linjc16/ctgov huggingface dataset:
Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that circulating endothelium-derived microparticle (EMP) may be a useful surrogate marker of atherosclerosis and future episode of cerebrovascular events. Peripheral blood is drawn at the time of carotid ultrasound examination. Circulating EMPs are counted using flow-cytometry. The correlation among circulating EMP, ultrasound findings, and atherosclerotic risk factors are determined by multiple stepwise regression analysis. The prevalence of cerebrovascular events is also determined during 3-year follow-up period.

Official Title
-----------------
Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo carotid ultrasound examination for screening of atherosclerosis Exclusion Criteria: Cerebrovascular events within the last 12 months Acute coronary syndrome, coronary and peripheral intervention within the last 6 months Uncontrolled heart failure Other severe systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Carotid atherosclerosis group<br>Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of circulating EMPs |  | at the time of carotid ultrasound examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of cerebrovascular and/or cardiovascular events |  | 3 years |
A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.

Detailed Description
-----------------
Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.

Official Title
-----------------
An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia

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

Intervention / Treatment
-----------------
* Drug: Clozapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attended the previous Phase IIb (core) study Improved during the core study No safety issues during the core study Exclusion Criteria: Discontinued the core study Pregnant or nursing (lactating) women Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: 1<br> | Drug: Clozapine<br> <br> * Other names: Clozaril;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events during the long term treatment (until NDA approval) |  | Baseline to 52 weeks | 
| Vital signs at every 4 weeks |  | Baseline to 52 weeks | 
| Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks) |  | Baseline to 52 weeks | 
| ECG at every 12 weeks |  | Baseline to 52 weeks | 
| Echo cardiogram at every 24 weeks |  | Baseline to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks |  | Baseline to 52 weeks | 
| Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks |  | Baseline to 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, treatment-resistant, clozapine
Italian Pulmonary Embolism Registry - IPER

Study Overview
=================
Brief Summary
-----------------
RAZIONALE Pulmonary embolism is a complex disease, with a highly variable clincal presentation. Diagnosis starts with clinical probability assessment mainly based on medical history and rapidly available clinical data. Pulmonary embolism can be managed by emergency department, cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical management can varies based on the attitude of the attending physician. Diagnosis is a crucial point as it can influence short term mortality. OBJECTIVE The registry has 3 main objectives: educational objective, improvement in the knowledge of epidemiology, management and outcome of acute pulmonary embolism in Italy scientific objective

Official Title
-----------------
Italian Pulmonary Embolism Registry

Conditions
-----------------
Acute Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive patients with acute pulmonary embolism Exclusion Criteria: age <18 years

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 |
| --- | --- |
| patients with acute pulmonary embolism<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome

Study Overview
=================
Brief Summary
-----------------
The trial will investigate the treatment of growth failure in children with Noonan syndrome. Abnormalities in the growth hormone (GH) - insulin-like growth factor-I (IGF-I) axis resulting in low IGF-I levels have been suggested as a possible cause of short stature seen in Noonan syndrome children. Administration of our investigational product is intended to bypass the abnormalities in the GH-IGF axis, and hopefully improve body growth.

Official Title
-----------------
A Phase 2, Open-Label, Multicenter, Clinical Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 in Children With Growth Failure Due to Noonan Syndrome

Conditions
-----------------
Noonan Syndrome

Intervention / Treatment
-----------------
* Drug: rhIGF-1/rhIGFBP-3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of Noonan syndrome Height less than the 3rd percentile for age and sex (height SDS < -1.88) Basal IGF-I less than the mean for age and sex (IGF-I SDS < 0) Chronological age greater than 2 years Bone age ≤ 11 years for boys, and ≤ 10 years for girls Pre-pubertal Documented pre-treatment height velocity less than the mean for age and sex Exclusion Criteria: Clinically significant diseases Chronic illnesses Prior treatment with rhIGF-1

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: rhIGF-1/rhIGFBP-3|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Glycemic Control and Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Does diabetic patients' glycemic control affect their response to laser and/or intravitreal injection therapy in terms of visual and anatomical outcomes.

Detailed Description
-----------------
To evaluate the visual and anatomical response to therapy in patients with diabetic macular edema (DME) in relation to their glycemic control. Patients with DME with central foveal thickness (CFT) > 250µm with no proliferative disease had their glycosolated hemoglobin (HbA1c) measured at baseline and 3 months. CFT by optical coherence tomography, and best corrected visual acuity (BCVA) in logMARs were measured at baseline, 1, and 3 months. Exclusion criteria: laser or intravitreal injections within 6 months, hard exudates within 500um of the foveal center, or macular traction. Therapy included laser and intravitreal anti VEGFs. HbA1c graded as: G1=<7%, G2= 7-7.9%, G3= 8-8.9%, G4 = >9%; and as: low <8%, high ≥ 8%.

Official Title
-----------------
The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Other: Respond to therapy for diabetic macular edema


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Central foveal thickness more than 250 microns Exclusion Criteria: Proliferative Diabetic Retinopathy. Traction Macular Membranes Previous Laser or intravitreal injections within 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| HBA1c<br> | Other: Respond to therapy for diabetic macular edema<br>* Correlate HBA1c with visual acuity outcome to therapy.<br>* Other names: Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Correlate baseline HBA1c to the visual outcomes. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Macular Edema, Glycemic Control
Perennial Allergic Rhinitis Study In Pediatric Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.

Detailed Description
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to <12 Years with Perennial Allergic Rhinitis (PAR)

Official Title
-----------------
A Two Week Randomized, Double Blind Placebo Controlled, Parallel Group Study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in Pediatric Subjects With Perennial Allergic Rhinitis

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: GW685698X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of perennial allergic rhinitis. Exclusion criteria: Have significant concomitant medical conditions. Use of corticosteroids or other allergy medications during the study. Have abnormal ECG. Have laboratory abnormality. Have abnormal eye exam.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW685698X|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perennial allergic rhinitis, pediatric
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

Study Overview
=================
Brief Summary
-----------------
The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction. The main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. Clinical characteristics and biomarker will be used to predict adverse reaction.

Official Title
-----------------
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

Conditions
-----------------
Adverse Reaction to Drug, 3HP

Intervention / Treatment
-----------------
* Drug: 3HP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: close contact with active TB patients patients with autoimmune diseases preceding biological therapy health-care workers other clinical conditions, which increased the risk of LTBI. LTBI was confirmed by QuantiFERON-TB Gold In-Tube test (QFT-GIT; Qiagen, Valencia, CA, USA) with a cut-off value of 0.35 IU/ml. Exclusion Criteria: age less than 20 years pregnant women active TB or suspected active TB in the clinical evaluation severe liver disease ESRD organ transplantation close contact with a multidrug-resistant TB patient obesity (BMI>30 Kgw/m2) and other conditions inappropriate for participation in this study as judged by the investigators.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| had >= grade 2 adverse reactions<br> | Drug: 3HP<br>* all patients taking 3HP under directly observed preventive therapy (DOPT) program<br>|
| had <2 frade 2 adverse reactions<br> | Drug: 3HP<br>* all patients taking 3HP under directly observed preventive therapy (DOPT) program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) |  | Change from Baseline sTREM1 at 2 weeks | 
| sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) |  | Change from Baseline sTREM1 at SARs | 
| sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) |  | Change from Baseline sTREM1 at 2 weeks | 
| sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group) |  | Change from Baseline sTREM1 at SARs |
Pharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture

Study Overview
=================
Brief Summary
-----------------
Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.

Detailed Description
-----------------
Throat swabbing by two port germ Amines agar (copan) swabs,then the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.

Official Title
-----------------
Comparison of Immunochromatographic Test for Rapid Detection of Group A Streptococcal Antigen With Culture in Pediatric Patients

Conditions
-----------------
Pharyngitis

Intervention / Treatment
-----------------
* Procedure: Rapid Immunochromatographic streptococcal test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting with the possible diagnosis of Bacterial pharyngitis,between 1-14 years of age. Exclusion Criteria: Patients who received antibiotics within two weeks from presentation

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 14 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid Immunochromatographic Streptococcal test<br>Throat swabbing by two port germ Amines agar (copan) swabs,the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment. | Procedure: Rapid Immunochromatographic streptococcal test<br>* Throat swab obtained for rapid strep test in addition to throat culture,in order to check the accuracy of Rapid Immunochromatographic streptococcal test in detection of streptococcal pharyngitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of true negative rapid immunochromatographic strep test when compared throat culture |  | upto 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of true positive rapid immunochromatographic strep test when compared to throat culture |  | upto 48hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Group A streptococcal pharyngitis, Rapid streptococcal test, Throat swab culture
Methorexate and Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.Synovial inflammation and proliferation has emerged as a key component of OA and as a potential predictor of worsening disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate (MTX) in decreasing pain and inflammation in symptomatic knee OA. 128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited. Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores. Keywords: methotrexate knee osteoarthritis inflammation pain reduction physical funtion

Conditions
-----------------
Pain Reduction, Physical Function Improvement

Intervention / Treatment
-----------------
* Drug: 25 mg/week oral methotrexate tablets
* Drug: 25mg/week oral placebo tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary knee osteoarthritis synovitis pain Exclusion Criteria: other inflammatory conditions hepatic insufficiency renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 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 |
| --- | --- |
| Experimental: Methotrexate<br>25mg oral MTX tablets | Drug: 25 mg/week oral methotrexate tablets<br> <br> * Other names: interventional drug;|
| Placebo Comparator: Placebo<br>25 mg/week placebo tablets | Drug: 25mg/week oral placebo tablets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | The primary outcome measure was pain reduction.Pain was assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function improvement | Functional assessment was performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores. | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methotrxate, knee osteoarthritis, inflammation, pain, function