linjc16/ctgov huggingface dataset:
Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Detailed Description
-----------------
Epilepsy is a common serious neurological disorder, regularly presenting with seizures that can affect patients without warning. Any seizure has the potential to cause significant injury to patients or sudden unexplained death in epilepsy (SUDEP). As such, many patients with epilepsy and their caregivers live with a fear that a seizure may occur, fundamentally impacting their quality of life. New technology including the use of wearable devices have the potential to identify a seizure and notify caregivers immediately of a person in danger. These devices use sensors that look out for the types of movements demonstrated during a seizure and are able to send alerts automatically when connected to a smartphone and the internet. One example of this device is the Empatica Embrace2 which is a wrist worn wearable that has been approved for use in epilepsy. This relatively new technology is available to purchase by the public, but it is not yet clear what value this device offers. Whilst man of these devices may be been cleared for use by regulators and available to buy on the consumer market. It remains unclear on the value that they can offer to patients. The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Official Title
-----------------
EPIVIEWS: Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: The participant is over the age of 18 The participant has access to a smartphone The participant has a history of generalised tonic-clonic seizures in the past year Exclusion Criteria: The participant lacks capacity to give informed consent (e.g. has intellectual disability) The participant is a paediatric patient (aged below 18)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in Epilepsy Inventory (QOLIE-31) |  | Prior to admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wearable device
Ultrasound Analysis of Suspected Long Bone Fractures in the Emergency Department - Diagnostic Performance Compared to Radiography.

Study Overview
=================
Brief Summary
-----------------
Ultrasound tool in bones trauma is underused in the emergency department of the University Hospital of Saint-Etienne. This prospective non randomized monocentric study will measure how much this non irradiant method of diagnostic is sensible and specific in long bones fractures, and will evaluate it advantages versus conventional X ray examination.

Detailed Description
-----------------
This study is based on physical examination (swelling, hematoma, edema) and concerns all long bones, including benign trauma (non deforming and closed fractures). The necessary time to make an ultrasound conclusion and the operator certitude degree will be measured.

Official Title
-----------------
Ultrasound Analysis of Suspected Long Bone Fractures in the Emergency Department - Diagnostic Performance Compared to Radiography.

Conditions
-----------------
Bone Fracture

Intervention / Treatment
-----------------
* Other: Collection of datas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with low kinetic, non-deforming, non-open long bone trauma Exclusion Criteria: Opened fracture, deforming trauma

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with low kinetic, non-deforming, non-open long bone trauma<br>Children with low kinetic, non-deforming, non-open long bone trauma will be included. Collection of datas of medical record. | Other: Collection of datas<br>* Collection of datas: datas of physical examination (swelling, hematoma, edema), benign trauma (non deforming and closed fractures), ultrasound and radiographic images and evaluation of pain.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis concordance between the ultrasound and radiographic method for the diagnosis of long bone fractures. | Analysis datas collected. | Year: 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis diagnostic performance between the ultrasound and radiographic method | Analysis datas collected. | Year: 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone trauma, bone, Ultrasound, fracture, radiography
Residual or Recurrent Obstruction After Septal Myectomy

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to report the outcomes after septal myectomy in young children and infants and identify the mechanisms of residual or recurrent obstruction after surgery. in The main question[s] it aims to answer are: What is the early and mid-term results of septal myectomy in young children and infants with severe and extensive obstructive hypertrophic cardiomyopathy (HCM)? What are the mechanisms of residual or recurrent obstruction? Echocardiography and clinical course of children and infants under the age of 14 who underwent septal myectomy for hypertrophic obstructive cardiomyopathy from January 2013 to December 2020 will be followed up.

Official Title
-----------------
Residual or Recurrent Obstruction After Septal Myectomy in Young Children and Infants With Hypertrophic Cardiomyopathy

Conditions
-----------------
Hypertrophic Obstructive Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of hypertrophic obstructive cardiomyopathy (HOCM) Age young than 14 years Patients who have undergone septal myectomy Exclusion Criteria: older than 14 years old; secondary left ventricular hypertrophy (LVH) related to subaortic stenosis or aortic stenosis.

Ages Eligible for Study
-----------------
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | postoperative death during follow-up | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent obstruction | postoperative recurrent obstruction during follow-up | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Septal myectomy, Residual or recurrent obstruction, children and infants, hypertrophic obstructive cardiomyopathy
Digital, Innovative, Sustainable, and Knowledge-based Acute Municipal Healthcare Services Illness and Trauma

Study Overview
=================
Brief Summary
-----------------
Through introducing physicians in front in the medical assessment and decision-making processes in acute and sub-acute illness in the municipalities, as well as including machine learning in analyzing prospective and retrospective data, the project will develop and implement innovative and knowledge-based digital diagnostic tools and decision-making support systems to be used in the municipalities. As such, the project will contribute to early identification of severe illness, prevent deterioration of disease, and facilitate early medical intervention.

Detailed Description
-----------------
The overall objective of the project is to determine if and how innovative digital decision-making tools based on artificial intelligence (AI) can help to develop more accessible, efficient, cost-effective, and sustainable municipal healthcare services. More specifically, the project aims are: to explore different outcomes of a municipal rapid response car manned with dedicated physicians to compare outcomes from Norwegian and Swedish out-of-hospital EMS in acute illness to explore how decision-making tools based on AI can be used to optimize dispatch to explore how decision-making tools based on AI can assist dispatched personnel and in prehospital care to determine the quality and efficacy of the different systems explored through cost-analyses and exploration of stakeholders' experiences with the decision-making tools

Official Title
-----------------
Developing and Implementing Digital, Innovative, Sustainable, and Knowledge-based Municipal Healthcare Services in Acute Illness and Trauma

Conditions
-----------------
Multiple Chronic Conditions, Acute Disease

Intervention / Treatment
-----------------
* Other: Receiving physician manned rapid response car services


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:all patients receiving services from the physician manned rapid response car - Exclusion Criteria:none -
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acutely ill persons in the municipality<br>Patients recieving services from a rapid response vehicle manned with dedicated physicians from the municipality | Other: Receiving physician manned rapid response car services<br>* All patients receiving services from the physician manned rapid response car will be included<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At location | Patients treated at location | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transported | Patients being transported for further diagnostics | 2 hours |
To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effect of food on the pharmacokinetics and safety of DWP16001 after oral administration.

Detailed Description
-----------------
The study design is A randomized, Open-label, Oral, Single-dose, Two-way crossover study.

Official Title
-----------------
A Phase 1 Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics and Safety of DWP16001 After Administration in Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DWP16001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial. A person who is 19 years of age or more at the time of screening. Those with a weight of 50.0 kg or more and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less. Exclusion Criteria: A person who has a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. A person who has a history of gastrointestinal surgery/disease, such as Crohn's disease, ulcer, acute or chronic pancreatitis, which may affect the absorption of drug for clinical trials. (Except for simple appendectomy or hernia surgery)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP16001 to Group A<br>Group A: Fasting in Period 1 / Fed in Period 2 | Drug: DWP16001<br>* DWP16001 0.3mg<br>* Other names: DWP16001 0.3mg;|
| Experimental: DWP16001 to Group B<br>Group B: Fed in Period 1 / Fasting in Period 2 | Drug: DWP16001<br>* DWP16001 0.3mg<br>* Other names: DWP16001 0.3mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t of DWP16001 | AUC0-t of DWP16001 | 0 to 72 hours | 
| Cmax of DWP16001 | Cmax of DWP16001 | 0 to 72 hours |
Quality of Care and Welfare Services for Disabled Middle Older Adults in Iran Lebanon

Study Overview
=================
Brief Summary
-----------------
The findings of this research will be a basis for improving the quality of care and welfare services for the disabled middle-aged and older people in Iran and Lebanon using the SERVQUAL model.

Official Title
-----------------
Comparison of Quality of Care and Welfare Services for Disabled Middle Older Adults in Iran Lebanon A Cross Sectional Study in 2023

Conditions
-----------------
Quality of Life, Health Care Acceptability, Disabilities Mental

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 50 of years and above. Being Disabled. Receiving Health Care Services out of 1 year ago. Exclusion Criteria: Unwillingness to Participate in the Study Death and/or Migration

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Iranians<br>Disabled Middle and Older Adults | |
| Lebanese<br>Disabled Middle and Older Adults | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ServQual | Quality of Services to the Clients upon SERVQUAL Model | 8 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Middle Aged, Older People, Disabled, ServQual Model, LEBANON, Quality of Services, Health System, Instrumentation, Quality of Caring, IRAN
Prospective Radiomics Study for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective study is to develop MRI-based models representing tumor microenvironment in participants with invasive breast cancer. The main purpose of this study is to analyze the association of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images of 3T MRI before treatment with the immunohistochemical reactivity of tumor microenvironment including the extracellular matrix and immune cells of core-needle biopsy specimens For this purpose, investigators extract 16145 radiomic features from the intratumoral and peritumoral regions on MRI of participants with invasive breast cancer before treatment.

Detailed Description
-----------------
The written informed consents for the participation into this prospective study is done in participants who are diagnosed with invasive breast cancer before surgery with curative intent. After enrollment, breast MRI is done for particpants and diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images are extracted from the results of MRI of participants. The tumor tissue samples are archived from participants before surgery through core-needle biopsy and the immunohistochemistry is done to assess the components of tumor microenvironment including intraturmoal and peritumoral components through volume histochemical assessment. Radiomic feature selection and prediction model building are performed using the least absolute shrinkage and selection operator and linear regression analysis, respectively. The investigators apply fivefold cross-validation to prevent overfitting, and the performance is evaluated using the area under the receiver operating characteristic curve (AUC) and the DeLong test.

Official Title
-----------------
Prospective Study of MRI-based Radiomics in Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with invaseiv breast cancer Exclusion Criteria: Diagnosed with other cancers

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MRI|MRI based assessment of tumor microenvironment in breast cancer mass|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The signal intensity of Magnetic Resonance Images for tumor microenvironment | The percentage of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images correlated with the percentage of immune cells infiltrating tumor microenvironment of breast tumor tissue | Baseline, pre-surgery |
Discovering Factors in Metastatic Breast Cancer Patients' Clinical Trial Experiences

Study Overview
=================
Brief Summary
-----------------
Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups. This trial will evaluate the safety and efficacy of metastatic breast cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future metastatic breast cancer studies.

Official Title
-----------------
An Observational Medical Trial Assessing Patterns in Experiences of Participants of Metastatic Breast Cancer Clinical Trials

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years of age Patient is able and willing to comply with the treatment/follow-up schedule and requirements Patient must provide written informed consent Exclusion Criteria: Women who are pregnant, intend to become pregnant, or are lactating Inability to perform regular electronic reporting Participants who are vulnerable to any intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who decide to enroll in a metastatic breast cancer clinical study. |  | 3 months | 
| Number of metastatic breast cancer study participants who remain in clinical trial until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic breast cancer
Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State

Study Overview
=================
Brief Summary
-----------------
This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(2.5/500 mg) at fasting state.

Official Title
-----------------
An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DA-1229_01 2.5/500mg (Before)
* Drug: DA-1229_01 2.5/500mg (After)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers BMI between 18 and 30 kg/m2 Body weight : Male≥50kg, Female≥45kg Exclusion Criteria: Allergy or Drug hypersensitivity Clinically significant Medical History

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A(Before→ After)<br> | Drug: DA-1229_01 2.5/500mg (Before)<br>* single dose administration (one tablet once a day)<br>Drug: DA-1229_01 2.5/500mg (After)<br>* single dose administration (one tablet once a day)<br>|
| Experimental: Sequence B(After→ Before)<br> | Drug: DA-1229_01 2.5/500mg (Before)<br>* single dose administration (one tablet once a day)<br>Drug: DA-1229_01 2.5/500mg (After)<br>* single dose administration (one tablet once a day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | area under the curve | pre-dose 96 hours post-dose | 
| Cmax | maximum plasma concentration | pre-dose 96 hours post-dose |