linjc16/ctgov huggingface dataset:
Supplementation of Infant Formula With Synbiotics

Study Overview
=================
Brief Summary
-----------------
The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.

Official Title
-----------------
Supplementation of Infant Formula With the Synbiotics (Lactobacillus Paracasei Ssp. Paracasei Strain F19 and Fructo- and Galactooligosaccharides).

Conditions
-----------------
Infant Formula

Intervention / Treatment
-----------------
* Other: Lactobacillus paracasei paracasei strain F19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy infants of mothers who voluntarily resigned completely from breastfeeding infant age 28 days delivered between 38 and 42 weeks of gestation vaginal delivery birth weight > 2700 g and < 4200 g parent or the subject's legal representative has to speak and understand Polish Exclusion Criteria: fully or partially breastfed infants malformations, handicaps or congenital diseases that could affect normal growth treatment with antibiotics fed infant formula with pre- and/or probiotics

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: IF (Infant formula)<br> | |
| Experimental: IF with L. paracasei strain F19<br> | Other: Lactobacillus paracasei paracasei strain F19<br>* Provided in an infant formula, 10^8 CFU per day from 28 days to 6 months of infant age<br>* Other names: F19;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth (body weight, length, head circumference) |  | From 28 days to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
F19, Lactobacillus paracasei paracasei
Pharmacotherapy and Intensive Treatment - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric disorders.

Official Title
-----------------
Pharmacotherapy and Intensive Treatment

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Carbamazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity addiction |  |  | 
| Depression |  |  | 
| Depression, anxiety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. After randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the other group. Investigators will compare clinical recurrence rate, complication rate, and procedure time, etc.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: circumferential pulmonary vein isolation
* Procedure: Linear ablation in addiction to circumferential pulmonary vein isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with persistent Atrial fibrillation (20 80 years) LA diameter <55mm patients possible to anticoagulation and anti arrhythmic drug Exclusion Criteria: Structural cardiac disease Contraindication to brain perfusion CT Catheter ablation history for AF, Cardiac surgery for AF active internal bleeding Impossible to anticoagulation or antiarrhythmic drug valvular AF (MA> GII, Mechanical valve, Mitral valve replacement) Patients with severe medical disease Expected survival < 1year Severe alcoholics, drug addiction

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: circumferential pulmonary vein isolation<br>circumferential pulmonary vein isolation | Procedure: circumferential pulmonary vein isolation<br> <br> |
| Experimental: Linear ablation in addiction to pulmonary vein isolation<br>Linear ablation in addiction to pulmonary vein isolation | Procedure: Linear ablation in addiction to circumferential pulmonary vein isolation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial fibrillation after catheter ablation |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time |  | 1 day | 
| procedure related complication rate |  | 12 month | 
| rate of hospitalization |  | 12 month |
Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea

Study Overview
=================
Brief Summary
-----------------
To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12 23 months

Detailed Description
-----------------
To compare the Vero cell-derived inactivated Japanese encephalitis(JE) vaccine 'KD-287(JEIMMUGEN INJ.)' with the mouse brain-derived inactivated JE vaccine in terms of the immunogenicity and safety, in Korean healthy children aged 12 23 months

Official Title
-----------------
A Multi-center, Active-control, Randomized, Double-blind Phase 3 Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine 'KD-287(JEIMMUGEN INJ.) in Korean Healthy Children Aged 12 23 Months

Conditions
-----------------
Japanese Encephalitis

Intervention / Treatment
-----------------
* Biological: JE vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children aged 12-23 months Written informed consent Exclusion Criteria: History of documented HIV Known or suspected impairment of immunologic function History of serious chronic disease Received any JE vaccine prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 23 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vero cell-derived JE vaccine<br>vero cell-derived vaccine group | Biological: JE vaccine<br>* 3 times, IM<br>|
| Active Comparator: Mouse brain-derived JE vaccine<br>Mouse brain-derived JE vaccine group | Biological: JE vaccine<br>* 3 times, IM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunogenicity | the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination | pre-dose, after 3rd vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
JEV, vero cell
Assessing Ocular Surface Changes After Changing Glaucoma Medications

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Changing to Travatan Z therapy increases the tear film break up time of subjects on Xalatan therapy presenting with ocular surface disease.

Detailed Description
-----------------
Patients who have been taking Xalatan monotherapy to treat their glaucoma and presenting with ocular surface disease will be advised to switch their medication to Travatan Z. Test results will be recorded at the day that the medication was changed and at follow-up to determine if there is a measurable change in tear film break up, corneal staining and in the Ocular Surface Disease Index.

Official Title
-----------------
Assessing Changes at the Ocular Surface Following the Switch From Xalatan to Travatan Z.

Conditions
-----------------
Glaucoma, Monotherapy With Xalatan From 1 to 18 Months, Ocular Surface Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: on Xalatan monotherapy from 1 to 18 months 18 years of age or older has been diagnosed with ocular surface disease Exclusion Criteria: special populations such as children, pregnant females, prisoners, etc.

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 |
| --- | --- | --- |
| Change in Signs and Symptoms of Ocular Surface Disease |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Travatan Z, glaucoma, tear film break up time
The Relationship Between White Matter Hyperintensity With Cognition and Emotion

Study Overview
=================
Brief Summary
-----------------
White matter hyperintensity (WMH) has been found to be related with cognitive and emotional dysfunction. A presumed mechanism is that WMH disrupts the structural connectivity within a large-scale brain network, thereby impairing the brain's ability to integrate the neural processes efficiently. It is not yet clear, what the pattern of brain network disruption relates to WMH and how the brain network disruption induced by WMH has an effect on cognition and emotion performance. Using multi-model magnetic resonance imaging (MRI) techniques, we aimed to explore the mechanisms of cognitive decline and depression related with brain network dysfunction in patients with WMH, and to provide objective imaging marker for early diagnosis and prevention of WMH associated cognitive decline and depression.

Official Title
-----------------
The Relationship Between White Matter Hyperintensity With Cognition and Emotion

Conditions
-----------------
Aged, Leukoaraiosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: white matter hyperintensity visible on T2 fluid-attenuated inversion recovery images; age between 35 to 80 years; without stroke lesion (except lacunar infarction) on current diffusion weighted images; without a history of multiple sclerosis, Alzheimer's disease, Parkinson's disease and head trauma. Exclusion criteria: white matter lesions of nonvascular origin (immunological-demyelinating, metabolic, toxic, infectious, other); intracranial hemorrhage; with severe head motion on magnetic resonance images

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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 |
| --- | --- |
| Control<br> | |
| White matter hyperintensity<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fazekas Scale of white matter hyperintensity |  | 1 year | 
| Mini-Mental State Examination (MMSE) |  | 1 year | 
| Hamilton Depression Scale (HAMD) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
white matter hyperintensity, brain network, MRI, cognition, emotion
Observation of Intraosseous Vascular Access in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. The primary hypothesis is that powered intraosseous vascular access will decrease the amount of time needed to obtain vascular access.

Official Title
-----------------
An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department

Conditions
-----------------
Patients Requiring Urgent Vascular Access

Intervention / Treatment
-----------------
* Device: EZ-IO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring vascular access who would otherwise receive a central venous catheter due to lack of other options. Exclusion Criteria: Fracture in target bone, or significant trauma to the site Excessive tissue and/or absence of adequate anatomical landmarks in target bone Infection in target area IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intraosseous vascular access<br>subjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established. | Device: EZ-IO<br>* powered intraosseous vascular access system<br>* Other names: EZ-IO by Vidacare, Powered intraosseous vascular access;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to vascular access | Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route. | at time of patient's arrival to emergency department, average within 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications with intraosseous device | Reported complications by intraosseous device operators. | time subject has intraosseous vascular access, an average of 24 hours |
Comparision of Different Methods of Enviromennt Disinfection

Study Overview
=================
Brief Summary
-----------------
Multidrug resistance bacteria infection is common in ICU. Infection incidence is associated with age, organ dysfunction, invasive treatment and enviroment cleaning. According to hospital hygienic standard for disinfection, total numbers of colony of air and the object surface in ICU must be ≤4CFU/cm2（5min）and≤10CFU/cm2. in this study, the two different methods will be used to evaluate the disinfection effects in ICU enviroments.

Official Title
-----------------
Comparision of Different Methods of Enviromennt Disinfection

Conditions
-----------------
Enviroment Cleaning

Intervention / Treatment
-----------------
* Other: manual cleaning
* Device: machine clean


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no patients recruitment Exclusion Criteria: no patients recruitment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Manual clean<br>clean the rag and floor towel manually | Other: manual cleaning<br>* manual clean the rag and floor towel<br>|
| Other: machine clean<br>clean the rag and floor towel by machine | Device: machine clean<br>* machine clean the rag and floor towel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of infection |  | up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose of antibiotics |  | up to one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clean supplies, ICU floor, bacteria colony, catheter associated with infection
Analysis and Accuracy of Mortality Prediction Scores

Study Overview
=================
Brief Summary
-----------------
Patients admitted to the ICU in a tertiary burn centre in Kuwait were analysed using multiple mortality prediction scores. The accuracy of these scores were compared to each other to ascertain which prediction modality provides the most accurate prognosis.

Detailed Description
-----------------
The aim of this study is to determine the accuracy of three established scoring systems used for burn patients admitted to the intensive care unit and to determine the risk factors associated with poor outcomes. A total of 211 patients with who were admitted to the ICBU in a tertiary care centre in Kuwait from January 2017 to December 2019 were analysed retrospectively. Data were collected using patient medical records. The FLAMES, BOBI and revised Baux scores were calculated, and the survivor and non-survivor scores of patients were analysed to determine the sensitivity, specificity and Area Under the Receiver Operating Characteristics (AUROC) of the different scoring modalities.

Official Title
-----------------
The Analysis and Accuracy of Mortality Prediction Scores in Burn Patients Admitted to the Intensive Care Burn Unit (ICBU)

Conditions
-----------------
Burns, Morality

Intervention / Treatment
-----------------
* Other: Mortality scores


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric burn patients with partial/full thickness burns>10% TBSA Adult patients with partial/full thickness burns >15% TBSA Patients with electric burns Patients iwth burns involving the voice Any patient with suspected inhalational injury Burn patients with significant comorbidities Exclusion criteria: Patients with incomplete data records
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Mortality scores|Revised Baux, BOBI and FLAMES scores|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve of the 3 aforementioned mortality prediction scores |  | 4 years |
Ultrasound Guided Esophageal Pressure

Study Overview
=================
Brief Summary
-----------------
The investigator aimed to evaluate the effect of ultrasound guided esophageal pressure on the incidence of gastric insufflation during anesthetic induction in infants and small children undergoing general anesthesia.

Detailed Description
-----------------
effect of ultrasound guided esophageal pressure on the incidence of gastric insufflation in children

Official Title
-----------------
The Effect of Real Time Ultrasound Guided Esophageal Pressure on Preventing Gastric Insufflation in Infants and Children: an Exploratory Study

Conditions
-----------------
Aspiration, Infant Conditions

Intervention / Treatment
-----------------
* Other: US_Eso


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing general anesthesia with endotracheal intubation Exclusion Criteria: patients with hypertrophic pyloric stenosis patients with delayed gastric emptying patients with esophageal stenosis patients with at risk of gastric aspiration patients with ileus, hepatomegaly, ascites (cannot visualize gastric antrum with ultrasound)

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US_Eso<br>US application on the participant | Other: US_Eso<br>* After applying ultrasound guided esophageal pressure, the peak inspiratory pressure increased from 10cmH2O to 24cmH2O (increased by 2 cmH2O) during mask ventilation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of gastric air insufflation | the incidence of gastric air insufflation during induction of anesthesia when applying real time ultrasound guided esophageal pressure. | during face mask ventilation, maximum 3 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric insufflation detected by esophageal ultrasound |  | during face mask ventilation, maximum 3 minutes. | 
| ventilatory parameters | tidal volume, end tidal carbon dioxide, minimal oxygen saturation | during face mask ventilation, maximum 3 minutes. | 
| POGO (percentage of glottic opening) score | POGO (percentage of glottic opening, 0-100) score with videolaryngoscope | during endotracheal intubation, maximum 3 minutes | 
| relative position of esophagus with trachea |  | during anesthetic induction, maximal 3 minutes |