linjc16/ctgov huggingface dataset:
Sonic Window Study Evaluation Plan

Study Overview
=================
Brief Summary
-----------------
The goals of this study are as follows; evaluation of the products' readiness to market, ascertain initial reactions by target users, evaluate actual use in potential clinical settings and any difficulties encountered with product use and actual venous cannulation.

Detailed Description
-----------------
This study was cancelled

Official Title
-----------------
Observational Study of the Sonic Window Handheld Ultrasound System for Assistance With Vascular Access and Needle Placement

Conditions
-----------------
Non-palpable Veins

Intervention / Treatment
-----------------
* Device: Use of Ultrasound to assist in needle placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient Requires needle placement Exclusion Criteria: Under 18 years of age Needle placement not required.

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 |
| --- |
|Device: Use of Ultrasound to assist in needle placement|Use of the Sonic Window handheld Ultrasound device to assist in needle placement by providing a coronal image of the patient anatomy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Stick Success | With this study we want to confirm that The Sonic Window aids in locating and accessing non-palpable veins in a group of up to 50 patients. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular Access, Sonic Window, Ultrasound
Feeding Trial in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
This is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.

Detailed Description
-----------------
This prospective observational study seeks to assess ability to achieve enteral feeding goals with a new tube feeding product in pediatric patients with developmental disabilities.

Official Title
-----------------
Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities

Conditions
-----------------
Developmental Disabilities

Intervention / Treatment
-----------------
* Other: enteral formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child aged 1-13 years old with development disabilities Currently tolerating enteral feeding Requiring nutritional management to meet 50-90th% weight for age on the Kennedy Kreiger Growth Charts Requires enteral tube feeding for at least 14 days. Exclusion Criteria: Unable to access gastrointestinal tract for feeding via tube Other condition which contraindicates tube feeding

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 13 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 |
| --- | --- |
| Pediatric developmental disabilities<br>Children aged 1-13 years old with development disabilities, requiring enteral tube feeding for at least 14 days | Other: enteral formula<br>* Complete feeding of study enteral formula, route and regimen prescribed by the physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to feeding goal achievement |  | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal measures assessment |  | up to 21 days | 
| Percentage of nutrition goal met |  | daily up to 21 days | 
| Serum biochemical markers assessment |  | baseline and completion of study | 
| Assessment of frequency and nature of adverse events |  | daily up to 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Developmental disabilities, Enteral Nutrition, Tube feeding, Nutrition support
Study of Arterial Recanalization of the Central Retinal Artery Occlusions

Study Overview
=================
Brief Summary
-----------------
Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke (IS) at the retinal level. They share the same risk factors and common pathology. Their incidence is lower (8.5 / 100,000) and the functional prognosis is unfavorable in 80% of cases with visual acuity (VA) <1/10. The diagnosis of an CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia. There is no data on early retinal arterial recanalization after CRAO, nor on the relationship between early recanalization (spontaneous or post-thrombolysis) and visual prognosis.

Official Title
-----------------
Study of Arterial Recanalization of the Central Retinal Artery Occlusions

Conditions
-----------------
Central Retinal Artery Occlusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Central Retinal Artery Occlusion ≤ 24 hours Exclusion Criteria: Retinal Dynamic angiography not performed within 48 hours of onset of symptoms Occlusion of a branch of the central retinal artery

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 |
| --- | --- | --- |
| Dynamic retinal angiography data at 24 hours (+/- 24 hours) | Proportion of patients with early arterial recanalization.The recanalization rate will be compared between thrombolysed patients and non-thrombolysed patients | 24 hours (+/- 24 hours) following the beginning of symptoms | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombolysis, Recanalization, Dynamic retinal angiography
Attitudes and Knowledge of Oral Health Among Nursing Personnel

Study Overview
=================
Brief Summary
-----------------
Oral Health care has been shown to have low priority among nursing personnel, especially among personnel with shorter education.

Detailed Description
-----------------
As the population gets older and keep their natural teeth high up in age, in most cases throughout life, it is of importance to help the older maintain a good oral health when the cognitive functions and physical ability decreases. In 1999, a new dental care system was introduced with the aim to offer elderly with long-term need for extensive care, home visits for oral health assessment and, if necessary, be offered the necessary dental care. The aim was also to offer nursing personnel education and training in dental health and oral care, in order to provide and perform oral care. The effect of the education program has never been evaluated.

Official Title
-----------------
Attitudes and Knowledge of Oral Health Among Nursing Personnel

Conditions
-----------------
Knowledge, Attitudes, Practice, Attitude, Oral Health

Intervention / Treatment
-----------------
* Other: Attitudes, knowledge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nursing personnel in nursing home for elderly Must be able to read and understand Swedish Exclusion Criteria: - None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Attitudes, knowledge|To investigate attitudes and knowledge to oral Health and oral care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes to Oral Health and oral care | A questionnaire, Dental Coping Beliefs Scale (DCBS) will be used to investigate attitudes to, and knowledge of oral health among nursing staff caring for home-dwelling older people. DCBS investigates three dimensions; Locus of control (internal and external), self-efficacy and oral-health care believes. Apart from descriptive statistics, a logistic regression model will be used to analyze the relationship between the sum scores for the factors Oral health care beliefs, Internal locus of control, External locus of control and background variables (age, work experience and earlier adjunct education). | February 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Attitudes, Knowledge, Oral Health, Nursing personnel
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.

Official Title
-----------------
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: LEO 90100
* Drug: Vehicle
* Drug: Petrolatum ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out. 2. Healthy male or female subjects, 18 to 65 years of age inclusive at screening. Exclusion Criteria: 1. Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding 2. Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. Subjects with scars, moles or other abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 90100<br> | Drug: LEO 90100<br> <br> |
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br> <br> |
| Other: Petrolatum ointment<br> | Drug: Petrolatum ointment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Cumulative Irritation index and maximal dermal response during induction phase |  | 3 weeks | 
| Number of subjects with positive sensitisation reaction at each test site in the challenge phase |  | 6 weeks |
Postpartum Contraception Counseling on the Rate of Unintended Pregnancy

Study Overview
=================
Brief Summary
-----------------
Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are also a great social and financial burden on societies and countries. According to World-health-organization statistics, there are an estimated 200 million pregnancies around the world each year, and a third of these, 75 million, are unwanted. Unintended pregnancy also is a major health problem in the United States of America. In the 2002 National Survey of Family Growth assessment, 1.22 million, or 31%, were reported as unintended. When abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all pregnancies

Official Title
-----------------
Influence of Immediate Postpartum Contraception Counseling on the Rate of Unintended Pregnancy in Primigravida: A Randomized Controlled Study

Conditions
-----------------
Improving Quality of Life

Intervention / Treatment
-----------------
* Other: counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: above 18 years Primigravida Women who will accept to participate in Exclusion Criteria: Women who are not intended to use contraception Multiparous Women who refuse to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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 |
| --- | --- |
| Experimental: counseling group<br>will receive counseling about contraceptive methods using illustrations through postpartum interview with the study | Other: counseling<br> <br> |
| No Intervention: NO counseling<br>will not receive any counseling about contraceptive methods | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the rate of unintended pregnancy in both groups |  | 6 months |
Timing of Closure of Patent Foramen Ovale Following Birth

Study Overview
=================
Brief Summary
-----------------
It is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent foramen ovale by echocardiography until 6-24 months. The purpose of this study is to observe the natural profile of closure of the foramen ovale and ductus arteriosus for the first 36 hours after birth. This understanding may help to avoid unnecessary treatment and exams for newborns with findings that are natural for their stage of development.

Detailed Description
-----------------
We will observe the patency and size of foramen ovale five times within the first 36 hours of life. We will also describe the anatomy of the foramen ovale and the septum primum during this time. The direction of flow across the foramen ovale will also be observed. Other cardiac lesions will be checked for as well. We will measure the change in size of the pulmonary arteries and the closure of the ductus arteriosus.

Official Title
-----------------
Timing of Closure of Patent Foramen Ovale and Patent Ductus Arteriosus Following Birth

Conditions
-----------------
Closure of the Foramen Ovale and Ductus Arteriosus

Intervention / Treatment
-----------------
* Device: no interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any baby born in term and with normal delivery Exclusion Criteria: sick newborns in need of neonatal intensive care for any medical reason. newborns with congenital heart disease except for small, muscular ventricular septal defects

Ages Eligible for Study
-----------------
Minimum Age: 30 Minutes
Maximum Age: 4 Hours

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 |
| --- | --- |
| Healthy term newborn<br>Any healthy term newborn born in Wolfson Medical Center | Device: no interventions<br>* no interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patent Foramen Ovale size using 2 echocardiography positions, shunt direction and distance of septum primum to Superior Vena Cava |  | 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours and 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patent Ductus Arteriosus size, shunt direction and the size of the Left Pulmonary Artery, the Right Pulmonary Artery and the Pulmonary Annulus |  | 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours, 36 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patent Foramen Ovale, Patent Ductus Arteriosus, PFO, PDA
Impact of the Techniques for Intrathoracic Esophagogastric Anastomosis on Outcome in Ivor-Lewis Oesophagectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of the side-to-side stapled intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.

Official Title
-----------------
Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: side-to-side stapled esophagogastric anastomosis
* Procedure: circular-stapled esophagogastric anastomosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer of the distal esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III. Received no previous treatment for esophageal cancer Adequate bone marrow, liver and kidney function Patients must be able to understand the nature consent of the study and give written informed consent. Exclusion Criteria: Age < 18 years History of significant heart disease Inoperable on the basis of co-existent medical problems

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: side-to-side stapled esophagogastric anastomosis arm<br> | Procedure: side-to-side stapled esophagogastric anastomosis<br>* 20 patients of distal esophageal cancer receive side-to-side stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy<br>|
| Active Comparator: circular-stapled esophagogastric anastomosis arm<br> | Procedure: circular-stapled esophagogastric anastomosis<br>* 20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long and short outcome related with anastomoses | Include anastomotic leakage,anastomotic stricture,regurgitation,heartburn, dumping syndrome and anastomoses diameter. | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and function outcomes |  | 3 year |
Endoscopic Ultrasound-Guided Gastroenterostomy In Catalonia: Prospective Registry.

Study Overview
=================
Brief Summary
-----------------
This is project of help and support for the introduction of the GASTROENTEROANASTOMOSIS technique guided by ENDOSCOPIC -ULTRASOUND (EUS-GE) in centers in Catalonia, facilitating a teacher training. The main objective is facilitate a safe introduction of the technique, limiting technical failures, and if necessary, support in rescue techniques.

Official Title
-----------------
Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy In Catalonia Based On A Learning Protocol And Prospective Registry.

Conditions
-----------------
Endoscopic Surgical Procedure, Safety, Training

Intervention / Treatment
-----------------
* Device: Gastroenterostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or more Gastric outlet obstruction (GOO) caused by passable /unpassable stenosis in the antrum-duodenal region, to malignant or non-malignant conditions Patient capable of understanding and signing informed consent form Patient understanding the type of study and complying with the follow-up of complementary tests during the study's duration Exclusion Criteria: Massive ascites. Complete stenosis Failure to sign informed consent form Patients with intellectual handicap who are unable to understand the nature and possible consequences of the study, unless there is a competent legal representative Patients unable to adhere to subsequent follow-up requirements Severe coagulation disorder: INR > 1.5 not correctible with administration of plasma and/or platelets < 50,000/mm3
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Gastroenterostomy|Endoscopic ultrasound guided gastroenterostomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety introduction of EUS-gastroenterostomy | To determine the safety of this interventional technique, measuring prospectively the adverse events and incidents after after a learning project for helping to introduce this technique. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Learning curve | To assess the number of procedures related to a competence in the EUS-Gastroenterostomy | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic ultrasound, gastroenterostomy, lumen apposing stent