linjc16/ctgov huggingface dataset:
Indocyanine Green for Solid Tumors

Study Overview
=================
Brief Summary
-----------------
According to the World Health Organization, cancer is a leading cause of death in men and women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismally low. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence from patients and thus overall survival.

Official Title
-----------------
A Pilot and Feasibility Study of Intraoperative Imagery of Solid Tumors With Indocyanine Green

Conditions
-----------------
Solid Tumor, Neoplasms

Intervention / Treatment
-----------------
* Drug: Indocyanine Green (ICG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients over 18 years of age Patients presenting with a solid tumor presumed to be resectable cancer and are at risk for local recurrence on pre-operative assessment Good operative candidate as determined by the treating physician and multidisciplinary team Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery Subjects with a history of iodide allergies Vulnerable patient populations People who would be easily lost to follow up Patients unable to participate in the consent process (children and neonates).

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG injection group<br>This group will receive a single dose of ICG, infused over 40 minutes. During surgery, they will be imaged with a camera and an imaging probe the investigators have developed. | Drug: Indocyanine Green (ICG)<br> <br> * Other names: ICG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability of the imaging system to detect the expression of the ICG in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor. |  | Before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants that will have an adverse reaction to the ICG. |  | Day 1-Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid Tumor
Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids

Study Overview
=================
Brief Summary
-----------------
This study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Half of participants will receive corticosteroids alone, while the other half will receive corticosteroids with biliary stent at the beginning.

Conditions
-----------------
Autoimmune Pancreatitis, IgG4-related Sclerosing Cholangitis, Obstructive Jaundice

Intervention / Treatment
-----------------
* Drug: corticosteroids
* Procedure: biliary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults greater than 18 years-old; autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis; obstructive jaundice Exclusion Criteria: malignancies; active infections; pregnancy or breast feeding; standard contraindications to ERCP; unwillingness or inability to consent for 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroids group<br>The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone. | Drug: corticosteroids<br>* prednisone 0.6mg/kg/d<br>|
| Active Comparator: Stent group<br>The patients will be treated with oral corticosteroids and biliary stent. | Drug: corticosteroids<br>* prednisone 0.6mg/kg/d<br>Procedure: biliary stent<br>* placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission rate of obstructive jaundice |  | Day 60 |
Airway Manoeuvers - Implications for Airway Management?

Study Overview
=================
Brief Summary
-----------------
In anesthesia, intubation is a technique used to secure an airway. This technique is not always straightforward. Sometimes it is difficult to place an endotracheal tube. There are two manners of giving pressure to the patients neck, to improve view and facilitate intubation. The investigators hypothesize that by giving this pressure the effective work area is likely to be smaller. The investigators would like to quantify this effect by measuring the effective work area, using a specially designed computer program.

Detailed Description
-----------------
Cricoid pressure (CP) and the backward-upward-rightward pressure (BURP) manoeuver, are extralaryngeal manoeuvers which are widely applied during endotracheal intubation, respectively offering potential protection against passive gastric regurgitation and improved laryngeal view in emergency airway management. Their validity in achieving an improvement of the laryngeal view has been questioned. The objective of this study is to measure the change in mean anterior-posterior rima glottidis (APRIMA) distance and mean area under the vocal cords after backward upward rightward pressure (BURP) and cricoid pressure (CP). The investigators will measure the APRIMA distances and areas under the vocal cords, using a specially created module in the program DeVIDE. The measurements assessed during BURP and CP will be expressed relative to the measurements when no external pressure is applied.

Official Title
-----------------
The Effect of Cricoid Pressure and Backward Upward Rightward Pressure on Airway Dimensions - Implications for Airway Management?

Conditions
-----------------
Airway Management

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 200 consecutive adult patients scheduled for elective surgery requiring endotracheal intubation Exclusion Criteria: BMI > 35 kg.m-2); chronic obstructive pulmonary disease; history of difficult intubation; mouth opening < 3 cm; inadequate neck mobility; history of oropharyngeal pathology.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cricoid pressure (CP), backward upward rightward pressure (BURP), AP-rima distances, Glottic area, Extralaryngeal manoeuvres
Gastric Accommodation and Gastroesophageal Reflux

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal reflux events generally happen during relaxation of lower esophageal sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead to reflux events. To test this hypothesis, a study was designed to measure the gastric accommodation in patients undergoing esophageal impedance monitoring.

Detailed Description
-----------------
Gastroesophageal reflux events happen during relaxations of lower esophageal sphincter not related to swallowing, called transient. These transient lower esophageal sphincter relaxations (tLESR) are generally triggered by gastric distension and its physiological purpose is to vent the stomach. The gastric accommodation is a physiological process in which the gastric fundus actively relaxes during a meal in order to accommodate it. This study is driven by the hypothesis that impairment of the gastric accommodation may facilitate triggering tLESR and, therefore, reflux events. We aim to evaluate the relation between gastric fundic relaxation and the number of gastroesophageal reflux events in children. We also aim to evaluate if there is a relation between the gastric emptying and the number of reflux episodes.

Official Title
-----------------
Gastric Accommodation as a Factor Influencing the Number of Reflux Episodes in Children and Adolescents

Conditions
-----------------
Gastroesophageal Reflux Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD* symptoms Exclusion Criteria: continuous feeding previous fundoplication

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 30 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 |
| --- | --- |
| Study group<br>Patients with symptoms suggesting gastroesophageal reflux and referred to perform an impedance study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NUMBER OF REFLUX EPISODES | It is a cross-sectional exam, and the number of reflux episodes at baseline, after a clinically indicated 24-hour impedance study | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric volume ratio: 10 min/baseline | It is a cross-sectional study. This variable will be assessed by ultrasound in the next morning of the impedance study. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal reflux disease, gastric motility
Sex Differences in Gene Expression in Human Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
This project was created to assess sex differences in adipose tissue gene expression in different locations in the body. The primary objectives are to understand: The mechanisms of differential body fat distribution in men and women How body fat distribution is affected by reproductive hormones The mechanisms linking fat distribution to health risks such as diabetes

Official Title
-----------------
Sex Differences in Gene Expression in Human Adipose Tissue

Conditions
-----------------
Healthy, Obesity

Intervention / Treatment
-----------------
* Procedure: Adipose Biopsy
* Procedure: Blood sample
* Radiation: CT Scan
* Radiation: DEXA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian men and women 20-35 years of age Lean (BMI less than 25) Obese (BMI 30-35) Exclusion Criteria: Hormonal birth control Pregnancy Smokers History of diabetes, kidney, liver or thyroid disease History of cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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 |
| --- | --- |
| 1<br>Five caucasian women | Procedure: Adipose Biopsy<br>* Adipose tissue will be sampled from the abdomen and buttock<br>Procedure: Blood sample<br>* Blood will be sampled from an IV line<br>Radiation: CT Scan<br>* Single image at the level of the liver<br>Radiation: DEXA<br>* Whole body scan<br>|
| 2<br>Five caucasian men | Procedure: Adipose Biopsy<br>* Adipose tissue will be sampled from the abdomen and buttock<br>Procedure: Blood sample<br>* Blood will be sampled from an IV line<br>Radiation: CT Scan<br>* Single image at the level of the liver<br>Radiation: DEXA<br>* Whole body scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adipose and blood sampling |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT scan and DEXA scan |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adipose, lean, obese, overweight, healthy
Evaluation of Subclinical COronary Atherosclerosis for Risk Stratification Using Coronary Computed Tomography (CT) Angiography

Study Overview
=================
Brief Summary
-----------------
To evaluate the prognostic value of coronary CT angiography (CCTA) for risk stratification in asymptomatic adults in comparison with conventional risk stratification (CRS) and coronary artery calcium scoring (CACS).

Detailed Description
-----------------
The risk stratification of cardiovascular disease (CVD) in asymptomatic individuals represents a major challenge. For this purpose, a lot of risk prediction models that take demographic and clinical characteristics into account have been developed. Although Framingham risk score (FRS) is most widely used among multiplr risk prediction models, it has some limitation for prediction of CVD especially in young adult and women. Recently, coronary artery calcium score (CACS) has known to be powerful screening method for CVD, however, it cannot detect the noncalcified coronary plaques (NCP), so it does not represent the entire spectrum of atherosclerotic plaques and it also cannot evaluate the degree of stenosis. On the contrary, Coronary CT angiography (CCTA)can provide detailed coronary artery anatomy and plaque imaging about the location, burden and characteristics of atherosclerotic plaque per se, which might give additional insight to stratify the risk of future cardiac events and therapy. In this study, we will evaluate the prevalence and characteristics of subclinical coronary atherosclerosis on CCTA in asymptomatic population. And we will investiage the follow up data for major cardiac adverse event such as cardiac death, nonfatal myocardial infarction, unstable angina and revascularization. Therefore, we will finally evaluate the prognostic value of CCTA for risk stratification in asymptomatic adults in comparsion with conventional risk stratification such as FRS and CACS.

Official Title
-----------------
Prognostic Value of Coronary CT Angiography in Relation to Evaluation of Subclinical Coronary Atherosclerosis for Risk Stratification in Asymptomatic Individuals From ESCORT Study

Conditions
-----------------
Coronary Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asymptomatic subjects adults > 20 years subjects who underwent both calcium score and coronary CT angiography Exclusion Criteria: typical or atypical chest pain subjects who underwent previous percutaneous coronary intervention serious comorbid conditions(i.e. malignancy) insufficient medical record poor image quality

Ages Eligible for Study
-----------------
Minimum Age: 20 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
-----------------
coronary Atheroslcerosis, Computed Tomography
RCT About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt Postpartum Urinary Retention

Study Overview
=================
Brief Summary
-----------------
A randomized controlled trial of two different regimens of intermittent catheterization in women with overt postpartum urinary retention. Participants will be randomized to one of two groups with different cut-offs for accepted postvoid residual urine (150 ml vs 250 ml). Primary endpoint is be the time to regain normal bladder function in each group. Secondary endpoints are 1) presence/absence of bacteriuria or urinary tract infections, 2) the duration of hospital stay, 3) scores on the adapted version of the German pelvic floor questionnaire section about bladder function and postpartum symptoms. The calculated sample size is 96 (48 in each group).

Official Title
-----------------
A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial

Conditions
-----------------
Urinary Retention, Postpartum Period

Intervention / Treatment
-----------------
* Procedure: Intermittent catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed overt postpartum urinary retention. Age ≥ 18 years at delivery date. Delivery at study site. signed informed consent. Exclusion Criteria: Refusal to participate. Language barrier.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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 |
| --- | --- |
| Active Comparator: Women with postvoid residual volume cut-off at 150 ml<br> | Procedure: Intermittent catheterization<br>* Intermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group.<br>|
| Experimental: Women with postvoid residual volume cut-off at 250 ml<br> | Procedure: Intermittent catheterization<br>* Intermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to regain normal bladder function | The time until bladder function returned to normal. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum, postpartum urinary retention, intermittent catheterization, postvoid residual volume
Arterial Stiffness in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Diurnal variations in the cardiovascular system apparent in healthy individuals, are different in chronic kidney disease patients. Therefore, diurnal variations in arterial stiffness may also differ in chronic kidney disease patients. This study aims to identify and evaluate diurnal variations in arterial stiffness in chronic kidney disease patients and compare them to those in age matched healthy controls.

Official Title
-----------------
Diurnal Variations in Arterial Stiffness in Patients With Chronic Kidney Disease and Healthy Age Matched Controls

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic blood pressure <160 whether or not on antihypertensive medication diastolic blood pressure <100mmHg whether or not on antihypertensive medication Chronic kidney disease stage 2-5 Exclusion Criteria: Systolic blood pressure ≥160mmHg Diastolic blood pressure ≥100mmhg Significant comorbidity (investigator opinion but to include alcoholism and terminal illness)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| Healthy controls<br>Healthy age matched controls | |
| Chronic kidney diease<br>Chronic kidney disease patients stage 2-4 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal variations in arterial stiffness | The principal objective of this study is to evaluate whether diurnal variations in arterial stiffness are blunted in chronic kidney disease compared to healthy age matched controls | Over one 26 hour period arterial stiffness measurements will be obtained every 30 minutes from 7am to 12am and every 60 minutes from 12am to 7am | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal variations in aortic and brachial blood pressure | Secondary objective of this study is to evaluate whether diurnal variations in aortic and brachial blood pressure are blunted in chronic kidney disease compared to healthy age matched controls | Over one 26 hour period blood pressure measurements will be obtained every 30 minutes from 7am to 12am and every 60 minutes from 12am to 7am | 
| Relationship between changes in blood pressure and arterial stiffness | Secondary objective of this study is to evaluate whether diurnal variations in arterial stiffness are dependent on changes in blood pressure in both chronic kidney disease patients and age matched controls. | Over one 26 hour period |