linjc16/ctgov huggingface dataset:
Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

Study Overview
=================
Brief Summary
-----------------
Dengue virus serological reagent, included antigen and antiserum, is a serum test for identification of serum antibodies to dengue virus.

Detailed Description
-----------------
The developed assay helps to diagnose diseases caused by this virus and to provide information on disease epidemiology. This virus is mainly transmitted by mosquito bites to people and will make flu-like symptoms, including fever, fatigue, cough and headache, which can cause severe hemorrhagic dengue.

Official Title
-----------------
Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

Conditions
-----------------
Dengue Fever

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:A total of 95 cases and 100 controls (suspected cases(>50 %) and normal subjects) are expected to enroll. Case group: adults having a medical visit or admission due to dengue / dengue hemorrhagic fever / dengue shock syndrome, and medical care of by (defined by CDC). Any of the following positive test results for the case of 100 adults. clinical specimens (blood) isolated and identified dengue virus. clinical specimens positive for molecular detection of nucleic acids. serological antigen (referring to non-structural proteins of dengue virus non-structural protein 1, NS1) testing positive (based on the test of Bio-Rad DENGUE NS1 Ag STRIP). paired serum (restored period and acute phase), the dengue virus specific immunoglobulin M or immunoglobulin G antibodies or negative or ≧ 4 times increase. Suspected cases: adults having medical visits or admissions due to infectious disease, but their NS1 (based on the test of Bio-Rad DENGUE NS1 Ag STRIP), immunoglobulin G,immunoglobulin M, real time-Polymerase chain reaction testing were negative. Control group: adults without having medical visits or admissions due to Fever. - Exclusion Criteria:non-adult case -
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 |
| --- | --- | --- |
| Clinical specimens testing program of dengue antigen detection reagents | Calculate two products of the dengue immune detection accuracy, sensitivity, specificity, false positive, false negative. | one year |
Randomized ActiveStep Clinical Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number and severity of falls in older adults. This is a pilot study. The information collected will be used to support a grant application for a large multi-center trial in the future.

Official Title
-----------------
Randomized ActiveStep Clinical Evaluation

Conditions
-----------------
Fall Prevention

Intervention / Treatment
-----------------
* Device: ActiveStep
* Other: Standard Physical Therapy for Fall Prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 or older Referred for balance training Exclusion Criteria: Age < 65

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Standard physical therapy for fall prevention | Other: Standard Physical Therapy for Fall Prevention<br>* Standard physical therapy for fall prevention<br>|
| Experimental: Group B<br>Physical therapy for fall prevention that includes ActiveStep | Device: ActiveStep<br>* ActiveStep™ is a training simulator. The system uses a computer-controlled treadmill to recreate life-like dynamic balance challenges such as slipping and tripping in a safe, controlled environment.<br>Other: Standard Physical Therapy for Fall Prevention<br>* Standard physical therapy for fall prevention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With at Least One Fall | Subjects who had at least one fall subsequent to treatment. | 3 months |
Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women

Official Title
-----------------
A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Crossover Phase I Study Assessing Pharmacokinetics and Pharmacodynamics of Two Different SMC021 0.8 mg Variants and the Effect of Timing of Drug Intake in Healthy Postmenopausal Women

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: Oral salmon calcitonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy postmenopausal women Exclusion Criteria: Previous treatment with other osteoporosis medication Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral salmon calcitonin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of the new variant compared to the current variant on Day 1 |  |  | 
| Effect on bone resorption biomarker on Day 1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on bone resorption biomarker 24 hours after the last dosing on Day 3 |  |  | 
| Effect on bone resorption biomarker after drug intake at different timepoints |  |  | 
| Effect of dosing at different timepoints on the pharmacokinetic profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopausal, osteoporosis, Pharmacokinetics/dynamics, Calcitonin
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.

Official Title
-----------------
A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fed Conditions in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Megace 800mg/20ml
* Drug: DW-ES(B) 625mg/5ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 20 to 40 years at screening. No significant congenital/chronic disease. No symptoms in physical examination. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation Exclusion Criteria: History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion. History of taking megestrol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Megace 800mg/20ml<br>Fed condition | Drug: Megace 800mg/20ml<br>* Megestrol acetate 800mg/20ml, Suspension, Single dose<br>* Other names: Megestrol Acetate;|
| Experimental: DW-ES(B) 625mg/5ml<br>Fed condition | Drug: DW-ES(B) 625mg/5ml<br>* Megestrol acetate 625mg/5ml, Nano suspension, Single dose<br>* Other names: Megestrol Acetate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of Megace 800mg/20mL |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose | 
| AUC of DW-ES(B) 625mg/5mL |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose | 
| Cmax of Megace 800mg/20mL |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose | 
| Cmax of DW-ES(B) 625mg/5mL |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose |
Treatment Program for Anemia in AIDS Patients

Study Overview
=================
Brief Summary
-----------------
The objective of the Eprex (erythropoietin) Treatment Program is to provide erythropoietin for the treatment of anemia in AIDS patients.

Official Title
-----------------
Treatment Program for Anemia in AIDS Patients

Conditions
-----------------
HIV Infections, Cytopenias

Intervention / Treatment
-----------------
* Drug: Epoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Life expectancy < 3 months. = or < grade 4 performance score. AIDS-related dementia. Uncontrolled hypertension. Acute symptomatic opportunistic infection or other AIDS-defining illness. Patients with the following are excluded: Life expectancy < 3 months. = or < grade 4 performance score. AIDS-related dementia. Uncontrolled hypertension. Acute symptomatic opportunistic infection or other AIDS-defining illness. Patients must have: A clinical diagnosis of AIDS. Hematocrit < 30 percent. Endogenous serum erythropoietin level = or < 500 U/ml. A life expectancy = or > 3 months. > Grade 4 performance score.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin alfa|nan|

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
-----------------
Recombinant Proteins, Drugs, Investigational, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, Zidovudine
Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant

Study Overview
=================
Brief Summary
-----------------
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants

Detailed Description
-----------------
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.

Official Title
-----------------
An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year

Conditions
-----------------
Inflammation, Uveitis

Intervention / Treatment
-----------------
* Procedure: Fluocinolone Acetonide 0.59 mg
* Procedure: Fluocinolone Acetonide 2.1 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had the FA intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one(1) year Able and willing to follow instructions Able and willing to provide informed consent Exclusion criteria: Is monocular Has current or relevant medical history that would interfere with their participation in this study, based on the judgment of the Investigator Had bilateral FA intravitreal implants Has a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Fluocinolone Acetonide 0.59 mg<br>Participants who have had the fluocinolone acetonide (FA) drug delivery system 0.59 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year. | Procedure: Fluocinolone Acetonide 0.59 mg<br>* At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.<br>* Other names: Retisert;|
| Fluocinolone Acetonide 2.1 mg<br>Participants who have had the fluocinolone acetonide (FA) drug delivery system 2.1 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year. | Procedure: Fluocinolone Acetonide 2.1 mg<br>* At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.<br>* Other names: Retisert;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Endothelial Cell Density | Bilateral specular microscopy will be performed and endothelial cell density will be recorded. | 1 Visit |
Intravitreal Bevacizumab vs. Bevacizumab Combined With Triamcinolone for Neovascular AMD

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety results of intravitreal bevacizumab alone with bevacizumab + triamcinolone acetonide in neovascular AMD.

Conditions
-----------------
Neovascular Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: bevacizumab
* Drug: bevacizumab + triamcinolone acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases of active neovascular AMD with visual acuity of 20/400- 20/40 Exclusion Criteria: History of glaucoma or ocular hypertension Disciform scar

Ages Eligible for Study
-----------------
Minimum Age: 50 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>Injection of intravitreal bevacizumab | Drug: bevacizumab<br>* Injection of intravitreal bevacizumab<br>|
| Active Comparator: 2<br>Injection of bevacizumab + triamcinolone acetonide | Drug: bevacizumab + triamcinolone acetonide<br>* Injection of bevacizumab + triamcinolone acetonide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central macular thickness |  |  | 
| leakage in fluorescein angiography |  |  | 
| intraocular pressure |  |  | 
| anterior chamber reaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bevacizumab,, Triamcinolone, Age-related macular degeneration, Choroidal neovascular membrane
DURABILITY™ Iliac Study

Study Overview
=================
Brief Summary
-----------------
The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™ Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common and/or external iliac arteries.

Official Title
-----------------
Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)

Conditions
-----------------
Peripheral Arterial Disease, Claudication

Intervention / Treatment
-----------------
* Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4. Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery. Willing to comply with all follow-up evaluations at the specified times. Provides written informed consent prior to enrollment in the study. Exclusion Criteria: Previous implantation of stent(s) in the target vessel. Received endovascular treatment of the target lesion within six months prior to the index procedure. Known hypersensitivity to contrast material that cannot be adequately pretreated. Known hypersensitivity to nickel-titanium. Life expectancy of less than 12 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems<br>The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery. | Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.<br>* Implantation of one or more study devices in the common and/or external iliac artery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event Rate |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral arterial disease, claudication, stent, EverFlex, GPS, Iliac Artery
Prediction of Fluid Responsiveness From Passive Leg Raising Induced Changes in Perfusion Index and Pleth Variability Index

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate whether changes in Perfusion Index (PI) and Pleth Variability Index (PVI) during passive leg raising test can predict fluid responsiveness in spontaneously breathing patients. Fluid responsive patients are defined as showing an increase in cardiac output >10% during a passive leg raising test, measured semi-invaseively with FloTrac® (Edwards LifeSciences. Irvine, United States).

Official Title
-----------------
Prediction of Fluid Responsiveness From Passive Leg Raising Induced Changes in Perfusion Index and Pleth Variability Index

Conditions
-----------------
Fluid Responsiveness

Intervention / Treatment
-----------------
* Diagnostic Test: Passive Leg Raising Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients admitted to the intensive or intermediate care unit after abdominal surgery (including urological and gynecological surgery performed in laparotomy) Spontaneous breathing Arterial line already in place Oral and written informed consent obtained Exclusion Criteria: Age <18 years Abdominal trauma as the reason for surgery Missing 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Passive Leg Raising Test|A passive leg raising test is performed in all patients included in the study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PI difference | Difference in the change of perfusion index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders | 90 seconds | 
| PVI difference | Difference in the change of pleth variability index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders | 90 seconds |