linjc16/ctgov huggingface dataset:
Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the protective effect of an approved medication on asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure to cats.

Detailed Description
-----------------
The duration of treatment is 2 weeks.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Crossover Study Investigating the Clinical Effect of Montelukast in Patients With Concomitant Asthma and Allergic Rhinitis Upon Controlled Exposure to Cat Allergen

Conditions
-----------------
Asthma, Bronchial, Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: MK0476, montelukast sodium
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Increased sensitivity to cat allergen proven by positive allergy testing, and by decreased lung function and increased symptoms of allergic rhinitis (runny nose) upon exposure to cats. Exclusion Criteria: Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0476, montelukast sodium|nan|
|Drug: Comparator: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-Primary endpoints: (1) Area Under the Curve (AUC) for the percent fall from prechallenge FEV1 during allergen challenge; (2) Area Under the Curve for the increase from prechallenge Nasal Symptoms score during allergen challenge |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (1) Maximum percent fall from prechallenge FEV1; (2) AUC for the increase from prechallenge Chest Symptoms score (3) AUC for the increase from prechallenge Nasal Symptoms score collected over 60 minutes after terminating the challenge. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhinitis, Allergic
Long-term Outcome After Isolated Tricuspid Valve Repair

Study Overview
=================
Brief Summary
-----------------
Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Treatment options for isolated repair have not been investigated thoroughly. The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. By doing this, the investigators want to evaluate predictors of outcome after repair.

Conditions
-----------------
Tricuspid Valve Insufficiency

Intervention / Treatment
-----------------
* Procedure: follow-up of isolated tricuspid valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tricuspid valve insufficiency Exclusion Criteria: younger than 18 years associated valvular surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Isolated TI repair<br>Patients that underwent isolated tricuspid valve repair | Procedure: follow-up of isolated tricuspid valve repair<br>* follow-up of patients that underwent TV repair in the past.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 10 year | 
| Redo surgery |  | 10 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional capacity assessed by CPET |  | 10 year | 
| Atrial fibrillation |  | 10 year | 
| Hospitalisation | hospitalisation for cardiovascular reasons | 10 year | 
| Functional capacity assessed by NYHA functional class |  | 10 years |
Current Trend of Epidemiology of Psychiatric Emergency and the Stress of Duty Psychiatric Resident

Study Overview
=================
Brief Summary
-----------------
Agitation, paranoia, and suicide risk of the psychiatric patients made them difficult to be managed when they visited medical emergency services. The prolonged waiting time at medical emergency services and the stigmatization of psychiatric medicine also made the psychiatric emergency services full of challenges. However, in recent years, the random killings, celebrity suicide and other major social events attracted much attention to the emergency psychiatry. Following the establishment of the National Health Insurance, the law of mandatory admission, and the prevalence change of all psychiatric diseases, we are now dealing with totally different types of emergent psychiatric conditions, i.e., depression and suicide. However, the real epidemiological data need to be updated. Psychiatric emergency is one of the entrances of the psychiatric network. A comprehensive review of the psychiatric emergency would be needed for the base of further research. This study is aimed to investigate the prevalence of psychiatric diagnosis of patients who came to Emergency Department of National Taiwan University Hospital and needed a psychiatric consultation. The epidemiological data will be compared to those collected 30 years ago in the same hospital to examine the 30-year trend. On the other hand, the visiting time and the staying time will be analyzed. The stress of on-duty and the contributing factors will be assessed by a 2-hour in-depth interview with psychiatric residents.

Official Title
-----------------
Current Trend of Epidemiology of Psychiatric Emergency and the Stress of Duty Psychiatric Resident

Conditions
-----------------
Emergent Psychiatric, Consultation, Residentship

Intervention / Treatment
-----------------
* Diagnostic Test: interview, Tridimensional Personality Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psychiatric resident in NTUH Exclusion Criteria: Major psychiatric illness
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 |
| --- | --- |
| psychiatric resident in NTUH<br> | Diagnostic Test: interview, Tridimensional Personality Questionnaire<br>* interview of the residents about 15-20 minutes, then use Tridimensional Personality Questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Research | for 16 residents, interview data | until 2018/11/1 |
Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroenteritis

Study Overview
=================
Brief Summary
-----------------
Cytokines, such as IL-6 and IL-8 can be used as markers of acute infections, including acute gastroenteritis. This study aims to evaluate serum levels of interleukins 6 and 8 in children with acute gastroenteritis.

Official Title
-----------------
Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroentritis

Conditions
-----------------
Acute Gastroenteritis, Acute Diarrhea

Intervention / Treatment
-----------------
* Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8


Participation Criteria
=================
Eligibility Criteria
-----------------
Group 1: Cases (Children with acute diarrhea) Inclusion Criteria: Children aged 6 months to 5 years. Acute diarrhea: defined according to WHO criteria as the passage of loose or watery stools at least three times in a 24 h period, lasts less than 14 days, with or without fever or vomiting, but considering the importance of change in stool consistency rather than frequency, and the usefulness of parental insight in deciding whether children have diarrhea or not. Exclusion Criteria: Malnutrition or obesity History of antibiotic therapy in the last 72 hours. Acute diarrhea in association with systemic infections Malignancy Chronic diarrhea Autoimmune and autoinflammatory diseases. Chronic renal/liver failure Diabetes mellitus Group 2: Controls (Healthy control children) Inclusion Criteria: • Healthy children aged 6 months to 5 years. Exclusion Criteria: Acute diarrhea Malnutrition or obesity History of antibiotic therapy in the last 72 hours. Acute diarrhea in association with systemic infections Malignancy Chronic diarrhea Autoimmune and autoinflammatory diseases. Chronic renal/liver failure Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 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 |
| --- | --- |
| Cases<br>Children with acute diarrhea | Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8<br>* Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits)<br>|
| Control<br>Healthy control children | Diagnostic Test: Evaluation of serum levels of IL-6 and IL-8<br>* Evaluation of serum levels of IL-6 and IL-8 by Luminex Assay (multiplexed ELISA kits)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum level of Interleukin 6 | Difference in serum level of interleukin 6 between cases and control groups | Within the first 3 days of acute diarrhea | 
| Serum level of Interleukin 8 | Difference in serum level of interleukin 8 between cases and control groups | Within the first 3 days of acute diarrhea |
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Study Overview
=================
Brief Summary
-----------------
This is a randomised trial comparing the efficacy of 3 different analgesic strategies in newborns on prostaglandin for ductus dependent congenital heart disease.

Official Title
-----------------
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: acetaminophen and nalbuphine
* Drug: acetaminophen and morphine
* Drug: acetaminophen and reduced dosage of prostaglandin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full-term newborn Under one month of age With ductus dependent congenital heart disease requiring prostaglandin infusion and elevated pain score Exclusion Criteria: Contraindication to either morphine, acetaminophen, or nalbuphine Other painful condition Poor neurological condition Cardiac instability requiring urgent surgery

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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: acetaminophen and nalbuphine|nan|
|Drug: acetaminophen and morphine|nan|
|Drug: acetaminophen and reduced dosage of prostaglandin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | before inclusion and at 8 hours (H8), H24, H48, H72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of apnea |  |  | 
| Need for mechanical ventilation |  |  | 
| Incidence of fever |  |  | 
| Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostaglandin, analgesia, congenital, heart, defect, induced
Antenatal Allopurinol During Fetal Hypoxia

Study Overview
=================
Brief Summary
-----------------
A former study (submitted) in 32 severely asphyxiated infants participating in a randomized double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after birth) was administered to reduce free radical formation and consequently reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and no clinically relevant improvement in morbidity in infants treated with allopurinol. It was hypothesized that postnatal allopurinol treatment started too late to reduce reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus with (imminent) hypoxia already via the mother during labor will be more effective to reduce free radical-induced post-asphyxial brain damage.

Official Title
-----------------
Does Antenatal Allopurinol Administration Reduce Post-hypoxic-ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn?

Conditions
-----------------
Fetal Hypoxia, Reperfusion Injury

Intervention / Treatment
-----------------
* Drug: Allopurinol sodium
* Drug: Mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age of 36 weeks or more Non-reassuring CTG, significant events on the STAN-monitor AND/OR FBS < 7.20 Exclusion Criteria: Chromosomal abnormalities
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 |
| --- | --- |
| Experimental: Allopurinol<br>500 mg allopurinol/ 50 mL water for injection intravenously | Drug: Allopurinol sodium<br>* Allopurinol sodium 500 mg / 50 mL, intravenously, single dose<br>* Other names: Acepurin;|
| Placebo Comparator: Placebo<br>500 mg mannitol/50 mL water for injection intravenously | Drug: Mannitol<br>* Mannitol 500 mg/50 mL water for injection, intravenously, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free radical production and markers of neuronal damage |  | Up to 24 hours postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developmental outcome |  | Up to 5 years of age | 
| Mortality |  | Up to 28 days postpartum | 
| Severe composite morbidity |  | Up to 28 days postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allopurinol, neuroprotection, reperfusion injury, fetal hypoxia, post hypoxic-ischemic reperfusion damage
Written Versus Verbal Education for Mild Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or alteration in mental status induced by an external mechanical force to the head. Education about symptoms and reassurance of a prompt recovery usually results in full recovery. However, a subgroup appears to have persistent symptoms and disability. This study will recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable patient characteristics that can delay or prevent full recovery. A secondary aim is to determine if providing education in writing or in-person makes a difference.

Official Title
-----------------
Written Versus Verbal Education for Mild Traumatic Brain Injury

Conditions
-----------------
Mild Traumatic Brain Injury

Intervention / Treatment
-----------------
* Other: Educational Brochure
* Other: Verbal education module


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmation of a likely concussion without hospital admission Participants live locally with a fixed address Participants experience at least one new symptom Exclusion Criteria: Participants who cannot understand/read English

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

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

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

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

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: Written Education<br> | Other: Educational Brochure<br>* Participants will receive written education materials about mild traumatic brain injury.<br>|
| Active Comparator: Verbal Education<br> | Other: Verbal education module<br>* A structured in-person education module about mild traumatic brain injury.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Postconcussional Syndrome | The primary outcome is the presence of Postconcussion Syndrome, defined as 3+ symptoms endorsed as mild or greater on the Rivermead Postconcussion Symptom Questionnaire. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale-Extended (GOS-E) | Structured interview to assess disability level. | 3 Months | 
| Patient Health Questionnaire-9 (PHQ-9) | Depressive symptoms questionnaire. | 3 Months | 
| PTSD Checklist-Civilian version (PCL-C) | Post-traumatic stress symptoms questionnaire. | 3 Months |
Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to determine the capacity of a questionnaire to predict a normal balance sheet of haemostasis.

Detailed Description
-----------------
Recent recommendations formalized by experts of the French society of anaesthesiology on systematic pre-interventional examinations recommend assessing the risk of bleeding from personal and family history of bleeding diathesis and after physical examination . They recommend not to prescribe a systematic hemostasis laboratory tests in patients with a history and physical examination do not suspect a disorder of hemostasis. However, there is currently no validated questionnaire in the general population to assess the preoperative bleeding risk allowing a reliable assessment of the personal and family bleeding diathesis. The establishment of a structured questionnaire, the patient could filled before surgery consultation to guide the possible prescription of a balance sheet, could meet the new recommendations. It seems therefore important to establish this type of questionnaire in order to optimize the operation of the structure, and to limit the requirements of routine hemostasis balance sheets. To do this, the investigator wants to carry out a preliminary study to ensure the interest of the established questionnaire. The questionnaire assessed in this study is drawn from existing specialized questionnaires, the description of hemostasis disorders described factor for deficits from the doctor in charge of hemophilia expertise center and expertise of a psychologist, to refine best.

Official Title
-----------------
Creation and Evaluation of a Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative

Conditions
-----------------
Preoperative Assessment of Hemostasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults addressed in programmed anesthesia consultation, regardless of whether surgery and consultation site Exclusion Criteria: Patients minors Physical or mental disability in Patient to agree and complete the questionnaire Major patients undergoing a protective measure Refusal of participation

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| hemostasis tests (normal or abnormal) |  | Inclusion |