linjc16/ctgov huggingface dataset:
ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures

Study Overview
=================
Brief Summary
-----------------
To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules

Detailed Description
-----------------
Selection of patients is according to the criteria detailed below. If the patient is deemed eligible for the study, he will be asked to read and sign the informed consent. Besides standard history taking, physical examination and radiographic imaging, a standardized ultrasound examination of the ankle joint will be performed by a lay experimenter. Care will be provided by the attending physician and, according to standard of care, treatment decisions will be based on history taking, physical examination and conventional ankle x-ray series. Sonographic results will not be used for this purpose. All ankle x-ray series will be reviewed by a senior resident radiologist.

Official Title
-----------------
ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures

Conditions
-----------------
Fractures Bone

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient with acute ankle trauma + one or more criteria of the Ottawa ankle rules : Inability to walk 4 steps immediately after the trauma or in the emergency room, pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone. Exclusion Criteria: Any patient under the age of 18 years Any patient unable to sign the informed consent Skin lesions contraindicating sonography (e.g. open fracture wound, … ) An unstable patient whose inclusion in the study would delay vital treatment

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 |
| --- | --- | --- |
| Negative predictive value | Negative predictive value of ultrasound compared to standard radiography in the detection of long bone fractures | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | of ultrasound compared to standard radiography in the detection of long bone fractures | at inclusion | 
| Specificity | of ultrasound compared to standard radiography in the detection of long bone fractures | at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fracture ankle, Fracture foot, Frature metatarsus, Ultrasound, X-ray
Effect of CPAP Therapy on LPR Among Patients With OSAS

Study Overview
=================
Brief Summary
-----------------
This study will investigate the changes in the reflux symptom index (RSI) and reflux finding score (RFS) among patients with obstructive sleep apnea after regular humidified CPAP therapy. Since these two diseases have strong associations then one may consider the possible benefits from therapy in between them.

Official Title
-----------------
Effect of CPAP Therapy on Symptoms and Signs of Laryngopharyngeal Reflux Among Patients With Obstructive Sleep Apnea

Conditions
-----------------
Laryngopharyngeal Reflux, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have to stop proton pump inhibitors (PPI) therapy 1 month before enrollment in the study. To be eligible as LPR patients in our study, patients must have presented a RSI score > 13 and a RFS score > 7. These thresholds were highly correlated with pathological pH monitoring (pH < 4) Exclusion Criteria: Noncompliance for CPAP Use: According to the standard Medicare criteria to define CPAP compliance, the patients who demonstrated CPAP use ≥ 4 h/ night for ≥ 70% of the nights are considered compliant. Antireflux therapy during the period of the study.

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

| Intervention/Treatment |
| --- |
|Device: CPAP|Continuous positive airway pressure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux symptom index (RSI) change | Assessment of the changes in the reflux symptom index (RSI) among patients with obstructive sleep apnea according to the determined time frame | Change from the baseline RSI at 3 months of regular humidified CPAP application | 
| Reflux finding score (RFS) change | Assessment of the changes in the reflux finding score (RFS) among patients with obstructive sleep apnea according to the determined time frame | Change from the baseline RFS at 3 months of regular humidified CPAP application |
Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate antihypertensive (lowering blood pressure) effectiveness of three combinations of approved study drugs compared to both study drugs being given alone.

Detailed Description
-----------------
The duration of treatment is 3.5 months.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind, Parallel Study of the Anti-Hypertensive Efficacy and Safety of Losartan Monotherapy as Compared to HCTZ Monotherapy and to the Combination of Losartan and HCTZ in Japanese Patients With Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: MK0954A, hydrochlorothiazide (+) losartan potassium
* Drug: Comparator: placebo, losartan, hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese ancestry Stable high blood pressure defined by the study criteria Exclusion Criteria: Pregnant or nursing Significant concurrent kidney, liver, blood, or other disease Recent heart attack or heart surgery History of stroke, severe hypertension (high blood pressure), significant heart failure or cardiac arrhythmias Significant lab abnormalities Uncontrolled blood sugar History of certain drug allergies

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 74 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: MK0954A, hydrochlorothiazide (+) losartan potassium|nan|
|Drug: Comparator: placebo, losartan, hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean trough SiDBP after 8 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  |
Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

Study Overview
=================
Brief Summary
-----------------
The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction.

Official Title
-----------------
Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 (Randomised Controlled Phase II Clinical Trial)

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as 2- or 3-walled vertical intrabony defect >=3 mm deep from the top of the remaining alveolar bone with mobility of the tooth of degree 2 or less with width of attached gingiva appropriate for Guided Tissue Regeneration Exclusion Criteria: concomitant administration of adrenal cortical steroid within 4 wks after the surgery administeration of calcium antagonist during the 4 weeks preceding administration of the investigational drug coexisting malignant tumour or history of the same coexisting diabetes (HbA1C >= 6.5%) an extremely poor nutritional condition (serum albumin concentration <2 g/dL) pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)<br> <br> |
| Experimental: L<br>low dose (0.03 %) | Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)<br> <br> |
| Experimental: M<br>medium dose (0.1 %) | Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)<br> <br> |
| Experimental: H<br>high dose (0.3 %) | Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of increase in alveolar bone height |  | 36 weeks after administration | 
| clinical attachment level (CAL) regained |  | 36 weeks after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time course of rate of increase in alveolar bone height |  | within 36 weeks after administration | 
| time course of CAL regained |  | within 36 weeks after administration | 
| the other periodontal inspections (PD, BOP, GI etc.) |  | within 36 weeks after administration |
Biomarker Study in Tissue Samples From Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: Determine the frequency of acute myeloid leukemia (AML) that originates in CD33+ precursors or in which uncontrolled growth is restricted to CD33+ precursors. OUTLINE: Cryopreserved acute myeloid leukemia cell samples are separated from endothelial cell by fluorescent-activated cell sorting (FACS) and analyzed for X-chromosome inactivation patterns by cytogenetic/molecular analysis and/or Humara assay.

Official Title
-----------------
Assessment of Stem Cell Heterogeneity in AML in Co-Culture Systems Using X Chromosome Inactivation Patterns

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: cytogenetic analysis
* Other: HUMARA assay
* Other: fluorescence activated cell sorting
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosed with acute myeloid leukemia Known CD34+ progenitor cells Available freshly isolated, uncultured cell samples PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: cytogenetic analysis|nan|
|Other: HUMARA assay|nan|
|Other: fluorescence activated cell sorting|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of AML that originate in CD33+ or in which uncontrolled growth is restricted to CD33+ precursors |  |  | 
| Extent of clonal hematopoiesis in small numbers of AML cells |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute myeloid leukemia, childhood acute myeloid leukemia/other myeloid malignancies
Correlation Between Changes in End-Tidal Carbon Dioxide and Stroke Volume Variation Detected by Electrical Cardiometry as A Predictor of Fluid Volume Responsiveness in Hemodynamically Unstable Patients in the Intensive Care

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to assess the role of end-tidal carbon dioxide (PETCO2) monitoring to predict the fluid volume responsiveness in correlation with stroke volume variation detected by electrical cardiometry in patients with hemodynamic instability.

Official Title
-----------------
Correlation Between Changes in End-Tidal Carbon Dioxide and Stroke Volume Variation Detected by Electrical Cardiometry as A Predictor of Fluid Volume Responsiveness in Hemodynamically Unstable Patients in the Intensive Care

Conditions
-----------------
End Tidal Carbon Dioxide, Cardiometry, Fluid Responsiveness, Shock

Intervention / Treatment
-----------------
* Device: end tidal carbon dioxide by capnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who will be 18 years or older. Patients on mechanical ventilation in the intensive care. Patients developing hypotension (MABP) <65 mmHg. Exclusion Criteria: Patients with organ/s failure at presentation. Patients with deep venous thrombosis. Patients with limb and pelvic fractures. Pregnant patients

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fluid responders<br> | Device: end tidal carbon dioxide by capnography<br>* Moreover, since PETCO2 is mainly determined by tissue CO2 production (VCO2), alveolar ventilation and CO, when stable metabolic conditions are assumed and minute ventilation is kept constant, acute changes in PETCO2 have been shown to correlate strongly with changes in CO. Thus, PETCO2 has been suggested as a simple economic and noninvasive alternative for continuous assessment of CO in different shock states.<br>|
| fluid non responders<br> | Device: end tidal carbon dioxide by capnography<br>* Moreover, since PETCO2 is mainly determined by tissue CO2 production (VCO2), alveolar ventilation and CO, when stable metabolic conditions are assumed and minute ventilation is kept constant, acute changes in PETCO2 have been shown to correlate strongly with changes in CO. Thus, PETCO2 has been suggested as a simple economic and noninvasive alternative for continuous assessment of CO in different shock states.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of sensitivity and specificity of end tidal carbon dioxide monitoring in predicting fluid responsiveness in correlation with stoke volume variation detected by cardiometry |  | 24 hour |
Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among Adults

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized cross-over study was to determine the effects of legume consumption on adiponectin and inflammatory factors among first degree relatives of diabetic patients

Official Title
-----------------
Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among First Degree Relatives of Diabetic Patients

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: nutritional intervention
* Other: life style intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 30 years no history of chronic diseases no use of blood glucose lowering drugs Exclusion Criteria: do not use recommended amounts of legumes incidence of chronic diseases during the study to start use of blood glucose lowering drugs

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: legume consumption<br>legume consumption, 4 servings per week, for 6 weeks | Other: nutritional intervention<br> <br> |
| Active Comparator: healthy dietary recommendations<br>no nutritional intervention | Other: life style intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high sensitive C reactive protein (mg/l) | amounts of hs-CRP | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 (pg/ml) | amounts of IL-6 | 14 weeks | 
| Tumor necrosis factor-α (pg/ml) | amounts of TNF-α | 14 weeks | 
| Adiponectin (ng/ml) | amounts of adiponectin | 14 weeks |
To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent

Study Overview
=================
Brief Summary
-----------------
to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)

Detailed Description
-----------------
A Multicenter, subject-blinded, randomized study to evaluate safety and efficacy of CGBIO stent compared to Biomatrix Flex stent in patients undergoing drug-eluting stent procedure after coronary angiography

Official Title
-----------------
A Multicenter, Subject-blinded, Randomized Study to Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent in Patients Undergoing Drug-eluting Stent Procedure After Coronary Angiography

Conditions
-----------------
Ischemic Heart Disease, Stable Coronary Artery Disease, Stable Angina, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI

Intervention / Treatment
-----------------
* Device: CGBio stent
* Device: Biomatrix flex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one lesion with a diameter stenosis >50% suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm; Gr 1 ≤TIMI flow Exclusion Criteria: ST-segment elevation MI Bifurcation lesion Chronic total occulusion Restenosis lesion Graft vessel lesion Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year Cardiogenic shock or hemodynamic compromise Existing impairment in liver and kidney.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGBIO stent (DES)<br>The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C) | Device: CGBio stent<br>* Percutaneous Coronary Intervention<br>|
| Active Comparator: Biomatrix flex(DES)<br>The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG | Device: Biomatrix flex<br>* Percutaneous Coronary Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-segment late loss | angiographic in-segment late loss measure by QCA program | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-stent late loss | angiographic in-stent late loss measure by QCA program | 9 month | 
| MACE | death, MI and TVF | 9 month | 
| Restenosis rate | angiographic restenosis rate | 9month |