linjc16/ctgov huggingface dataset:
Pertinence of Pediatric Message Delivered to Parents During Antenatal Consultations

Study Overview
=================
Brief Summary
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Antenatal consultations are experienced as traumatic for many couples. Moreover, when informations are given urgently ; comprehension and psychological impact aren't well evaluate. This project aims to evaluate comprehension and psychological impact, for both members of the couple, when informations are provided urgently or during usual consultations.

Official Title
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Pertinence of Pediatric Message Delivered to Parents During Antenatal Consultations

Conditions
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Information Understanding and Psychological Impact

Intervention / Treatment
-----------------
* Other: Pediatric consultation's survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents whom pregnancies need antenatal pediatric consultation Non opposition Exclusion Criteria: < 18 years old Psychiatric illness

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 |
| --- | --- |
| Parents after pediatric antenatal consultation<br>Survey after pediatric antenatal consultation, for both members of couple if possible | Other: Pediatric consultation's survey<br>* Realization of a pediatric consultation. At the end, evaluation of comprehension and psychological impact with a survey (completed by parents).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehension and psychological impact ; urgently informations compared with usual consultations | After non opposition, surveys are given to parents Scale built by investigators. With items about comprehension and psychological impact. From 0 to 23. One point per item. Higher values (23/23) represent a better outcome (comprehension and good psychological impact (0/23 if not)). | At pregnancy follow-up visit up to 36 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between both members of the couple | Same survey for both members, evaluation and comparison of answers. Same scale | At pregnancy follow-up visit up to 36 weeks gestation | 
| Comprehension and psychological impact, at pregnancy's theoric term compared with first survey Same scale | Same survey, realized at pregnancies' theoric terms | At delivery at 41 weeks gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric consultation, psychological, comprehension
Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.

Detailed Description
-----------------
A sufficient number of subjects will be enrolled to achieve a required minimum of cell culture-positive specimens for each sample type, nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. The 510(k) study will include combined results from all sites and require the following for all three sample types: a minimum of 50 fresh positive results for influenza A, and 30 fresh positive results for influenza B. The CLIA Waiver submission will include combined results from all sites for a total of 120 positive specimens for both influenza A and influenza B. The nasal swab will be the primary sample type planned for the CLIA Waiver submission. However, depending upon the prevalence of influenza, nasopharyngeal swab and/or nasopharyngeal aspirate/wash may also be submitted for CLIA Waiver.

Official Title
-----------------
Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study

Conditions
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Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, of all ages (assuming appropriate consent is obtained). Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI). For example: Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days. Nasal congestion Rhinorrhea Sore throat Cough Headache Myalgia Malaise Exclusion Criteria: Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days. Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Investigational testing<br>Pending the outcome of culture, the subject may be treated with an approved antiviral medication at the doctors discretion. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of infection with influenza | Accurate diagnosis of infection with influenza A or influenza B confirmed by culture | 15 minutes |
To Test The Relative Bioavailability Of PF-04191834 When Dosed As An Immediate Release Tablet Compared With Solution Following Single And Multiple Dosing

Study Overview
=================
Brief Summary
-----------------
To test the relative bioavailability of PF-04191834 when dosed as an Immediate Release tablet compared with solution following single and multiple dosing.

Official Title
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An Open Randomised 4-Way Crossover Single Dose And A Parallel Group Multiple Dose Comparative Pharmacokinetic Study Of The PF-04191834 Phase 2 Tablet And The Phase 1 Dispersion Formulations.

Conditions
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Asthma

Intervention / Treatment
-----------------
* Drug: PF-04191834


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Body Mass Index (BMI) of approximately 17.5 kg/m2 to 30.5 kg/m2 and a total body weight > 50 kg (110 lbs). An informed consent document signed and dated by the subject or a legally acceptable representative. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Subjects who have urinary LTE4 levels greater than or equal to 30 pg/mg Creatinine at screening following spot urinary collection for Cohort 2. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Any condition possibly affecting drug absorption (eg, gastrectomy). A positive urine drug screen.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| relative bioavailability<br> | Drug: PF-04191834<br>* PF-04191834. 100mg Immediate Release Tablets or oral suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic parameters of PF-04191834 |  | hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum concentration |  |  |
Platelet Function on Abacavir and Tenofovir

Study Overview
=================
Brief Summary
-----------------
This is a small observational study aimed at observing differences in platelet function in HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation between platelet activation and cardiovascular disease- this study will act as a pilot to see if platelet activation among abacavir users may explain the correlation between abacavir and cardiovascular disease in HIV positive patients. This study will enroll 44 participants total; 22 on abacavir-based treatment, 22 on tenofovir-based treatment. There is only one study visit which includes a blood draw, physical assessment, and review of medical history.

Official Title
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Differences in Platelet Function in Patients on Abacavir Versus Tenofovir Based Antiretroviral Regimens

Conditions
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Cardiovascular Diseases, Platelet Aggregation, Spontaneous, HIV/AIDS

Intervention / Treatment
-----------------
* Diagnostic Test: Platelet aggregation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive Stable antiretroviral regimen for > 3months containing either abacavir or tenofovir Suppressed HIV viral load Exclusion Criteria: Current cigarette smoking Pre-existing platelet disorder current or recent (last 6 months) antiplatelet therapy pregnancy

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 |
| --- | --- |
| Abacavir Group<br>HIV positive individuals currently taking an abacavir based regimen | Diagnostic Test: Platelet aggregation<br>* Platelet aggregation<br>|
| Tenofovir Group<br>HIV positive individuals currently taking a tenofovir based regime | Diagnostic Test: Platelet aggregation<br>* Platelet aggregation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation | Degree of platelet aggregation in response to adenosine diphosphate | At screening visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Markers of coagulation | sGPVI | At screening visit | 
| Plasma Markers of Coagulation | sPSelectin | At screening visit | 
| Plasma markers of endothelial function | sICAM | At screening visit |
Understanding and Diagnosing Allergic Disease in Twins

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain better understanding of how the immune system works in twins with and without allergic disease. Healthy volunteers are not specifically targeted. Healthy non-allergic study participants may be found through the course of evaluation for the presence of allergies.

Detailed Description
-----------------
The purpose of this study is to study the genetic control and gain better understanding of how the immune system works in twins with and without allergic disease. Although healthy volunteers are not specifically targeted, they might be identified when non-allergic study participants are found through the course of evaluation for the presence of allergies.

Official Title
-----------------
Understanding and Diagnosing Allergic Disease in Twins

Conditions
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Allergies

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Twin participants ages 0 to 80 years who are with or without allergy disease. Exclusion Criteria: Patients with special risks attendant to venipuncture will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 80 Years

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 |
| --- | --- |
| Twins<br>Twins that are ages 0 to 80 years, with or without allergy disease. | Other: No Intervention<br>* This study does not involve any intervention other than obtaining blood, nasal/cheek/throat/skin swabs, saliva, sputum, urine, and stool samples, breathing and skin tests.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing immune systems of food allergic twins | Differences in genetic and phenotypic characteristics between twin siblings | 2 years |
Prevention of Human Papillomavirus (HPV) Infection in Paediatric Kidney and Liver Transplant Recipients and in Paediatric Patients With Advanced Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Due to their immunosuppressive therapy, solid-organ transplant (SOT) recipients bear a 10 to 100 times higher risk of human papillomavirus (HPV)-associated malignancies than healthy individuals. The objectives of this observational, non-interventional multi-national, multi-centre research project are to gain an insight into current HPV vaccination strategies and to investigate the immune response to different routinely administered HPV vaccines in European paediatric SOT candidates and immunocompromised transplant recipients, enabling patients at risk of vaccination failure to be identified.

Official Title
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Prevention of Human Papillomavirus (HPV) Infection in Paediatric Kidney and Liver Transplant Recipients and in Paediatric Patients With Advanced Chronic Kidney Disease: a Prospective, Observational Multi-centre Vaccine Surveillance Study (HPVaxResponse Study)

Conditions
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Paediatric Kidney or Liver Transplantation, Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paediatric Kidney and/or Liver transplant recipients Paediatric patients with CKD Who receive HPV vaccination according to country-specific vaccine schedule Exclusion Criteria: No HPV vaccination according to country-specific vaccine schedule No written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 9 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 |
| --- | --- | --- |
| Immune Response to HPV vaccine | HPV vaccine antibodies | Change of immune response from baseline (prior to vaccination) to 4-12 weeks after vaccination and to 18+- 3 months after vaccination will be assessed. |
Shortened Preoperative Fasts in ICU

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial assessing the safety and benefits of shortening preoperative fasts on intubated ICU patients undergoing tracheotomy.

Detailed Description
-----------------
Patients undergoing bedside tracheotomy in an ICU are enrolled and randomized into two groups. Arm A receive a standard fast of at least 6 hours. Arm B receive a shortened fast of only 45 minutes, just before the surgery begins. Patients will be monitored for aspiration, pneumonia and our ability to delivery better nutrition as a result of the intervention.

Official Title
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Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy

Conditions
-----------------
Intubated ICU Patients

Intervention / Treatment
-----------------
* Other: shortened fast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult, proxy available for consent Exclusion Criteria: pregnant, <18yo, cannot tolerate enteral feeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A - control<br>standard fast, at least 6 hours prior to tracheotomy | |
| Experimental: B - shortened fast<br>fast of only 45 minutes prior to incision | Other: shortened fast<br>* fast of 45 minutes prior to surgery as opposed to standard 6 hour fast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calories delivered | Calories delivered before and after surgery | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspiration | intraoperative or postoperative aspiration | 5 days |
The Community United to Challenge Asthma

Study Overview
=================
Brief Summary
-----------------
This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education on two risk factors for asthma exacerbations in high-risk Puerto Rican children in high school. The self-management intervention will be a series of home visits provided by Puerto Rican community health workers. During home visits, the family will be educated using a standard asthma Core Curriculum which is tailored to individual needs, strengths, and beliefs. Specific Aim 1 is to test the ability of this tailored community health worker self-management intervention to reduce home asthma triggers and increase medication adherence in Puerto Rican adolescents with asthma. Specific Aim 2 is to test if any changes in triggers and adherence associated with this intervention are sustained 8 months after the completion of the active intervention. Another goal of the study is to build community capacity for asthma management in the target high-risk community.

Official Title
-----------------
A Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans

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

Intervention / Treatment
-----------------
* Behavioral: community health worker
* Behavioral: mailed information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Puerto Rican In high school Have asthma Exclusion Criteria: More than 18 years old In last year of school Mild intermittent or controlled asthma

Ages Eligible for Study
-----------------
Maximum Age: 18 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: community health worker<br>community health workers will provide education in the home | Behavioral: community health worker<br>* community health workers will provide education in the home<br>|
| Active Comparator: mailed information<br>information will be mailed to the home on the same schedule as the experimental intervention | Behavioral: mailed information<br>* information will be mailed to the home on the same schedule as the experimental intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma medication adherence |  | before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma trigger reduction |  | before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance) |