linjc16/ctgov huggingface dataset:
Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Gastric Inflammation Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.

Official Title
-----------------
A Double-blind, Multicenter, Randomized Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Korean Patients With Gastric Inflammation

Conditions
-----------------
Acute and Chronic Gastric Inflammation Patients

Intervention / Treatment
-----------------
* Drug: DW-3101_150mg
* Drug: DW-3101_300mg
* Drug: DW-3101_600mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males/females aged 20 75 years Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents Subjects who voluntarily agree to participate in this clinical test with written consent Exclusion Criteria: Patients impossible gastroscopy In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded) Patients with malignant tumor on digestive organ Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DW-3101_150mg<br>150mg a day | Drug: DW-3101_150mg<br> <br> |
| Experimental: DW-3101_300mg<br>300mg a day | Drug: DW-3101_300mg<br> <br> |
| Experimental: DW-3101_600mg<br>600mg a day | Drug: DW-3101_600mg<br> <br> |
| Placebo Comparator: a tablet same as experimental agents in formation and shape<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of gastric erosion score | The erosion score is evaluated by gastroscopy. Erosion score The number of erosion 0 1 2 3 5 More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness. | 14day±3 |
PANGeA - Physical Activity and Nutrition for Quality Ageing

Study Overview
=================
Brief Summary
-----------------
General objectives of the project Defining healthy ageing factors; Setting up content-related bases of the international excellence centre (SLO-ITA) in the field of health of elderly citizens; Raising awareness on the significance of healthy ageing, social inclusion and mobility of less privileged populations (the elderly); Reducing the costs of health care; Connecting the existing health care, social and private entities and improving their mutual coordination.

Detailed Description
-----------------
Physical activity, dietary habits, social and private entities strongly affect the quality of health and quality of life of the elderly. The main object of this study will be to evaluate physical and cognitive performance in combination with physical activity and dietary habits of the elderly. The investigators are interested in longitudinal monitoring of the elderly that participated in measurements in 2013 and measurements after a decade. The results of this study will give important epidemiological information about physical and cognitive status, health status in combination with physical activity which occurs in a longer period of time.

Official Title
-----------------
Longitudinal PANGeA Mass Measurement - Physical Activity and Nutrition for Quality Ageing

Conditions
-----------------
Aging, Sarcopenia, Cognitive Decline

Intervention / Treatment
-----------------
* Other: Longitudinal observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singed written consent age above 60 healthy Exclusion Criteria: severe musculoskeletal injuries inability to follow instructions when performing the test

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 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 |
| --- | --- |
| Longitudinal observation<br>No specific intervention, pre-post measurements only | Other: Longitudinal observation<br>* No specific intervention, longitudinal (pre-post measurements) only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Grip strength measured using a hand-held dynamometer | change in grip strength between two observational time points (pre-post 8-10years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed | Gait speed measured for four meters self selected speed | change in gait speed between two observational time points (pre-post 8-10years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, longitudinal, physical activity, cognition, dietary habits
Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development

Study Overview
=================
Brief Summary
-----------------
We have identified focussing problems related to myopia getting worse. Our trial uses optical and orthoptic interventions that correct the focussing problems to see if this retards myopia progression.

Detailed Description
-----------------
Myopia is a burgeoning health and social problem. Currently there is no acceptable clinical treatment that prevents progression. This study is a double masked placebo controlled block randomized clinical trial of two interventions, to treat accommodative factors we have identified as being significantly correlated to myopia progression (rather than to the presence of myopia). We have shown that the interventions normalise the accommodative factors, and this trial examines the effect of these interventions on myopia progression.

Official Title
-----------------
Accommodation Training and Aberration Control in Myopia Development

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Aberration controlled contact lens
* Behavioral: Vision training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Best corrected visual acuity of 6/5 in each eye Myopia in each meridian of at least 0.50 D Willingness to give consent Willingness to undertake any treatment option Exclusion Criteria: History of systemic/ocular pathology History of any ocular surgery More than 10D of myopia Astigmatism more than 1.00 D

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Aberration controlled contact lens|nan|
|Behavioral: Vision training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in refractive error in myopia in 6 monthly intervals for 2 years |  |  | 
| Change in axial length in 6 monthly intervals for 2 years |  |  | 
| Age effects on refractive changes over 2 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in accommodative response in 6 monthly intervals for 2 years |  |  | 
| Change in accommodative facility in 6 monthly intervals for 2 years |  |  | 
| Change in peripheral refraction in 6 monthly intervals for 2 years |  |  | 
| Change in AC/A ratio in 6 monthly intervals for 2 years |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aberration control, Accommodative facility, Accommodative response, Peripheral refraction, Accommodative convergence to accommodation ratio
Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)

Study Overview
=================
Brief Summary
-----------------
To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.

Detailed Description
-----------------
This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.

Official Title
-----------------
Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis

Conditions
-----------------
Toxic Epidermal Necrolysis

Intervention / Treatment
-----------------
* Drug: Remicaide (infliximab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to burn unit with a histologic diagnosis of TENs Exclusion Criteria: Pregnancy hypersensitivity to remicaide history of heart failure documented bacteremia history of cancer inability to consent

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Remicaide (infliximab)|a single dose infusion of 5mg/kg Remicade (Infliximab)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety labs and adverse events |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ten, toxic epidermal necrlysis
The Children's Amalgam Trial

Study Overview
=================
Brief Summary
-----------------
The Children's Amalgam Trial is one of only two randomized trials of its kind, and the only such trial in the United States, to address the potential impact of mercury exposure from amalgam restorations on neuropsychological and renal function in children.

Detailed Description
-----------------
The safety of silver amalgam as a dental restorative material has been controversial since its introduction 150 years ago, but until recently it has been assumed that the exposure to mercury from dental amalgam is limited to the acute placement phase. However, some recent studies have raised safety concerns by demonstrating chronic release of mercury vapor from amalgam fillings during chewing and brushing. The Children's Amalgam Trial (CAT) is a two-arm randomized trial of safety, comparing amalgam with a mercury-free restorative material. A single masking procedure is used to ensure that all investigators and staff measuring outcomes are unaware of assigned trial arm. The study follows 534 New England children, aged 6-10 years at enrollment, for 5 years. The children were recruited from two northeastern U.S. communities, one in rural Maine, and one in urban Massachusetts. No trial subjects received prior amalgam restorations, and all were in need of at least two posterior occlusal fillings. Participants were randomized to receive either amalgam or composite material for all posterior restorations at baseline and at subsequent visits. The primary endpoint will be 5-year change in IQ scores. Secondary endpoints will include measures of other neuropsychological assessments and renal functioning.

Official Title
-----------------
Health Effects of Dental Amalgams in Children

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Device: Dispersed phase amalgam restoration /composite restoration


Participation Criteria
=================
Eligibility Criteria
-----------------
6 - 10 years of age at last birthday Fluent in English No prior or existing amalgam restorations Two or more posterior teeth with dental caries such that restoration would include the occlusal surfaces No clinical evidence of existing psychological, behavioral, neurologic, immunosuppressive, or renal disorders.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dispersed phase amalgam restoration /composite restoration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IQ as measured by the WISC III Test |  |  |
Clinical Characteristics and Prognostic Factors of Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

Detailed Description
-----------------
As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

Official Title
-----------------
Clinical Characteristics and Prognostic Factors of Patients With COVID-19 in Chibi Hospital of Hubei Province

Conditions
-----------------
Coronavirus

Intervention / Treatment
-----------------
* Other: retrospective analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged >=18years old; Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia. Exclusion Criteria: Near-death state (expected survival time less than 24 hours); Malignant tumor; Pregnancy or puerperium women; Patients who refused to participant.

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 |
| --- | --- |
| COVID-19 patients<br>Hospitalized patients with COVID-19 | Other: retrospective analysis<br>* The investigators retrospectively analyzed the hospitalized patients with COVID-19<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to negative conversion of severe acute respiratory syndrome coronavirus 2 | The primary outcome is the time to negative conversion of coronavirus | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital | The time of hospitalization | 1 month | 
| Survival | The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. | 1 month | 
| Intubation | The rate of intubation within hospitalization of these patients will be tracked | 1 month |
Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture

Study Overview
=================
Brief Summary
-----------------
The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography

Detailed Description
-----------------
The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography.The indexes include Arterial Diameter,Peak Systolic Velocity,End Diastolic Velocity,Resistive Index,Pulsatility Index,Systolic/End Diastolic Ratio,Time AverageMean Velocity and Blood Flow.

Official Title
-----------------
Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture

Conditions
-----------------
Blood Flow Indexes

Intervention / Treatment
-----------------
* Device: Ultrasound assess


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II,candidates for general anesthesia undergoing thoracic surgery Exclusion Criteria: Patients were excluded if they do not want to cooperate with the test, had a history of upper extremity arteriosclerosis obliterans or thromboangitis obliterans,had a history of radial artery puncture or coronary artery bypass grafting,had acute vessel trauma,or had been diagnosed with Raynaud' disease,had suffered from mental or neurological disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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
Interventional Model Description: Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound assess group<br>The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography | Device: Ultrasound assess<br>* The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of Peak Systolic Velocity | The Change of Peak Systolic Velocity before and after surgery | baseline and 30 minutes after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of modified Allen test | the change of modified Allen test before and after surgery | baseline and 30 minutes after surgery |
Autonomic Nervous System Alteration Induce by Sepsis: Assessment and Prognosis Impact

Study Overview
=================
Brief Summary
-----------------
Severe sepsis and septic shock are causes of admission in intensive care units.Modification of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to intensive care units.

Detailed Description
-----------------
Our principal aim is to characterize modulation of cardiac sympathic nervous system in sepsis through the study of sinusal change and myocardiac fixing of MIBG. The second aim is 1)to assess links between alteration of cardiac sympathic nervous system and NT-PRoBNP variations in sepsis and 2)To know prognostic impact in sympathic nervous system compare to NTproBNP.

Official Title
-----------------
Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact

Conditions
-----------------
Septic Shock, Severe Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years admitted in intensive care unit and having severe sepsis criteria or septic shock documented or suspected define as Bone Criteria hemodynamically stable situation sinusal rhythm Patient for social security Exclusion Criteria: Minors Patient under guardianship or trusteeship pregnant or lactating women diabetic cardiomyopathy known and/or treated or detect in admission electro-systolic process permanent or transitory neurological history or degenerative pathology chronic respiratory insufficiency Chronic renal insufficiency

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission |  | 48 hours post admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autonomic nervous system, Sepsis shock, severe sepsis, sinusal change, Myocardiac fixing, NTproBNP, Patient in intensive care unit with sepsis shock or severe, Sepsis