linjc16/ctgov huggingface dataset:
A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.

Detailed Description
-----------------
Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-52 weeks. Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin After Oral Administration in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise

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

Intervention / Treatment
-----------------
* Drug: evogliptin 5mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with 6.5%≤HbA1c≤10.0% at screening Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening Subjects with 6.5%≤HbA1c≤10.0% at Visit 2 Subjects with 20kg/m2≤BMI≤40kg/m2 at screening Exclusion Criteria: Subjects with fasting plasma glucose≥270mg/dL at screening Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening Subjects with ALT and AST 2.5 times or higher than upper normal range

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: evogliptin 5mg<br>evogliptin 5mg QD | Drug: evogliptin 5mg<br>* evogliptin 5mg, QD<br>* Other names: Suganon;|
| Placebo Comparator: placebo<br>Placebo QD | Drug: Placebo<br>* Placebo, QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | unit: % | Change from baseline at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose | unit: mg/dL | Change from baseline at 24 weeks | 
| HbA1c response rate | unit: % | Change from baseline at 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suganon, DA-1229, evogliptin, DPP-IV inhibitor, DPP-4 inhibitor
Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

Study Overview
=================
Brief Summary
-----------------
NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)

Official Title
-----------------
Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

Conditions
-----------------
Brain Damage, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age < 28 weeks
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 |
| --- | --- | --- |
| Brain white matter damage (WMD, defined by MRI ,US, EEG) |  | during stay in NICU and until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developmental assessment |  | at 2 years of age |
Air Barrier System for the Reduction of Airborne Colony Forming Units During Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total knee arthroplasty surgeries.

Detailed Description
-----------------
The Air Barrier System (ABS) is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne CFU at the surgery site during total knee arthroplasty surgery.

Official Title
-----------------
Air Barrier System for the Reduction of Airborne Particulate and Colony Forming Units (CFU) During Total Knee Arthroplasty

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Air Barrier System
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for total knee arthroplasty Exclusion Criteria: Prior history of infection Revision surgery Screens positive for MRSA

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>In the control arm, the ABS device will be placed as usual on the patient, but the airflow will NOT be activated. Only the technician in the room will be aware whether the device is turned on or not. | Other: Control<br>* The Air Barrier System will be deployed onto the surgical field, but the airflow will not be activated, so this is a sham control comparator.<br>|
| Experimental: Air Barrier System<br>In the experimental (intervention) arm, the ABS device will be placed as usual on the patient, and the airflow will be activated. Only the technician in the room will be aware whether the device is turned on or not. | Device: Air Barrier System<br>* The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne microorganisms that are shed into the air from people present in the operating room.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the number of colony-forming units captured at incision sites | A length of tubing will be placed at the incision and will draw air onto agar plates that are changed every ten minutes in both the control and ABS arms. | Four months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total knee replacement, Operating room airborne CFU
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)

Study Overview
=================
Brief Summary
-----------------
This study (ARD-3150-1201, ORBIT-3) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)

Conditions
-----------------
Non Cystic Fibrosis Bronchiectasis

Intervention / Treatment
-----------------
* Drug: Ciprofloxacin dispersion for inhalation
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Verified bronchiectasis diagnosis Pseudomonas aeruginosa lung infection Exclusion Criteria: Cystic Fibrosis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciprofloxacin dispersion for inhalation<br>Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin | Drug: Ciprofloxacin dispersion for inhalation<br> <br> * Other names: Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin;|
| Placebo Comparator: Placebo<br>Liquid formulation of empty liposomes | Drug: Placebo<br> <br> * Other names: Liquid formulation of empty liposomes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first exacerbation |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbations |  | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiectasis, non-CF, Ciprofloxacin, Liposome
Autosomal Dominant Retinitis Pigmentosa: Prevalence of Known Genes Identification of New Loci / Genes

Study Overview
=================
Brief Summary
-----------------
Identify new genes responsible for autosomal dominant retinitis pigmentosa (ADRP), one of the most common causes of hereditary diseases of the retina, and thus better understand the mechanisms involved of the disease.

Detailed Description
-----------------
Two hundred and fifty samples from unrelated patients, from which 150 were provided by the national reference center of rare disease in Montpellier and 100 recruited in the 9 participating centers over a period of two years.To identify the missing genes, we proceed in two steps. A first step in selecting families negative for the 8 major genes genes, by systematic sequencing of exons most frequently involved. A second step in finding new loci / genes by locus exclusion using microsatellite markers and SNP genotyping.

Official Title
-----------------
Autosomal Dominant Retinitis Pigmentosa: Prevalence of Known Genes Identification of New Loci / Genes

Conditions
-----------------
Autosomal Dominant Retinitis Pigmentosa

Intervention / Treatment
-----------------
* Genetic: genetic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: retinitis pigmentosa diagnosed Autosomal dominant transmission diagnosed Aged from 5 to 80 years Informed consent Affiliated or benefit from an insurance regimen Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 80 Years

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

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

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 |
| --- | --- |
| Other: patient<br>Patient suffering of adRP that accept to participate at this study have a blood prelevement for genetic analysis (intervention) | Genetic: genetic analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of unknown loci and genes responsible of Autosomal dominant retinitis pigmentosa (adRP) |  | for 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autosomal dominant retinitis pigmentosa, Rare disease, Genetics
Comparing Prognostic Performance of SEPSIS 2 and SEPSIS 3 Strategies at the Emergency Service

Study Overview
=================
Brief Summary
-----------------
In 2016, the Third International Consensus proposed a new strategy to screen aggravating risk in patients with septic shock. This strategy is based on quick-SOFA and the SOFA score. The main objective is to compare the prognostic performance of SEPSIS 3 against the previous strategy SEPSIS 2 to predict the admission in intensive care unit or the intra-hospital death.

Detailed Description
-----------------
This study compare the prognostic performance of two strategies. It's a monocentric, retrospective study in patients admitted to the emergency department.

Official Title
-----------------
Comparing Prognostic Performance of SEPSIS 2 and SEPSIS 3 Strategies at the Emergency Service

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged of 18 years or more Initiation of one or more antibiotics in the Accident and Emergency Department in the Metz-Thionville hospital (CHR) site Mercy, for curative purpose, regardless of the infectious aetiology Hospitalized in the CHR Metz-Thionville thereafter Exclusion Criteria: Minors patients Absence of antibiotic treatment initiated in the Emergency department Prescription of antibiotic treatment in the emergency department for preventive purpose Transferred by hospitalisation service of CHR Metz-Thionville in the emergency department Absence of hospitalisation following their passage through the emergency department Transferred to hospitalisation in an other establishment Presence, at the admission, of an antibiotic treatment Patients deceased in the emergency department

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 |
| --- | --- | --- |
| Intrinsic and Extrinsic properties of SEPSIS 3 strategy | The percentage of patients with high qSOFA score (2 or more) who were admitted in intensive care unit or who have died during their stay in hospital and rather the percentage of patients with a small qSOFA score who survived without passing through intensive care unit | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between lactate levels and mortality | lactate levels at their admission | Day 1 |
Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

Study Overview
=================
Brief Summary
-----------------
This study investigates the prevalence and pathophysiology of dental and periodontal involvement in pediatric patients with symptomatic or asymptomatic gastroesophageal reflux (GER) or gastroesophageal reflux disease (GERD). Primary objectives are to compare the prevalence of oral disease in children with and without a diagnosis or symptoms/signs of GERD in a cross-sectional study. Secondary objectives are to examine factors that might lead to the pathogenesis of the dental and periodontal lesions observed in this group of subjects. The primary hypothesis is to prove that children aged 10-18 years diagnosed with or having symptoms or signs of GERD have a significantly higher amount of dental erosions in comparison to a matched control group. Secondary hypotheses are that children aged 10 - 18 years diagnosed with or having signs of GER have higher DMFS (Decayed, Missing, Filled permanent tooth Surfaces) rates, higher SBI (Sulcus Bleeding Index) rates, worse Periodontal status, and lower saliva buffering capacity.

Conditions
-----------------
Gastroesophageal Reflux, Dental Erosion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 9.0 to 18.0 years, of either gender Able to give verbal / written assent / consent themselves and/or informed consent from a parent/guardian Willing to comply with all study procedures and protocols, Willing to get dental photographs and impressions taken Willing to sign the Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research form Exclusion Criteria: Subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis) Other conditions that may decrease the likelihood of adhering to study protocol, Subjects who will leave the area and are unable to complete the study.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum 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 |
| --- | --- |
| Pediatric patients with symptoms or diagnosis of GER<br> | |
| Control group of pediatric subjects with no symptoms of GER.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Spironolactone and Insulin Resistance in Chronic Heart Failure (CHF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

Detailed Description
-----------------
Diuretics is useful in CHF patients. On the other hand, they deteriorate glucose metabolism. Therefore, the purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

Official Title
-----------------
Effects of Spironolactone on Insulin Resistance in Patients With Chronic Heart Failure

Conditions
-----------------
Chronic Stable Heart Failure

Intervention / Treatment
-----------------
* Drug: spironolactone + furosemide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic stable heart failure Exclusion Criteria: renal dysfunction or under treatment with antidiabetic agents
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: spironolactone + furosemide|spironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, insulin resistance, inflammatory cytokine, spironolactone, furosemide
Pharmacokinetics Study for Probucol

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.

Detailed Description
-----------------
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.

Official Title
-----------------
A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: probucol
* Drug: probucol
* Drug: probucol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Korean Male Age from 20 to 40 years at time of informed consent BMI more than 19.0 and less than 25.0 Subjects who meet the following criteria at the time of the screening Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values Exclusion criteria History or clinical evidence of significant medical history Present or previous significant drug allergy to any prescription or OTC medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Group 2(probucol 500mg BID) | Drug: probucol<br>* group 2: 250 mg 2 tablets at once in the morning<br>* Other names: Lorelco;|
| Active Comparator: 1<br>Group 1(Probucol 250mg) | Drug: probucol<br>* group 1: 250 mg<br>* Other names: lorelco;|
| Active Comparator: 3<br>Group 3(Probucol 500mg once daily) | Drug: probucol<br>* group 3: 250 mg 1 tablet in the morning and evening<br>* Other names: Brand name: Lorelco;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PK assessment for healthy male volunteer, Healthy male subjects aged 20 to 40 years