[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Northern California Institute of Research and Education\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":134},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,78,102],{"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":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100513292","phase-3-stroke-minimization-through-additive-anti-atherosclerotic-agents-in-routine-treatment-ii-study-smaart-ii-100513292",false,"NCT05963568","Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)","Inclusion Criteria:\n\n* Above the age of 18 years; male or female\n* Ischemic stroke diagnosis no greater than two months before enrollment. Ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible\n* Subjects with stroke may present with at least one of the following additional conditions:\n\nDocumented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \\>140\u002F90mmHg or previous treatment with antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml\u002Fmin\u002F1.73m2); Prior myocardial infarction\n\n* Legally competent to sign informed consent.\n\nExclusion Criteria:\n\n* Unable to sign informed consent\n* Contraindications to any of the components of the polypill\n* Hemorrhagic stroke\n* Severe cognitive impairment\u002Fdementia or severe global disability limiting the capacity of self-care\n* Severe congestive cardiac failure (NYHA III-IV)\n* Severe renal disease, eGFR \\\u003C30ml\u002Fmin\u002F1.73m2), renal dialysis; awaiting renal transplant or transplant recipient\n* Cancer diagnosis or treatment in past 2 years\n* Need for oral anticoagulation at the time of randomization or planned in the future months;\n* Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)\n* Nursing\u002Fpregnant mothers\n* Do not agree to the filing, forwarding and use of his\u002Fher pseudonymized data.","ALL","18 Years","100 Years",{"count":19,"type":20},1000,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 1000 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.",[26,27],"Stroke","Medication Adherence","RECRUITING","2026-07-01",{"date":31,"type":32},"2026-07-06","ACTUAL",{"date":34,"type":32},"2026-04-01",{"date":36,"type":20},"2029-02-01",{"name":38,"class":39},"Northern California Institute of Research and Education","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100646627","phase-4-suvorexant-3---pe-pc-100646627","NCT07686731","Suvorexant 3 - PE-PC","Suvorexant: Targeting Orexin to Augment Exposure Therapy in Veterans With PTSD and Insomnia","Inclusion Criteria:\n\n1. Adults 18-75 years who are U.S. military Veterans; able to read\u002Funderstand English and provide written informed consent;\n2. Exposure to a DSM-5 Criterion A traumatic event;\n3. Current PTSD, duration \\> 3 months, CAPS-5 total score ≥ 12\n4. Insomnia diagnosis indicated by ISI score \\>14\n5. If taking non-exclusionary psychotropics (e.g., SSRI\u002FSNRI, tetracyclic antidepressants, tricyclics, antipsychotics, and mood stabilizers, insomnia medication, neuroleptics, anti-psychotics) must be on a dose stable ≥ 4 weeks before randomization.\n6. If in supportive psychotherapy, stable ≥ 6 weeks before randomization (no concurrent exposure-based PTSD or CBT-I).\n7. Women of childbearing potential: negative urine pregnancy test at screening; agree to use a medically acceptable contraception method during treatment.\n\nExclusion Criteria:\n\n1. DSM-5 alcohol, marijuana, and\u002For other substance use disorder in the last 3 months. Mild alcohol and marijuana use not meeting criteria for disorder permissible;\n2. Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features;\n3. Exposure to trauma in the last 3 months;\n4. Prominent suicidal or homicidal ideation, any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS)83, or increased risk of suicide that necessitates additional therapy or inpatient treatment;\n5. Pre-existing sleep apnea by type III device with AHI \\>15 in the absence of adherence to effective treatment (such as CPAP or oral device);\n6. Night shift work or extreme morning or evening tendencies;\n7. Neurologic disorder or systemic illness affecting CNS function;\n8. Chronic or unstable medical illness (i.e., angina, myocardial infarction within the past 6 months, congestive heart failure, preexisting hypotension or orthostatic hypotension, heart block or arrhythmia, chronic renal or hepatic failure, pancreatitis, and severe chronic obstructive pulmonary disease);\n9. Severe cognitive impairment as assessed by the MoCA (or alternative validated threshold per site SOP)\n10. Pregnancy or breastfeeding, or unwillingness to use effective contraception (women of childbearing potential).\n11. Previous adverse reaction to a hypnotic;\n12. Current use of sedative-hypnotics, benzodiazepines, moderate or strong CYP3A inhibitors, or strong CYP3A inducers or Digoxin;\n13. Current participation in exposure-based PTSD or behavioral insomnia treatments.","75 Years",{"count":49,"type":20},142,[51],"PHASE4","The goal of this clinical trial is to learn if combining suvorexant (a sleep medication) with a shorter form of prolonged exposure therapy called PE-PC works to treat PTSD symptoms and improve sleep in Veterans and military personnel with PTSD and insomnia, with and without mild-to-moderate traumatic brain injury (TBI). The main questions it aims to answer are:\n\nDoes suvorexant, when combined with PE-PC therapy, reduce PTSD symptoms more than PE-PC with a placebo (a look-alike substance that contains no drug)? Does suvorexant, when combined with PE-PC therapy, improve psychosocial and physical functioning more than PE-PC with a placebo?\n\nResearchers will compare PE-PC combined with suvorexant to PE-PC combined with a placebo to see if adding suvorexant improves PTSD symptoms, sleep, and overall functioning in Veterans.\n\nParticipants will:\n\nReceive weekly PE-PC therapy sessions for 8 weeks Take suvorexant (10-20 mg) or a placebo each night during the 8-week treatment period.\n\nComplete repeated assessments of PTSD symptoms, sleep, and psychosocial and physical functioning throughout the study.",[54,55,56],"PTSD - Post Traumatic Stress Disorder","Insomnia","TBI (Traumatic Brain Injury)",[58,55,59,60,61,62,63,64,65,66,67],"PTSD","Sleep","Veterans","TBI","Prolonged Exposure Therapy for Primary Care (PE-PC)","Stress Disorders, Post-Traumatic","suvorexant","Sleep Initiation and Maintenance Disorders","Orexin Receptor Antagonists","Dual Orexin Receptor Antagonists (DORA)","NOT_YET_RECRUITING","2026-06-29",{"date":71,"type":32},"2026-07-07",{"date":73,"type":20},"2026-09-01",{"date":75,"type":20},"2029-08-30",{"name":38,"class":39},1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":77},"100586780","phase-3-cilostazol-for-prevention-of-recurrent-stroke-in-africa-100586780","NCT06919835","CiLostAzol for pReventIon of Recurrent sTroke in Africa","CLARITY-Africa","Inclusion Criteria:\n\n1. Above the age of 30 years; male or female (sex is a biological variable of interest)\n2. Ischemic stroke or high-risk TIA (ABCD2 score \\>= 6) diagnosis no greater than six months before enrollment. Ischemic strokes including lacunar, large vessel atherosclerotic, embolic stroke of undetermined source subtypes are eligible (Ischemic stroke or TIA should be confirmed by either with a cranial CT or MRI within 10 days of symptom onset)\n3. Aspirin or clopidogrel monotherapy\n4. Subjects with stroke may present with two or more of the following additional conditions: age ≥65 years, documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \\>140\u002F90mmHg or previous treatment with anti-hypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml\u002Fmin\u002F1.73m2); Prior myocardial infarction\n5. Legally competent to sign informed consent or have a LARs who is able to provide consent for them\n6. In the opinion of the treating physician, patient is medically stable, capable of participating in a randomized trial, and willing and able to attend follow-up.\n7. Able to do labs at all study intervals (7 visits total)\n\nExclusion Criteria:\n\n1. Unable to provide a valid informed consent\n2. Contraindications to cilostazol (namely (i) hypersensitivity, (ii) active pathologic bleeding, e.g. bleeding peptic ulcer, intracranial bleeding due to reversible platelet aggregation, (iii) congestive cardiac failure.)\n3. Hemorrhagic stroke survivor within the last 2 years\n4. Use of an anticoagulant medication or indication for use of an anticoagulant (e.g. atrial fibrillation)\n5. On dual antiplatelet therapy (patients are eligible after completion of a course of dual antiplatelet therapy)\n6. Modified Rankin Scale 5\n7. Thrombocytopenia (platelet count \\\u003C1000,000)\n8. Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C)\n9. Congestive heart failure, defined as NYHA Class III or above (marked limitation of physical activity)\n10. Nursing\u002Fpregnant mothers","30 Years",{"count":87,"type":20},1100,[23],"Global estimates suggest that sub-Saharan Africa (SSA) now has the highest incidence, prevalence, and worst survival outcomes of stroke. With an estimated 1.4 million stroke survivors, outcomes of stroke in SSA are abysmal with 1-month case fatality at 30% and 3-year mortality rate of 84%. Stroke survivors in Africa are at an inordinately high (and worsening) risk of adverse outcomes including recurrent stroke and cardiac events over the medium- to longterm. Given the paucity of resources in the region, testing of therapies, which are potentially highly clinically efficacious and cost-effective, while developing local stroke research capacity and contributing to the global secondary stroke prevention evidence base, is urgently needed. Cilostazol, a phosphodiesterase 3 inhibitor, has shown promising efficacy and safety mainly among an Asian population by cutting risk of major adverse cardiovascular events including stroke, in half, when added to aspirin or clopidogrel (8% vs. 4%, HR 0.52, 95% CI 0.35-0.77), with no increased risk in bleeding or serious adverse events. Cilostazol's potentially strong efficacy, presumed pleiotropic effects, and relatively low cost, make it a highly appealing agent for use in stroke-prone, low-resource settings. Therefore, the overall objective of the CiLostAzol for pReventIon of recurrent sTroke in Africa (CLARITY-AFRICA) study is to deploy a hybrid study design to demonstrate the efficacy and safety of cilostazol twice daily in reducing MACE over 24 months vs. placebo among 1100 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, CLARITY-AFRICA also seeks to develop an implementation strategy for routine integration and policy adoption of cilostazol for post-stroke cardiovascular risk reduction in an under-resourced system. Given its compelling efficacy among a predominantly Asian population, the National Institute of Neurological Disorders and Stroke (NINDS) is poised to fund a US-based clinical trial to assess the longer-term efficacy and safety of cilostazol in a study titled CiLostAzol for pReventIon of recurrent sTroke (CLARITY). The investigators are also aware that European and Australian funding agencies are considering stroke trials of cilostazol. A concurrently executed CLARITYAfrica trial would allow recruitment of a historically underrepresented and high-risk group (Africans), test a therapy that if efficacious could be affordable for broader regional implementation, permit transcontinental mentorship\u002Fcollaborations, and leverage NINDS impending investment. CLARITY-AFRICA will assess implementation outcomes such as adoption, acceptability, cost, pertinent to uptake of cilostazol in Ghana to inform policy. Regardless of its outcome, findings from CLARITYAFRICA will contribute meaningful information from the African perspective to inform the formulation of guidelines for global adoption of cilostazol into routine care for secondary CVD risk prevention by international bodies such as the World Health Organization. This application will focus on the first 2 aims of CLARITY-AFRICA to conduct the trial and assess secondary outcomes.",[26],[26,92,93],"Africa","post-stroke","2026-06-17",{"date":96,"type":32},"2026-06-18",{"date":98,"type":20},"2026-08-01",{"date":100,"type":20},"2029-08-31",{"name":38,"class":39},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100559284","tbi-rehabilitation-and-activation-in-veterans-100559284","NCT06562127","TBI Rehabilitation and Activation in Veterans","TBI Rehabilitation and Activation in Veterans (TRAIN-Vets)","TRAIN-Vets","Inclusion Criteria:\n\n* Veteran, age 50-89 years\n* History (more than 6 months post injury) of mild or moderate TBI defined by the Ohio State University TBI Identification Method and DOD\u002FVA Clinical Practice Guidelines for Definition of TBI\n* Sufficient vision and hearing to allow cognitive testing\n* Willingness to participate in water-based exercise program + cognitive training program for eight months\n* Approval of primary medical provider to participate in a water-based exercise program\n* Subjective cognitive complaints as evidenced by self-report\n* English proficiency to allow for cognitive testing\n* Internet connected device to participate in testing and cognitive training\n\nExclusion Criteria:\n\n* Current severe and unstable psychiatric disorder\n* Diagnosis of dementia, Montreal Cognitive Assessment score less than 18, or delirium\n* TBI within the past 6 months\n* Acute illness or unstable chronic illness\n* Current severe cardiac disease\n* Severe TBI or open head injury\n* Inability to exercise consistently\n* Inability to read, verbalize understanding, and voluntarily sign the Informed Consent","50 Years","89 Years",{"count":113,"type":20},120,[115],"NA","This trial will evaluate the impact of a multicomponent program (TBI Rehabilitation and Activation in Veterans; TRAIN-Vets) on improving cognitive function over an 8-month trial period in older Veterans with traumatic brain injury (TBI). Older Veterans with a history of TBI and subjective cognitive complaints will be enrolled and randomly assign to either the TRAIN-Vets intervention (consisting of aquatic-based exercise training, cognitive training, and lifestyle coaching) or the Health Education Control, where they will receive educational materials about brain health and healthy lifestyles.",[118],"Traumatic Brain Injury",[120,121,122,123,124],"Cognition","Cognitive training","Physical exercise","Head injury","Traumatic brain injury","2025-05-14",{"date":127,"type":32},"2025-05-16",{"date":129,"type":32},"2025-05-12",{"date":131,"type":20},"2028-02",{"name":38,"class":39},2,""]