linjc16/ctgov huggingface dataset:
Short- and Long Term Growth in Children With Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma

Detailed Description
-----------------
When children with asthma are treated with inhaled corticosteroids there is a risk of systemic adverse events such as growth suppression. It has been reported that treatment with budesonide 200 microgram per day does not affect short term growth in children with asthma. The aim of the present study is to assess if an unaffected short term growth means that also long term growth will be unaffected. Short and long term growth in asthmatic children treated with budesonide will be compared with the growth in asthmatic children treated with montelukast.

Official Title
-----------------
Short- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 6-11, prepubertal, asthma, normal weight and height, informed consent Exclusion Criteria: treatment with systemic/inhaled/intranasal corticosteroids within the last week, major surgery within 4 weeks, usage of drugs that significantly inhibit CYP3A4

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Budesonide | Drug: Budesonide<br>* 200µg daily<br>|
| Active Comparator: 2<br>Montelukast | Drug: Montelukast<br>* 5 mg daily<br>* Other names: Singulair;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower leg growth rate |  | one year | 
| Height |  | one year |
Rosuvastatin ORBITAL Germany

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to compare the effect of rosuvastatin therapy plus compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term cumulative direct and indirect disease-related costs during the 36 month.

Official Title
-----------------
Effects of a Twelve Months ROSUVASTATIN Treatment Plus Additional Care (Drug Intake Adherence and Lifestyle Enhancing Initiatives ) Compared to ROSUVASTATIN Treatment Alone on Long-Term Disease-Related Costs in Patients With an Indication for Statin Treatment According to the Joint European Guidelines

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high cholesterol with an indication for cholesterol-lowering medication (statins) Exclusion Criteria: contra-indications for statin therapy

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative direct/indirect disease-related costs were compared applying a societal perspective |  |  | 
| Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L) |  |  | 
| Changes in the lipid profile and compliance with therapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia, statin, compliance
Ultrasonography in Confirming Proper Position of Endotracheal Tube

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the applicability of using ultrasonography in confirmation of the position of the endotracheal tube (ETT) after intubated to patients.

Detailed Description
-----------------
To assess the applicability of using ultrasonography as compared to routine portable CXR in confirmation of ETT position. To determine the accuracy of ultrasonography in measuring the depth of ETT as compare to standard CXR method.

Official Title
-----------------
Ultrasonography in Confirming Proper Position of Endotracheal Tube in Emergency Department at Siriraj Hospital: Applicability and Accuracy

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

Intervention / Treatment
-----------------
* Device: Ultrasonography (Sonosite )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years old with either endotracheal or nasotracheal intubation having normal airway anatomy performed portable CXR after intubation Exclusion Criteria: presence in history of neck radiation, cervical spine immobility/instability unstable vital signs unwilling to participate or denial of informed consent

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 |
| --- | --- |
| Intubate<br> | Device: Ultrasonography (Sonosite )<br>* Sonosite MICROMAXXTM with linear probe L38e/10-5 MHz<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The confirmation of ETT depth | A transcricothyroid membrane view of the ultrasonography was chosen for confirmation of ETT depth measurement. Firstly, measured the distance from probe (skin) to anterior surface of ETT. Then, measured the distance from probe (skin) to balloon cuff level. Finally the depth of ETT (Distance from vocal cord to balloon cuff) was calculated by using Pythagorus rule. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The confirming the presence of ETT in airway. | A transcricothyroid membrane view was chosen for confirmation of ETT position. Various glottic structures such as True Vocal Cord (TVC), False Vocal Cord (FVC), and arythenoid cartilage can be visualized. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasonography, US, Confirming, Confirmation, Proper, Position, Endotracheal tube, ETT, Emergency department, ED, Applicability, Accuracy
Aripiprazole Oral Acceptability Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.

Official Title
-----------------
Aripiprazole Oral Acceptability Trial

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Aripiprazole
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable patients currently receiving aripiprazole or other antipsychotic medications.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: Aripiprazole<br>* Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).<br>* Other names: Abilify;|
| Experimental: A2<br> | Drug: Aripiprazole<br>* Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).<br>* Other names: Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability |  |  |
Serratus Plane Block vs Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery

Study Overview
=================
Brief Summary
-----------------
Interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. In this study, we aimed to compare the effects of serratus plane block (SPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery

Official Title
-----------------
Comparison of the Effects of Serratus Plane Block and Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery

Conditions
-----------------
Breast Cancer, Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II Age: 18 - 65 years unilateral breast surgery Exclusion Criteria: Does not approve the study Pregnant Emergency ASA III-IV History of local anesthetic allergy Infection in the block area Coagulation disorder Morbid obesity (body mass index> 40 kg / m²) Severe organ failure Previous neurological deficit Psychiatric disease History of chronic pain

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

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

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

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 |
| --- | --- |
| Active Comparator: Group S<br>Serratus plane block with 25 ml %0.25 bupivacaine | Drug: Bupivacaine Injection<br>* Block with bupivacaine<br>|
| Active Comparator: Grup E<br>Erector spinae plane block with 25 ml %0.25 bupivacaine | Drug: Bupivacaine Injection<br>* Block with bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score | Visual analog scale (0-10), <4 is adequate analgesia | Postoperative 24 hours | 
| Postoperative tramadol consumption | Postoperative opiodi consumption with patient controlled analgesia | Postoperative 24 hours | 
| Rescue analgesic | If VAS score is 4 or more, paracetamol 1 gr is administered | Postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia time | Time from block performing to first analgesia requirement | Procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serratus plane block, erector spinae plane block, postoperative analgesia
Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.

Study Overview
=================
Brief Summary
-----------------
Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery

Detailed Description
-----------------
The presence of gastric content increases the risk of aspiration during general anesthesia. Delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. This study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.

Official Title
-----------------
Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI<40 kg.m-2; Age over 18 years; American Society of Anesthesiologists' physical status status I-III who were to undergo elective surgery and had the ability to understand the rationale of the study and provide informed consent Exclusion Criteria: Pregnancy Recent upper gastrointestinal bleed (< 1 month) Abnormal anatomy of the upper gastrointestinal tract (such as hiatal hernias and gastric tumors) Previous surgical procedures on the esophagus, stomach, or upper abdomen Gastroesophageal reflux disease Previous use of prokinetics or high doses of opiates.

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 |
| --- | --- |
| Diabetic patients<br>Diabetic patients undergoing scheduled surgery | |
| Non-diabetic patients<br>Non-diabetic patients undergoing sheduled surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual gastric volume | Residual gastric volume measured by ultrasounds | Preoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antral cross-sectional area | Antral cross-sectional area measured by ultrasounds | Preoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Gastric ultrasound, Full stomach, Surgery
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate and compare the bioavailability of mesalamine

Detailed Description
-----------------
The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions.

Official Title
-----------------
Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Apriso 0.375G ER CAP
* Drug: APRISO 375 mg extended-release capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female, at least 18 years of age Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive) Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and laboratory tests Exclusion Criteria: Any contraindication to mesalamine according to the applicable labeling

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center, laboratory-blinded, randomized, two-treatment, two-sequence, four-period, full replicate, crossover bioequivalence study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apriso 0.375G ER CAP<br>Apriso 0.375G ER Cap | Drug: Apriso 0.375G ER CAP<br>* ER capsule<br>|
| Active Comparator: APRISO 375 mg extended-release capsules<br>APRISO 375 mg ER cap | Drug: APRISO 375 mg extended-release capsules<br>* 375 mg extended-release capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum observed plasma concentration) | Maximum observed plasma concentration levels used for descriptive analysis | 3 hours after oral dose is taken |
Usability Study of Spaced Retrieval Exercise Using Mobile Devices for Alzheimer's Disease Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The focus of this work is to explore the use of modern mobile technology to enable people with Alzheimer's disease to improve their abilities to perform activities of daily living and hence to promote independence and participation in social activities. This work also aims at reducing the burden on caregivers by increasing the AD patients' sense of competence and ability to handle behavior problems.

Detailed Description
-----------------
The investigators developed ADcope, an integrated application that includes several modules that target individuals with Alzheimer's disease , using mobile devices. The investigators developed two different user interfaces: a text-based and a graphic-based. To evaluate the usability of the application, participants with early stages of AD were asked to run the two user interfaces of the spaced retrieval memory exercise using a tablet mobile device.

Official Title
-----------------
Usability Study of Spaced Retrieval Exercise Using Mobile Devices for Alzheimer's Disease Rehabilitation

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Other: Text-based task
* Other: Graphic-based Task


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Have early stages of Alzheimer's decease

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Text-based Task<br>This group is required to do the text-based task | Other: Text-based task<br>* Participants are required to take text-based exercise.<br>|
| Graphic-based Task<br>This group is required to do the graphic-based task | Other: Graphic-based Task<br>* Participants are required to take the graphic-based exercise.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NASA Task Load Index Measure | NASA-TLX is a multi-dimensional rating procedure that derives an overall workload score based on a weighted average of ratings on six subscales. These subscales include Mental Demands, Physical Demands, Temporal Demands, Own Performance, Effort, and Frustration. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test Score | Test score measures the percentage of questions answered by the participants correctly from the first trial. | 1 Hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease Rehabilitation
Study of the Relationship Between Blood Vessels and Insulin Response in Adolescents

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether there is a relationship between the way insulin and blood vessels work. The difference in the interaction between Caucasian and African American adolescents will also be examined. This may play a role in the differing rates of heart disease and diabetes between the two groups.

Detailed Description
-----------------
Purpose: The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) and insulin work in adolescents. Abnormalities in how the blood vessels and insulin work in adolescents may cause high blood pressure, type 2 diabetes, stroke and heart disease. Healthy adolescents between 8 and 18 years of age are being studied in the Ohio State University General Clinical Research Center. Two visits will be necessary. One will be a screening visit to determine the child's stage of puberty and obtain a medical history. The second will be the study visit. During the latter, blood vessel function will be determined by studying the change in forearm blood flow before and after blood flow to the forearm is stopped. Insulin sensitivity will be determined using glucose water given into a vein.

Official Title
-----------------
Relationship of Endothelial Function to Insulin Sensitivity in African American and Caucasian Adolescents

Conditions
-----------------
Diabetes Mellitus, Type 2, Hypertension, Heart Disease, Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian or African American adolescent Between 8 and 18 years of age Exclusion Criteria: Pregnancy Chronic Disease Acute Disease Medication Requirement

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 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 |
| --- | --- |
| Caucasian Adolescents<br>Caucasian Adolescents | |
| African-American Adolescents<br>African-American Adolescents | |

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
-----------------
adolescence, insulin sensitivity, endothelial function, lipids, puberty