linjc16/ctgov huggingface dataset:
Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if treating a donor site wound with the ACell dressing is as good as or better than the dressings we currently treat harvested donor sites with. This will be tested on consenting burn patients who require excision and grafting surgery for their burn wounds. Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less than the mean healing time for wounds treated with the Standard of Care dressing.

Detailed Description
-----------------
This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of the ACell Dressing for use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing, which is currently Xeroform.

Official Title
-----------------
Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Device: ACell dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less than 30% total body surface area burn burn wounds do not involve the donor site harvesting areas requires excision and grafting of sufficient extent to justify two donor site of roughly equal size on non-dependent body surfaces. The scheduled excision and grafting procedure is the first such operation for the subject subject agrees to participate in follow-up evaluations Exclusion Criteria: Critical illnesses such as those requiring ventilator support, systemic infection, or hemodynamic instability Major acute or chronic medical illness that could affect wound healing Cellulitis or other infection of the potential donor sites Donor site has been previously harvested for grafting Subjects who are pregnant Religious objections or allergy to porcine products

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Device: ACell dressing<br>* dressing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The specific aim of this study is to determine if the ACell dressing is superior to the ISR Burn Center's current standard of care dressing with respect to speed of healing, patient comfort or wound cosmesis. |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burns, ACell, Donor Site
Psychiatric Disorders in Children With Psychogenic Cough

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate psychiatric disorders and clinical features of children with psychogenic cough. Psychiatric disorders are assessed via a semi-structured interview (Kiddie Schedule for Affective Disorders and Schizophrenia) and clinical features are investigated via sociodemographic form, which was developped by researchers. Investigator planned to compare psychiatric diagnoses, specifically anxiety and depression, with children referred to pediatric clinics.

Official Title
-----------------
Psychiatric Disorders and Clinical Features of Children With Psychogenic Cough

Conditions
-----------------
Psychogenic Cough

Intervention / Treatment
-----------------
* Diagnostic Test: Kiddie Schedule for Affective Disorders and Schizophrenia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having psychogenic cough for study group. Referred to pediatric clinics. Exclusion Criteria: Chronical psychiatric disorder and pediatric disease history for control group.

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Children with psychogenic cough<br>children who were examined by Pediatric Respiratory Disease specialist and diagnosed as having a psychogenic cough. | Diagnostic Test: Kiddie Schedule for Affective Disorders and Schizophrenia<br>* Both of the clinical and control group will be evaluated via Psychiatric semi-structured interview<br>|
| control subjects<br>children who were referred to pediatrics clinics and do not have a chronical disease. | Diagnostic Test: Kiddie Schedule for Affective Disorders and Schizophrenia<br>* Both of the clinical and control group will be evaluated via Psychiatric semi-structured interview<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric disorders | Total rate of psychiatric disorders, specifically internalizing disorders, identified via semi-structured diagnostic interview | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychiatry, children, habit cough
Regional Anesthesia in Cardiac Pediatric Patients Less Than 5 Years Old

Study Overview
=================
Brief Summary
-----------------
This retrospective review presents a comparison of pediatric patients less than 5 years old undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time to extubation, reintubation, and hypercarbia.

Detailed Description
-----------------
Intra-operative anesthesia medical records of pediatric patients undergoing cardiac surgery will be acquired from July 2007 to July 2013. Allocation of regional anesthesia, and the use of spinal versus epidural versus epidural with catheter administration will be determined by provider preference. Date of surgery, age in months, gender, type of surgery, type of anesthesia, regional drugs, PaCO2 upon arrival in the PICU, time to extubation, and reintubation if applicable will be recorded. Time to extubation will be categorized into within the OR, less than 24 hours, or greater than or equal to 24 hours. PaCO2 levels will be categorized into hypercarbia (PaCO2 ≥ 50mmHg) and normal (PaCO2 < 50mmHg).

Official Title
-----------------
Retrospective Review of Regional Anesthesia in Cardiac Pediatric Patients

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be pediatric patients undergoing cardiac surgery under the age of 5 years old between the years 2007 and 2013 Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 59 Months

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 |
| --- | --- | --- |
| To expect difference in time to extubation |  | 24 hours |
Clinical Evaluation of PoreSkin

Study Overview
=================
Brief Summary
-----------------
PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine, Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is a permanent dermal substitute aiming to reduce skin contracture. The objective of this study is to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.

Official Title
-----------------
Clinical Evaluation of PoreSkin: A Human Acellular Dermal Matrix

Conditions
-----------------
Treatment

Intervention / Treatment
-----------------
* Device: PoreSkin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 18-60 years with burn scar contracture and hypertrophic scar Exclusion Criteria: Undergoing immunosuppressive therapy Immunocompromise host (DM, HIV infected) Evidence of malnutrition Active malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Treatment group<br>PoreSkin, a human acellular dermal matrix, were used for scar contracture treatment | Device: PoreSkin<br>* a human acellular dermal matrix<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The engraftment rate |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any local complications | erythema, infection, fever, and rejection of the graft | 1 month | 
| the final cosmetic result | evaluated by Vancouver Scar scale | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human acellular dermal matrix, burns, wound healing
Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

Detailed Description
-----------------
randomized, double-blind, placebo-controlled, phase 3

Official Title
-----------------
Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial

Conditions
-----------------
Vasomotor Rhinitis

Intervention / Treatment
-----------------
* Drug: Pseudoephedrine / Levocetirizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of vasomotor rhinitis Exclusion Criteria: Significant concomitant medical condition Use corticosteroids or other allergy medications during the study Considered by investigator as not appropriate to participate in the clinical study with othe reason

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo | Drug: Pseudoephedrine / Levocetirizine<br>* tablet, BID everyday<br>* Other names: Cossac L;|
| Experimental: Cossac L<br>Pseudoephedrine 120mg + Levocetirizine 2.5mg | Drug: Pseudoephedrine / Levocetirizine<br>* tablet, BID everyday<br>* Other names: Cossac L;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TVRSS(Total Vasomotor Rhinitis Symptom Score) | the change from baseline in TVRSS | 2week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TVRSS, VRSS | the change from baseline in TVRSS during 1st week and 2nd week the change from baseline in each vasomotor rhinitis symptom score at overall, during 1st week/2week | 1week or 2 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vasomotor, pseudoephedrine, levocetirizine
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

Study Overview
=================
Brief Summary
-----------------
The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Official Title
-----------------
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

Conditions
-----------------
Japanese Encephalitis

Intervention / Treatment
-----------------
* Biological: Japanese Encephalitis purified inactivated vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Male and female healthy adults aged at least 18 years, with written informed consent and either no childbearing potential or negative pregnancy test Main Exclusion Criteria: History of immunodeficiency or immunosuppressive therapy, Known Human Immunodeficiency Virus (HIV); OR Drug addiction including alcohol dependence

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IC51 Batch A<br> | Biological: Japanese Encephalitis purified inactivated vaccine<br>* IC51 6 mcg i.m. injection on Day 0 and Day 28<br>|
| Active Comparator: IC51 Batch B<br> | Biological: Japanese Encephalitis purified inactivated vaccine<br>* IC51 6 mcg i.m. injection on Day 0 and Day 28<br>|
| Active Comparator: IC51 Batch C<br> | Biological: Japanese Encephalitis purified inactivated vaccine<br>* IC51 6 mcg i.m. injection on Day 0 and Day 28<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody |  | Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion Rate |  | Day 56 | 
| Safety and Adverse Events |  | Day 56 |
Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Background and Significance: In the United States approximately 220,000 patients undergo cardiac surgery per annum. Among potential complications, the incidence of atrial fibrillation (AF) is estimated at 30 - 60 %, and therefore presents the most common adverse event after cardiac surgery. Multiple complications may be associated with AF: Patients are usually subject to an increased length-of-stay in the intensive care unit and in the hospital. Furthermore, the risk for stroke and development of long-term AF is elevated, while further anticoagulation is required putting the patient at risk for bleeding. On average, an additional $10,000 - $20,000 is spent for each patient with AF. However, the exact burden of postoperative AF still remains unknown. Specific Aims of Research Project: To collect data from an electrocardiogram (EKG) monitoring patch, we aim to accurately determine the prevalence of atrial fibrillation in patients undergoing cardiac surgery at our center. To collect data on epidemiological characteristics to investigate risk factors for developing perioperative atrial fibrillation in patients undergoing cardiac surgery. This will allow us to create robust risk prediction models.

Official Title
-----------------
Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Atrial Fibrillation, Cardiac Surgery

Intervention / Treatment
-----------------
* Device: BraveHeart wearable life sensors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective open heart surgery Age > 20 years Exclusion Criteria: Refusal to participate (patient or health care proxy) Participation in other pharmacological trials Lack of data or poor data quality which cannot be analyzed for any heart rhythm in 80% of the postoperative study period.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients undergoing cardiac surgery<br> | Device: BraveHeart wearable life sensors<br>* Collection of EKG data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation | Atrial Fibrillation | Up to 30 days after discharge from the hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other arrhythmias | Other arrhythmias | Up to 30 days after discharge from the hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wearable Device
Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

Study Overview
=================
Brief Summary
-----------------
Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma. The study was randomised, placebo-controlled double-blind in patients, monoallergic to grasspollen, presenting symptoms of rhinitis and asthma during season. Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of treatment intranasal allergen challenge was performed. Measurements were performed during the full study period. The study was performed out of pollen season.

Official Title
-----------------
Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge. Impact on Bronchial Hyperresponsiveness and the Effect of Intranasal Corticosteroid Treatment

Conditions
-----------------
Allergic Rhinitis, Asthma

Intervention / Treatment
-----------------
* Drug: INCS
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: monoallergy to grass symptoms of allergic rhinitis for at least the two most recent grasspollen seasons asthma symptoms of asthma for at least two of the four most recent grasspollen seasons age 18 or older Exclusion Criteria: pregnancy or lactation fertile women, not sterilised or using sufficient anticonception Corticosteroid treatment (parenteral, oral, inhaled or intranasal) within two months prior to enrolment Any other disease, condition or treatment, which to the discretion of the investigator has the potential to interfere with study results

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INCS<br>Fluticasone propionate 400 microgram daily | Drug: INCS<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Eosinophil Cationic Protein (ECP) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Eosinophil Peroxidase (EPO) |  | 1 month | 
| Nasal lavage Eosinophil Cationic Protein (ECP) |  | 1 month | 
| Nasal lavage Eosinophil Peroxidase (EPO) |  | 1 month | 
| Blood Eosinophils |  | 1 month |
Comparison of Coronary CT With IVUS in Heart Transplant Population

Study Overview
=================
Brief Summary
-----------------
To compare results of Intravascular Ultrasound (which occurs during cardiac catheterization) with Computed Tomography (CT) scan to detect blockages or narrowing of the arteries that feed the heart. These will be studied in the cardiac transplant population.

Official Title
-----------------
Comparison of Non-invasive Coronary CT With IVUS for the Detection of Coronary Artery Vasculopathy in a Cardiac Transplant Population

Conditions
-----------------
Heart Transplantation

Intervention / Treatment
-----------------
* Device: Computed tomography (CT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart transplant patients coming to the Cardiac Cath Lab for their yearly angiogram which includes intravascular ultrasound (IVUS) Exclusion Criteria: Patients with a history of allergic reactions to contrast material Creatine >1.5 Clinical or hemodynamic instability Those who are unable to consent for enrollment into the study

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Computed tomography (CT)|Computed tomography (CT), as performed by Dual Source Computed Tomography (DSCT)(Siemens Medical Solutions Germany) to be conducted no sooner than 3 days before or after cardiac catheterization, but with 3 months of the cardiac cath.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if Computed Tomography (CT) of the arteries that feed the heart is more sensitive than Intravascular Ultrasound (IVUS) which is performed during cardiac catheterization |  | within 3 months of cardiac cath with IVUS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blocked arteries, narrowing arteries, IVUS, CT