linjc16/ctgov huggingface dataset:
A Phase 1 Study Assessing Local Cutaneous Effects of SB204

Study Overview
=================
Brief Summary
-----------------
In this study, color (erythema) and pH will be measured on 3 consecutive days after application of 2 doses of SB204 to the cheeks of healthy volunteers.

Detailed Description
-----------------
This study is to evaluate local cutaneous effects, including intensity and duration of erythema and changes in pH following 5 applications (twice daily for two days and once daily on the third day) of SB204 2% and SB204 4% twice daily to the face for 3 days.

Official Title
-----------------
A Phase 1, Single-Center, Split-Face Study Assessing Local Cutaneous Effects After Application of SB204 2% and SB204 4% in Healthy Volunteers

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: SB204


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Women who are pregnant or nursing Subject with known sensitivity to a component of the test materials

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Topical SB204<br>Topical application of SB204 2% and 4% twice daily for 2 days and once on Day 3 | Drug: SB204<br>* Applied topically twice a day on days 1, 2 and 3 to left and right cheeks<br>* Other names: NVN1000;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of erythema following application of SB204 2% and SB204 4%. |  | 3 days | 
| Duration of erythema following application of SB204 2% and SB204 4%. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH on the surface of the skin after topical application of 2 concentrations of SB204 |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne
Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward

Study Overview
=================
Brief Summary
-----------------
There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life. Blood circulation velocity values within the cerebral arteries have been well documented in newborns and infants a few days old. However, the initial values of these velocities and their variations during the first hours of life are not well known. The objective of this study is to describe the evolution of brain circulation at birth in newborns over 35 weeks of gestational age and to investigate the effect of arterial canal closure on brain circulation.

Official Title
-----------------
Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward

Conditions
-----------------
Newborn

Intervention / Treatment
-----------------
* Diagnostic Test: transcranial doppler ultrasound scan
* Diagnostic Test: ultrasound scan centered on the arterial canal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent of parent Newborns over 35 weeks of amenorrhoea hospitalized in the maternity ward Exclusion Criteria: person not affiliated to a health insurance scheme Sepsis Ductal dependent heart disease Neurological impairment (anoxoischemic encephalopathy Sarnat>1, pH<7 and/or lactates>11, meningitis) Obstetrical trauma (instrumental delivery by forceps, vacuum cup or spatulas) Potentially lethal malformation Anemia (hemoglobin<14g/dl) Polyglobulia (hemoglobin>22g/dl) Small for gestational age (weight<10th percentile) Large for gestational age (weight>97th percentile) Proven gestational diabetes (non-insulin-dependent and insulin-dependent) Maternal medical treatment (cardiac or anti-epileptic) Inadequate parent understanding

Ages Eligible for Study
-----------------
Maximum Age: 6 Hours

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: transcranial doppler ultrasound scan|Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 10 minutes)|
|Diagnostic Test: ultrasound scan centered on the arterial canal|Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 5 minutes)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right and left average velocity of the cerebral artery |  | Change from birth to 48 hours of life |
Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis

Study Overview
=================
Brief Summary
-----------------
Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES). The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.

Detailed Description
-----------------
Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES). The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis. The study was planned as a non-inferiority trial based on the hypothesis that PCI may be able to reach similar long-term results as compared to CABG.

Official Title
-----------------
PCI With DES Versus CABG for Patients With Significant Left Main Stenosis

Conditions
-----------------
Coronary Stenosis, Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Percutaneous coronary intervention (left main)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Significant left main coronary stenosis >= 50% Exclusion Criteria: Acute myocardial infarction (STEMI < 48h)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous coronary intervention (left main)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status (CCS-class) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left main coronary artery, coronary artery disease
Immune Thrombocytopenia (ITP) Immune-Genetic Assessment

Study Overview
=================
Brief Summary
-----------------
Primary ITP has wide heterogenous biology, presentation and response to therapy. The immune-genetic assessment of ITP may help to identify differences among patients with ITP and optimize the therapeutic choice.

Official Title
-----------------
IMMUNE-GENETIC ASSESSMENT OF PRIMARY ITP IN ADULT

Conditions
-----------------
Thrombocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with primary ITP Exclusion Criteria: Secondary ITP

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 |
| --- | --- |
| Asymptomatic ITP patients<br> | |
| ITP patients treated with Rituximab<br> | |
| ITP patients treated with steroids<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with primary Immune Thrombocytopenia (ITP)
Experience of Patients Starting Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives.

Detailed Description
-----------------
Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives, understand what made patient experiences better, and what could further improve their experiences when patients first start dialysis. The investigators will enroll patients within 90 days of starting dialysis, and conduct semi-structured recorded interviews with patients. All patients will provide informed consent. The interviews will be transcribed verbatim. The transcripts will be reviewed line by line by qualitative researchers to identify concepts and themes, and will be developed into a coding schema. The preliminary themes will be discussed among the investigators to facilitate consensus.

Official Title
-----------------
Experience of Patients Starting Hemodialysis: A Qualitative Study

Conditions
-----------------
ESRD

Intervention / Treatment
-----------------
* Other: None. This is a qualitative interview study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving in-center hemodialysis care at Satellite Healthcare at the start of the study period. Patients who started with in-center hemodialysis as a first renal replacement therapy. Patients receiving dialysis for ≤ 90 days. Exclusion Criteria: Age < 18 years. Unable to understand or communicate in English. Inability to participate because of cognitive impairment or active psychological condition.

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

| Intervention/Treatment |
| --- |
|Other: None. This is a qualitative interview study.|There is no intervention in this study. This is a qualitative research study where patients will be interviewed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experiences of patients starting dialysis. | Collect information from interviews to understand the experiences of patients starting dialysis. | One time interview. |
Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.

Detailed Description
-----------------
MG1109 is purified, inactivated influenza viral antigen.

Official Title
-----------------
Randomized Phase I/II Study to Evaluate the Safety and Immunogenicity of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Step 1
* Biological: Step 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults who are available for follow-up during the study Exclusion Criteria: Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine Subjects with immune system disorder including immune deficiency disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 58 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MG1109 - Step 1<br> | Biological: Step 1<br>* Investigational Product : MG1109 Dose : Cohort 1 : 0.125 mL Cohort 2 :0.25 mL Cohort 3 :0.5 mL Cohort 4 :1.0 mL intramuscularly injection, twice at an interval of 21 days<br>|
| Placebo Comparator: Normal Saline - Step 1<br> | Biological: Step 1<br>* Investigational Product : MG1109 Dose : Cohort 1 : 0.125 mL Cohort 2 :0.25 mL Cohort 3 :0.5 mL Cohort 4 :1.0 mL intramuscularly injection, twice at an interval of 21 days<br>|
| Experimental: MG1109 - Step 2<br> | Biological: Step 2<br>* Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group |  | 42 days after vaccination | 
| Number of subjects with Solicited / Unsolicited adverse events |  | With in 24 weeks after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Avian influenza
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.

Official Title
-----------------
Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Conditions
-----------------
Hypercholesterolemia, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Pitavastatin
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females (18-75 years) Must have been following a restrictive diet Diagnosis of primary hypercholesterolemia or combined dyslipidemia Exclusion Criteria: Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia; Conditions which may cause secondary dyslipidemia. Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%) Abnormal serum creatine kinase (CK) above the pre-specified level Abnormal pancreatic, liver or renal function Significant heart disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin 2 mg<br>Pitavastatin 2 mg once daily | Drug: Pitavastatin<br>* Pitavastatin once daily<br>|
| Active Comparator: Simvastatin 20 mg<br>Simvastatin 20 mg once daily | Drug: Simvastatin<br>* Simvastatin once daily<br>|
| Experimental: Pitavastatin 4 mg<br>Pitavastatin 4 mg once daily | Drug: Pitavastatin<br>* Pitavastatin once daily<br>|
| Active Comparator: Simvastatin 40 mg<br>Simvastatn 40 mg once daily | Drug: Simvastatin<br>* Simvastatin once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks | Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Cholesterol Education Program (NCEP) LDL-C Target Attainment | Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12 | 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia, kowa, dyslipidemia, pitavastatin, NK-104, Primary Hypercholesterolemia or Combined Dyslipidemia
Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients

Study Overview
=================
Brief Summary
-----------------
Cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. Here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual acuity, intraocular pressure and slit-lamp images. The management strategy can also change according to postoperative time.

Official Title
-----------------
Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients: A Clinical Trial

Conditions
-----------------
Cataract, Postoperative Complications, Artificial Intelligence

Intervention / Treatment
-----------------
* Device: An artificial intelligence system for postoperative management of cataract patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had surgery of cataract extraction combined with introcular lens implantation. Patients should be aware of the contents and signed for the informed consent.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eligible patients for AI test<br>Device: an artificial intelligence system for postoperative management of cataract patients. These patients are enrolled in primary healthcare units and the AI clinic at Zhongshan Ophthalmic Center. | Device: An artificial intelligence system for postoperative management of cataract patients<br>* This system can detect multiple postoperative complications of cataract patients and then provide a management strategy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of accurate, mistaken and miss detection of this artificial intelligence diagnostic system. |  | Up to 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suppurative endophthalmitis, Conjunctival hyperemia, Pterygium, Intraocular lens dislocation, Posterior capsule opacification, Pupil malformation
The Study of Blood Pressure Variability to Impact Arterial Stiffness and Carotid Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether and what extent blood pressure variability is associated with arterial stiffness and carotid atherosclerosis, furthermore to compare the difference in the relationship of the types of blood pressure variability with arterial stiffness and carotid atherosclerosis.

Official Title
-----------------
The Relationship of Blood Pressure Variability, Arterial Stiffness and Carotid Atherosclerosis in Beijing Residents

Conditions
-----------------
Carotid Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Can step by himself/herself Exclusion Criteria: Cardiovascular and cerebrovascular diseases Secondary hypertension Chronic cardiac, renal, gastro-intestinal, pulmonary or any other systemic disease process requiring chronic intake of prescription medications

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- | --- |