linjc16/ctgov huggingface dataset:
Ultrasound Assessment of Gastric Emptying of Korean Meals: Rice and Noodle

Study Overview
=================
Brief Summary
-----------------
The investigators evaluate gastric emptying time of common Korean meals (rice, noodles) in healthy volunteers.

Detailed Description
-----------------
The investigators assess the gastric volume and contents of healthy volunteers at 4, 5, 6, 7, 8 hours after eating common Korean meal (rice or noodle) using a ultrasonography.

Official Title
-----------------
Ultrasound Assessment of Gastric Emptying of Korean Meals in Healthy Volunteer: Rice and Noodle

Conditions
-----------------
Preoperative Fasting

Intervention / Treatment
-----------------
* Other: Evaluation of gastric volume and content


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy volunteers Exclusion Criteria: History of gastrectomy Anatomical abnormalities or mass of stomach

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rice<br>Group that healthy volunteers eat rice. | Other: Evaluation of gastric volume and content<br>* The gastric volume and gastric content are assessed at 4, 5, 6, 7, and 8 hours after eating a meal.<br>|
| Noodle<br>Group that healthy volunteers eat noodle. | Other: Evaluation of gastric volume and content<br>* The gastric volume and gastric content are assessed at 4, 5, 6, 7, and 8 hours after eating a meal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying time | The time for digesting a meal | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of full stomach | The incidence of full stomach is assessed by using ultrasonography. | At 4, 5, 6, 7, and 8 hours after eating a meal. | 
| Cross sectional area of the stomach | The cross sectional area of the stomach is assessed by using ultrasonography in the supine and right lateral positions. | At 4, 5, 6, 7, and 8 hours after eating a meal. | 
| Gastric volume | The volume of stomach is assessed using the following formula; volume of stomach (mL) = 27.0 + 14.6 x cross-sectional area (right lateral position) - 1.28 x age. | At 4, 5, 6, 7, and 8 hours after eating a meal. | 
| Type of gastric contents | The type of gastric contents is assessed using ultrasonography. | At 4, 5, 6, 7, and 8 hours after eating a meal. |
Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance

Study Overview
=================
Brief Summary
-----------------
Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

Detailed Description
-----------------
Prospective, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis (phase angle, fat mass, muscle mass, fat-free mass, body water) before and after ultramarathon.

Official Title
-----------------
Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: body bioelectrical impedance performed by Z-Métrix (class IIa) - BIOPARHOM 12 allée des lacs de garde, Savoie Technolac BP 238, 73374 Bourget du lac, France


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation to ultramarathon Exclusion Criteria: pregnancy women

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultramarathon<br> | Device: body bioelectrical impedance performed by Z-Métrix (class IIa) - BIOPARHOM 12 allée des lacs de garde, Savoie Technolac BP 238, 73374 Bourget du lac, France<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of fat-free mass, using bioelectrical impedance analysis |  | before and after ultramarathon of 105 km (at day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of phase angle, using bioelectrical impedance analysis |  | at day 1(before and after ultramarathon) | 
| Correlation between order in the course,duration of course and indices of body composition |  | at day 1 (during ultramarathon of 105 km) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultramarathon, bioelectrical impedance, Phase-Angle
Morphological and Functional Evaluation of Adult Flat Foot Before and After Corrective Surgery

Study Overview
=================
Brief Summary
-----------------
Morphological weight bearing computed tomography parameters and gait analysis can implement the evaluation of the flat foot. Weight bearing CT is useful to verify the severity of the 3D deformities typical of flat foot, while kinematic and kinetic variables of gait is able to quantify the functional improvements of the foot after surgery.

Official Title
-----------------
Pilot Study of Morphological and Functional Evaluation of Adult Flat Foot by Weight Bearing CT and Gait Analysis Before and After Corrective Surgery

Conditions
-----------------
Flat Feet

Intervention / Treatment
-----------------
* Procedure: morphological and functional evaluation of adult flat foot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with idiopathic flat foot with indication for corrective surgical treatment according to Grice (arthrodesis of the subtalar joint) age between 18 and 65 years BMI less than 40 signature of informed consent. Exclusion Criteria: patients with severe alterations or other pathologies affecting the foot and lower limb severe vascular and neurological systemic diseases systemic diseases that can compromise bone consolidation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flat foot patients<br>20 patients recruited consecutively and candidates for surgery to correct the adult flat foot according to the Grice technique. | Procedure: morphological and functional evaluation of adult flat foot<br>* Evaluations are realized by weight bearing computed tomography and by Gait analysis in the pre-operative phase and at a 6-months follow-up from the surgery with Grice technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight bearing computed tomography parameter | calcaneal pitch angle (degree) | change from baseline at 6-months | 
| Gait Analysis parameter | medial longitudinal arch | change from baseline at 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain clinical examination parameter | visual analogue scale of the foot | pre-operative phase and at a 6-months follow-up from the intervention | 
| Posture clinical examination parameter | Foot Posture Index | pre-operative phase and at a 6-months follow-up from the intervention | 
| Function clinical examination parameter | Foot function Index | pre-operative phase and at a 6-months follow-up from the intervention |
Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the anti-atherosclerotic effect of long-term anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical atherosclerosis of carotid arteries.

Official Title
-----------------
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis

Conditions
-----------------
Carotid Atherosclerosis

Intervention / Treatment
-----------------
* Dietary Supplement: Inflaminat
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 40 to 70 years Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1000-2000 mcm) Arterial normotension or mild arterial hypertension (systolic blood pressure <160 mm Hg, diastolic blood pressure <90 mm Hg) Absence of chronic diseases demanding permanent drug administration (more than 2 month per year) Exclusion Criteria: Personal history of stroke or transient ischemic attacks Chronic diseases demanding drug administration more than during 2 month per year Individual intolerance of Inflaminat or appearance of side effects

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inflaminat<br>Inflaminat 500 mg tablet by mouth three times a day | Dietary Supplement: Inflaminat<br> <br> |
| Placebo Comparator: Sugar pill<br>Placebo 500 mg tablet by mouth three times a day | Drug: Placebo<br>* Sugar pill manufactured to mimic Inflaminat 500 mg tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B-mode ultrasound of carotid arteries | Variation of intima-media thickness of common carotid arteries | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of serum atherogenicity | Change of the ability of serum to induce cholesterol accumulation in cultured cells | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerosis, inflammation, intima-media thickness
Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

Study Overview
=================
Brief Summary
-----------------
The study objectives were to assess 1/the immune status of healthcare professionals with suggestive symptomatology of Covid-19 infection and 2/the sensitivity and specificity of AAZ rapid test by comparing it with a serological ELISA test. An open-label, monocentric, prospective, non-randomized study, is conducted, including 50 hospital healthcare professionals and 50 private health professionals. Knowledge of serostatus will achieve the implementation of a strategy of management of patients according to specific immunity of health professionals

Official Title
-----------------
Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2

Conditions
-----------------
Covid-19 Immune Status of Healthcare Workers

Intervention / Treatment
-----------------
* Diagnostic Test: AAZ Covid-19 rapid test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthcare professionals with symptoms suggestive of Covid-19 infection Exclusion Criteria: any other subject pregnant women protected adult

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric, open-label, prospective, non-randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hospital healthcare workers<br>Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test | Diagnostic Test: AAZ Covid-19 rapid test<br>* To assess the immune status<br>* Other names: ELISA test;|
| Other: private health professionals<br>Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test | Diagnostic Test: AAZ Covid-19 rapid test<br>* To assess the immune status<br>* Other names: ELISA test;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the predictive value of Covid-19 rapid test | Comparative study with Elisa Test | One week | 
| Compare the results of rapid tests on serum and capillary samples | Performance evaluation of rapid tests according to the samples used | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology | Use of rapid test | one week | 
| Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology | Analysis of clinical data | One week |
Changes of Immunologic Function in Patients of Prostate Cancer Induced After Cryoablation.

Study Overview
=================
Brief Summary
-----------------
1. The overall objective of the study: By evaluating the curative effect of CSAP in localized prostate cancer, locally advanced prostate cancer and metastasis advanced prostate cancer, and the change of state in cellular immunity and humoral immunity before and after CSAP. Validate the clinical therapeutic effect of all kinds of prostate cancer, as well as the change of immune status before and after CSAP. 2. The main content of the study: Included in the samples are patients in hospitals for CSAP. The sample capacity are planned to be 80. The main purpose of the study is to observe the overall survival rate , disease free survival rate, the progress time of the PSA biochemical recurrence as well as the disease progress time. Measure the change of concentration in peripheral blood T lymphocyte subsets (CD3 + T, CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells) and regulatory T cells before and after cryoablation within 1 month, 3 months and 6 months. Measure the change of concentration in peripheral blood IFN-1, IL-4, IFN-1/IL-4 ratio (Thl/Th2 ratio), and detect the secretion of CD4 + Th tumor-specific IFN-l and the activity of tumor-specific killer CD8 + CTL before and after cryoablation within 2 weeks and 1 month. Before cryoablation, detect the expression and distribution of Follistatin-Like1 (FSTL-1), Besides, verify the connection between the number and activation ratio of tumor local dendritic cells (DC) and the FSTL-1, evaluating the cryoablation effect on the immune response.

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with prostate cancer by pathology the age of patients should be from 40 to 80 years old do not receive other treatments like radical prostatectomy, radiotherapy, etc Exclusion Criteria: can not receive surgery because of bad performance status abnormal coagulation function receive other treatment before CSAP do not want to achieve CSAP because of any reasons

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| humoral immunity and cellular immunity will be activated after CSAP for patients of prostate cancer | All 80 participants' peripheral blood will be collected before CSAP and after CSAP to detect the concentration of T lymphocyte subsets (CD3 + T, CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells), IFN-1, IL-4, IFN-1/IL-4 ratio (Thl/Th2 ratio) and FSTL-1, and to comment the change of activity of humoral immunity and cellular immunity. | 3 years |
Function of Circulating Exosomes in Sepsis-induced Immunosuppression

Study Overview
=================
Brief Summary
-----------------
This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.

Official Title
-----------------
Function of Circulating Exosomes in Sepsis-induced Immunosuppression

Conditions
-----------------
Sepsis, Septic Shock, Sepsis Syndrome, Sepsis Bacterial, Sepsis, Severe, Sepsis Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 50 years with ≥ 2 chronic comorbidities Highly suspected bacterial infection based on clinical or radiologic evidence ≥ 2 systemic inflammatory response syndrome (SIRS) criteria Actual/anticipated admission to intensive care unit (ICU) Anticipated length of hospital stay ≥ 5 days Exclusion Criteria: Pregnancy Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases) Current immunotherapy use Confirmed COVID-19 infection

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Sepsis<br>I. ≥ 50 years with ≥ 2 chronic comorbidities II. Highly suspected bacterial infection based on clinical or radiologic evidence III. ≥ 2 systemic inflammatory response syndrome (SIRS) criteria IV. Actual/anticipated admission to intensive care unit (ICU) V. Anticipated length of hospital stay ≥ 5 days | |
| Control<br>I. ≥ 50 years with ≥ 2 chronic comorbidities II. No suspected bacterial infection III. Actual/anticipated admission to intensive care unit (ICU) IV. Anticipated length of hospital stay ≥ 5 days | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | All-cause mortality | From enrollment to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality | All-cause mortality | From enrollment until hospital discharge, up to 90 days | 
| 90-day mortality | All-cause mortality | From enrollment to 90 days | 
| Length of stay | Hospital length of stay | From enrollment until hospital discharge, up to 90 days | 
| Duration of infection | Time to resolution of infection | From enrollment until resolution of SIRS, up to 90 days |
Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System

Study Overview
=================
Brief Summary
-----------------
Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2) in upper airways of mechanically ventilated patients. Optimal ETT cuff inflation will lead to a reduction of complication rate related to mechanical ventilation procedure. This study was design in order to evaluate the feasibility of using the AnapnoGuard system.

Official Title
-----------------
Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Device: AnapnoGuard 100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 (men and woman); Patient is admitted to ICU and expected to receive mechanical ventilation for at least 48 hours; Normal chest X-ray; Connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation; Signed informed consent by subject's legally acceptable representative. Exclusion Criteria: Patients who had been treated with mechanical ventilation during the last year; Fever from known chest/lung origin; Patients with facial, oropharyngeal or neck trauma; BMI>35; Height < 1.6 m; Any chest X-ray pathology during the first 24 hours post intubation; More than 7 days hospitalization prior to the intubation. Chest/lung infection.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AnapnoGuard<br> | Device: AnapnoGuard 100<br>* Respiratory guard system during mechanical ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU). |  | during intubation (2-14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events occurrence |  | During intubation (2-14 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VAP