An observational study in Longitudinal Studies, Prospective Studies and Biomarkers, sponsored by Truway Health, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Truway Health, Inc. · Observational
TH-CLINICAL-TIME is a prospective, longitudinal observational study evaluating how changes in clinical measurements over time may help researchers better understand patient health trajectories and clinically meaningful outcomes. The study will examine patterns such as changes from an individual's baseline, rate of change, persistence of abnormalities, variability, recurrence, and recovery following clinical events. Data may include routinely collected clinical measurements, physiologic observations, laboratory results, cardiac measurements, imaging-derived measurements, patient-reported information, and remote or digital health data when available and permitted by the study protocol. The study will investigate whether these temporal patterns provide additional information beyond individual measurements taken at a single point in time. The planned study horizon extends from 2026 through 2076, while individual participant follow-up will occur according to the approved study schedule, consent, and applicable requirements.
TH-CLINICAL-TIME is a prospective longitudinal observational research study designed to investigate the role of temporal dynamics in clinical medicine. The fundamental premise is that a clinical measurement may have different significance depending on its relationship to a patient's prior measurements, the direction and rate of change, the duration of an observed abnormality, the sequence of preceding or subsequent observations, and the patient's subsequent recovery or deterioration.
The study will establish longitudinal research datasets that permit evaluation of individual and population-level clinical trajectories. Depending on the participating cohort and available clinical data, observations may include vital signs, physiologic measurements, electrocardiographic information, cardiovascular measurements, point-of-care ultrasound or other imaging-derived measurements, laboratory results, symptoms, medications, procedures, healthcare encounters, patient-reported outcomes, and appropriately governed remote or digital health measurements.
A principal research objective is to determine whether time-dependent clinical features provide incremental information beyond conventional point-in-time measurements. Investigational temporal features may include baseline deviation, velocity of change, acceleration or deceleration, persistence, variability, recurrence, temporal sequence, time between clinically relevant observations, and recovery kinetics.
The study will investigate the concept of an individualized Clinical Temporal Phenotype, representing the longitudinal behavior of selected clinical variables rather than a single measurement. Individualized analyses may compare a participant's current observations with their own longitudinal baseline as well as with appropriate population reference distributions.
The research program may evaluate whether temporal patterns are associated with predefined clinical outcomes, including clinically meaningful deterioration, hospitalization, emergency evaluation, cardiovascular events, procedure-related outcomes, recovery characteristics, readmission, or other protocol-defined outcomes. Specific endpoints, populations, data sources, analytic methods, and follow-up schedules will be prespecified in the applicable study protocol and statistical analysis plan.
Where appropriate, longitudinal statistical and computational methods may be used to evaluate trajectories and dynamic prediction. These may include longitudinal regression, survival analysis, time-dependent modeling, recurrent-event analysis, joint longitudinal-survival models, dynamic risk prediction, and machine-learning methods. Any predictive models will be evaluated using appropriate temporal validation methods designed to prevent incorporation of future information into predictions of earlier events.
An additional research objective is to evaluate clinical lead time, defined as the interval between identification of a prespecified research signal and a subsequently documented clinical event or clinical recognition point. Research analyses may also evaluate whether recovery kinetics, recurrent deviations, or accelerating changes contain prognostic information.
Remote and digital data may be incorporated when specifically permitted by the study protocol, participant authorization, applicable privacy requirements, and institutional policies. Research-generated alerts or analytical signals will not independently constitute clinical diagnoses or treatment recommendations unless a separately authorized clinical-care process exists.
The study has a planned 50-year study-level horizon from 2026 through 2076 to permit investigation of long-term longitudinal patterns. The study horizon does not imply that every participant will be followed continuously for 50 years. Individual participation and follow-up duration will be governed by the approved protocol, informed consent or other applicable authorization, participant withdrawal, availability of follow-up data, and applicable institutional and regulatory requirements.
The study will employ coded research identifiers and appropriate data-governance procedures. Direct participant identifiers will be maintained separately from research datasets to the extent required by the applicable protocol and institutional policies. Research data will be subject to appropriate access controls, auditability, security safeguards, quality-control procedures, and retention and disposition requirements.
The study is observational and does not, by itself, assign participants to an experimental drug, biologic, or device intervention. Any clinical care received by participants remains under the direction of their treating healthcare professionals and is not altered solely by participation in the observational research unless separately specified in an approved protocol.
The overarching scientific objective is to determine whether clinical time itself can be characterized as a measurable dimension of patient state, and whether longitudinal trajectories, rather than isolated observations, can yield reproducible research biomarkers of clinical change, deterioration, and recovery.
224 studies on the registry are indexed under Sexual Behavior; 30 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 324 across 41 observational studies indexed under Sexual Behavior.
Browse Sexual Behavior studies →Truway Health, Inc. is the lead sponsor of 16 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adults aged 18 years and older, including individuals with and without established medical conditions. Participants will be followed longitudinally to characterize individualized clinical trajectories and temporal dynamics using available clinical, physiologic, laboratory, imaging-derived, patient-reported, and remote or digital health information as permitted by the protocol. The population is intended to support evaluation of temporal biomarkers, longitudinal patterns, clinical trajectory features, and time-dependent associations with clinically meaningful outcomes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants enrolled in this prospective observational cohort will be followed longitudinally according to the approved study schedule. The cohort will be evaluated for temporal clinical dynamics, including changes from individualized baseline, rate and acceleration of change, persistence, variability, recurrence, temporal sequence, and recovery following clinically meaningful events. Analyses will integrate available longitudinal clinical, physiologic, laboratory, imaging-derived, patient-reported, and remote or digital health measurements when permitted by the study protocol. No experimental intervention is assigned by the study.
Other: No Study-Assigned Intervention
This is a prospective observational study with no protocol-assigned drug, biologic, device, behavioral intervention, or other therapeutic intervention. Participants receive clinical care according to usual practice and applicable clinical decisions. The study observes and analyzes longitudinal clinical and physiologic data to characterize temporal dynamics and their association with clinically meaningful outcomes. Data collection may include routinely available clinical measurements, laboratory results, imaging-derived measurements, patient-reported information, and remote or digital health measurements when permitted by the protocol.
Time-Dependent Predictive Discrimination of Clinically Meaningful Patient Outcomes
Change in predictive discrimination of longitudinal temporal clinical features compared with point-in-time clinical measurements for prespecified clinically meaningful patient outcomes. Predictive discrimination will be quantified using the prespecified time-dependent area under the receiver operating characteristic curve (AUC) or concordance index (C-index), as applicable to the outcome and statistical analysis plan. Temporal features will include individualized baseline values and longitudinal rates of change.
Time frame: At baseline and at 30 days, 90 days, 6 months, and 12 months after enrollment.
Within-Participant Temporal Trajectory Variability
Quantification of within-participant longitudinal variability in prespecified physiologic and clinical measurements using the coefficient of variation calculated from repeated assessments. The analysis will characterize individualized temporal trajectories while preserving participant-level longitudinal structure.
Time frame: At 30 days, 90 days, 6 months, and 12 months after enrollment.
Clinical Lead-Time to Prespecified Outcome
Time in days between the first prespecified temporal signal meeting the protocol-defined detection threshold and the subsequent occurrence or clinical recognition of the corresponding prespecified clinically meaningful outcome. Lead-time will be calculated only for participants experiencing the applicable outcome during observation.
Time frame: From baseline through 12 months after enrollment.
Calibration of Time-Dependent Clinical Prediction Models
Calibration of prespecified longitudinal clinical prediction models for clinically meaningful patient outcomes, assessed by the calibration slope and calibration-in-the-large at each scheduled assessment point. Model calibration will be evaluated according to the prespecified statistical analysis plan.
Time frame: At 30 days, 90 days, 6 months, and 12 months after enrollment.
Temporal Phenotype Stability
Proportion of participants whose prespecified individualized temporal phenotype classification remains concordant across consecutive scheduled longitudinal assessments. Stability will be determined using the protocol-defined phenotype classification algorithm.
Time frame: At 90 days, 6 months, and 12 months after enrollment.
Plan to share: Yes — Individual participant-level data (IPD) will be considered for sharing with qualified researchers following publication of the primary study results, subject to applicable informed consent, institutional policies, privacy requirements, data-use agreements, and regulatory requirements. Shared datasets will be de-identified or appropriately anonymized and will exclude direct participant identifiers. Requests will be evaluated based on scientific merit, data availability, participant privacy, and compatibility with the study consent and governance framework. Data may be provided through a controlled-access process rather than unrestricted public release.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Individual participant-level data (IPD) and supporting information will become available after publication of the primary study results and completion of data-quality, privacy, and governance review. Data will be available beginning at that time for qualified research purposes through a controlled-access process. The study protocol, statistical analysis plan, clinical study report, and analytic code will be made available when finalized and permitted by applicable policies and agreements. Access will continue for as long as the data and supporting materials remain available and appropriate for controlled research use, subject to applicable privacy, consent, regulatory, and institutional requirements.
Access criteria: De-identified individual participant-level data and applicable supporting information may be requested by qualified researchers for scientifically valid research purposes. Requests will be reviewed by the designated study research governance authority for scientific merit, feasibility, data availability, participant privacy, consistency with informed consent, and applicable regulatory and institutional requirements. Approved researchers will be required to execute an appropriate data-use agreement and comply with confidentiality, security, and permitted-use restrictions. Data will be provided through a controlled-access mechanism; direct participant identifiers will not be provided. Supporting materials may include the study protocol, statistical analysis plan, clinical study report, and analytic code, as available and permitted.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2076, 600 months after the start.
Of 18 observational studies under Sexual Behavior, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 33. This study's planned 600 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.