[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundacion SEIMC-GESIDA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100651449","effect-of-extra-virgin-olive-oil-consumption-on-the-occurrence-of-cardiovascular-events-in-population-living-with-hiv-100651449",false,"NCT07761819","Effect of Extra Virgin Olive Oil Consumption on the Occurrence of Cardiovascular Events in Population Living With HIV","EFFECT OF EXTRA VIRGIN OLIVE OIL CONSUMPTION ON THE OCCURRENCE OF CARDIOVASCULAR EVENTS IN POPULATION LIVING WITH HIV","OLEUM VIHTAE","Inclusion Criteria:\n\n* HIV-1 infection with at least one year since diagnosis\n* Ability to sign the informed consent form\n* Age between 50 and 75 years (including those who have already turned 50 and those under 76) at the time of signing the informed consent form\n* ART for at least one year, with a viral load \\\u003C50 copies\u002FmL for at least the last year, or elite controller (Western Blot serology + with viral loads \\\u003C50 copies\u002FmL in the absence of ART)\n* HIV-1 viral load ≤50 copies\u002FmL for at least 6 months prior to signing the consent form. If the viral load is \\>50 copies\u002FmL at the baseline visit, the participant will not be excluded and the investigator will act in accordance with standard clinical practice.\n* If in the previous 6 months the participant has had an isolated viral load of \\\u003C200 copies\u002FmL with another subsequent viral load \\\u003C50 copies\u002FmL, entry into the trial will be accepted provided that in the 12 months prior to entry into the trial there was only one isolated detectable determination.\n* No reported intolerance to EVOO\n* Willingness to change diet\n* Presence of at least one of the following risk factors: hypertension, DM2, high LDL cholesterol, low HDL, high lipoprotein (a), tobacco use, first-degree family history of early cardiovascular disease (\\\u003C55 years in men or \\\u003C65 years in women)\n\nExclusion Criteria:\n\n* Presence of ischemic heart disease, cerebrovascular disease, or peripheral arterial disease in any form.\n* Cardiovascular risk calculated by ASCVD VR10 less than 5%.\n* Life expectancy of less than one year in the investigator's opinion.\n* Inability to complete the study in the investigator's opinion.\n* Presence of Child stage C cirrhosis, end-stage renal failure (eGFR by CKD-EPI \\\u003C10 mL\u002Fmin or dialysis in any form), dementia.\n* Diagnosis prior to inclusion in the study of diseases requiring chemotherapy, radiotherapy, or major surgery\n* Completion of chemotherapy or radiotherapy within three months prior to inclusion in the study\n* Major surgery in the three months prior to inclusion in the study (any procedure performed in an operating room that involves incision, excision, manipulation, or suturing of tissue; generally requires regional or general anesthesia or deep sedation for pain control).\n* Current diagnosis of wasting syndrome or BMI\\>40\n* Inability to follow a Mediterranean diet\n* Institutionalized or dependent patients\n* Patients with chronic inflammatory conditions other than HIV (e.g., inflammatory bowel disease, lupus, rheumatoid arthritis, etc., except for skin diseases treated exclusively with topical therapy). In cases where there is doubt about the inclusion of a particular condition, the investigator should consult with the study monitor beforehand.\n* Presence of diseases or conditions that, in the investigator's opinion, may hinder absorption.\n* Active neoplasia at the time of inclusion or in the previous six months, except for non-melanoma skin cancer or anal carcinoma in situ.\n* Reported intake of at least 30 mL of EVOO per day (equivalent to two tablespoons of oil)","ALL","50 Years",{"count":20,"type":21},1324,"ESTIMATED","INTERVENTIONAL",[24],"NA","Study Summary: OLEUM VIHTAEGeneral Information Sponsor: Fundación SEIMC - GESIDA Study Title: Effect of Extra Virgin Olive Oil (EVOO) consumption on the occurrence of cardiovascular events in people living with HIV.\n\nProtocol Code: GESIDA 12725 (Version 2.0, Jan 13, 2026) Study Design: National, multicenter, randomized, open-label clinical trial. Intervention Product: Extra Virgin Olive Oil (EVOO). Estimated Enrollment: 1,324 participants (662 per arm). Study Duration: Approximately 60 months (5 years) per participant. Objectives\n\nPrimary Objective:\n\nTo analyze the incidence of a composite index of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), including acute coronary syndrome, peripheral arterial disease, coronary\u002Fcerebral\u002Fperipheral revascularization, cerebrovascular disease, and cardiovascular or cerebrovascular death.\n\nSecondary Objectives:\n\nIncidence of individual cardiovascular events (Stroke, TIA, Heart Failure, Atrial Fibrillation).\n\nAll-cause and cardiovascular mortality. Changes in metabolic and physical parameters (weight, blood pressure, glucose, lipid profile).\n\nDevelopment of new comorbidities (HTA, DM2, Obesity) and initiation of related treatments.\n\nExploratory sub-studies: Changes in gut microbiota, epigenetic aging markers, inflammation panels (96 cytokines), and urinary hydroxytyrosol levels.\n\nStudy Population\n\nKey Inclusion Criteria:\n\nHIV-1 infected individuals (diagnosed ≥ 1 year). Age: 50 to 75 years. On Antiretroviral Therapy (ART) ≥ 1 year with suppressed viral load (\\\u003C50 copies\u002FmL) for at least 6 months.\n\nPresence of at least one cardiovascular risk factor (HTA, DM2, high LDL, low HDL, smoking, or family history).\n\nWillingness to modify diet and no intolerance to EVOO.\n\nKey Exclusion Criteria:\n\nPre-existing ischemic heart disease, cerebrovascular disease, or peripheral arterial disease.\n\nCalculated cardiovascular risk (RV10 ASCVD) \\\u003C 5%. Life expectancy \\\u003C 1 year or inability to complete the study. Severe comorbidities: Stage C Cirrhosis, end-stage renal failure, dementia, or active malignancy.\n\nCurrent high EVOO intake (≥30 mL\u002Fdaily). Treatment Plan\n\nParticipants will be randomized (1:1 ratio) into two groups:\n\nEVOO Group: Daily intake of 50 mL of Extra Virgin Olive Oil. Control Group: Continuation of their usual diet (verified as not rich in EVOO). Statistical Analysis \\& Monitoring Primary Endpoint: Proportion of patients meeting the composite cardiovascular morbidity\u002Fmortality index at 5 years.\n\nMethodology: Analysis by protocol and intention-to-treat (ITT) using SPSS v28. Generalized linear models for repeated measures, adjusted for covariates.\n\nInterim Analysis: Planned for Year 2 and Year 4. Ethics Board (Board Affiliation): CEIm Hospital Costa del Sol, Marbella, Spain.",[27],"HIV - Human Immunodeficiency Virus",[29,30,31,32,33,34,35,36,37],"cardiovascular","extra virgin olive oil","HIV","elderly population","Gut microbiota","Epigenetic age","Hydroxytyrosol","Inflamm-aging","Inflammatory biomarkers","NOT_YET_RECRUITING","2026-08-10",{"date":41,"type":42},"2026-08-12","ACTUAL",{"date":44,"type":21},"2026-10-31",{"date":46,"type":21},"2031-12-15",{"name":48,"class":49},"Fundacion SEIMC-GESIDA","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":50},"100650548","gram-negatives-study-100650548","NCT07749508","GRAM NEGATIVES STUDY","Design of a Predictive Model of Mortality in Critically Ill Patients Colonized by Multiresistant Gram-negative Bacteria. MR-GEIPC STUDY","MR-GEIPC","Inclusion Criteria:\n\n* Patients aged ≥18 years\n* Have given informed consent.\n\nExclusion Criteria:\n\n* Patients who do not agree to participate in the study\n* Admission to the ICU \\\u003C 24 hours",{"count":60,"type":21},1500,"OBSERVATIONAL","This is a prospective, observational, multicenter study whose main objective is to develop a predictive model of mortality in critically ill patients colonized by multidrug-resistant Gram-negative bacteria (MDR-GNB).\n\nSecondary objectives include: determining the characteristics of patients colonized by MRGB who require admission or acquire colonization during their stay in an intensive care unit (ICU); studying the infectious complications they develop, their etiology, clinical impact, and prognosis.",[64],"Multi-resistant Gram-negative Bacteria Cause Infection",[66,67,68,69,70,71,72,73,74,75,76,77],"Intensive Care Unit","Critical Patients","Multidrug Resistant Bacteria","Fungical infections","Viral infections","Gram-negative colonization","Focus of infection","Sequential Organ Failure Assessment","Gram-Negatives","Increment score","Charlson index","Glasgow coma scale","RECRUITING","2026-08-05",{"date":81,"type":42},"2026-08-06",{"date":83,"type":42},"2026-03-02",{"date":85,"type":21},"2027-05-31",{"name":48,"class":49},""]