linjc16/ctgov huggingface dataset:
Evaluation of the Child and Family Traumatic Stress Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of the Child and Family Traumatic Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder (PTSD) when implemented within 30 days of a potentially traumatic event.

Official Title
-----------------
Evaluation of the Child and Family Traumatic Stress Intervention

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Child and Family Traumatic Stress Interv (CFTSI)
* Behavioral: Psychoeducational Comparison


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Youth exposed to a potentially traumatic event within the last 30 days who have one new symptom on the Posttraumatic Checklist (PCL) Exclusion Criteria: Already receiving mental health treatment Autism or Developmental Disability Diagnosed with psychosis or bipolar disorder Non-english speaking

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Child and Family Traumatic Stress Interv<br>4-session secondary prevention model that focuses on family communication about symptoms of a child aged 7-16. | Behavioral: Child and Family Traumatic Stress Interv (CFTSI)<br>* 4 sessions involving both the target child and a parent/caregiver<br>|
| Active Comparator: Psychoeducational Comparison<br>4-sessions focused on individual child using psychoeducation and relaxation skills | Behavioral: Psychoeducational Comparison<br>* 4 individually focused sessions including psychoeducation and relaxation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UCLA Posttraumatic Reaction Index (PTSD-RI) |  | 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trauma Symptom Checklist for Children (TSCC) |  | 3 Months post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
School age children and adolescents exposed to a potentially traumatic event
Are Corneal Epithelial Defects Related to Changes in Ocular Bacterial Flora in Patients With ANLDO

Study Overview
=================
Brief Summary
-----------------
Comparison between patients with nasolacrimal duct obstruction and healthy patients and the influence of their bacterial flora on the corneal epithelium.

Detailed Description
-----------------
Any patient with nasolacrimal duct obstruction above the age of 18 Comparing changes in their bacterial ocular flora to healthy patients without obstruction and above 18 years of age

Official Title
-----------------
To Estimate Whether Corneal Epithelial Defects Occur in Patients With Acquired Nasolacrimal Duct Obstructions is Linked to Changes Occurring Within Ocular Bacterial Flora in These Patients, and What Are the Specific Changes in Their Flora.

Conditions
-----------------
Acquired Nasolacrimal Duct Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older, nasolacrimal duct obstruction Exclusion Criteria: younger then 18 years of age ocular infections patients after repair of lacrimal duct surgery systemic active diseases patients taking medication that are know to influence bacterial flora of the eye

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| the change of ocular normal flora in patients with nasolacrimal duct obstruction as a comparison to general population. | as the literature suggests most of the ocular flora is composed of Staphylococcus and Haemophilus, any change in these composition will be considered abnormal. | 6 month |
Voice Tessitura and Size of the Required Laryngeal Mask

Study Overview
=================
Brief Summary
-----------------
The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller. The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable). I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia. Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests. The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious. This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.

Official Title
-----------------
Voice Tessitura and Size of the Required Laryngeal Mask

Conditions
-----------------
Laryngeal Masks

Intervention / Treatment
-----------------
* Other: General anesthesia with laryngeal mask i-gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 10 years Planned surgical procedure with the use of a laryngeal mask Exclusion Criteria: • Refusal to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| > 18 years<br> | Other: General anesthesia with laryngeal mask i-gel<br>* General anesthesia with laryngeal mask i-gel<br>|
| 10 to 18 years<br> | Other: General anesthesia with laryngeal mask i-gel<br>* General anesthesia with laryngeal mask i-gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between the weight and the tessitura threshold | Concordance between the size of the mask proposed as a function of the weight and that determined after determination of the tessitura threshold for each mask size by ROC curves. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the tessitura threshold corresponding to each mask size | tessitura threshold (the most serious sound emitted by the patient) corresponding to each mask size | 1 day |
Safety and Efficacy of Long-term Somatropin Treatment in Adults

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).

Official Title
-----------------
Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In need of somatropin or current user

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Users of somatropin<br> | Drug: somatropin<br>* Prescribed at the discretion of the treating physician according to product labelling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (Body Mass Index) |  | Up to 10 years | 
| HbA1c change |  | Up to 10 years | 
| IGF-I (Insulin-Like Growth Factor I) |  | Up to 10 years |
Adults With Moderate to Severe Asthma

Study Overview
=================
Brief Summary
-----------------
A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

Official Title
-----------------
A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide
* Drug: Budesonide
* Drug: Budesonide
* Drug: Budesonide
* Drug: Budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 12 or over who have asthma Ability to properly use an electronic diary Able and willing to nebulize for up to 20 minutes every morning and evening Exclusion Criteria: Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months Planned hospitalisation during the study pregnant women or women planning to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 12 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: 1<br>Pulmicort RESPULES | Drug: Budesonide<br>* 0.5mg once daily<br>* Other names: Pulmicort RESPULES;Drug: Budesonide<br>* 1mg once daily<br>* Other names: Pulmicort RESPULES;Drug: Budesonide<br>* 1mg twice daily<br>* Other names: Pulmicort RESPULES;Drug: Budesonide<br>* 2mg once daily<br>* Other names: Pulmicort RESPULES;|
| Experimental: 2<br>Pulmicort TURBUHALER | Drug: Budesonide<br>* 4.00mcg twice daily<br>* Other names: Pulmicort TURBUHALER;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg. |  | Day -14, 1, and every 28 days thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of symptom free days |  | Day -14, 1, and every 28 days thereafter | 
| Percentage of symptom free nights |  | Day -14, 1, and every 28 days thereafter | 
| Percentage of symptom free 24-hours |  | Day -14, 1, and every 28 days thereafter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Pulmicort, budesonide, respules, turbuhaler
Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX

Study Overview
=================
Brief Summary
-----------------
Patients who were diagnosed as postoperative CME and administrated with intravitreal OZURDEX injection were reviewed. Outcome will include best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT). Recurrent CME and corresponding treatments were recorded.

Detailed Description
-----------------
Patients who were diagnosed as postoperative CME after uneventful intraocular surgery and administrated with intravitreal OZURDEX injection were reviewed. All patients underwent ophthalmic examinations at the initial visit and were followed up at months 1, 2, 3 and 6 with measurement of best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT). Recurrent CME and corresponding treatments were recorded. Risk factors of recurrent CME were analyzed

Official Title
-----------------
Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX

Conditions
-----------------
Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were diagnosed as postoperative CME after successful phacoemulsification or vitrectomy and administrated with intravitreal dexamethasone implant (OZURDEX, Allergan, Inc, California, USA) injection were reviewed. Exclusion Criteria: patients with retinal vascular diseases, including retinal vein occlusion (RVO), diabetic retinopathy (DR), hypertensive retinopathy, retinal artery occlusion (RAO), Coats disease, Eales disease; patients with macular disease before surgery, such as age-related macular degeneration (ARMD), macular choroidal neovascularization (CNV), myopic macular degeneration, macular hole (MH), epiretinal membrane(ERM); patients with uveitis before surgery, including anterior, intermediate, posterior and generalized uveitis; patients with autoimmune disease, such as ankylosing spondylitis (AS), Vogt-Koyanagi-Harada (VKH) disease, Behcet disease.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with recurrent macular edema<br>after intravitreal injection of OZURDEX, patients with macular edema relapse during follow-up were recruited. | |
| patients without recurrent edema<br>after intravitreal injection of OZURDEX, patients without macular edema relapse during follow-up were recruited. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Measurement of best-corrected visual acuity (BCVA) by Snellen scale and was converted into logarithmic scale (LogMAR). | All patients underwent the examination at baseline and changes were followed up at months 1, 2, 3 and 6. |
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Eldery

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to determine the prognostic utility of established risk predictors following acute ST elevation myocardial infarction in patients over 75 years of age.

Official Title
-----------------
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Eldery

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute myocardial infarction; aged >75 years Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 76 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assessment, Risk, Autonomic nervous system, Aged
Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to determine whether statin pretreatment decrease myocardial infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.

Official Title
-----------------
Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Conditions
-----------------
Angioplasty, Transluminal, Percutaneous Coronary

Intervention / Treatment
-----------------
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset ST segment elevation more than 1 mm in two or more contiguous leads or presumably a new onset left bundle branch blockage Exclusion Criteria: Cardiogenic shock History of myocardial infarction Chronic liver disease Previous or current statin use
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 |
| --- | --- |
| Experimental: 1<br>Atorvastatin group | Drug: atorvastatin<br>* atorvastatin 80mg/day before primary coronary intervention<br>|
| No Intervention: 2<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarct size by SPECT |  | between 5 and 14 days after acute myocardial infarction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarct size measured by contrast-enhanced MRI |  | within 14 days after acute myocardial infarction | 
| Myocardial blush grade after the procedure |  | immediate after procedure | 
| complete ST resolution |  | at 60 minutes after the procedure | 
| major adverse cardiac events related to left ventricular dysfunction (death, new-onset sustained hypotension or heart failure, and hospital readmission for left ventricular dysfunction) |  | at 6 months after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarct size, Atorvastatin, SPECT, Hydroxymethylglutaryl-CoA Reductase Inhibitors
Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis

Study Overview
=================
Brief Summary
-----------------
The current study aims to explore and analyse the decision making process of couples in regards to continuing or discontinuing infertility treatment. A longitudinal, prospective cohort design is used which allows the monitoring of patients over a longer period of time. Data will be collected quantitatively (questionnaires) as well as qualitatively (in-depth interviews) to allow for a more specific and in depth experience than can be obtained by using a questionnaire study. Innovative aspects of the study include: exploration of determinants of continuing and discontinuing infertility treatment by using a comprehensive psychological theory (both surface and in-depth) exploration of gender differences in the decision making process in continuing or discontinuing treatment longitudinal and prospective arm of the study will allow to gain insight into the 'process' prediction of continuing/discontinuing treatment based on psychological variables.

Official Title
-----------------
Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Behavioral: self-report questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first IVF/ICSI treatment sufficient knowledge of Dutch to fill out questionnaires heterosexual couples Exclusion Criteria: insufficient knowledge of Dutch having had previous IVF/ICSI treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Included in questionnaire study<br> | Behavioral: self-report questionnaire<br>* validated self-report questionnaires on psychosocial determinants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychological predictors of continuing or discontinuing infertility treatment |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drop-out, predictors of treatment continuation/discontinuation, IVF/ICSI, infertility, counseling, psychology, Assisted Reproduction, Counselling