linjc16/ctgov huggingface dataset:
How Would the Creation of a Follow-up Methodology in Consultation Improve the Care of the Epileptic Patient?

Study Overview
=================
Brief Summary
-----------------
The goal of this observationnal study is to identify the informative and educational needs of epilepsy patients to avoid interrupting the therapeutic pathway. The main question it aims to answer are : Identify the patient's expectations of a nurse specializing in epilepsy in the areas of information, predictive elements of good care and adaptation to their state of health Identify under-addressed or misunderstood themes Identify patient resources and interventions already in place Ensuring better continuity of care Improve the knowledge of patients and their relatives about the management of their pathology After a consultation with the neurologist (as part of their usual follow-up), the participants will be referred to a nurse for a semi-directive, individual interview, lasting 30 minutes and composed of open and closed questions. The announcement of the diagnosis, the quality of life or the factors contributing to the difficulties and their repercussions on a daily basis will be discussed during the interview.

Official Title
-----------------
How Would the Creation of a Follow-up Methodology in Consultation Improve the Care of the Epileptic Patient?

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult epileptic patients, over 18 years old Patients with focal or generalized epilepsy Patients affiliated or entitled to a social security scheme Patients who have received informed information about the study and who have co- signed, with the investigator, a non-objection to participation in the study Patients whose diagnosis has been made for at least 6 months Exclusion Criteria: Patients with intellectual disabilities Minors Untreated patients, in remission Patients without affiliation to a social security scheme Patients under guardianship or curatorship

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the informative and educational needs of epileptic patients to avoid disrupting the therapeutic course by an interview with an nurse. |  | At inclusion |
Determining Patterns In Study Experiences of Neuroblastoma Patients

Study Overview
=================
Brief Summary
-----------------
Historically, participation in clinical research is highly skewed towards particular demographic groups of people. This study will invite several participants to gather a wide range of information on clinical trial experiences for neuroblastoma patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of neuroblastoma. The data collected from this study will help improve future outcomes for all neuroblastoma patients as well as those in under-represented demographic groups.

Official Title
-----------------
Neuroblastoma Clinical Trials: Looking at Patterns About How Patients Feel About Participating in Clinical Trials

Conditions
-----------------
Neuroblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of neuroblastoma Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination. Exclusion Criteria: Women of childbearing potential without a negative pregnancy test; or women who are lactating. Any serious and/or unstable pre-existing medical disorders Enrolled in another research study

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 |
| --- | --- | --- |
| Number of patients who decide to enroll in a neuroblastoma clinical trial |  | 3 months | 
| Rate of patients who remain in neuroblastoma clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuroblastoma
Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.

Study Overview
=================
Brief Summary
-----------------
Patients undergoing surgery for lumbar spinal stenosis will have biopsies of the ligamentum flavum sent to the department of pathology for histologic screening. If the ligament biopsy contains amyloid, patients will receive an echocardiogram, an ecg, biomarker testing, and a bone tracer scintigraphy diagnostic of cardiac amyloidosis.

Official Title
-----------------
Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.

Conditions
-----------------
Cardiac Amyloidosis, Spinal Stenosis

Intervention / Treatment
-----------------
* Diagnostic Test: DPD scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for surgery for lumbar spinal stenosis Age > 65 years Informed written consent Exclusion Criteria: Known amyloidosis Myelomatosis Monoclonal gammopathy of unknown significance, MGUS Morbus Waldenstrøm

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients undergoing surgery for lumbar spinal stenosis. Patients will have a biopsy taken from the ligamentum flavum and test for the presence of amyloid. Patients with amyloid in the ligamentum flavum will be referred for a DPD scintigraphy. | Diagnostic Test: DPD scintigraphy<br>* Bone tracer scintigraphy, diagnostic for transthyretin cardiac amyloidsis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of cardiac amyloidosis | DPD scintigraphy with a Perugini Grade 2 og higher. | 1 year |
ManagemEnt of Antifungal Drug in Invasive Aspergillosis：a Real-word Study

Study Overview
=================
Brief Summary
-----------------
To assessed the current situation and outcome of critically ill patients with invasive aspergillus infection.

Detailed Description
-----------------
To assessed the current situation and outcome of critically ill patients with invasive aspergillus infection.

Official Title
-----------------
ManagemEnt of Antifungal Drug in Invasive Aspergillosis：a Real-word Study

Conditions
-----------------
Invasive Aspergillosis

Intervention / Treatment
-----------------
* Other: Record the information data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 year-old Diagosed as invasive aspergillus infection Exclusion Criteria: Pregnant

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Survivors<br>Critically ill patients with invasive aspergillus infection who survived | Other: Record the information data<br>* Record the information data<br>|
| Nonsurvivors<br>Critically ill patients with invasive aspergillus infection who not survived | Other: Record the information data<br>* Record the information data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 28 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
invasive aspergillus infection
Reving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

Study Overview
=================
Brief Summary
-----------------
The goal of this randomized trial is to compare the diagnostic yield of a screen-like early diagnosis strategy to usual primary care to detect coronary artery disease (CAD), atrial fibrillation (AF) and heart failure (HF) in community people aged 50-80 years who participate in the Utrecht Health Project. The diagnosis strategy consists of a questionnaire with questions related to symptoms suggestive of CAD, AF or HF, a focused physical examination, laboratory testing, electrocardiography, and echocardiography.

Official Title
-----------------
Reving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

Conditions
-----------------
Coronary Artery Disease, Atrial Fibrillation, Heart Failure

Intervention / Treatment
-----------------
* Diagnostic Test: Early diagnosis strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a participant of LRGP Aged 50-80 years Having indicated in the LRGP informed consent to be interested in participating in further research. Exclusion Criteria: Diagnosed with coronary artery disease and atrial fibrillation and heart failure. Undergoing major (cardiovascular) surgery, and/or revascularisation therapy and/or transplantation treatment within 3 months after enrolment. Not willing to give written informed consent for RED-LRGP. Not allowing incidental findings to be reported to him/herself or their own GP.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early diagnosis strategy<br>RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography | Diagnostic Test: Early diagnosis strategy<br>* RED-CVD early diagnosis questionnaire, physical examination, laboratory testing, electrocardiography, echocardiography<br>|
| No Intervention: Usual primary care<br>No measurements | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery disease | Expert panel diagnosis by evaluation of all available diagnostic information | 1 year | 
| Atrial fibrillation | Expert panel diagnosis by evaluation of all available diagnostic information | 1 year | 
| Heart failure | Expert panel diagnosis by evaluation of all available diagnostic information | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early diagnosis, cardiovascular diseases, cohort study, primary health care
Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas

Study Overview
=================
Brief Summary
-----------------
To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas.

Official Title
-----------------
Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas

Conditions
-----------------
Glaucoma, Open-Angle, Suprachoroidal Space, Pseudo Exfoliation Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects from 40 years up to 90 years old Diagnosis of primary open angle glaucoma (POAG) and pseudo-exfoliative glaucoma Subject is able to understand and sign a written informed consent form Subject who underwent SST implantation and agreed to come for the cross-sectional follow-up Exclusion Criteria: Close angle forms of glaucoma Congenital or developmental glaucoma Pseudophakic with an anterior chamber intraocular lens (IOL), iris fixed IOL, or implantable contact lens (ICL) Prior glaucoma procedures such as Selective Laser Trabeculoplasty (SLT), Microinvasive Glaucoma Surgery (MIGS) or Episcleral Shunts History of corneal transplant, corneal refractive surgery, corneal dystrophy, or corneal ectasia (such as either keratoconus or keratoglobus) in the study eye Chronic ocular inflammatory disease, or clinically significant ocular inflammation or infection (e.g., uveitis, iritis, iridocyclitis, retinitis). Any condition that, in the Investigator´s opinion, can interfere with full participation in the study, including study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Main outcome measures | A successful outcome was defined as Intraocular Pressure (IOP) reduction in ≥20%, with the IOP range 5-21mm/Hg. Successful outcomes were further categorized into two groups: Complete success - IOP reduction in ≥20%, with unmedicated the IOP range 5-21mm/Hg and Qualified success where reduction and ranges of IOP is the same but with antiglaucoma medications. Failure was defined as IOP reduction in <20% or IOP >21mm/Hg at last follow up. Permanent hypotony was defined as IOP < 5mm/Hg during more than 4 weeks. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MIGS, Suprachoroidal Space, Glaucoma, Open-Angle, Suprachoroidal Silicone Tube, Suprachoroidal Shunt, Glaucoma Shunt
a Cohort Study of Ischemic Cerebrovascular Disease

Study Overview
=================
Brief Summary
-----------------
This study aims to establish a multicenter, large-scale, prospective cohort of patients with ischemic stroke. Various biological samples such as blood, feces, and urine are collected to identify biomarkers associated with ischemic stroke. By integrating demographic information, clinical indicators, imaging parameters, and biomarker parameters, the study aims to develop risk assessment, early warning, and prognosis prediction models. Additionally, the study aims to identify key genes and explore relevant signaling pathways related to ischemic stroke.

Official Title
-----------------
a Prospective, Multicenter Cohort Study of Ischemic Cerebrovascular Disease

Conditions
-----------------
Ischaemic Stroke

Intervention / Treatment
-----------------
* Other: Intravenous thrombolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ischemic stroke. Age ≥ 18 years. Signed informed consent form. Exclusion Criteria: Patients with moderate to severe mental disorders or dementia who cannot cooperate to complete the informed consent and follow-up procedures. Patients with neurological functional impairment caused by conditions such as migraine aura, epilepsy, or other non-ischemic strokes. Agitated patients who cannot cooperate with imaging examinations. Pregnant or lactating patients, as well as those planning to become pregnant within 90 days. Patients with concurrent malignant tumors or severe systemic diseases with an expected survival period of less than 90 days. Patients who have participated in other clinical studies within 30 days prior to enrollment or are currently participating in other interventional clinical studies.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| those with favorable prognosis<br> | Other: Intravenous thrombolysis<br>* Intravenous thrombolysis with alteplase within the time window of stroke onset in stroke patients<br>|
| those with unfavorable prognosis<br> | Other: Intravenous thrombolysis<br>* Intravenous thrombolysis with alteplase within the time window of stroke onset in stroke patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrovascular events | Cerebrovascular events, including ischemic stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage | 3 months of onset in patients | 
| mRS scores | Assessing patients' neurological functional impairment status using the mRS score | 3 months of onset in patients |
A Study to Evaluate the DDI of HSK7653 With Metformin

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.

Official Title
-----------------
A Phase I Clinical Study to Evaluate the Drug-Drug Interaction Between HSK7653 and Metformin in Healthy Subjects

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: HSK7653
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 and Age ≤60 years BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index) Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures. Exclusion Criteria: Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening; Fasting blood glucose <3.9mmol/L or ≥6.1mmol/L; Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug; Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV); Treatment with an investigational drug within 3 months; Other protocol-defined exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSK7653 and Metformin<br> | Drug: HSK7653<br>* Part 1: Day 1 to Day 4, not take; Part 2: Day 6 - Take HSK7653 35 mg; HSK7653 25 mg on day 13, day 20, day 27, and day 34; Part 3: Day 41 - Take HSK7653 25 mg<br>Drug: Metformin<br>* Part 1: Day 1 to Day 4, 1000mg BID; Part 2: Not take; Part 3: Day 38- day 47, 1000mg BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects. |  | Day4, day 27 and day 41 | 
| The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects. |  | Day4, day 27 and day 41 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |  | First dose of study drug up to 62 days after last dose of study drug | 
| Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated |  | Day 41 |
TDF and Entekavir - Hepatitis B Reactivation

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis.

Official Title
-----------------
Efficacy of TDF and Entekavir Prophylaxis at Hepatitis B Reactivation: Multi Center Retrospective Study

Conditions
-----------------
Hepatitis B Reactivation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients used entekavir or TDF for Hepatitis B prophylaxis Exclusion Criteria: Patients lower then 18 years old.

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 |
| --- | --- | --- |
| Reactivation Rate | Percentage of patients reactivated during the Entekavir or TDF | 12 months |