linjc16/ctgov huggingface dataset:
Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.

Study Overview
=================
Brief Summary
-----------------
Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions, sometimes life-threatening. Thus, priority is given to urgent somatic care, children medicalization is strong, invasive technics have to be used, and medical monitoring is close. A stay in PICU often leaves a painful memory to the child and family, and can lead to psychological morbidity such as post-traumatic stress disease. This study aims to assess parents' experience during their child hospitalization in PICU, and the impact of this stay on the entire family in the following month.

Official Title
-----------------
Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.

Conditions
-----------------
Intensive Care Unit Syndrome

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent (mother or /and father) of a recovered child in PICU. No limit of age, disease or admission mode. First stay in PICU, for at least a 3 days stay. Parents having been informed and having accepted the participation in the study. Exclusion Criteria: Death of the child during the stay in PICU or during the month following the discharge from PICU Non-fluent french speakers/readers.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Parents will be recruited in a Pediatric Resuscitation Department of the Mother and Child Hospital for 3 months. The doctor taking care of a child and his parents meeting the eligibility criteria will distribute, during the stay, a questionnaire accompanied by a pre-stamped envelope to the two parents not opposing the study. A phone call and / or an email reminder by the intern in the month of the exit will invite each parent to return the questionnaire. The completed questionnaire will be mailed back by the parents using the pre-stamped envelope.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyse qualitatively the parents'experience during the PICU stay of their child | Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale) | 1 month | 
| Assessment of the impact on the family of this PICU stay of their child | Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale) | 1 month |
Study of the Pathogenesis of Rett Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS). II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive a comprehensive clinical evaluation including an ophthalmologic exam; speech, communication, and developmental assessment; nutritional evaluation; neurologic exam; respiratory monitoring; and cytogenetic studies. Selected patients with malnutrition are given night feedings of Pediasure with Fiber by nasogastric tube. Specific recommendations for feeding techniques and diet are made. Selected patients with seizures or severe hyperventilation and progressive rigidity are nonrandomly assigned to dextromethorphan or topiramate therapy. Oral dextromethorphan is maintained 6 months to 1 year; duration of therapy depends on response. Oral topiramate is given for 6 months to 1 year, and Aricept for 6 months to 1 year. Concurrent anticonvulsants may require dose adjustments while on above protocols. Supportive care for constipation, scoliosis, and weight loss is allowed.

Conditions
-----------------
Rett Syndrome

Intervention / Treatment
-----------------
* Drug: dextromethorphan
* Drug: topiramate
* Drug: Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Rett syndrome Diagnosis confirmed on study

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dextromethorphan|nan|
|Drug: topiramate|nan|
|Drug: Donepezil|nan|

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
-----------------
Rett syndrome, neurologic and psychiatric disorders, rare disease
Protocols for Prevention of PPH During CS in High Risk Group

Study Overview
=================
Brief Summary
-----------------
PPH is one of the most leading causes of maternal mortality,. It means loss of 500 ml blood after vaginal delivery and 1000 ml blood after cesarean delivery. Although it's preventable it represents about 27%of maternal deaths. Atony is the main cause of PPH. 70%of PPH corresponds to uterine atony. Uterotonics like oxytocin, misoprostol, ergometrine, carbetocin and combinations of these drugs can be used but until now there is no agreement on medication that can be the most effective.

Official Title
-----------------
Different Protocols for Prevention of Atonic Postpartum Hemorrhage During Cesarean Delivery in High Risk Group

Conditions
-----------------
Atonic PPH

Intervention / Treatment
-----------------
* Drug: Syntocinon, papal, misotac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Pregnant full term>37 w 2. Maternal age 19- 40 3.physical state 1&2 4.patient willing to enter the study Exclusion Criteria: 1.who refuse to participate in study 2.immunocomprmized and patients who had contraindicated from any of drugs used 3.patients with hypersensitivity to any drug

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women who receive oxytocin<br> | Drug: Syntocinon, papal, misotac<br>* Using different drugs to prevent atonic PPH during CD in high risk group<br>|
| Pregnant Women who receive carbetocin<br> | Drug: Syntocinon, papal, misotac<br>* Using different drugs to prevent atonic PPH during CD in high risk group<br>|
| Pregnant women who receive misoprostol<br> | Drug: Syntocinon, papal, misotac<br>* Using different drugs to prevent atonic PPH during CD in high risk group<br>|
| Pregnant women who receive ergometrine<br> | Drug: Syntocinon, papal, misotac<br>* Using different drugs to prevent atonic PPH during CD in high risk group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of blood loss | Decrease amount of blood loss | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finding the drug most effective with least adverse effects |  | 1 year |
Application of the Propofol Precise Infusion Model

Study Overview
=================
Brief Summary
-----------------
Propofol is one of the most commonly used anesthetics in the world. However, the dose-response of propofol was remarkable variety. Herein, this study aims to investigate the possible association of gene polymorphism and propofol susceptibility, and to research more precise infusion model of this drug.

Detailed Description
-----------------
Patients undergoing gastrointestinal endoscopy will be recruited. Anesthesia is induced with propofol via TCI at 1.5µg/ml, and increases 0.5µg/ml for every 3min until OAA/S score 0. During this period, OAA/S score will be evaluated every 1min until OAA/S score 0. At this moment, the blood concentration of propofol, the doses of propofol, the onset time and BIS are recorded, and blood sample for gene polymorphism detection were required.

Official Title
-----------------
Application of the Propofol Precise Infusion Model

Conditions
-----------------
Propofol Overdose of Undetermined Intent

Intervention / Treatment
-----------------
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who undergoing gastrointestinal endoscopy with anesthesia age ≥18 years Exclusion Criteria: hepatic or kidney function injured; received hypnotic sedative drug regularly; Pregnancy, excessive drinking, or current smoker; be allergic to propofol patients who with difficulty communication

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| propofol susceptibility group<br>patients undergoing gastrointestinal endoscopy | Drug: Propofol<br>* anesthesia induction is initiated with intravenous infusion propofol at 1.5µg/ml, and increased 0.5µg/ml every 3min until OAA/S score 0.<br>* Other names: Diprivan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene polymorphism of propofol susceptibility | combination of the blood concentration of propofol (ng/ml) with the onset time(min) at OAA/S score of 0 to demonstrate propofol susceptibility, the gene polymorphism of propofol susceptibility will be detected with the blood sample of subjects. | from anesthesia induction to the end of the gastrointestinal endoscopy |
Impact of Swaddle Blanket on Gastroesophageal Reflux

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. A novel approach to the mangement of GERD in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and pH (acid) changes.

Official Title
-----------------
Impact of Swaddle Blanket on Gastroesophageal Reflux

Conditions
-----------------
Apnea, Gastroesophageal Reflux, Bradycardia, Oxygen Desaturations

Intervention / Treatment
-----------------
* Other: Swaddle Blanket


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - NICU patients who have a 5 channel study requested by the attending neonatologist - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 180 Days

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: swaddle blanket<br> | Other: Swaddle Blanket<br>* Two arms involve varying time spent in blanket<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH | all epochs of pH values below 4.0 will be measured | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea | all breathing pauses greater than 20 seconds will be noted | 24 hours |
Prediciton of the Round Window Visibility Through Posterior Tympanotomy by CT Scan Analysis

Study Overview
=================
Brief Summary
-----------------
It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery. The primary purpose of the study is to define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. Define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. The secondary purpose is to validate the investigator's scanner reading protocol for a prospective study.

Official Title
-----------------
Preoperative CT Scan Analysis to Predict Perioperative Round Window Visibility Through the Posterior Tympanotoy in Cochlear Implant Surgery

Conditions
-----------------
Tympanostomy Tube Insertion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged subject from 9 months and over Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018 Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research. Exclusion Criteria: Refusal of the patient to participate in the study CROP does not make it possible to evaluate the visibility of the FR Preoperative or uninterpretable scanner Major anatomical malformation Subject under the protection of justice Subject under guardianship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 9 Months

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 |
| --- | --- | --- |
| Measure of the correlation between preoperative CT measurements and the visibility of the round window observed intraoperatively (based on the operative records) | Analysis of patient records (operative reports and preoperative CT-scan) from patients who underwent cochlear implantation between 01/01/2010 and 01/03/2018. | 1 day after cochlear implantation surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Round window visibility, Cochlear implantation
Venous Pressure Measurement of the Great Saphenous Vein Using Controlled Compression Ultrasound in Healthy Persons and Patients With Chronic Venous Disease as a New Non Invasive Method for Investigation of the Pathophysiology in Primary Varicose Veins

Study Overview
=================
Brief Summary
-----------------
Part I: Proof of concept trial to achieve normal venous pressure values under different provocation maneuvers in healthy persons Part II: Non invasive measurement of venous pressure under different provocation maneuvers in patients with chronic venous disease

Conditions
-----------------
Chronic Venous Insufficiency

Intervention / Treatment
-----------------
* Procedure: Ultrasound (venous pressure measurement)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Part I: Healthy persons without clinical signs of venous disease, informed consent Part II: Patients with chronic venous disease with complete incompetence of the great saphenous vein (Hach IV) Informed consent Exclusion criteria: Part I: Clinical signs of venous disease, former deep vein thrombosis (DVT) Part II: Former deep vein thrombosis, former vein surgery

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: Ultrasound (venous pressure measurement)|increased venous pressure is predictive for chronic venous insufficiency|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.

Official Title
-----------------
Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Other: herbal extract; root of woody shrub grown in India/Sri-Lanka


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes Between 18 and 75 years of age Male or non-pregnant, non-lactating female, at least 6 weeks postpartum If of childbearing potential, is practicing birth control BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2 If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit Exclusion Criteria: Uses insulin for glucose control or has type 1 diabetes History of diabetic ketoacidosis. Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks. Active malignancy Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure End state organ failure or status post organ transplant History of renal disease Current hepatic disease History of severe gastroparesis Has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV Currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose Clotting or bleeding disorders Allergic or intolerant to any ingredient found in the study products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: herbal extract; root of woody shrub grown in India/Sri-Lanka|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive AUC for plasma glucose |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive AUC for serum insulin; adjusted peak values for plasma glucose and serum insulin; baseline plasma glucose and serum insulin concentrations; adjusted values for plasma glucose and serum insulin at individual postprandial time points. |  | 4 hours |
A Study of Xenical (Orlistat) in Overweight and Obese Adolescents

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is <100 individuals.

Official Title
-----------------
Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Diet and Exercise
* Drug: orlistat [Xenical]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adolescent patients, 12-14 years of age overweight or obese Exclusion Criteria: age <12 or >14 years BMI in normal range

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Diet and Exercise<br>* mildly hypocaloric diet and physical exercise<br>Drug: orlistat [Xenical]<br>* 120mg po tid<br>|
| Other: 2<br> | Behavioral: Diet and Exercise<br>* mildly hypocaloric diet and physical exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI |  | At each clinic visit, every 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, laboratory parameters |  | At each clinic visit, every 4 weeks |