PlasticizersNCT05892029
Develop a Risk Prediction Model for Phthalate-ester-induced Diseases
An observational study of Plasticizers, run by National Taipei University of Nursing and Health Sciences at 2 sites in Taiwan.
Trial summary
This exploratory study collected basic demographic and laboratory data from the Taiwan Biobank using artificial intelligence algorithms and applied data mining to identify the correlations between phthalate esters [di(2-ethylhexyl) phthalate, DEHP], lifestyle, and disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Plasticizers
- How many people
- 1,136 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Jan 2021to 31 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study included 1337 subjects, with an average age of 48.98 years. Male subjects (51.8%) outnumbered the females. In addition, 75.1% of the subjects were married, 9.4% had drinking habits, 57.4% did not exercise regularly, 15.3% worked in the manufacturing industry, 47.4% were overweight according to BMI, 45.2% had a body fat percentage higher than normal, and 16.8% had bone density below 2.5. Table 1 shows the analysis results.
Who may be able to join
- The target subjects of this study are individuals aged 30 to 70 years old
- who were tested for PAEs from January 1, 2016 to December 31, 2020.
Who cannot join
- 1who have not been tested for plasticizers
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Cheng Hsin General Hospital
Taipei
National Taipei university of nursing and health science
Taipei
About this study
Official title: Using Machine Learning Algorithms to Develop a Risk Prediction Model for Phthalate-ester-induced Diseases and Suggestions for Improved Nursing Assessment
This exploratory study collected basic demographic and laboratory data from the Taiwan Biobank using artificial intelligence algorithms and applied data mining to identify the correlations between phthalate esters [di(2-ethylhexyl) phthalate, DEHP], lifestyle, and disease.
Read the detailed description
This study was designed as exploratory research. The Institutional Review Board and the Taiwan Biobank approved the study before it was conducted (Approval Number: TWBR11007-06). The data set included information from participants between 30 and 70 years old who were tested for PAEs between 2016 and 2022 (1337 cases). The data set includes (1) questionnaire responses, such as basic personal information, individual health behaviors, and female health issues; (2) physical examination results, such as body mass index (BMI), body fat percentage, waist circumference, hip circumference, waist-to-hip ratio, blood pressure, heart rate, pulmonary function, and bone mineral density; (3) blood and urine analyses results from blood tests, serology tests, hepatobiliary function tests, renal function tests, and urinalysis; and (4) data on PAE content of urine
- Conditions
- Plasticizers
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk assessment analysis of disease and PAEs
(1) questionnaire responses, such as basic personal information, individual health behaviors, and female health issues; (2) physical examination results, such as body mass index (BMI), body fat percentage, waist circumference, hip circumference, waist-to-hip ratio, blood pressure, heart rate, pulmonary function, and bone mineral density; (3) blood and urine analyses results from blood tests, serology tests, hepatobiliary function tests, renal function tests, and urinalysis; and (4) data on PAE content of urine.
Measured: 2022
Artificial intelligence prediction model for diseases and PAEs
to apply machine learning to establish the correlations between the environmental hormone PAE and high disease risk and suggest assessment items for nursing intervention.
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PlasticizersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,136 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Hung Liao, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892029
- Sponsor's protocol ID
- (862)110-08
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu HT, Liao CC, Peng CF, Lee TY, Liao PH. Exploring the application of machine learning to identify the correlations between phthalate esters and disease: enhancing nursing assessments. Health Inf Sci Syst. 2024 Dec 29;13(1):10. doi: 10.1007/s13755-024-00324-4. eCollection 2025 Dec.
PubMed 39736874
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Machine Learning Algorithms to Develop a Risk Prediction Model for Phthalate-ester-induced Diseases and Suggestions for Improved Nursing Assessment
- ClinicalTrials.gov ID
- NCT05892029
- Acronym / sponsor ID
- (862)110-08
- Conditions
- Plasticizers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,136 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory study collected basic demographic and laboratory data from the Taiwan Biobank using artificial intelligence algorithms and applied data mining to identify the correlations between phthalate esters [di(2-ethylhexyl) phthalate, DEHP], lifestyle, and disease.
Detailed description
This study was designed as exploratory research. The Institutional Review Board and the Taiwan Biobank approved the study before it was conducted (Approval Number: TWBR11007-06). The data set included information from participants between 30 and 70 years old who were tested for PAEs between 2016 and 2022 (1337 cases). The data set includes (1) questionnaire responses, such as basic personal information, individual health behaviors, and female health issues; (2) physical examination results, such as body mass index (BMI), body fat percentage, waist circumference, hip circumference, waist-to-hip ratio, blood pressure, heart rate, pulmonary function, and bone mineral density; (3) blood and urine analyses results from blood tests, serology tests, hepatobiliary function tests, renal function tests, and urinalysis; and (4) data on PAE content of urine
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included 1337 subjects, with an average age of 48.98 years. Male subjects (51.8%) outnumbered the females. In addition, 75.1% of the subjects were married, 9.4% had drinking habits, 57.4% did not exercise regularly, 15.3% worked in the manufacturing industry, 47.4% were overweight according to BMI, 45.2% had a body fat percentage higher than normal, and 16.8% had bone density below 2.5. Table 1 shows the analysis results.
Key inclusion criteria (2 listed)
- The target subjects of this study are individuals aged 30 to 70 years old
- who were tested for PAEs from January 1, 2016 to December 31, 2020.
Key exclusion criteria (1 listed)
- 1who have not been tested for plasticizers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk assessment analysis of disease and PAEs
Time frame: 2022
(1) questionnaire responses, such as basic personal information, individual health behaviors, and female health issues; (2) physical examination results, such as body mass index (BMI), body fat percentage, waist circumference, hip circumference, waist-to-hip ratio, blood pressure, heart rate, pulmonary function, and bone mineral density; (3) blood and urine analyses results from blood tests, serology tests, hepatobiliary function tests, renal function tests, and urinalysis; and (4) data on PAE content of urine.
Artificial intelligence prediction model for diseases and PAEs
Time frame: 2022
to apply machine learning to establish the correlations between the environmental hormone PAE and high disease risk and suggest assessment items for nursing intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Derived from this study: PubMed 39736874Wu HT, Liao CC, Peng CF, Lee TY, Liao PH. Exploring the application of machine learning to identify the correlations between phthalate esters and disease: enhancing nursing assessments. Health Inf Sci Syst. 2024 Dec 29;13(1):10. doi: 10.1007/s13755-024-00324-4. eCollection 2025 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasticizers, run by National Taipei University of Nursing and Health Sciences at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk assessment analysis of disease and PAEs (time frame: 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.