linjc16/ctgov huggingface dataset:
Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients

Study Overview
=================
Brief Summary
-----------------
This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.

Official Title
-----------------
Effect of Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients in Korea

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: Procalcitonin guided treatment
* Other: Conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with suspicious or confirmed sepsis at admission or during stay in ICU Patients with antibiotic duration of less than 48 hours before enrollment Exclusion Criteria: Age less than or equal to 18 years Known pregnancy Specific infections for which long-term antibiotic treatment for 3 weeks more is strongly recommended: infective endocarditis, empyema, osteomyelitis et al. severe immunocompromised patients : HIV infected patients (CD4 count < 200 cells/mm3), Neutropenia (ANC count < 500/mm3) Presence of do-not-resuscitate order

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: Procalcitonin guided treatment<br>Patients who will be randomized to this arm will receive antibiotics therapy based on procalcitonin-guided algorithm. | Other: Procalcitonin guided treatment<br>* Patients who will be randomized to arm will receive antibiotics therapy based on procalcitonin measurement on day 1, 3, 5, 7, 9, 11 and 13.<br>|
| Active Comparator: Conventional treatment<br>Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice. | Other: Conventional treatment<br>* Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of antibiotic treatment |  | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response to treatment for infection | success vs failure vs relapse after treatment | up to 28 days | 
| In ICU mortality |  | up to 28 days | 
| All cause mortality |  | up to 28 days | 
| In hospital mortality |  | up to 90 days |
Stress Management Intervention in Inner City Adolescents With Asthma

Study Overview
=================
Brief Summary
-----------------
The study will utilize a stress management program delivered over 10 sessions that is hypothesized to result in decreased stress levels and improved coping strategies in an inner city adolescent asthma population. Participants will include adolescents ages 10-15 years with physician diagnosed asthma. The outcome measures will be obtained via psychosocial questionnaires and spirometry.

Official Title
-----------------
Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients.

Conditions
-----------------
Asthma, Psychosocial Stress

Intervention / Treatment
-----------------
* Behavioral: Stress management program
* Other: Peer viewed movies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 8-15 years of age Physician diagnosed asthma based on NHBLI guidelines English speaking Child assent/parental consent Exclusion Criteria: Refusal of child assent/parental consent Non-English speaking History of psychiatric illness, autoimmune disease, HIV/AIDs, smoking history.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress management program<br> | Behavioral: Stress management program<br>* 10 session intervention utilizing a cognitive behavorial program with a goal of stress reduction<br>|
| Active Comparator: peer viewed movies<br> | Other: Peer viewed movies<br>* PG rated movies to be viewed over 10 sessions in peer setting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope |  | 5 weeks | 
| Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory |  | 5 weeks | 
| Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescents
Children With Diabetes at Risk for Heart Disease.

Study Overview
=================
Brief Summary
-----------------
Patients with type 1 diabetes type 1 (DM1) have increased risk of death due to heart disease and stroke. These cardiovascular conditions (CVD) are the leading cause of death in patients with DM1 younger than 40 years of age and up to 35% of all persons with DM1 will die before age 55 from CVD. Strategies are needed to help identify adolescents with DM1 at risk for CVD so that interventions to prevent heart disease and stroke can be undertaken.

Detailed Description
-----------------
Patients with type 1 diabetes and healthy controls will have evaluation of their lipid profile. Arterial stiffness, heart rate variability and adiposity measurements will be done in patients with type 1 diabetes and healthy controls. Blood pressure and heart rate will be recorded. 50 ml of urine will be collected from patients and controls. All studies will be performed as a single outpatient visit at Georgetown University.

Official Title
-----------------
Identifying Children With Diabetes Type 1 at High Risk for Cardiovascular Disease.

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetes Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes type 1 or Healthy Exclusion Criteria: Taking medications that lower cholesterol Duration of type 1 diabetes < 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 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 |
| --- | --- |
| Diabetes<br>Children with diabetes type 1 , 12-21 years old | |
| Healthy<br>Healthy children 12-21 years old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| small LDL particles | Blood test, based on NMR | This is an observational cross sectional study. Samples will be collected through study completion, on average of 6 years duration. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Cholesterol
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.

Detailed Description
-----------------
Same as above.

Official Title
-----------------
An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: Clobetasol Propionate, 0.05%
* Drug: Calcipotriene and betamethasone dipropionate ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe psoriasis involving 3-20% of the body surface area Exclusion Criteria: Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® Spray or more than 100 grams per week of Taclonex® Ointment Subjects having psoriasis that involves the scalp, face, or groin

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Clobex® Spray | Drug: Clobetasol Propionate, 0.05%<br>* Topical, twice daily for 4 weeks<br>* Other names: Clobex® Spray;|
| Active Comparator: 2<br>Taclonex® Ointment | Drug: Calcipotriene and betamethasone dipropionate ointment<br>* Topical, once daily<br>* Other names: Taclonex® Ointment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Disease Severity |  | End of treatment (Week 4) | 
| Tolerability assessments, incidence of adverse events |  | Baseline, Weeks 1, 2, 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Disease Severity |  | Weeks 1, 2 and 8 | 
| Investigator Global Assessment |  | End of treatment (week 4) and Weeks 1, 2 and 8 |
An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities

Study Overview
=================
Brief Summary
-----------------
This Expanded Access Program is intended to facilitate the availability of OFEV to patients suffering from non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) with a progressive clinical course despite Standard of Care treatment and for whom no satisfactory authorised alternative therapy exists or who cannot enter a clinical trial.

Official Title
-----------------
Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease

Conditions
-----------------
Lung Diseases, Interstitial

Intervention / Treatment
-----------------
* Drug: OFEV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: None Exclusion Criteria: - Patients who are eligible for and can participate in an ongoing non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) study will be excluded from participation in this Expanded Access Program (EAP).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OFEV|twice daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma? The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.

Official Title
-----------------
A Single-Blind, Randomized, Positive-controlled Study to Compare Monotherapy With an Inhaled Corticosteroid (Mometasone) to Combination Therapy With an Inhaled Corticosteroid + a Long-Acting Bronchodilator (Advair) in Patients With Milder Persistent Asthma

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

Intervention / Treatment
-----------------
* Drug: Mometasone
* Drug: Advair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects 18 to 65 years of age a >2 year history of asthma FEV1 > 80% for subjects currently using Advair®. Exclusion Criteria: severe asthma current smokers pregnant or breast-feeding women other chronic significant illnesses

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone<br> | Drug: Mometasone<br> <br> |
| Experimental: Advair<br> | Drug: Advair<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as Assessed my Pulmonary Function Tests |  | change from baseline to study completion |
Blue Light Phototherapy

Study Overview
=================
Brief Summary
-----------------
This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and Grover's Disease.

Official Title
-----------------
Development & Preliminary Clinical Validation Blue Light Phototherapy Systems for T-Cell

Conditions
-----------------
Grover's Disease, Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Device: Blue light phototherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's aged 18-89 at time of enrollment Previous diagnosis of psoriasis vulgaris or Grover's disease Exclusion Criteria: All Groups: Subjects who are younger than 18 years of age or older than 90 years of age Patients who have received topical or systemic treatment within the prior 2 weeks of planned phototherapy Patients prescribed any of the following drugs for issues not related to their psoriasis or Grover's disease topical steroids calcineurin inhibitors methotrexate retinoids biologic agents Unable to schedule phototherapy sessions We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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: Adult treatment arm<br>Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient. | Device: Blue light phototherapy<br>* Phototherapy- Wavelength: 417±15 nm<br>* Other names: DusaPharma Blu-U model 4170;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Blue Light Therapy for Patients With Grover's Disease | Demonstrate preliminary skin efficacy as measured by lesion count | Time Frame: 5 weeks | 
| Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment. | The DLQI is a questionnaire with 10 questions. The maximum score is 30 and minimum is 0. The higher the score, the more quality of life is impaired. | Time Frame: 5 weeks |
The Effect on Small Airways of Addition of Theophylline as Inducer of Histone Deacilase Activity for Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Treated With Inhaled Steroids and Long Acting Beta Agonists

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) is a chronic progressive respiratory disorder causing disability with an increasing burden to the patient, his family and to the health services. Treatment of COPD patients depends on the stage of the disease. COPD responds poorly to corticosteroids, in spite of inflammation is a major component in its pathogenesis. A major barrier to therapy of COPD is resistance to the anti-inflammatory effects of corticosteroids. The molecular mechanisms for this corticosteroid resistance are now being elucidated, particularly as the molecular basis for the anti-inflammatory effects of corticosteroids is better understood (12). An important mechanism of corticosteroid resistance in COPD, which is also linked to amplification of the inflammatory process, is a reduction in the critical nuclear enzyme histone deacetylase (HDAC)2 . Since the major changes are at the level of small airways. We will examine the effect of addition of theophylline product to stable COPD patients treated with combined inhaler of inhaled corticosteroids.

Conditions
-----------------
COPD

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up Exclusion Criteria: Heart failure Malignancy Immune suppressed

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Theophylline<br>100 twice a day | Drug: Theophylline<br>* 100 mg twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air trapping |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endurance time |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Forced expiratory volume in one second, Inspiratory capacity, endurance time, residual volume
Sedation Monitoring During Open Muscle Biopsy in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare sedation monitoring by bispectral index and comfort score during open muscle biopsies in children.

Conditions
-----------------
Sedation Monitoring in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants, children, adolescents undergoing open muscle biopsy as diagnostic procedure Exclusion Criteria: missing caregiver or patient consent intolerance of sedative agents in patients´medical history structural brain abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BIS, Comfort, open muscle biopsy
Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer

Study Overview
=================
Brief Summary
-----------------
S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1.

Official Title
-----------------
Pharmacokinetic and Pharmacodynamic Study of S-1 and Its Effects in Patients With the Digestive Organ Cancer With Reference to Genetic Polymorphism and Activity of CYP2A6 and DPD

Conditions
-----------------
Gastric Cancer, Esophageal Cancer, Pancreatic Cancer, Colon Cancer

Intervention / Treatment
-----------------
* Drug: S-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with digestive organ cancer Exclusion Criteria: Patients without digestive organ cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: S-1|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect and motility of patients treated with S-1 |  |  |