Ricerca e Innovazione Cardiovascolare ETS","OTHER",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":15,"minAge":198,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":73,"phases":201,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100384702","phase-4-cognitive-outcomes-after-dexmedetomidine-sedation-in-cardiac-surgery-patients-100384702","NCT04289142","Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients","Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial","CODEX","Inclusion Criteria:\n\n* Planned CABG (+\u002F- valve, including off-pump) or valve replacement via sternotomy\u002Fthoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)\n* Age ≥60\n\nExclusion Criteria:\n\n* Lack of patient consent\n* Pre-operative major cognitive dysfunction (CogState Brief Battery score \\\u003C 80) at screening\n* Aortic arch replacement\u002Fre-implantation (surgery requiring hypothermic circulatory arrest, e.g. Bentall procedure)\n* Allergy\u002Fcontraindication to dexmedetomidine (untreated 2nd degree type 2 or 3rd degree heart block (pacemaker), cirrhosis, HR \\\u003C 50 , grade 4 LV, renal failure or on renal replacement therapy)\n* Unlikely to comply with study assessments (e.g. no fixed address, cannot complete cognitive tests at the 3, 6, and 12 month time points)","60 Years",{"count":200,"type":20},2400,[202],"PHASE4","Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.",[205,206,207,208,82,209,210,211,212,213,214,215,34,30,216,28,38],"Delirium","Cognitive Dysfunction","Cognition Disorder","Neurocognitive Disorders","Confusion","Neurobehavioral Manifestations","Neurologic Manifestations","Nervous System Diseases","Signs and Symptoms","Dexmedetomidine","Hypnotics and Sedatives","Analgesics, Non-Narcotic","2025-11-27",{"date":219,"type":54},"2025-12-01",{"date":221,"type":54},"2019-12-01",{"date":223,"type":20},"2029-03",{"name":225,"class":189},"Sunnybrook Health Sciences Centre",8,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":15,"minAge":234,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":73,"phases":238,"briefSummary":239,"conditions":240,"keywords":245,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":5},"100605825","phase-3-the-study-of-efficacy-and-safety-of-dimephosphon-in-acute-ischemic-stroke-100605825","NCT07167550","The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke","Multicenter, Randomized, Double-blind, Placebo-controlled Comparative Study of the Efficacy and Safety of the Drug Dimephosphon®, Concentrate for Solution for Intravenous Administration, 1 g, in Acute Ischemic Stroke Patients","Inclusion Criteria:\n\n1. Written informed consent was obtained from the patient or their legally authorized representative prior to study participation.\n2. Age 35-80.\n3. Patients must exhibit neurological manifestations consistent with acute ischemic stroke, with a documented onset-to-intervention interval ranging from 24 to 72 hours at the time of scheduled initial administration of the investigational drug.\n4. Verified by CT\u002FMRI current hemispheric ischemic stroke.\n5. NIHSS score ≥5 and ≤15 at screening.\n6. Ability to comply with all protocol-specified procedures, prohibitions, and restrictions.\n7. Willingness and ability to adhere to highly effective contraceptive methods as outlined in the study protocol.\n\nExclusion Criteria:\n\n1. Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries\n2. Vertebrobasilar stroke and\u002For development of acute insufficiency syndromes in the arteries of the vertebrobasilar system\n3. A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study.\n4. The presence of anatomical abnormalities of the cerebral vessels (arteriovenous malformations, cavernous malformations, aneurysms, atresia of at least one of the extracranial arteries) according to the anamnesis or CT\u002FMRI data.\n5. Progression of neurological symptoms of stroke, defined as an increase in the NIHSS score by 4 points at the second assessment (immediately before randomization) from the value obtained at the first assessment (immediately after signing the informed consent form).\n6. Surgery on the carotid arteries less than 1 year before screening.\n7. History of stroke less than 1 year before screening.\n8. Myocardial infarction less than 6 months before screening.\n9. Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml\u002Fmin).\n10. Pregnancy or lactation.\n11. Participation in another trial within 28 days prior to enrollment.\n12. Use of prohibited medications.","35 Years","80 Years",{"count":237,"type":20},184,[110],"A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke",[241,242,243,244,30],"Stroke","Acute Stroke","Ischemic Stroke","Cerebrovascular Disorders",[246,247,248,249,250,251,242,243,252],"Neuroprotective Agents","Protective Agents","Neuroprotection","Anti-acidemic agents","Dimephosphon","Dimethyloxobutylphosphonyldimethylate","Antioxidants","2025-09-10",{"date":255,"type":54},"2025-09-11",{"date":257,"type":20},"2025-09-06",{"date":259,"type":20},"2026-04-30",{"name":261,"class":130},"Tatchempharmpreparaty, JSC"]