linjc16/ctgov huggingface dataset:
Implications of Pacifier Use in Israeli Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine pacifier sucking habits among children, and to assess implications of the oral habit - for example malocclusions and drooling. The effect of pacifier sucking will be recorded and compared to pacifier type and frequency of use.

Detailed Description
-----------------
Pacifier study protocol The study will take place in children day care centers in Jerusalem and HaSharon area. First step = Receiving an approval from the Children's parents and the day care management for the research. Next step = Examine a total of 400 children who use a pacifier, with a dental mirror in regular lighting condition. The procedure is short, no need of repetition or tracing and without any side effects or discomfort. Part 1- a short questionnaire of demographic background- will be answered by the parents: Personal details- Parents names and ages, child's name and ID number, relation to the child (mother, father…) Social economic status - mother's education, place of residence, number of children in the family. Child's personal details -gender, age, number of siblings Pacifier use habits- period of use, type of pacifier, frequency of use, reason of using a pacifier. Child's Dental condition- drooling, cross bite, open bite. Parents' Awareness of pacifier's effect on mouth development. Parents' approval for child examination. Part 2- clinical- visual examination for identification of relevant findings 1. Child's pacifier type. 2. Dental clinical examination performed in a lightened room: Diagnosis of caries- data will be written in a chart. Diagnosis of malocclusion- open bite or cross bite 3. Diagnosis of drooling from mouth corners which indicates malocclusion. Redness or dryness around lips and chin can imply drooling.

Official Title
-----------------
Observational Study - Pacifier Use in Israeli Children

Conditions
-----------------
Crossbite, Openbite, Drooling

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children aged 3-4 years that use a pacifier Exclusion Criteria: children suffering from a chronic or developmental disease that can affect the orofacial region finger sucking children children suffering from low muscle tonus, abnormal drooling

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pacifier sucking, children, occlusion, drooling
The Effect of Dosage of Caffeine on Intraocular Pressure

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to determine the effect of different doses of caffeine on intraocular pressure. We hypothesized that higher dosage of caffeine would increase intraocular pressure more than lower doses. Eligible subjects will be randomized into three groups: group 1: intake of decaffeinated coffee group 2: intake of coffee with lower caffeine dose group 3: intake of coffee with higher caffeine dose Intraocular pressure will be measured at 0, 30, 60 and 90 minutes after coffee intake.

Detailed Description
-----------------
decaffeinated coffee contains 0.5-2 mg of caffeine regular dose coffee contains 91.8 mg of caffeine high dose coffee contains 144 mg of caffeine all three groups' intraocular pressure will be measured with the Goldmann applanation tonometer at 4 timepoints: 0 minutes (baseline) 30 minutes after intake 60 minutes after intake 90 minutes after intake

Official Title
-----------------
The Effect of Dosage of Caffeine on Intraocular Pressure in Healthy Subjects

Conditions
-----------------
Intraocular Pressure, Caffeine Dosage

Intervention / Treatment
-----------------
* Other: decaffeinated coffee
* Other: regular dose coffee
* Other: high dose coffee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects normal central corneal thickness normal baseline intraocular pressure Exclusion Criteria: any ocular disease baseline intraocular pressure over 21 mmHg central corneal thickness less than 520 microns or more than 540 microns

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group1: Decaffeinated coffee<br>contains 0.5-2 mg of caffeine | Other: decaffeinated coffee<br>* contains caffeine 0.5-2 mg<br>|
| Active Comparator: Group2: regular dose coffee<br>contains 91.8 mg of caffeine | Other: regular dose coffee<br>* contains 91.8 mg of caffeine<br>|
| Active Comparator: Group3: high dose coffee<br>contains 144 mg of caffeine | Other: high dose coffee<br>* contains 144 mg of caffeine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in intraocular pressure (mmHg)after caffeine intake | intraocular pressure measured at 4 timepoints: 0 minutes (baseline) 30 minutes after intake 60 minutes after intake 90 minutes after intake | 0, 30 minutes, 60 minutes, 90 minutes post-caffeine intake | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraocular pressure, caffeine, dosage
Subserosal Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .

Official Title
-----------------
Subserosal Laparoscopic Cholecystectomy for Safe Gall Bladder Surgery

Conditions
-----------------
Cholecystitis

Intervention / Treatment
-----------------
* Procedure: laparoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult with age of or above 18 years. Diagnosis of chronic cholecystitis , symptomatic cholelithiasis Exclusion Criteria: Previous operation or adhesion severe Acute Calculus pancreatitis gall bladder cancer Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia) Recurrent cases

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscope|subserosal manipulation of gallbladder with laparoscope .|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of safety of subserosal laparoscopic cholecystectomy in comparison to conventional technique. | incidence of bleeding after subserosal laparoscopic cholecystectomy in comparison to conventional technique. | 6 months |
Improving Decision Making About Feeding Options for Dementia

Study Overview
=================
Brief Summary
-----------------
This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.

Detailed Description
-----------------
This research study is a cluster randomized controlled trial of a decision aid to improve decision-making about feeding options for patients with advanced dementia. Surrogate decision-makers in the nursing homes randomized to the intervention will review the decision aid and be prompted to discuss it with the primary health care provider, while those in the control sites receive usual care. We measure the immediate, 1 and 3 month effects of the decision aid on the quality of surrogate decision-making for nursing home residents with advanced dementia.

Official Title
-----------------
Improving Decision Making About Feeding Options for Dementia

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Other: Feeding Options in Dementia Decision Aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dementia diagnosis advanced cognitive impairment feeding problem age >= 65 surrogate decision maker Exclusion Criteria: feeding tube decision made hospice BMI > 26 major psychosis or developmental delay

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision support<br>Structured decision aid with prompting to share information in discussion with primary treating health care providers. | Other: Feeding Options in Dementia Decision Aid<br>* Structured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider.<br>|
| No Intervention: Control<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict Scale | Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent With Treatment Decisions | Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Nutrition, Feeding
Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases

Study Overview
=================
Brief Summary
-----------------
The long-term outcome of patients resected for colorectal liver metastases (CLM) after neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as the immune response to the tumor and to the CHT. The aim of this study was to investigate the impact of the pathological and immunological response in patients undergoing liver resection for CLM after CHT in regards to the long-term outcome.

Detailed Description
-----------------
The immunoreactivity to CD3+ and NKp46+ cells inside the tumor, at the border between the tumor and the normal liver, and inside the normal liver will be tested by computer-assisted image analyses in patients undergoing liver resection for CLM between 2005 and 2013 preoperatively treated with oxaliplatin or irinotecan with or without bevacizumab or cetuximab. The survival will be assessed in relation to several prognostic factors and to that immunoreactivity.

Official Title
-----------------
Role of CD3+ and NKp46+ Cells in Resected Colorectal Liver Metastases.

Conditions
-----------------
Colorectal Liver Metastases

Intervention / Treatment
-----------------
* Procedure: Hepatic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological proven colorectal liver metastases complete clinical, surgical, pathological and follow-up data Exclusion Criteria: non-radical surgery incomplete clinical, surgical, pathological and follow-up data

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 |
| --- |
|Procedure: Hepatic resection|Removal of a part of the liver during surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NK-cells, T-cells
Utility of Interface Pressure Mapping

Study Overview
=================
Brief Summary
-----------------
To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.

Conditions
-----------------
Bedsores, Ulcers

Intervention / Treatment
-----------------
* Device: Mapping System
* Device: Non-Mapping System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older, care giver trained on mapping system Exclusion Criteria: Less than 18 years, pregnant women, weight greater 550 lbs, and subjects requiring a specialty mattress

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were assigned randomly to either a medical intensive care unit with pressure mapping beds or a unit that did not have them
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients on mapping systems<br> | Device: Mapping System<br>* Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning<br>|
| Active Comparator: Patients not on mapping systems<br> | Device: Non-Mapping System<br>* Standard ICU bed with no mapping system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Mapping Reducing Hospital Acquired Pressure Ulcers | Comparing number of pressure ulcers when using pressure mapping compared to when not. | Time admitted in the Medical Intensive Care Unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients, susceptible to, hospital, acquired pressure
Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

Study Overview
=================
Brief Summary
-----------------
Helium-oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome in previous studies，but the evidence was limited．The aim of the study was to assess the effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70% helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in meconium aspiration syndrome.

Official Title
-----------------
Study on the Effect of Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome Parallel Synchronized Intermittent Mandatory Ventilation; Synchronous Maudatory Ventilation

Conditions
-----------------
Neonatal Meconium Aspiration

Intervention / Treatment
-----------------
* Device: helium oxygen mixture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has the diagnosis of neonatal meconium aspiration syndrome Subject has Synchronous instruction ventilation Exclusion Criteria: History of congenital or hereditary disease

Ages Eligible for Study
-----------------
Minimum Age: 37 Weeks
Maximum Age: 40 Weeks

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

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

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 |
| --- | --- |
| Active Comparator: experimental group<br>Using helium oxygen mixture | Device: helium oxygen mixture<br> <br> * Other names: Air oxygen mixture;|
| No Intervention: matched group<br>Using air oxygen mixture | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood gas analysis | Time detection after treatment | 2 hour | 
| blood gas analysis |  | 6 hour | 
| blood gas analysis |  | 12 hour | 
| blood gas analysis |  | 24 hour | 
| blood gas analysis |  | 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory response index (IL-6,IL-8, TNF-a,CRP) |  | 0 hour | 
| Inflammatory response index (IL-6,IL-8, TNF-a,CRP) |  | 6 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
helium oxygen mixture, Meconium aspiration syndrome
A Phase I Clinical Study of the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.

Study Overview
=================
Brief Summary
-----------------
This study is designed to multiple dose and dose escalation study

Detailed Description
-----------------
A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Single Dose Escalation Study of the Safety, Tolerabiluty, and Pharmacokinetics of HX-1171 in Healthy Male Subjects

Official Title
-----------------
A Phase I Clinical Study, Randomized, Single-blind,Placebo-controlled, Multiple Doses, Dose Escalation Study fo the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.

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

Intervention / Treatment
-----------------
* Drug: HX-1171


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 20 to 40 years at screening. Be able to comply with the requirement of the study. Subject must provide written informed consent prior to study participation. Exclusion Criteria: History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or gastrointestinal disorders. History of known hypersensitivity to drugs including HX-1171.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HX-1171|Anti-oxidatant, Anti-inflamation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate whether infusion of autologous bone marrow derived stem cells can improve cardiac function in the aftermath of a myocardial infarction.

Detailed Description
-----------------
Primary coronary intervention within a few hours of a myocardial infarction has greatly reduced mortality as well as the risk of developing chronic heart failure. There are though still a large number of patients that develop symptoms of heart failure in the form of fatigue and breathlessness with physical exertion in spite of medical treatment. With the advance in stem cell technology there is now hope for the possibility of regenerating/repairing dead myocardial tissue, hence improving cardiac function. The current study is a pilot study that is going to precede a later double blinded randomized study. The aim of the study is to evaluate patient safety, optimize procedures, and to be used in power calculation in the design of the following study.

Official Title
-----------------
Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: Coronary catherization and stem cell infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chestpain Troponin T, > 0,1ng/ml Succesfull revascularization of culprit lesion with PCI. No more than stenosis of 2 major epicardiel coronary arteries. Exclusion Criteria: Cardiogenic shock Known LVEF<45% Cardiomyopathy Atrialfibrillation or fluctuation Takyarytmia Infection Chronic inflammatory disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Coronary catherization and stem cell infusion|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stem cell, autologous bone marrow transplantation, Myocardial infarction