- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05153876
An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients (NLPH-OPEN)
May 14, 2024 updated by: University Hospital, Ghent
NLP Headache Open: an Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
Headache disorders are among the most prevalent medical conditions worldwide.
The diagnosis of headache disorders is based on medical history taking.
Digital solutions such as natural language processing (NLP) may be of aid to understand the linguistic aspects of headache attack and headache related disability descriptions by patients.
Participants will provide a written description of their headache disorder.
The results will hopefully lead to a better understanding of the potential use of NLP in headache disorders.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- University Hospital, Ghent: Department of Neurology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with headache disorders
Description
Inclusion Criteria:
- 18 year or older
- Have a headache disorder with at least one headache attack over the last three months
- voluntary participation
- accepted the patient information sheet and gave informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants
Participants filling in the questionnaires
|
Headache attack descriptions, Headache related disability descriptions, Questionnaires, MIDAS, MSQv2.1,
SF36
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lexical diversity and differences between migraine and cluster headache
Time Frame: through study completion, an average of 1 year
|
Chi-square measurement of a word token used by migraine patients versus cluster headache patients
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of machine learning experiments for the correct classification of headache disorders
Time Frame: through study completion, an average of 1 year
|
Machine learning experiments to investigate the potential to build modelling algorithms that accurately classify the self-given diagnosis by the patient based on text.
|
through study completion, an average of 1 year
|
|
F1 scores of machine learning experiments for the correct classification of headache disorders
Time Frame: through study completion, an average of 1 year
|
Machine learning experiments to investigate the potential to build modelling algorithms that accurately classify the self-given diagnosis by the patient based on text.
|
through study completion, an average of 1 year
|
|
Word counts
Time Frame: through study completion, an average of 1 year
|
Counts of word tokens of different headache disorder groups
|
through study completion, an average of 1 year
|
|
Sentences counts
Time Frame: through study completion, an average of 1 year
|
Counts of sentence tokens of different headache disorder groups
|
through study completion, an average of 1 year
|
|
Paragraph counts
Time Frame: through study completion, an average of 1 year
|
Counts of paragraph tokens of different headache disorder groups
|
through study completion, an average of 1 year
|
|
Term-frequency inverse document frequency scores (TF-IDF)
Time Frame: through study completion, an average of 1 year
|
TF-IDF scores of word tokens of different headache disorder groups
|
through study completion, an average of 1 year
|
|
Migraine Disabillity Assessment [MIDAS] score calculation with text input
Time Frame: through study completion, an average of 1 year
|
Machine learning experiments to investigate the potential to build modelling algorithms that accurately predict the impact score from Migraine Disabillity Assessment [MIDAS] based on text.
|
through study completion, an average of 1 year
|
|
Migraine Specific Questionaire versie 2.1 [MSQv2.1] score calculation with text input
Time Frame: through study completion, an average of 1 year
|
Machine learning experiments to investigate the potential to build modelling algorithms that accurately predict the impact score from Migraine Specific Questionaire versie 2.1 [MSQv2.1]
based on text.
|
through study completion, an average of 1 year
|
|
RAND SF-36 Dutch version score calculation with text input
Time Frame: through study completion, an average of 1 year
|
Machine learning experiments to investigate the potential to build modelling algorithms that accurately predict the impact score from RAND SF-36 Dutch version based on text.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 11, 2021
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
January 1, 2024
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
November 29, 2021
First Posted (Actual)
December 10, 2021
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 14, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-10635
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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