- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07558187
Systematic Examination of Health Inequalities: Documentation, Patterns, and Determinants (CHANCE)
22 aprile 2026 aggiornato da: Aristidis Veskoukis, University of Thessaly
Assessment of Lifestyle Parameters and Biomarkers of Biochemistry and Physiology to Address Health Inequalities: An Exploratory Cohort Study
The existence of social inequalities is a major global issue and a salient challenge for the European Union.
During COVID-19 pandemic, health disparities became more evident.
Indeed, the low-income residents in several European countries, including Greece, had limited access to the healthcare system for several reasons.
In addition, vulnerable populations, with patients suffering from opioid use disorders and incarcerated individuals being among them, do not have the same chances regarding health services, compared to the general population.
According to the World Health Organization, physical activity is a key non-pharmaceutical intervention for both prevention of chronic non-communicable diseases and address of social health inequalities.
Thus, this study will focus on specific population groups of the Region of Thessaly, Greece, who have limited access to healthcare services.
It aims, primarily, to the assessment of demographic characteristics (i.e., body mass index, alcohol consumption, smoking, educational level etc), which are fundamental parameters for the assessment of health inequalities.
Secondly, quality of life, physical activity levels and biomarkers in the level of Biochemistry (i.e., blood oxidative stress and inflammation) and Physiology (i.e., cardiorespiratory fitness, body composition) will be collected a well.
All data will be integrated into an interactive digital platform that will be accessible by any putative stakeholder in the area of health system or administration.
Based on scientifically robust data and evidence-based findings, the research team of the project will draft recommendations and guidelines that will be communicated to all stakeholders.
To that end, the problem of limited access to health system that the examined populations face, will be highlighted and targeted actions and policies are expected to be adopted by local (i.e., in the province of Thessaly) and national (i.e., Greek) authorities.
In this respect, non-pharmaceutical interventions and guidelines will be proposed towards the trajectory of holistically approaching the issue of health inequalities.
Panoramica dello studio
Stato
Reclutamento
Descrizione dettagliata
Background: Health is defined as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.
The delectation of the highest attainable standard of health - and therefore quality of life - is a fundamental human right, regardless of race, religion, political opinion or socio-economic status.
Thus, the key aspects of health definition according to WHO include multidimensionality (i.e., it covers the physical, mental, and social dimension), absence of illness (i.e., health is defined by positive well-being) and right to health (i.e., the attaining of the highest standard of health is a fundamental and universal right).
Apart from the biological characteristics or individual choices, human health is also shaped to a significant extent by the social, economic and environmental conditions in which people are born, grow up, live, work and age.
These conditions are referred to as social determinants of health and decisively influence morbidity, mortality and overall quality of life of populations.
Health determinants can be distinguished into social and economic (i.e., income, educational level and occupational status), environmental (i.e., housing and working conditions, behavioral factors related to lifestyle) and biological factors (i.e., age, gender and heredity).
The problem of health inequalities is a major issue worldwide and is inextricably linked to the aforementioned health determinants.
Health inequalities have been extensively defined as health disparities, within and between countries, that are judged to be unfair, unjust, avoidable, and unnecessary (meaning: are neither inevitable nor unremediable) and that systematically burden populations rendered vulnerable by underlying social structures and political, economic, and legal institutions.
Populations who suffer from health inequalities are, among others, the elderly and individuals with non-communicable diseases who reside in rural areas away from cities, as well as often socially marginalized populations, namely patients with opioid use disorders (OUDs) and incarcerated individuals.
Indeed, the above-mentioned populations face limited access to health services due to poverty, low education, geographical isolation and lack of infrastructure, while factors such as social isolation, lack of insurance coverage and limited social structures enhance their vulnerability.
In the biochemical level, patients with OUDs are characterized by impaired blood antioxidant mechanisms that highly influence their health.
This is also the case for inmates in correctional facilities, since their nutrition is very poor in compounds like vitamins, which protect blood and tissues from elevated levels of oxidized substrates, hence they suffer from oxidative stress.
As a result, they are vulnerable to diverse mental and other health issues.
Among environmental factors, physical activity and dietary habits significantly affect the occurrence of chronic diseases and the overall health status of populations, therefore they could be considered as interventions towards tackling the vast public health problem of health inequalities.
According to OECD, approximately 40% of adults do not perform sufficient physical activity, a fact that increases the risk of developing cardiovascular diseases and other chronic pathologies.
The interaction of physical activity with the social determinants, characterized also as demographic data, highlights the multifactorial nature of health and the need for integrated public health interventions.
According to the international guidelines, a crucial non-pharmaceutical intervention towards improvement of health and reduction of the frequency of non-communicable disease onset is exercise/physical activity.
Aim: Based on the above, it appears that the problem of health inequalities is serious; however, the available data is limited, especially in Greece.
To that end, this study aims to collect evidence from populations in the Region of Thessaly, Greece, who have limited access to health services and to both qualitatively and quantitatively document this problem.
Methods: In particular, data from validated questionnaires, blood biomarkers and physiology measurements will be collected in three populations.
These comprise members of the urban and rural population, who are both healthy or suffer from non-communicable disease, patients with OUDs who are under medication for addiction treatment with methadone or buprenorphine and incarcerated individuals.
The data that will be collected from all volunteers are the following: Demographic data (e.g., body mass index, smoking, alcohol consumption, place of residence, health insurance, educational status, family status, financial status etc), physical activity level through the international physical activity questionnaire (IPAC), quality of life and mental health based on the internationally established questionnaire SF-36, and craving for heroin use (this applies only to the patients with OUDs).
In sub-populations, biomarkers of blood oxidative stress and antioxidant potential (e.g., concentrations of glutathione and protein carbonyls, catalase activity and total antioxidant capacity), as well as cardiorespiratory fitness and body composition as indicators of physical activity and health status will also be obtained.
All data will be integrated in an interactive digital platform and will be available to health stakeholders, the Greek authorities and everyone who needs to be informed about the problem of health inequalities.
Based on these scientifically robust data and evidence-based findings, the research team of the project will draft recommendations and guidelines that will be communicated to all stakeholders.
Anticipated outcomes: The problem of limited access to health services that the examined populations face, will be highlighted and targeted actions and policies are expected to be adopted by local and national authorities.
In this respect, non-pharmaceutical interventions and guidelines will be proposed towards the trajectory of holistically approaching the global issue of health inequalities.
Tipo di studio
Osservativo
Iscrizione (Stimato)
2000
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Aristidis S Veskoukis, Associate Professor
- Numero di telefono: 0030 2431047114
- Email: veskoukis@uth.gr
Luoghi di studio
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Larissa, Grecia
- Non ancora reclutamento
- General Hospital of Larissa
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Contatto:
- Grigoris Vlachakis
- Numero di telefono: 0030 2413504100
- Email: gen.nosokomeio.laris@ghl.gr
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Larissa, Grecia
- Reclutamento
- Health structures in the Region of Thessaly
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Contatto:
- Maria Papagianni
- Numero di telefono: 0030 2431047115
- Email: mpapag@uth.gr
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Larissa, Grecia
- Non ancora reclutamento
- National Organization for the Prevention and Treatment of Addictions (EOPAE)
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Contatto:
- Vasilis Pinakas
- Numero di telefono: 0030 2410671842
- Email: vpinakas@gmail.com
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Trikala, Grecia
- Non ancora reclutamento
- General Hospital of Trikala
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Contatto:
- Lia Roganaki, Hospital Administrator
- Email: gnt.dioikitis@trikalahospital.gr
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Trikala, Grecia
- Non ancora reclutamento
- National Organization for the Prevention and Treatment of Addictions (EOPAE), Trikala
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Contatto:
- Marina Papageorgiou
- Numero di telefono: 0030 2431026481
- Email: papageorgiou.marina5@gmail.com
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Sources of study populations: Hospitals; Other health centers and structures in cities, towns or villages; National Organization for the Prevention and Treatment of Addictions (EOPAE); Correctional facilities (prisons)
Descrizione
Inclusion Criteria:
- Adults (>18 years of age)
- All healthy individuals who reside in rural and urban areas
- All patients with non-communicable diseases who reside in rural and urban areas
- Patients with opioid use disorders under medication for addiction treatment with methadone and buprenorphine
- Individuals incarcerated in correctional facilities
Exclusion Criteria:
- Minors (<18 years of age)
- Individuals with communicable diseases
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
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Patients with non-communicable diseases - residents of rural areas
No intervention
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Patients with non-communicable diseases - residents of urban areas
No intervention
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Healthy volunteers - residents of rural areas
No intervention
|
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Healthy volunteers - residents of urban areas
No intervention
|
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Patients with opioid use disorders under medication for addiction treatment
No intervention
|
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Individuals incarcerated in correctional facilities (prisons)
No intervention
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Demographic data
Lasso di tempo: Data will be collected at Baseline
|
Body mass index, smoking, alcohol consumption, place of residence, health insurance, educational status, family status and financial status will be collected among others through a questionnaire.
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Data will be collected at Baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physical activity
Lasso di tempo: Data will be collected at Baseline
|
It will be measured through the international physical activity questionnaire (IPAC)
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Data will be collected at Baseline
|
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Quality of life
Lasso di tempo: Data will be collected at Baseline
|
It will be measured through the SF-36 questionnaire.
This instrument has a physical component and a mental component.
Each domain is scored from 0 to 100.
Higher score = better health or better quality of life.
|
Data will be collected at Baseline
|
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Heroin craving
Lasso di tempo: Data will be collected at Baseline
|
It will be measured using the heroin craving questionnaire (HCQ).
The score is calculated with a 7-point Likert scale ranging from 1 (i.e., strongly disagree) to 7 (i.e., strongly agree).
Higher values = higher craving for heroin use.
It applies only to the patients with opioid use disorders.
|
Data will be collected at Baseline
|
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Concentration of reduced glutathione (GSH)
Lasso di tempo: Data will be collected at Baseline
|
The concentration of GSH, a crucial antioxidant metabolite, will be measured in the blood of sub-population of the volunteers
|
Data will be collected at Baseline
|
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Concentration of protein carbonyls
Lasso di tempo: Data will be collected at Baseline
|
Concentration of protein carbonyls, a biomarker of protein oxidation, will be measured in the blood of sub-population of the volunteers
|
Data will be collected at Baseline
|
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Total antioxidant capacity (TAC)
Lasso di tempo: Data will be collected at Baseline
|
TAC is crude biomarker of antioxidant status and will be measured in the blood of sub-population of the volunteers
|
Data will be collected at Baseline
|
|
Activity of catalase
Lasso di tempo: Data will be collected at Baseline
|
Activity of catalase, a substantial antioxidant enzyme, will be measured in blood of sub-population of the volunteers
|
Data will be collected at Baseline
|
|
Cardiorespiratory fitness
Lasso di tempo: Data will be collected at Baseline
|
A marker, which is associated to physical activity and health status, will be measured in sub-population of the volunteers.
In particular, resting energy expenditure and resting heart rate will be assessed through metabolic gas analyzer.
|
Data will be collected at Baseline
|
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Body fat percentage
Lasso di tempo: Data will be collected at Baseline
|
It is associated to physical activity and health status and will be measured in sub-population of the volunteers through bioelectrical impedance analysis.
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Data will be collected at Baseline
|
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Lean body mass
Lasso di tempo: Data will be collected at Baseline
|
It is associated to physical activity and health status and will be measured (in kg) in sub-population of the volunteers through bioelectrical impedance analysis.
|
Data will be collected at Baseline
|
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Muscle mass
Lasso di tempo: Data will be collected at Baseline
|
It is associated to physical activity and health status and will be measured (in kg) in sub-population of the volunteers through bioelectrical impedance analysis.
|
Data will be collected at Baseline
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Veskoukis AS, Tsatsakis A, Kouretas D. Approaching reactive species in the frame of their clinical significance: a toxicological appraisal. Food and Chemical Toxicology, 138:111206, 2020.
- Veskoukis AS, Kerasioti E, Priftis A, Kouka P, Spanidis Y, Makri S, Kouretas D. A battery of translational biomarkers for the assessment of the in vitro and in vivo antioxidant action of plant polyphenolic compounds: the biomarker issue. Current Opinion in Toxicology, 13:99-109, 2019.
- Veskoukis AS, Margaritelis NV, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood and tissues: the NADPH network. Redox Report, 23(1):47-56, 2018.
- Veskoukis AS, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood. Biomarkers, 21(3):208-17, 2016.
- Dinas PC, On Behalf Of The Students Of Module Introduction To Systematic Reviews, Karaventza M, Liakou C, Georgakouli K, Bogdanos D, Metsios GS. Combined Effects of Physical Activity and Diet on Cancer Patients: A Systematic Review and Meta-Analysis. Nutrients. 2024 Jun 2;16(11):1749. doi: 10.3390/nu16111749.
- Metsios GS, Moe RH, van der Esch M, van Zanten JJCSV, Fenton SAM, Koutedakis Y, Vitalis P, Kennedy N, Brodin N, Bostrom C, Swinnen TW, Tzika K, Niedermann K, Nikiphorou E, Fragoulis GE, Vlieland TPVM, Van den Ende CHM, Kitas GD; IMPACT-RMD Consortium. The effects of exercise on cardiovascular disease risk factors and cardiovascular physiology in rheumatoid arthritis. Rheumatol Int. 2020 Mar;40(3):347-357. doi: 10.1007/s00296-019-04483-6.
- Metsios GS, Moe RH, Kitas GD. Exercise and inflammation. Best Pract Res Clin Rheumatol. 2020 Apr;34(2):101504. doi: 10.1016/j.berh.2020.101504.
- Poulter M, Coe S, Graham CA, Leach B, Tammam J. A systematic review of the effect of dietary and nutritional interventions on the behaviours and mental health of prisoners. Br J Nutr. 2024 Jul 14;132(1):77-90. doi: 10.1017/S0007114524000849.
- da Costa, F.A.; Verschuuren, M.; Andersen, Y.; Stürup-Toft, S.; Lopez-Acuña, D.; Ferreira-Borges, C. The WHO Prison Health Framework: A framework for assessment of prison health system performance. Eur. J. Public Health 2022, 32, 565-570.
- Schoenthaler, S., Gast, D., Giltay, E. J., & Amos, S. (2023). The Effects of Vitamin-Mineral Supplements on Serious Rule Violations in Correctional Facilities for Young Adult Male Inmates: A Randomized Controlled Trial. Crime & Delinquency, 69(4), 822-840.
- Leventelis C, Barmpas PT, Nellas I, Tasoulis S, Veskoukis AS, Tsironi M. COVID-19 Pandemic Detrimentally Affects Craving and Quality of Life in Patients Under Medication-Assisted Treatment with Buprenorphine and Methadone: The Issue of Medication Dose. Psychiatry International, 5, 867-882, 2024.
- Leventelis C, Makri S, Ververi A, Papageorgiou K, Tentolouri A, Mountzouridi E, Tekos F, Barmpas PT, Tasoulis S, Metsios GS, Kouretas D, Veskoukis AS. Pomegranate juice ameliorates craving and oxidative stress on patients under medication for opioid addiction treatment with methadone and buprenorphine: a Ranzomised Controlled Trial. Clinical Nutrition ESPEN, 66, 34-44, 2025a.
- Leventelis C, Veskoukis AS, Rojas Gil AP, Papadopoulos P, Garderi M, Angeli A, Kampitsi A, Tsironi M. Methadone and Buprenorphine as Medication for Addiction Treatment Diversely Affect Inflammation and Craving Depending on Their Doses. Pharmacy (Basel), 13(2), 40, 2025b.
- Leventelis C, Barmpas PT, Kampitsi A, Iliopoulou K, Toutouktsi N, Malakopoulos P, Tasoulis S, Veskoukis AS. Pomegranate juice consumption improves sleep quality and melatonin concentration of patients with opioid use disorders under medication-assisted treatment with methadone and buprenorphine: a randomized controlled trial. Substance Use and Addiction Journal, 46(4):981-993, 2025c.
- Edwards, A., Hung, R., Levin, J. B., Forthun, L., Sajatovic, M., & McVoy, M. (2023). Health disparities among rural individuals with mental health conditions: A systematic literature review. Rural Mental Health, 47(3), 163-178. https://doi.org/10.1037/rmh0000228
- Cosgrave, C., Malatzky, C., & Gillespie, J. (2019). Social determinants of health and the rural health care gap: A scoping review. International Journal of Environmental Research and Public Health, 18(8), 2668. https://doi.org/10.3390/ijerph16030314
- Probst, J. C., Eberth, J. M., & Crouch, E. (2019). Structural urbanism contributes to poorer health outcomes for rural America. Health Affairs, 39(12), 2017-2024. https://doi.org/10.1377/hlthaff.2019.00914
- Holt-Lunstad, J. (2018). Why social relationships are important for physical health: A systems approach to understanding and modifying risk and protection. Annual Review of Psychology, 69, 437-458. https://doi.org/10.1146/annurev-psych-122216-011902
- Umberson, D., & Donnelly, R. (2023). Social isolation: An unequally distributed health hazard. Annual Review of Sociology, 49(1), 379-399. https://doi.org/10.1146/annurev-soc-031021-012001
- Aldridge, R. W., Story, A., Hwang, S. W., Nordentoft, M., Luchenski, S. A., Hartwell, G., & Hayward, A. C. (2018). Morbidity and mortality in homeless individuals, prisoners, sex workers, and individuals with substance use disorders in high-income countries: A systematic review and meta-analysis. https://doi.org/10.1016/S0140-6736(17)31869-X
- Tsai, J., O'Toole, T., & Kearney, L. K. (2017). Homelessness as a public mental health and social problem: New knowledge and solutions. Psychological Services, 14(2), 113-117. https://doi.org/10.1037/ser0000164
- Luchenski, S., Maguire, N., Aldridge, R. W., et al. (2018). What works in inclusion health: Effective interventions for marginalised and excluded populations. The Lancet, 391(10117), 266-280. https://doi.org/10.1016/S0140-6736(17)31959-1
- Triantafyllou, C., Latsou, D., Psiakis, V., Pierrakos, G., & Breda, J. (2025). Addressing health inequalities in Greece: A comprehensive framework for socioeconomic determinants of health. Healthcare, 13(19), 2394. https://doi.org/10.3390/healthcare13192394
- Krieger N. A glossary for social epidemiology: part II. J Epidemiol Community Health. 2001;55(55):693-700. doi: 10.1136/jech.55.10.693.
- OECD. (2025a). Health at a Glance 2025: OECD indicators. OECD Publishing. https://www.oecd.org/en/publications/health-at-a-glance-2025_8f9e3f98-en.html
- OECD. (2023). Health at a Glance: Europe 2023. https://www.oecd.org/en/publications/health-at-a-glance-2023_7a7afb35-en.html
- Douki, S., & Spyridakis, E. (2004). Inequalities in access to health services: The case of Greece. HAPSc Policy Briefs Series, 5(2), 27. https://doi.org/10.12681/hapscpbs.40777
- World Health Organization. (2025a). World report on social determinants of health equity 2025. WHO. https://www.who.int/teams/social-determinants-of-health/equity-and-health/world-report-on-social-determinants-of-health-equity
- World Health Organization. (2021). Social determinants of health and health inequalities in Europe. WHO Regional Office for Europe. https://www.who.int/europe/health-topics/social-determinants-of-health
- McCartney, G., Popham, F., McMaster, R., & Cumbers, A. (2019). Defining health and health inequalities. Public Health, 172, 22-30. https://doi.org/10.1016/j.puhe.2019.03.023
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
10 marzo 2026
Completamento primario (Stimato)
1 aprile 2028
Completamento dello studio (Stimato)
1 dicembre 2028
Date di iscrizione allo studio
Primo inviato
6 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 aprile 2026
Primo Inserito (Effettivo)
30 aprile 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 aprile 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 98 / 25.07.2025
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .