linjc16/ctgov huggingface dataset:
Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent B. pertussis infection between 8%--26% have been reported among adults with cough illness of at least 5 days duration who sought medical care. The CDC recommends vaccinating patients aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have been evaluated in healthy population, the safety and efficacy of this vaccine in patients suffering from rheumatic diseases have not been established. Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood will be drawn at each visit at tested for humoral response to tetanus and pertussis.

Official Title
-----------------
The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from RA Aged 18 to 64 years old Exclusion Criteria: Active disease requiring a change in drug regimen Known allergy to vaccine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tdap vaccination<br>Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine) | Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)<br>* a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of Tdap in patients suffering from rheumatoid arthritis | Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria | 4-6 weeks after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Tdap vaccine in RA patients | Safety will be evaluated using the disease activity score (DAS) at baseline and 4-6 weeks later | 4-6 weeks after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid pertussis tetanus
Integrated Treatment for Youth With Mood Disorders

Study Overview
=================
Brief Summary
-----------------
In an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to: evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity); evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.

Official Title
-----------------
Healthy Youth & Families: An Integrated Approach to Treating Mood Disorders

Conditions
-----------------
Mood Disorders in Children and Adolescents

Intervention / Treatment
-----------------
* Behavioral: Family-based treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents between the ages of 10 and 18 years; Diagnosed with a primary depressive or bipolar disorder; Admitted to the Child and Adolescent Integrated Mood Program (CAIMP) at Mayo Clinic. Exclusion Criteria: Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: two-week family-based treatment<br>Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design. | Behavioral: Family-based treatment<br>* 2-week family-based treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conner's Comprehensive Behavior Rating Scales | Likert scale items measuring symptom presentation | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, bipolar, caregivers, children, adolescents, treatment, parents
The Attitudes and Behaviors of Gastroenterology Specialists on Anesthesia Procedures in Endoscopy Units

Study Overview
=================
Brief Summary
-----------------
Most gastrointestinal endoscopic procedures are now performed with sedation and analgesia. Sedation and analgesia affects the quality of the procedure, patient co-operation and compliance as well as endoscopist's satisfaction. A wide variety of procedures have been reported worldwide for anesthesia during gastrointestinal endoscopy in adults. The current survey was primarily designed to provide national data on the attidutes and behaviors of gastroentorologist on anesthesia procedures in endoscopy units in Turkey.

Detailed Description
-----------------
Most gastrointestinal endoscopic procedures are now performed with sedation and analgesia. Sedation and analgesia affects the quality of the procedure, patient co-operation and compliance as well as endoscopist's satisfaction. Despite the use of numerous sedation and analgesic techniques for GI endoscopy procedures, the best method is still controversial. A wide variety of procedures have been reported worldwide for anesthesia during gastrointestinal endoscopy in adults.The current survey was primarily designed to provide national data on current sedation and monitoring practices that was carried out during gastrointestinal endoscopy. Secondary objectives were to provide data on the endoscopic application of the turkish gastroenterologist. The questionnaire consisting of 20 questions about the anesthesia methods applied in the procedures in the endoscopy unit will be sent to 1000 gastroenterologists registered in the Turkish Gastroenterology Association by e-mail. The questionnaire is covered the demographic data, types of endoscopic procedures and anesthesia methods applied, anesthetic agents, monitoring methods, anesthesia team, preanesthetic evaluation and consent forms, recovery unit and complications and interventions during anesthesia.

Official Title
-----------------
A Survey Investigating the Attitudes and Behaviors of Gastroenterology Specialists on Anesthesia Procedures in Endoscopy Units in Turkey

Conditions
-----------------
Attitude, Staff, Behavior, Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a Gastroenterology specialist Exclusion Criteria: -
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 |
| --- | --- | --- |
| gastroenterology specialists' anesthesia choices | questions to know their current anesthesia and monitoring practices during endoscopic procedures | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation, endoscopy, anesthesia, gastroenterologist
A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Multicenter Study to Evaluate the Safety and Efficacy of CLS001 Topical Gel Versus Vehicle Applied Once Daily for 12 Weeks to Female Subjects With Moderate to Severe Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Omiganan (CLS001) Topical Gel
* Drug: Vehicle Topical Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline. Subjects with ≥ 30 facial inflammatory lesions Exclusion Criteria: Subjects with < 10 or > 75 facial non-inflammatory lesions Subjects with > 3 facial nodular or cystic lesions at Baseline Standard exclusion criteria

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Omiganan (CLS001) Topical Gel applied once daily | Drug: Omiganan (CLS001) Topical Gel<br> <br> |
| Placebo Comparator: Vehicle Gel<br>Vehicle Topical Gel applied once daily | Drug: Vehicle Topical Gel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in inflammatory lesion counts at week 12 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions |  | 12 weeks | 
| Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit |  | 12 weeks | 
| Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit |  | 12 weeks | 
| Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit. |  | 12 weeks |
ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.

Official Title
-----------------
A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Drug: Mixed salts of a single-entity amphetamine
* Drug: Atomoxetine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary diagnosis of ADHD not naive to pharmacologic ADHD treatment valid driver's license with a minimum of 3 years driving experience Exclusion Criteria: recent history of drug dependence or substance use disorder any specific cardiac condition that would, in the opinion of the investigator, require exclusion history of seizure in last 2 years, tic disorder or Tourette's disorder female subject is pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 25 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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mixed salts of a single-entity amphetamine|nan|
|Drug: Atomoxetine hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Driving Safety Score derived by the driving simulator |  | Weeks 3 & 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Driving Safety Scores at individual time points |  | 2, 7, and 12 hours post-dose at Weeks 3 & 6 | 
| Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire |  | Weeks 3 & 6 | 
| AEs, laboratory screens, PE, vital signs, ECG |  | 6 weeks |
Effects of PEEP and FIO2 in ALI and ARDS

Study Overview
=================
Brief Summary
-----------------
Current American-European Consensus Conference (AECC) definitions for ALI and ARDS are inadequate for inclusion into clinical trials due to the lack of standardization for measuring the oxygenation defect. We questioned whether an early assessment of oxygenation on specific ventilator settings would identify patients with established ARDS (persisting over 24h).

Detailed Description
-----------------
We designed this study to determine whether standard ventilator settings applied on the day ARDS is identified (Day 0) or 24 hours (Day 1) later: (1) would have an impact on the reclassification of patients into ALI or ARDS, and (2) would identify groups with different clinical outcomes. Our hypothesis was that the assessment of PaO2/FiO2 on standard ventilator settings 24 hours after patients originally met the AECC definition of ARDS would identify patients with established ARDS (persisting over 24 h) from others with different degrees of lung injury. If this hypothesis is supported, it would suggest that patients with a better outcome could have been preferentially entered into one group of previously conducted clinical trials, resulting in a viable therapy being proved useless or useless therapy proven viable.

Official Title
-----------------
Effects of PEEP and FiO2 in the Evaluation of Severity of ALI and ARDS

Conditions
-----------------
Acute Respiratory Distress Syndrome, Acute Lung Injury, Acute Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: standard ventilatory settings
* Procedure: PEEP and FiO2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients meeting American-European Consensus Conference (AECC) ARDS criteria were approached for enrollment regardless of their current status or past medical history. Exclusion Criteria: The only patients excluded were those in which >24 hrs had pasted after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: standard ventilatory settings|nan|
|Procedure: PEEP and FiO2|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
-----------------
ALI, ARDS, Mechanical Ventilation, Outcome
Netrin-1 and Placenta Accreta

Study Overview
=================
Brief Summary
-----------------
Netrin-1 is a secreted protein, which was first identified as a neuronal guidance factor. It is expressed in a multitude of tissues as pancreas, lung, breast, and placenta. Netrin-1 is a multifunctional protein, involved in cell polarity, adhesion, angiogenesis, apoptosis, migration, morphogenesis, and differentiation of various cell types. Most of netrin-1 activity occur through signaling pathways induced by its two main receptors, DCC (deleted in colorectal cancer) and UNC5H (uncoordinated-5 homolog). Its receptors have been linked to the processes of apoptosis and angiogenesis. In absence of netrin-1, DCC and UNC5H receptors lead to apoptosis. In contrary, in presence of netrin-1, receptors transduce molecular cascades leading to proliferation, differentiation and migration of the cells. Netrin-1 has been involved in the pathogenesis of multiple diseases, as diabetes, cardiovascular diseases, and cancer. Serum Netrin-1 levels were high in preeclamptic patients.

Official Title
-----------------
The Implication of Placental Netrin-1 Receptor DCC in the Pathophysiology of Placenta Accreta

Conditions
-----------------
Placenta Accreta

Intervention / Treatment
-----------------
* Other: Pregnant women at 28-32 weeks
* Other: at delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20-40 years. Singleton pregnancy. Women with suspicion of PA by two-dimensional (2D) gray scale imaging and color Doppler flow mapping Exclusion Criteria: Multiple pregnancy, Fetal anomalies, Preterm premature rupture of membranes, or infection Any medical disorders, such as thyroid dysfunction, hypertension, and gestational diabetes Patients with known bleeding disorders or on anticoagulant therapy.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal pregnancy group<br> | Other: Pregnant women at 28-32 weeks<br>* Pregnant women at gestational age 28-32 weeks<br>Other: at delivery<br>* women delivered at term<br>|
| Other: Placenta accreta group<br> | Other: Pregnant women at 28-32 weeks<br>* Pregnant women at gestational age 28-32 weeks<br>Other: at delivery<br>* women delivered at term<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placental Netrin-1 level | will be measured by using enzyme-linked immunosorbent assay (ELİSA) in placental homogenate | 4 weeks |
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis

Study Overview
=================
Brief Summary
-----------------
To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)

Official Title
-----------------
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Biological: BAY14-2222_Kogenate-FS FVIII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, 2-<18 years Hemophilia A, based on documented prior testing and/or screening laboratory Patients who had received regular prophylaxis/bleeding prevention treatment, totally/partially with rFⅧ. Regular prophylaxis/bleeding prevention treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment weeks≥80%[10] , and total duration ≥12 weeks. During the regular prophylaxis period, if there were consecutive 4 weeks that <2 infusion/week, the beginning day of the 4 weeks is defined as the end of regular prophylaxis. Available patient medical data record Written informed consent by parent/legal representative. Consent should be sought from subjects if appropriate Exclusion Criteria: Patients with measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation (≥0.6BU by Bethesda assay at two different time points, documentation must be available) Any individuals with another bleeding disease that is different from hemophilia A (e.g, von Willebrand disease, hemophilia B)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Chinese hemophilia A pediatric patients with medical records who had accepted regular prophylaxis, totally/partially with rFⅧ between Nov. 1st 2007 and May 31st 2013 | Biological: BAY14-2222_Kogenate-FS FVIII<br>* Depends on Doctor's decision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of regular prophylaxis |  | Up to 1.5 years | 
| Prophylaxis infusion dose |  | Up to 1.5 years | 
| Percentage of rFVIII usage in prophylaxis |  | Up to 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding frequency |  | Up to 1.5 years | 
| Joint radiographic score |  | Up to 1.5 years | 
| Joint physical examination score |  | Up to 1.5 years | 
| Quality of life by questionnaire |  | Up to 1.5 years |