linjc16/ctgov huggingface dataset:
Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry

Study Overview
=================
Brief Summary
-----------------
The overall objective of CONFIRM2 is to perform the largest cardiovascular phenotype outcomes study ever.

Detailed Description
-----------------
CONFIRM2 is a retrospective and prospective, open-label, international, multicenter observational registry designed to evaluate associations between CCTA imaging findings and clinical presentation (cross-sectional) and their ability to predict mortality and major adverse cardiac events (longitudinal) in patients with chronic CAD.

Official Title
-----------------
Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Undergoing clinically indicated CCTA with >64-detector row CT Signed informed consent, including of release of medical information, long term follow-up and Health Insurance Portability and Accountability Act (HIPAA) documentation Exclusion Criteria: Individuals unable to provide informed consent Non-cardiac illness with life expectancy < 2 years Pregnancy

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 |
| --- | --- | --- |
| Coronary CT Angiography EvaluatioN For Clinical Outcomes | Examined the totality of information visualized by coronary CT angiography (CCTA) for optimal refinement of prognostic risk stratification | June 2020- June 2022 |
Diagnostic Accuracy of Emergency Physician Performed Bedside Ultrasound in Suspected Acute Appendicitis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the diagnostic yield and accuracy of bedside emergency physician performed ultrasound in the diagnosis of acute appendicitis.

Detailed Description
-----------------
Emergency physician (EP) performed bedside ultrasound is cost effective, repeatable and especially useful in the diagnosis of life treating conditions such as aortic dissection, traumatic bleedings. While abdominal pain is a common complaint in the emergency department and accurate diagnosis of its etiology may affect the patient's outcome, the accuracy and the diagnostic yield of bedside EP performed ultrasound is not well established. The diagnosis of a patient presented to emergency department with right lower abdominal pain is generally problematic and physician has to exclude acute surgical reasons such as acute appendicitis. In this study, patients who are suspicious to have acute appendicitis base on their clinical findings will be included. EP will record his diagnosis and then patient will undergo emergency physician performed ultrasound. After ultrasound EP will fill the study form according to US findings and record his diagnosis once again. At the end of the study the investigators evaluate and compare the radiology performed US reports and if there is operational biopsy results with the EP's pre- and post ultrasound diagnosis to estimate the diagnostic yield and accuracy of bedside emergency physician performed ultrasound in the diagnosis of acute appendicitis.

Official Title
-----------------
Diagnostic Accuracy and Clinic Utility of Bedside Ultrasonography Performed by Emergency Physicians in Suspected Acute Appendicitis

Conditions
-----------------
Acute Abdomen, Acute Appendicitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient presented with the complaint of right lower abdominal pain Suspected acute appendicitis Exclusion Criteria: Flank pain Previous appendectomy Pregnancy Unstable vital signs Frank peritonitis US performed before EP's examination

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 |
| --- | --- |
| Ultrasound<br>Ultrasound evaluation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of emergency physician performed bedside ultrasound in diagnosing of acute appendicitis |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergency ultrasound, acute appendicitis, bedside ultrasound
Using Virtual Reality (VR) Models for Preoperative Planning

Study Overview
=================
Brief Summary
-----------------
A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic partial nephrectomy) and improved patient care.

Official Title
-----------------
Using Virtual Reality (VR) Models for Preoperative Planning

Conditions
-----------------
Kidney Cancer, Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Device: Ceevra Reveal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is undergoing robotic partial nephrectomy being performed by participating surgeon Subject is willing to be randomized between intervention and control arms Exclusion Criteria: Cases involving subjects who are minors, pregnant or require an authorized representative for informed consent Cases in which the subject has a solitary or horseshoe kidney Cases in which the subject has more than two masses in the applicable kidney Cases involving a bilateral operation

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image | Device: Ceevra Reveal<br>* VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.<br>|
| No Intervention: Control Arm<br>Subjects whose surgeon will only be viewing CT/MR images in connection with the case | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Operative Time |  | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss |  | Measured at end of procedure | 
| Clamp Time |  | Measured at end of procedure | 
| Number of Patients With Conversion to Open Surgery |  | During procedure | 
| Number of Patients With Conversion to Radical Nephrectomy |  | During procedure | 
| Number of Patients With an Intraoperative Complication |  | During procedure | 
| Patient Hospital Stay |  | Measured at time of patient discharge, up to 10 days | 
| Number of Patients With a Positive Surgical Margin | Incomplete removal of tumor as defined by the surgical pathology | Measured 1-2 weeks after discharge | 
| Post-Op Complication |  | Measured up to 6 months after discharge | 
| Readmission |  | Measured up to 6 months after discharge |
Apoptic Biomarkers of Periodontal Disease

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to facilitate early diagnosis of gum disease. Proteins associated with cell death will be isolated from gum pockets of diseased and healthy patients and evaluated.

Detailed Description
-----------------
Early detection of the progression of periodontitis is difficult because it typically relies on comparisons of clinical measurements made with a calibrated probe and nonstandardized radiographs over time. Both methods detect periodontal breakdown only after it has occurred. Therefore, considerable emphasis has been placed on identifying more specific and sensitive methods to diagnose and detect periodontal disease progression. The overall goal of this project is to determine whether specific apoptosis-associated proteins, specifically fibronectin (FN) fragments, caspase-3, soluble Fas, and soluble Fas ligand, sampled from gingival crevicular fluid (GCF) can be used as markers for periodontal disease progression.

Official Title
-----------------
Apoptotic Biomarkers of Periodontal Disease

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

Intervention / Treatment
-----------------
* Other: collection of gingival crevicular fluid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over age of 18 Healthy or diagnosis of periodontitis Exclusion Criteria: Active treatment with anti-inflammatory agents such as NSAIDs or steroids and pregnant females

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Risk<br>High risk disease prone population | Other: collection of gingival crevicular fluid<br>* GCF samples will be collected at 3 month intervals<br>|
| Low Risk<br>Low risk disease population | Other: collection of gingival crevicular fluid<br>* GCF samples will be collected at 3 month intervals<br>|

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
-----------------
Apoptic biomarkers, Early detection periodontitis, Gingival crevicular fluid, Healthy subjects
AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease

Study Overview
=================
Brief Summary
-----------------
Alcohol contributes to over 5% of deaths worldwide, and death rates from alcohol-related liver disease (ARLD) in the UK continue to rise sharply. On-going alcohol use in ARLD leads to markedly increased mortality (Thursz et al, 2015), and maintaining abstinence is a key therapeutic goal. However, there are no effective pharmacological therapies for maintaining abstinence. Brief intervention (BI) is an effective psychological tool for reducing alcohol use, but is difficult to scale widely. AlcoChange is a smartphone app and breathalyser (AlcoChange), which facilitates self-monitoring and delivers BIs in response to patient triggers. The aim of this open-label study is provide AlcoChange to 60 patients with ARLD, to determine compliance with the app/breathalyser and changes in self-reported alcohol consumption. Recruitment of inpatients/outpatients with ARLD and recent alcohol use will take place at Royal Free London. The inclusion criteria are: intent to maintain abstinence, possession of compatible smartphone. The exclusion criteria are: inability to provide consent. Participants will be assessed at baseline and 3-months. The primary endpoint is self-reported alcohol use (units/week, timeline follow-back). Secondary endpoint is compliance with the app (monitored remotely).

Official Title
-----------------
AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease

Conditions
-----------------
Alcohol-Related Disorders

Intervention / Treatment
-----------------
* Device: AlcoChange


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of ARLD age 18-70 intent to maintain abstinence possession of compatible smartphone Exclusion Criteria: - inability to provide consent.

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: Treatment arm<br> | Device: AlcoChange<br>* Smartphone app and breathalyser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported alcohol consumption (average/week) | Assessed by time line follow back method over study period | 3-month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with the app (no. of logins, duration spent on the app) | This will be assessed independently, and for associations of compliance with the app and changes in alcohol consumption (primary endpoint) | 3-month study period |
Recognition of Abnormal Pediatric Blood Pressures in Primary Care

Study Overview
=================
Brief Summary
-----------------
This study will look at general pediatricians' effectiveness at screening children for elevated blood pressure values in the primary care setting. Two new screening tools will be introduced and their effectiveness will be measured against current practice by way of medical chart review.

Official Title
-----------------
Recognition of Abnormal Pediatric Blood Pressures in Primary Care

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

Intervention / Treatment
-----------------
* Device: PDA blood pressure screening program and chart reminder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health care supervision visit Documented measured blood pressure and height Between the ages of 3 years and 17 years Exclusion Criteria: Younger than 3 years of age Older than 17 years of age No documented blood pressure measurement Not a health supervision encounter

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PDA blood pressure screening program and chart reminder|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| written documentation by MD in medical record acknowledging elevated BP |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance with interventions |  |  |
Sleep Disorders After TIPS

Study Overview
=================
Brief Summary
-----------------
The Purpose of a study to investigate the incidence of postoperative sleep disorders in patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the relationship between risk factors and prognosis of sleep disorders.

Official Title
-----------------
The Incidence of Sleep Disorders After Transjugular Intrahepatic Portosystemic Shunt

Conditions
-----------------
Sleep Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of cirrhosis (clinical or by liver biopsy) Portal hypertension patients with defined indications for TIPS treatment Aged 18-75 years old Signed written informed consent Exclusion Criteria: mental or nervous system diseases Patients with alcoholic cirrhosis who are still drinking Accompanied by serious heart, lung, brain and kidney diseases Preoperative diagnosis of sleep disorder Patients who are illiteracy The total score of the preoperative Hamilton anxiety scale was greater than or equal to 14 points, and the total score of 17 points of the Hamilton depression scale was greater than or equal to 18 points

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| the patients who will undergo TIPS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of sleep disorders after TIPS | The number of patients who suffer from sleep disorders after TIPS | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hepatic encephalopathy | The number of patients who suffer from hepatic encephalopathy | 1 year | 
| mortality | The number of patients who died | 1 year |
Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis

Study Overview
=================
Brief Summary
-----------------
Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune disease with a endothelial dysfunction. This study is to evaluated the level of soluble VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.

Official Title
-----------------
Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis

Conditions
-----------------
Primary Raynaud Disease, Systemic Sclerosis

Intervention / Treatment
-----------------
* Biological: soluble Ve cadherin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: group 1: systemic sclerosis group 2: raynaud primary disease

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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Systemic sclerosis<br>patients with systemic sclerosis | Biological: soluble Ve cadherin<br>* dosage of soluble VE cadherine in each arms<br>|
| Sham Comparator: primary raynaud disease<br>patients with primary raynaud disease | Biological: soluble Ve cadherin<br>* dosage of soluble VE cadherine in each arms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of soluble Ve-cadherin and antibody VE-cadherin with ELISA TEST in Scleroderma group versus Primary Raynaud's Phenomenon | Level of human sVE and antibody VE-cadherin in blood will be determined by ELISA test in both groups Scleroderma and Primary Raynaud's Phenomenon. The methodology of dosage of sVE is based on the pattern:WO/2008/062314 The methodolody of the dosage of antibody VE-cadherin is based on the pattern WO/2012/136820 . Group Scleroderma (N=60) versus Primary Raynaud's Phenomenon (N=20). Shapiro test. | At 30 days average | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
soluble VE-cadherin, antibody, systemic slerosis
Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of music therapy before, during, and after cardiac catheterization is associated on (a) change in reactive hyperemia index measured before and after catheterization using peripheral arterial tonometry and (b) patient stress and discomfort measured by a questionnaire, as compared to the standard of care (no music during cardiac catheterization). The hypothesis of the study is that music therapy during cardiac catheterization will be associated with more favorable change in reactive hyperemia and higher patient satisfaction compared to no music playback.

Official Title
-----------------
FEAT: Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy

Conditions
-----------------
Coronary Artery Disease, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Other: Music therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Referred for clinically-indicated cardiac catheterization Exclusion Criteria: Refusal or inability to provide signed informed consent Significant hearing loss

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music therapy<br>The music played will be by MusiCure, by Niels Eje (slow, relaxing music designed for therapeutic use), and will be played from an audio pillow beneath the patient's head. | Other: Music therapy<br>* The music played will be by MusiCure, by Niels Eje (slow, relaxing music designed for therapeutic use), and will be played from an audio pillow beneath the patient's head.<br>|
| No Intervention: No music therapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in reactive hyperemia index measured by peripheral arterial tonometry |  | PAT will be performed within 2 hours before cardiac catheterizaiton and repeated within 2 hours after the end of cardiac catheterization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress and anxiety questionnaire | a stess and anxiety questionnaire will be completed within 2 hours after cardiac catheterization is completed | questionnaire will be completed within 2 hours after the end of cardiac catheterization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
music, cardiac catheterization, endothelial function