linjc16/ctgov huggingface dataset:
Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
Interventional, comparative, open label, single-center study to demonstrate that an early (from 6 months of age) and systematic (every 6 months) screening of Obstructive Sleep Apnea (OSA) by polysomnography (PSG) in children with Down Syndrome during the first 3 years of life is associated with an improved neurocognitive development at the age of 3 years.

Official Title
-----------------
Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome

Conditions
-----------------
Down Syndrome, Obstructive Sleep Apnea of Newborn

Intervention / Treatment
-----------------
* Diagnostic Test: Polysomnography (PSG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Down Syndrome Age 6 months or less for the Study Group Age 30 to 36 months for the Standard Care Group Living in Paris or Paris area (75, 77, 78, 92, 93, 94, 95) Parents or legal representative agreeing with the study requirements and able to understand, date and sign the informed consent form before study enrollment French language is native mother tongue Exclusion criteria : Gestationnel age < 36 completed amenorrhoea weeks Patient who have or had acute CNS suffering signs Patients with Down Syndrome already had continuous positive airway pressure treatment for OSA Patients participating in another clinical study or for whom a participation to another biomedical research is expected before the end or their follow-up

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 3 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional, comparative, open label, multi-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study group<br>Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years. | Diagnostic Test: Polysomnography (PSG)<br>* PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years<br>|
| Other: Standard Care Group<br>Will have a single PSG at home which will give a reference in the Down Syndrome population of 3 years old and will be used as reference to the study group | Diagnostic Test: Polysomnography (PSG)<br>* PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Griffith Mental Development Scale (GMDS) scores | Mean Griffith Mental Development Scale (GMDS) scores at the age of 3 years will be compared between the 2 groups | At the age of 3 years |
Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)

Study Overview
=================
Brief Summary
-----------------
To determine which of 2 doses of dapsone is effective prophylaxis for Pneumocystis carinii pneumonia (PCP) in patients with oral thrush or hairy leukoplakia and less than 400 CD4 lymphocytes per mm3. To determine whether the long-term toxicities associated with daily dapsone in this population are tolerable.

Official Title
-----------------
Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Dapsone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria The patient must have HIV positive antibody test and presence of oral thrush or hairy leukoplakia. Patient must be willing and able to sign informed consent. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Prior Pneumocystis carinii pneumonia (PCP) or AIDS-defining condition. Prophylaxis for PCP in preceding 3 months. Absence of detectable glucose-6-phosphate dehydrogenase (G6PD) activity. Prior type I hypersensitivity (anaphylaxis, urticaria, angioedema) or exfoliative dermatitis during treatment with dapsone. History of poor compliance. Concurrent Medication: Excluded: Zidovudine (AZT). Patients with the following are excluded: Prior Pneumocystis carinii pneumonia (PCP) or AIDS-defining condition. Prophylaxis for PCP in preceding 3 months. Absence of detectable glucose-6-phosphate dehydrogenase (G6PD) activity. Concurrent or prior therapy with zidovudine (AZT). Prior type I hypersensitivity (anaphylaxis, urticaria, angioedema) or exfoliative dermatitis during treatment with dapsone. History of poor compliance. Prior Medication: Excluded: Zidovudine (AZT).

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dapsone|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
-----------------
Dapsone, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Leukoplakia, Oral, AIDS-Related Complex, Candidiasis, Oral
Prevention of School Dropout for Mexican American Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the efficacy of a family-based psychosocial intervention to prevent school disengagement and reduce the incidence of depression, conduct disorders, and school dropout for Mexican American adolescents.

Detailed Description
-----------------
Mexican American adolescents are at an increased risk for interrelated problems of poor mental health and school dropout. Unfortunately, there is a lack of interventions specifically designed to address this risk. This study will evaluate a preventive intervention for low-income Mexican American adolescents. Participants are randomly assigned to either a multi-component intervention called the Bridges to High School Program or a Low Dose Workshop. The 11-week multi-component intervention takes place during the fall semester of seventh grade and consists of an adolescent group, a parenting group, a combined (parent-adolescent) family group, and a school liaison. This intervention focuses on adolescent coping skills, parenting practices, family cohesion, and parental support for education. The Low-Dose Workshop consists of a 3-hour workshop in which adolescents and parents are given information and resources to facilitate school engagement. Participants are assessed prior to and immediately following the intervention and again in eighth and ninth grade. Academic and mental health outcomes are measured with questionnaire-based interviews given to caregivers and adolescents. Teachers are asked to complete questionnaires; archival school data are also collected. Diagnostic interviews are conducted at the ninth grade assessment.

Official Title
-----------------
Preventive Intervention for Mexican American Adolescents

Conditions
-----------------
Depression, Conduct Disorder

Intervention / Treatment
-----------------
* Behavioral: Bridges to High School Project


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Mexican American adolescent with at least one primary caregiver Enrolled in seventh grade in one of four inner-city schools Adolescent and participating caregivers must be able to receive intervention in the same language (English or Spanish) Exclusion criteria: High risk for suicide

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 Years

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Bridges to High School Project|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective, single center data collection to assess bleeding and vascular complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral Introducer is used for vascular access.

Detailed Description
-----------------
This study is intended to collect data on the rate of vascular complications in subjects having transfemoral TAVI when the SoloPath® Balloon Expandable TransFemoral Introducer is used as a guide for introduction and delivery of TAVI devices. The use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with TAVI and further enhance the safety of accessing the femoral delivery route. In addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following TAVI.

Official Title
-----------------
A Single Center, Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications After Transcatheter Aortic Valve Implantation

Conditions
-----------------
Vascular Access Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have undergone a TAVI procedure with femoral access achieved with a 19Fr (ID) SoloPath (STFI) sheath. Male or female ≥ 18 years old. Exclusion Criteria: Subjects with Femoral or Iliac vessels less than 6mm on side of TAVI access will be excluded. Subjects treated before January 1, 2011, are excluded from this analysis.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SoloPath Sheath<br>The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular Access Site Complications | Rate of VARC-2 defined vascular complications within 30 days of TAVI. | withn 30 days of TAVI procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding Complications at the Access Site | VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding | within 30 days of TAVI procedure |
The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effects of subconjunctivally injected bevacizumab in patients with diffuse diabetic macular edema.

Detailed Description
-----------------
At baseline, the macular thicknesses of both eyes of the patients with persistant diabetic macular edema were measured by optical coherence tomography. After 3.75mg bevacizumab was injected into subconjunctival space of the eyes with diabetic macular edema. The measurements of the macular thicknesses were repeated by optical coherence tomography in 15th, 30th, 60th day after injections. The macular thickness measurements before and after injection were compared.

Official Title
-----------------
The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

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

Intervention / Treatment
-----------------
* Drug: Subconjunctival bevacizumab (Altuzan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having diffuse diabetic macular edema persisted at least 1 month No intravitreal injection in last 3 months. No retinal laser photocoagulation in last 6 months Not have any other macular disease causing macular edema Exclusion Criteria: Having ischemic macula Intravitreal injection in last 3 months. Retinal laser photocoagulation in last 6 months Have any other macular disease causing macular edema

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diabetic macular edema<br>Bevacizumab (Altuzan) was injected subconjunctival space of the patients. | Drug: Subconjunctival bevacizumab (Altuzan)<br>* Subconjunctival injections of Altuzan 3.75mg were applied in order to eliminate the macular edema.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Macular Thickness |  | one year (between May 2015 and May 2016) |
Intra-op POCUS for Identification of Endotracheal Tube Position in the Pediatric Population

Study Overview
=================
Brief Summary
-----------------
Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube (ETT) placement by anesthesiologists. Multiple studies have shown that  19% of all intubations result in inappropriate ETT placement. An adult study has shown that ultrasound point-of-care is superior to auscultation in determining the location of ETT. This study aims to determine if point-of-care is useful in determining ETT position in children.

Detailed Description
-----------------
Patients scheduled to have a procedure in the cardiovascular laboratory where fluoroscopy is routinely used will also undergo a point-of-care ultrasound exam to determine endotracheal tube position. An anesthesiologist will perform the ultrasound exam.

Official Title
-----------------
Intraoperative Point-of Care Ultrasound for Identification of Endotracheal Tube Position in the Pediatric Population

Conditions
-----------------
Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Intervention / Treatment
-----------------
* Device: Point-of-care ultrasound exam
* Radiation: Reposition ETT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children birth to 10 years of age; undergoing cardiac catheterization in the cath lab; general anesthesia with an endotracheal tube; subjects will also receive a chest x-ray as standard of care Exclusion Criteria: children ages birth to 10 years undergoing cardiac catheterization under GA without an endotracheal tube; emergency procedures; known airway anomalies; children who are non-English and non-Spanish speaking -

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum 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 |
| --- | --- |
| ultrasound exam<br>Child undergoing procedure in CVL requiring ETT and CXR as standard of care - received point-of-care ultrasound exam as part of the study | Device: Point-of-care ultrasound exam<br>* No intervention<br>* Other names: POC ultrasound;Radiation: Reposition ETT<br>* ETT will be repositioned based on CXR by fluoroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal Tube Position | The primary outcome marker for this study was the correlation between the weighted POCUS measurement of TT location and the weighted fluoroscopy measurement of TT location | through study completion, an average of 1 year |
N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France

Study Overview
=================
Brief Summary
-----------------
Non-interventional study to investigate the safety and tolerability of allergy immunotherapy ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (>18 years) with house dust mite allergy over a period of 12 months.

Detailed Description
-----------------
Condition: persistent moderate to severe HDM allergic rhinitis despite use of symptom-relieving medication HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment.

Official Title
-----------------
Non-interventional Study on the Safety and Use of Allergy Immunotherapy ACARIZAX® 12 SQ-HDM in Real-life Clinical Practice in Adult Patients With House Dust Mite Allergy in France

Conditions
-----------------
Allergic Rhinitis Due to House Dust Mite, Allergic Asthma Due to Dermatophagoides Farinae, Allergic Asthma Due to Dermatophagoides Pteronyssinus

Intervention / Treatment
-----------------
* Drug: Tablet, Dispersible


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At the discretion of the investigator, patient who will be prescribed ACARIZAX® in line with the approved Summary of Product Characteristics (SmPC) and who have been informed, after explicit written explanation and willing to participate in the study by signed consent Exclusion Criteria: Patient who did not have 12 months prior inclusion or have an on-going, House Dust Mite (HDM) Allergy Immunotherapy (AIT).

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tablet, Dispersible|1 tablet/day with 12 SQ-HDM per lyo-tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety analysis: Number of patients with at least one Adverse Event | Number of patients with at least one Adverse Events related to ACARIZAX®. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy, Allergic Rhinitis, Allergic Asthma, House Dust Mite, Immunotherapy
Validity and Reliability of the Baby Preparation and Worry Scale

Study Overview
=================
Brief Summary
-----------------
Background: Reliable and valid measurement tools are needed to capture key components of prenatal distress, including anxiety and anxiety states that may put women and children at increased risk in the postpartum period. Aim: The aim of this study is to determine the validity and reliability of the Baby Preparation and Worry Scale (Baby-PAWS), by adapting it to Turkish culture. .

Official Title
-----------------
Turkish Validity and Reliability of the Baby Preparation and Worry Scale

Conditions
-----------------
Mothers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Women who were married, older than 18 years, at least primary school graduates, in the third trimester of pregnancy and who accepted participation in the study were included. Exclusion Criteria: - Pregnant women with chronic disease and psychiatric disease history were not included in the research.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baby Preparation and Worry Scale (Baby-PAWS) developed by Erickson et al. to Turkish culture and perform validity and reliability studies to contribute a new scale tool specific to this field to the literature |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant Preparation, Worry, Mother health, Assessment Tool, Validity and Reliability,