linjc16/ctgov huggingface dataset:
CareTaker Self-Calibration Validation

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to test the capability of the CareTaker monitor to calibrate its continuous blood pressure readings independently. Currently the device requires another approved blood pressure monitor to provide a starting calibration. The new control module enables the CareTaker to perform a pressure sweep of the internal pressure in the finger cuff. The resulting data is analyzed using a combination of pulse analysis/oscillometry approach.

Detailed Description
-----------------
The specific objective of this project was to demonstrate the CareTaker's ability to perform self-calibration to the same performance standard as its predicate device. That device demonstrated efficacy by showing substantial equivalence to the performance of classical sphygmomanometry using a Riva-Rocci/Korotkoff (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg across 3 paired readings from at least 85 patients, for a total of at least 255 paired readings. The study was performed at the University of Virginia Medical Center in Charlottesville, Virginia. UVA's Institutional Review Board approved (#18686) and supervised the study for subjects who were University of Virginia hospital patients and staff > 18 years of age and who were able to give verbal consent.

Official Title
-----------------
CareTaker Self-Calibration Validation

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: non-invasive blood pressure monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age, who are able and willing to participate and have given verbal assent Exclusion Criteria: Unable to give verbal assent <18 years of age No or poor finger pulse, as determined through visual inspection for ischemic hands

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

| Intervention/Treatment |
| --- |
|Device: non-invasive blood pressure monitor|Equivalence of CareTaker blood pressure to classical sphygmomanometry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance comparison | Comparison with performance of classical sphygmomanometry using a Riva-Rocci/Korotkov (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg | 8 minutes for 3 paired readings | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-invasive blood pressure
Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Study Overview
=================
Brief Summary
-----------------
This is an observation study using the Flashback CRI T1 tablet to collect data on compensatory reserve index in pediatric trauma patients. Highest trauma activations at the institution will be enrolled in the study and data will be collected for 12-24 hours based on the patient's hemodynamic status. The device collects data via a pulse oximeter probe. No treatment decisions will be made based on the values of the on the CRI tablet. Data will be retrospectively reviewed to determine if any trends exist that correlate with blood loss, need for operation or blood transfusion.

Official Title
-----------------
Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Device: Flashback CRI T1 Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Children 31 days through 26 years (inclusive) of age who undergo Trauma Red (highest level) activation or Trauma Level 1 (mid-level) activation at Children's Hospital Colorado or Children's National Medical Center. Exclusion Criteria: Pregnant patients Incarcerated patients Patients who object to study participation at any time Limited access to or compromised monitoring sites for non-invasive finger sensors Brain death (GCS 3 with fixed, dilated pupils)

Ages Eligible for Study
-----------------
Minimum Age: 31 Days
Maximum Age: 26 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Trauma Patients<br>All pediatric patients >31 days who meet criteria for highest level trauma activation (Level Red or Level 1) at the Children's Hospital Colorado. | Device: Flashback CRI T1 Tablet<br>* Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with abnormal CRI values | Compare CRI values collected by the T1 tablet to standard traditional vital signs, i.e. heart rate and blood pressure, to identify if abnormal CRI values correlated with abnormal traditional vital signs | 12-24 hours | 
| Number of participants who require blood products | Compare CRI values collected by the T1 tablet to standard laboratory measures, i.e. hematocrit, to identify if abnormal CRI values correlated with blood loss | 12-24 hours | 
| Number of participants who require operation or angiographic intervention | Determine if CRI values collected by the T1 tablet are abnormal in the setting of patients who require operation or angiographic intervention for hemorrhage control | 12-24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric
Blood Biomarker in Early Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Currently, there are no cures or disease modifying therapies for Parkinson's disease (PD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for PD. Several detection parameters will be assessed through enrollment of Parkinson's patients and age matched healthy volunteers over 50 years of age to learn more about the analytical process and biological variability.

Official Title
-----------------
Blood Biomarker in Early Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Age matched to PD patient Parkinson's Disease Patients: 50 years and older PD patient who is seen at the Duke Movement Disorders Center Early PD diagnosis (Hoehn and Yahr scale ≤ 3) Non-smoking No cancer treatment in the last 5 years Able to read and speak English Healthy Control Participants: 50 years and older Non-smoking No cancer treatment in the last 5 years Able to read and speak English Exclusion Criteria: Parkinson's Disease Patients: Known additional neurological disease Clinical trial intervention within the last 6 months Healthy Control Participants: Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's) Clinical trial intervention within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 50 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 Volunteers<br> | |
| Parkinson's Disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological marker of Parkinson's disease | Test for biological marker of Parkinson's disease, mtDNA damage | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood, biomarker, Parkinson's disease
Managing Cyanosis Following Bidirectional Glenn Operation

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from January 1, 2003 to December 31, 2005 who were significantly cyanotic.

Detailed Description
-----------------
Infants following bidirectional Glenn operation are at times significantly cyanotic. The medical management of significant postoperative cyanosis has changed with the advent of nitric oxide, sildenafil and bosentan. The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from Jan 1, 2003 to Dec 31, 2005 who were significantly cyanotic. Summary of Procedures This is a retrospective study, therefore, the only procedure will be a chart review. I estimate the number of patients to be around 150, however, request permission to review the patient population in order to provide exact numbers. We request permission to review hospital charts from the time of bidirectional Glenn operation and the last clinic note within the dates Jan 1, 2003 to Dec 31, 2005. We will assign each chart a unique study number and collect data of: date of follow-up oxygen saturation during stay time since discharge 02 saturation at home home medications when discontinue medications

Official Title
-----------------
A Retrospective Review of Postoperative Management of Cyanosis Following Bidirectional Glenn Operation

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants Bidirectional Glenn operation between 1/1/03-12/31/05 Significant Cyanosis Exclusion Criteria: Those who do not meet inclusion criteria.

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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
-----------------
pediatric, Glenn operation, Cyanosis
Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap and Determining the Change in SIEA Diameter and Blood Flow

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether delaying the superficial inferior epigastric artery (SIEA) flap results in widening of diameter and enhancing of blood flow of its donor artery.

Official Title
-----------------
Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap: A Solution to the Problem of the Small Caliber of the Donor Artery

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Procedure: Delay procedure of SIEA flap.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing surgery for lower extremities varicose veins Exclusion Criteria: patients who previously underwent operations of the lower abdomen (abdominoplasty and inguinal hernia repair)

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIEA,delay procedure,widening of diameter<br> | Procedure: Delay procedure of SIEA flap.<br>* Ligating the deep inferior epigastric artery ipsilaterally to the planned raising of the SIEA flap 2 weeks prior to the reconstructive procedure.<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
-----------------
Superficial inferior epigastric artery flap, delay phenomenon
Cardiopulmonary Bypass (CPB) Pumps and Blood Activation

Study Overview
=================
Brief Summary
-----------------
Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome. The goal of this study is to compare blood activation induced by cardiopulmonary bypass performed with centrifugal pump or roller pump in patients undergoing coronary artery surgery.

Official Title
-----------------
Blood Activation During Cardiopulmonary Bypass Using Roller or Centrifugal Pumps

Conditions
-----------------
Cardiopulmonary Bypass, Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: pumps used for cardiopulmonary bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men undergoing coronary artery bypass grafting using cardiopulmonary bypass Aspirin therapy Exclusion Criteria: Redo surgery Acute coronary syndrome requiring urgent surgery Oral anticoagulant therapy Organ dysfunction or chronic inflammatory disease Surgery other than coronary artery bypass grafting

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pumps used for cardiopulmonary bypass|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.

Detailed Description
-----------------
Study participants take their immunosuppressant as usual. One day, blood is drawn at predose and 1, 2, 3, 4-hour postdose to compare observed concentration with model-predicted concentration of tacrolimus and mycophenolate.

Official Title
-----------------
Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Tacrolimus
* Drug: Mycophenolate mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 years or older At least 6 months after kidney transplantation Were on tacrolimus alone or tacrolimus plus mycophenolate based immunosuppressive regimen Maintained stable dose of immunosuppressants for at least two weeks Exclusion Criteria: AST or ALT >3 upper limit of normal range Had gastrointestinal disorder that may affect an absorption of drug Coadministration of drugs that may affect the pharmacokinetics of immunosuppressive drug Multi-organ transplant recipient Severe psychiatric disorder Drug or alcohol abuser Pregnant Low compliance

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 |
| --- | --- |
| Tacrolimus + Mycophenolate mofetil<br> | Drug: Tacrolimus<br>* Administered dose were individualized according to their own prescription<br>* Other names: Prograf;Drug: Mycophenolate mofetil<br>* Administered dose were individualized according to their own prescription<br>* Other names: Cellcept;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tacrolimus concentration |  | 0, 1, 2, 3, 4 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycophenolate concentration |  | 0, 1, 2, 3, 4 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplant, Kidney transplantation, Renal transplant, Renal transplantation
Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome

Study Overview
=================
Brief Summary
-----------------
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septal thickness among fetuses of diabetic mothers.

Detailed Description
-----------------
Thick Interventricular septum is thought to be related to poor glycemic control during pregnancy, and it causes variable degree of left ventricular outflow obstruction and hypertrophic cardiomyopathy. Hypertrophic cardiomyopathy requires specific management as digoxin and inotropic agents usually used in heart failure are contraindicated. So high index of suspicion is required in fetus of diabetic mother having thick Inter ventricular septum.

Official Title
-----------------
Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome

Conditions
-----------------
Maternal Diabetes Mellites Effect on Fetus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 35 weeks pregnancy diabetic mothers single intrauterine pregnancy Exclusion Criteria: any other medical disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| To study interventricular septal thickness in fetus of diabetic mother and correlate it with good glycemic control. |  | 6 month |
Does American Society of Anesthesiologists (ASA) Physical Status Scale Enough in Patients Assessment

Study Overview
=================
Brief Summary
-----------------
American Society of Anesthesiologists (ASA) physical status scale has been used worldwide for assessing the status of patients before operation. However, merely the value of ASA scale did not give enough information of patients to determine their prognosis and improvement of outcomes. Since 1948, World Health Organization (WHO) defined health as the state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. Therefore, the investigators hypothesized that the ASA scale only was needed to be modified and should be replaced by a comprehensive gauge to evaluate the status of patients in depth. Based on this thought, the investigators used a new system, i.e., physical-psycho-social (PPS) scale, to assess the overall state before surgical procedures.

Official Title
-----------------
Reevaluating the American Society of Anesthesiologists (ASA) Physical Status System in Patients Assessment and Compared With a New Scale of Physical-psycho-social Gauge Raised by Our Institution

Conditions
-----------------
Elective Surgery

Intervention / Treatment
-----------------
* Other: ASA scale
* Other: PPS scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective surgical operation Age from 18-65 years Exclusion Criteria: Age < 18 years or > 65 years Not willing to participate in this study Patients from emergency department

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients assessed with ASA physical status scale | Other: ASA scale<br>* ASA scale evaluation before operation<br>|
| 2<br>Patients assessed with PPS scale | Other: PPS scale<br>* PPS scale evaluation before operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of recovery |  | Six months after operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative consumption of drugs |  | 1 day after operation | 
| Incidence of side events |  | 72 hours after operation | 
| Hospitalization days |  | From 0 min after operation to the time duration of discharge home, this measure would be varied in different patients | 
| Psychological state |  | Six months after operation | 
| Life quality |  | Six months after operation | 

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