linjc16/ctgov huggingface dataset:
Assessment of GERD Knowledge Level Among Patients With it in Korea

Study Overview
=================
Brief Summary
-----------------
1. Research topic: How much do patients with GERD know about their own disease in Korea? (multicenter survey) 2. Questionnaires for multicenter survey: Questionnaire 1 - include items for basic characteristics of participant patients Questionnaire 2 - modification of GERD knowledge test which was used in BMC Health Services Research 2008;8:236 (Prof. Jorgen Urnes) 3. Subjects: patients with GERD in secondary or tertiary hospital 4. Participant institutes: GERD club members, The Korean Society of Neurogastroenterology and Motility

Detailed Description
-----------------
Validation process to produce Korean version of GERD knowledge test Forward Translation of GERD knowledge test of prof. Jorgen Urnes: through certified translation company Expert's review of the forward translated knowledge test : among members of GERD club, Pilot survey among nurses and some patients Korean Version, provisional Backward translation: through certified translation company Consultation with Prof. Jorgen Urnes about backward translated knowledge test Korean Version, final Print and distribution Study start

Official Title
-----------------
How Much do Patients With Gastroesophageal Disease Know About Their Own Disease in Korea?

Conditions
-----------------
Esophagitis, Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed as GERD by doctors Exclusion Criteria: Patients without GERD

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| Patients with GERD<br>The knowledge level on GERD among Korean patients with gastroesophageal disease was evaluated by the method of multicenter survey | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion (%) of patients with GERD who seek more information on GERD which represents the necessity of effective educational programs on the disease in Korea | GERD. gastroesophageal reflux disease | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average score in GERD knowledge test which means GERD knowledge level of the patients | GERD, gastroesophageal reflux disease | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal reflux disease, Knowledge
Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.

Detailed Description
-----------------
The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System

Official Title
-----------------
Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Fluorouracil 0.5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation. Exclusion Criteria: Age less than 50. Known allergy or sensitivity to topical Carac® in the subject. Inability to complete all study-related visits. Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study. Subjects should not receive surgical or cryotherapy while participating in the study. Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control

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

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

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

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: Fluorouracil 0.5%<br>each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions | Drug: Fluorouracil 0.5%<br>* Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions<br>* Other names: Carac;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis. | Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used | 12 weeks |
Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that approaching the internal jugular vein with the needle bevel down would produce less injury to the vessel wall compared to the bevel up approach during central venous catheterization.

Conditions
-----------------
Central Venous Catheterization

Intervention / Treatment
-----------------
* Device: bevel direction during central venous catheterization
* Device: bevel direction during central venous catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing surgery that requires the placement of a central venous catheter at the internal jugular vein Exclusion Criteria: anatomical anomaly in the neck region recent history of central venous catheterization

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bevel down<br>approaching the IJV with the needle bevel facing down | Device: bevel direction during central venous catheterization<br>* approaching the IJV with the needle bevel facing down<br>|
| Active Comparator: bevel up<br>approaching the IJV with the needle bevel facing up | Device: bevel direction during central venous catheterization<br>* approaching the IJV with the needle bevel facing up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| posterior wall puncture of internal jugular vein |  | immediately after catheterization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety during central venous catheterization
Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of bimatoprost in patients with glaucoma or ocular hypertension

Conditions
-----------------
Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of glaucoma or ocular hypertension in both eyes Patient requires IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical conditions Ocular seasonal allergies within the past 2 years

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bimatoprost|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering intraocular pressure (IOP) |  |  |
Institut Paoli Calmettes Colorectal Cancer Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer

Official Title
-----------------
Institut Paoli Calmettes Colorectal Cancer Database

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a colorectal cancer diagnosis Exclusion Criteria: Non applicable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Patients with colorectal cancer diagnosis<br> | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients with colorectal cancer | Overall survival of all patients who come in the center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective or retrospective studies | 10 years |
Caffeine for Preterm Infants With Apnea of Prematurity(AOP)

Study Overview
=================
Brief Summary
-----------------
Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce the intubation rate effectively is a challenge for neonatologists.

Detailed Description
-----------------
Less evidences about more dose of caffein used in preterm infants.

Official Title
-----------------
Caffeine for Preterm Infants With Apnea of Prematurity(AOP): a Randomized Controlled Trial

Conditions
-----------------
Caffeine, Apnea of Prematurity

Intervention / Treatment
-----------------
* Drug: 80mg/kg of caffeine
* Drug: 20mg/kg of caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational age less than 32 weeks; appear AOP; parents'consents are obtained. Exclusion Criteria: major congenital abnormalities; Parents' rejection

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 1 Month

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 80mg/kg of caffeine<br>80mg/kg of caffeine is given to treat AOP. | Drug: 80mg/kg of caffeine<br>* 80mg/kg of caffeine is given to treat AOP<br>|
| Active Comparator: 20mg/kg of caffeine<br>20mg/kg of caffeine is given to treat AOP. | Drug: 20mg/kg of caffeine<br>* 20mg/kg of caffeine is given to treat AOP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of AOP | AOP appears again in preterm infants | within 100 days |
Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.

Official Title
-----------------
Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: Eeva System Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs. At least 18 years of age. Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation. Basal FSH < 10 IU. At least 8 normally fertilized eggs (2PN.) Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm. Willing to comply with study protocol and procedures and able to speak English. Exclusion Criteria: Planned preimplantation genetic diagnosis or preimplantation genetic screening. Gestational carriers. Use of reinseminated eggs. Concurrent participation in another clinical study. Previous enrollment in this clinical study. History of cancer.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women undergoing IVF treatment<br> | Device: Eeva System Study<br>* The Eeva System will image embryos through cleavage and/or blastocyst stage.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5. | Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation. | Embryos cultured through blastocyst stage (Day 5). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Outcome | Chemical pregnancy outcome will be assessed using a serum pregnancy test at post transfer day 12-14. Clinical pregnancy outcome will be assessed using vaginal ultrasound at post transfer week 5-8 and week 9-12. Results will be recorded as positive or negative. | Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In vitro fertilization, Assisted reproduction, Noninvasive imaging of embryos, Time lapse imaging of embryos, Traditional morphological grading of embryos, Prediction of blastocysts
Diagnosis of Cancer Using Breath Samples

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect breath samples from healthy and cancer sick patients. The breath, collected to special bags, will be transferred to laboratories in the Technion and analyzed using an electronic nose system developed in Hossam Haick's labs (Chemical Engineering, Technion). The hypothesis is that based on the analysis of the chemical bio-markers present in the exhaled breath, cancer states can be distinguished from healthy subjects or before and after treatment, allowing a technique for diagnosis of cancer and/or cancer treatment.

Official Title
-----------------
Diagnosis of Cancer Using Breath Samples

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The cancer is local or homeostatic The subject did not undergo surgery for tumor removal, chemotherapy or radiation treatment prior to first sampling The subject signed an informed consent form Exclusion Criteria: The subject is addicted to drugs or alcohol The subject smoked in the last hour There are communication problems with the subject

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Breast cancer<br> | |
| Colon cancer<br> | |
| Lung Cancer<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
-----------------
Cancer, Breast Cancer, Colon cancer, Lung Cancer
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the safety, tolerability, PK and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of KPL-404 in healthy subjects

Detailed Description
-----------------
This study includes 2 single ascending dose (SAD) parts; (Part A) IV SAD (up to 5 planned dose level cohorts) and Part B SC SAD (up to 3 planned dose level cohorts). Safety assessments will include adverse events (AEs), concomitant medications, clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination. Serial blood samples for PK, PD, and anti-drug antibodies will be performed during each part of the study during the Treatment and Safety Evaluation Period.

Official Title
-----------------
A Phase 1 First-in-human Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of KPL-404 in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: KPL-404
* Other: Matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Healthy subjects Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2 Key Exclusion Criteria: Poor peripheral venous access Clinically-significant illness within 4 weeks of dose administration Active or acute infection requiring systemic antibiotic treatment within 2 weeks prior to Screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KPL-404 (IV Administration)<br> | Drug: KPL-404<br>* humanized IgG4 monoclonal antibody<br>Other: Matching Placebo<br>* Placebo<br>|
| Experimental: KPL-404 (SC Administration)<br> | Drug: KPL-404<br>* humanized IgG4 monoclonal antibody<br>Other: Matching Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEAEs following IV dosing | After single ascending IV doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) IV placebo group | Up to 65 days post dose | 
| TEAEs following SC dosing | After single ascending SC doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) SC placebo group | Up to 65 days post dose |