Cardiovascular DiseasesNCT00005452
Ti PC Software for Analyzing Longitudinal Data
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To develop TI (pronounced 'T-sub-I'), a personal computer program to analyze time-varying data generated by periodic patient reports, repeatedly-observed disease signs, or serial biomarkers to study chronic disease. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1991to Apr 1996
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To develop TI (pronounced 'T-sub-I'), a personal computer program to analyze time-varying data generated by periodic patient reports, repeatedly-observed disease signs, or serial biomarkers to study chronic disease.
Read the detailed description
BACKGROUND:
With the advent of quasi-likelihood, generalized estimating equations, and new ways to handle missing data, has come a striking increase in applicable models, perhaps more than after the 1972 introduction of the Cox model for survival data. TI provided a way to analyze the data.
DESIGN NARRATIVE:
TIl provided graphics for data exploration and model validation. TI ran under most current version of Windows, used Civilized Software's MLAB as its programming language, offered context-sensitive help, a dictionary of relevant terms, identification of file entries from their screen position, and simple animation. TI permitted the user to analyze time-varying data from the two perspectives of repeated measured using a variety of models and time series where both time and frequency domain tools were provided.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1991
- Study completionApr 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005452
- Sponsor's protocol ID
- 4385
- Other IDs
- R44HL047237
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ti PC Software for Analyzing Longitudinal Data
- ClinicalTrials.gov ID
- NCT00005452
- Acronym / sponsor ID
- 4385
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1991
- Study completion
- Apr 1996 (actual)
- First posted
- 26 May 2000 (estimated)
- 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.
To develop TI (pronounced 'T-sub-I'), a personal computer program to analyze time-varying data generated by periodic patient reports, repeatedly-observed disease signs, or serial biomarkers to study chronic disease.
Detailed description
BACKGROUND:
With the advent of quasi-likelihood, generalized estimating equations, and new ways to handle missing data, has come a striking increase in applicable models, perhaps more than after the 1972 introduction of the Cox model for survival data. TI provided a way to analyze the data.
DESIGN NARRATIVE:
TIl provided graphics for data exploration and model validation. TI ran under most current version of Windows, used Civilized Software's MLAB as its programming language, offered context-sensitive help, a dictionary of relevant terms, identification of file entries from their screen position, and simple animation. TI permitted the user to analyze time-varying data from the two perspectives of repeated measured using a variety of models and time series where both time and frequency domain tools were provided.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 16 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 16 Mar 2016.