[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Università degli Studi 'G. d'Annunzio' Chieti e Pescara\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100593419","nicotinamide-levels-in-serum-aqueous-humor-and-tear-film-in-glaucoma-and-correlations-with-mitochondrial-damage-associated-molecular-patterns-mtdamps-and-senescence-associated-secretory-phenotype-sasp-100593419",false,"NCT07006194","Nicotinamide Levels in Serum, Aqueous Humor, and Tear Film in Glaucoma and Correlations With Mitochondrial Damage-Associated Molecular Patterns (mtDAMPs) and Senescence-Associated Secretory Phenotype (SASP)","Group 1 Inclusion Criteria\n\n* Age \\> 18 years\n* Diagnosis of open-angle glaucoma (primary open-angle glaucoma)\n* Uncontrolled IOP (\\> 21 mmHg as the mean of three measurements between 8-10 am and 16),\n* Maximal medical therapy\n* Perimetric-OCT and ophthalmic optic neuropathy criteria\n* Indication for standalone or combined glaucoma surgery (any surgery allowing aqueous humor sampling: MIGS, MIBS, TRABE, DS, canal surgery, drainage tube implants, revision of surgical implant)\n\nGroup 2 and 4 Inclusion Criteria\n\n* Age \\> 18 years\n* Diagnosis of open-angle glaucoma\n* Controlled IOP (≤ 21 mmHg as the mean of three measurements between 8-10 am and 16) under medical therapy (excluding oral acetazolamide)\n* Perimetric-OCT and ophthalmic optic neuropathy criteria.\n\nGroup 3 Inclusion Criteria:\n\n* Age \\>18 years\n* IOP ≤ 21 mmHg\n* Absence of perimetric-OCT and ophthalmic optic neuropathy criteria for glaucoma.\n\nExclusion Criteria for all groups\n\n* Conditions and systemic therapies influencing NAM levels in biological fluids\n* Concomitant ocular pathologies beyond glaucoma or cataracts\n* Ocular therapies beyond hypotensive eye drops\n* Prior ocular surgeries\n* Secondary glaucomas (uveitic, silicone oil, traumatic, neovascular)\n* End-stage glaucoma or severe glaucoma (\\\u003C-20 dB)\n* Pregnancy and breastfeeding.\n* (only for Group 3) family history of glaucoma and transient IOP spikes",true,"ALL","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23],"NA","Background Glaucoma is a multifactorial, chronic, and progressive eye disease characterized by the irreversible loss of retinal ganglion cells (RGCs). It is the second leading cause of blindness globally, with approximately 76 million patients affected in 2020, a number expected to rise to 120 million in the coming decades, especially in Africa and Asia. Elevated intraocular pressure (IOP) is a significant risk factor for glaucoma, and its reduction remains the only scientifically proven approach to slowing visual function decline. However, many glaucoma patients continue to experience visual loss even with IOP values within the normal range, due to the disease's multifactorial nature. Besides IOP reduction, there is a need for direct neuroprotection to address other factors causing RGC damage.\n\nMitochondrial dysfunction has emerged as a critical early factor in RGC damage, making glaucoma, at least in part, resemble a mitochondrial disease. Mitochondria play a key role in cellular functions such as energy production, redox metabolism, and maintaining mitochondrial function. In glaucomatous conditions, mitochondrial damage leads to the release of mitochondrial damage-associated molecular patterns (mtDAMPs), triggering chronic inflammation and tissue damage. This inflammation is exacerbated by the Senescence-Associated Secretory Phenotype (SASP), a process where senescent cells secrete bioactive molecules that contribute to cellular dysfunction and glaucoma progression.\n\nAmong potential neuroprotective approaches, nicotinamide (NAM) and its precursor nicotinamide riboside (NR) are gaining attention. These compounds support mitochondrial function and NAD production, which is essential for cellular vitality. Research indicates that reductions in NAM levels correlate with glaucoma progression. For instance, studies have shown that NAD precursors may prevent or delay RGC degeneration, suggesting a promising adjunctive treatment for glaucoma patients.\n\nStudy Objectives The study aims to measure NAM levels in ocular and non-ocular biological fluids (serum, aqueous humor, and tear fluid) of patients at different stages of glaucoma. The study will correlate NAM concentrations with disease severity and mitochondrial function markers. Furthermore, NAD levels in peripheral blood mononuclear cells (PBMCs) will be assessed to investigate potential biomarkers for glaucoma progression. A secondary objective is to evaluate the impact of dietary supplementation with nicotinamide and nicotinamide riboside (iNAD®) on NAD levels in pharmacologically controlled glaucoma patients.\n\nMethods This cross-sectional, case-control, multi-center study involves three universities: University of G. d'Annunzio Chieti-Pescara, University of Pisa, and University of Sassari. Biological fluid analyses will be conducted at the Animal Biology Laboratory affiliated with the University of G. d'Annunzio Chieti-Pescara.\n\nPatients will be categorized into four groups:\n\n1. Uncontrolled glaucoma patients scheduled for glaucoma surgery.\n2. Controlled glaucoma patients scheduled for cataract surgery.\n3. Healthy controls undergoing cataract surgery.\n4. Pharmacologically controlled glaucoma patients supplemented with iNAD®. Biological fluids (plasma, PBMCs, tear fluid, and aqueous humor) will be collected for analysis, including measures of NAD, mtDAMPs, and SASP components. These measures aim to provide insights into the molecular mechanisms underlying glaucoma and potential biomarkers for disease progression.\n\nStatistical Analysis Sample size estimation was calculated using G\\*Power for a priori one-way ANOVA analysis. Assuming a mean NAM concentration of 0.14 μM (SD=0.12) for glaucoma patients and 0.19 μM (SD=0.13) for controls, with a power of 80% and alpha of 0.05, a minimum of 246 patients (82 per group) are required.",[26],"Glaucoma",[28,29,30,31,32,33,34],"glaucoma","Nicotinamide","mtDAMPs","SASP","aqueous humor","tear film","senescence","NOT_YET_RECRUITING","2025-05-27",{"date":38,"type":39},"2025-06-05","ACTUAL",{"date":41,"type":20},"2025-10-01",{"date":43,"type":20},"2026-12-31",{"name":45,"class":46},"Università degli Studi 'G. d'Annunzio' Chieti e Pescara","OTHER",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100557117","blue-green-space-physical-activity-the-parco-del-mare-study-100557117","NCT06533943","Blue-green Space Physical Activity: the \"Parco Del Mare\" Study","Engaging in Physical Activity Carried Out in a Blue-green Space to Improve Health, Quality of Life and Physical Performance Among the Population: the \"Parco Del Mare\" Study Protocol","Inclusion Criteria:\n\n* Adult population aged \\>18 years old\n* Resident in Rimini\n\nExclusion Criteria:\n\n* Any alterations in communication skills and\u002For sensory functions so severe as to make it impossible to understand and\u002For execute the instructions given by the trainer (dementia, aphasia, blindness, deafness)",{"count":56,"type":20},30,[23],"This study protocol, describe the innovative study intervention which will be performed in a green-blue space in Italy in order to investigate on the improvements in wellbeing following participation in the study. This will be significant because it will provide evidence on the effectiveness of the supervised physical activities carried out in green-blue space in improving health, quality of life, physical performance, anthropometric outcomes and physiological parameters in adults, indicating the reasonableness for public health authorities to developing such activities.",[60,61,62],"Healthy Adults","Natural Outdoor Environment","Health Promotion",[64,65,66,67],"blue-green space setting","physical activity intervention","outdoor exercise","public health","RECRUITING","2024-12-09",{"date":71,"type":39},"2024-12-13",{"date":73,"type":39},"2022-02-01",{"date":75,"type":20},"2024-12-20",{"name":45,"class":46},1,""]