linjc16/ctgov huggingface dataset:
Outcomes Following Pulmonary Valve Replacement in Adults

Study Overview
=================
Brief Summary
-----------------
One of the most common residual lesions in adult survivors of pediatric cardiac surgery is pulmonary valve disease, particularly regurgitation. Multiple studies have demonstrated that placement of a pulmonary valve in such patients, results in improved ventricular function and resolution of symptoms. However, the optimal prosthetic valve for use in the pulmonary position has not been defined. There are essentially three alternatives available: the stented bioprosthetic valve, stentless bioprosthetic tube grafts used to replace the entire right ventricular outflow tract and mechanical valves. All three of these valve options have been used in adults with congenital heart disease at Emory Healthcare and at Children's Healthcare of Atlanta at Egleston. The goal of this study is to evaluate and compare the indications and short and mid-term outcomes for these alternative therapies.

Official Title
-----------------
Review of Outcomes Following Pulmonary Valve Replacement for Congenital Heart Disease in Adults

Conditions
-----------------
Heart Disease, Congenital, Pulmonary Valve Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who have received a pulmonary valve replacement for congenital heart disease at Children's Healthcare of Atlanta at Egleston or are in the Emory Healthcare System between 1976 and 2004. - Exclusion Criteria: -

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
-----------------
Congenital Heart Disease, Pulmonary Valve Replacement
Heart Rate Changes With Propofol

Study Overview
=================
Brief Summary
-----------------
This is a prospective pilot study to quantify the changes in heart rate when propofol is administered after inhalational anesthesia induction.

Official Title
-----------------
Changes in Heart Rate Following Administration of Propofol After Inhalational Induction

Conditions
-----------------
Surgical Patients

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 1 year of age or older. Routine (elective) surgical patients with ASA classifications of 1 or 2 (healthy). Patients that are already scheduled to receive inhalational induction followed by IV propofol. Exclusion Criteria: 1. Premature infants of less than 30 weeks, who are less that 60 weeks post-gestational age at the time of study.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Propofol<br> | Other: Observation<br>* There is no intervention, this is an observational study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate |  | Baseline & every 30 secs for 3 mins |
Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being

Study Overview
=================
Brief Summary
-----------------
The present study will explore the effectiveness of a computer based neurobehavioral intervention in improving cognition and emotion regulation in a college freshmen population. It will increase understanding of emotion-regulation and cognition at a neural-circuit level and aid development of new interventions for emotion regulatory problems.

Official Title
-----------------
Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Computerized Neurobehavioral Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: internet access Exclusion Criteria: lifetime psychotic disorder, past-year substance dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Engaging computerized tasks<br>Participants will log into a personalized website and engage in computerized tasks online. | Behavioral: Computerized Neurobehavioral Intervention<br>* Targeted, computerized interventions completed from the participants' own home on a computer.<br>|
| Experimental: Neurobehavioral computerized tasks<br>Participants will log into a personalized website and engage in computerized tasks online. | Behavioral: Computerized Neurobehavioral Intervention<br>* Targeted, computerized interventions completed from the participants' own home on a computer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion-regulation - behavioral and fMRI |  | 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition - executive function behavioral reaction time |  | 3-month |
Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel

Study Overview
=================
Brief Summary
-----------------
A computerized registry of diabetes patients in a large health maintenance organization in Israel. The registry is aimed to be used by health professionals to identify diabetes patients and to follow the courses of their illnesses and risk factors.

Detailed Description
-----------------
The registry was initiated in 1998 by Maccabi Healthcare services, which is the second largest publicly funded HMO in Israel,serving 24% of the total population with a nationwide distribution. The registry uses advanced information technology that integrates personal computerized community and hospital records, data from laboratory tests, dispensed medications, physiological signals, radiological images, and reports from investigations and procedures.

Official Title
-----------------
Computerized Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel

Conditions
-----------------
Type 1 Diabetes, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patient was defined according to the criteria suggested by American Diabetes Association - symptoms diagnosed as diabetes and fasting plasma glucose >125 mg/dl (7.0 lmol/l) or casual (namely, any time of day without regard to time since last meal) plasma glucose concentration P200 mg/dl. In order to reach maximal validity, we also included any patient who answered to one of the following: (1) purchased at least two hypoglycemic medications or single insulin dose during 6 months. (2) Had HbA1c result of at least 7.25%. HbA1c of 6.5% was used as entry criterion to registry only when the patient was diagnosed as diabetic.
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 |
| --- | --- | --- |
| Prevalence rates of Diabetes |  | Up to 100 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of performance of eye examinations,blood and urine tests |  | up to 100 years | 
| Number and types of Drugs purchased |  | 100 years | 
| Number of visits to physician offices |  | up to 100 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry,Diabetes,Health Maintenance Organization
Bone Disease in Severely Burned Children

Study Overview
=================
Brief Summary
-----------------
Bone metabolism is adversely affected by severe burns in children for a period of time.

Detailed Description
-----------------
More closely monitored biochemical and radiologic parameters of bone and mineral metabolism will increase the likelihood of earlier detection of abnormalities and possible therapeutic interventions.

Official Title
-----------------
Bone Disease in Severely Burned Children

Conditions
-----------------
Burn

Intervention / Treatment
-----------------
* Drug: Tetracycline
* Radiation: Duel Energy X-Ray Absorptiometry (DEXA)
* Procedure: Bone Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age 5-18 years old with at least 40% or more of their body burned. Exclusion Criteria: Anyone with a burn covering less than 40% of the body or whose burn covers the front of both hipbones. Anyone younger than 5 years old, anyone with a history of cancer or other metabolic disease process, or anyone who is pregnant or has an allergy to Tetracycline will also be excluded. Anyone who has participated in an investigational drug trial within the past 60 days from date of admission will be excluded from this study.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 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 |
| --- | --- |
| Active Comparator: 1<br>Compare bone density of severly burned children to normal non-burned population | Drug: Tetracycline<br>* Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.<br>Radiation: Duel Energy X-Ray Absorptiometry (DEXA)<br>* DEXA before discharge from acute admission and again one year post burn.<br>* Other names: Duel Energy X-Ray Absorptiometry;Procedure: Bone Biopsy<br>* Bone biopsy to be taken in the operation room at the last skin grafting operation at the site of the iliac crest. A second bone biopsy will be taken one year later post discharge from the acute admission.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Bone Health(bone growth,strength,and content) in burn injured patients. |  | Admission to Burn Unit up to eighteen years old. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone, Dexa, Parathyroid, Diuretic, Tetracycline
Acute Salt Sensitivity of Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Dietary salt raises blood pressure in certain individuals immediately after ingestion (acute salt sensitivity; ASS) while not affecting others. It is hypothesized that ASS is a risk factor for hypertension. However, no thresholds or diagnostic guideline is available for ASS. This study is the first aim in the main study (HIPO CAP DITSH Study) aimed at determining the threshold or blood pressure cut-offs for ASS upon ingesting dietary salt.

Official Title
-----------------
HIV Integrated Personalized Care Approach to the Prevention, Diagnosis, and Control of Salt-sensitive Hypertension: The HIPO CAP DICTSH STUDY

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

Intervention / Treatment
-----------------
* Dietary Supplement: dietary salt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 years and above. Normotensive. If Hypertensive (should be off antihypertensive medication at least 2 weeks prior to the study) Exclusion Criteria: diabetes patients, ill participants

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
Intervention Model: Single Group Assignment
Interventional Model Description: Time series design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pre and post intervention group<br>Same individuals are examined before and after taking 2 tablets of salt | Dietary Supplement: dietary salt<br>* 2 grams of dietary salt<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute salt sensitivity | Mean arterial pressure change of 10 mmHg | 160 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic blood pressure change | Diastolic blood pressure change of equal to or more than 10 mmHg | 160 minutes | 
| Systolic blood pressure change | Systolic blood pressure change of equal to or more than 20 mmHg | 160 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
salt sensitivity, salt, acute salt sensitivity, Blood pressure, Mean arterial pressure
A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.

Official Title
-----------------
ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Multiple sclerosis (MS) Currently or recently pregnant Reside in a country where ozanimod is prescribed for treatment of MS Exclusion Criteria: Diagnostic prenatal test results known prior to first contact with the Registry Coordination Center (RCC) Exposure to known teratogens and/or investigational medications during pregnancy Other protocol-defined inclusion/exclusion criteria apply
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ozanimod-exposed<br>Pregnant women with a diagnosis of Multiple sclerosis (MS) who are exposed to ozanimod at any time during pregnancy | |
| Unexposed comparator cohort with MS<br>Pregnant women with a diagnosis of MS who are not exposed to ozanimod at any time during pregnancy | |
| Unexposed comparator cohort without MS<br>Pregnant women without a diagnosis of MS who are not exposed to ozanimod at any time during pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major congenital malformations |  | Up to first year of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor congenital malformations |  | Up to first year of life | 
| Pre-eclampsia |  | Through pregnancy | 
| Eclampsia |  | Through pregnancy | 
| Spontaneous abortion |  | Through pregnancy | 
| Stillbirth |  | Through pregnancy | 
| Elective termination |  | Through pregnancy | 
| Preterm birth |  | Through pregnancy | 
| Small for gestational age |  | Up to first year of life | 
| Postnatal growth deficiency |  | Up to first year of life | 
| Infant developmental deficiency |  | Up to first year of life | 
| Perinatal death |  | Up to first year of life | 
| Neonatal death |  | Up to first year of life | 
| Infant death |  | Up to first year of life | 
| Serious or opportunistic infant infection (SOI) |  | Up to first year of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Ozanimod, Pregnancy, Outcomes, Obstetric, Infant
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over

Study Overview
=================
Brief Summary
-----------------
Mild cognitive impairment (MCI) leading to Alzheimer's disease and related disorders (ADRD) represents a significant health and economic burden of the rapidly expanding senior population. The accurate detection and diagnosis of MCI and its common comorbidity, late-life depression (LLD), is essential for prolonging patient quality of life and developing advancements in research and treatment options. The purpose of the proposed program is to refine Miro Health's A.I. to accurately detect, differentiate and diagnose MCI and LLD.

Official Title
-----------------
The Proactive Screening and Diagnosis of Mild Cognitive Impairment and Depression in Patients Ages 60 and Over: An Implementation Study

Conditions
-----------------
Depression, Mild Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LLD: Age 60 or over; diagnosis of LLD or symptoms consonant with LLD; PHQ-9 score from 15 to 27 MCI: Age 60 or over; diagnosis of MCI or self-reported insidious onset and continued worsening of cognitive decline; intact activities of daily living HC: Age 60 or over Exclusion Criteria: Age 59 or younger; history of unresolved neurological or psychiatric conditions; current medications known to affect cognition; history of substance abuse; unable to perform activities of daily living; change in employment status due to condition

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Depression<br>Seniors diagnosed with late life depression or with a concern of late life depression. | |
| Mild cognitive impairment<br>Seniors with self-reported decline in cognitive function or with a diagnosis of mild cognitive impairment. | |
| Healthy controls<br>Seniors with no neurological or psychiatric symptoms or conditions. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure usability of Miro Health assessments (iOS and Android) for patients | Measure the (a) time point 1 in-assessment drop-out rate; and (b) the rate of lost-to-time-point-2-followup at 12 months. | Year 1, Q3 - Year 2, Q2 | 
| Measure acceptability of Miro Health assessments (iOS and Android) for patients | Measure the participant preference for pencil-paper test or Miro Health Mobile Assessment | Year 1, Q3 - Year 2, Q2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment | Pairwise correlations greater than 0.8 and statistically significantly greater than 0.7 will be considered successful. | Year 1, Q1 - Year 2, Q2 |
Study of Gut Microbiome and Colorectal Tumors

Study Overview
=================
Brief Summary
-----------------
Gut microbiota were assessed in 540 colonoscopy-screened adults by 16S rRNA gene sequencing of stool samples. Investigators compared gut microbiota diversity, overall composition, and normalized taxon abundance among these groups.

Detailed Description
-----------------
Colorectal cancer is a heterogeneous disease arising from at least two precursors-the conventional adenoma (CA) and the serrated polyp. A relationship between the human gut microbiota and colorectal cancer has been shown; however, its relationship to the different early precursors of colorectal cancer is understudied. This study tested, for the first time, the relationship of the gut microbiota to specific colorectal polyp types.

Official Title
-----------------
The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer

Conditions
-----------------
Serrated Polyp, Hyperplastic Polyp, Sessile Serrated Adenoma, Colorectal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Mobio PowerSoil DNA Isolation Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both men and women who have visited a gastroenterologist or surgeon, aged 18 or older will be included in this study. Both men and women residents in the United States, aged 18 or older will be included in this study. Exclusion Criteria: Women who are pregnant will be excluded from participating in this study Subjects on ongoing antibiotic therapy will be excluded from participating in this study.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SIT<br>Centers for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT) | Diagnostic Test: Mobio PowerSoil DNA Isolation Kit<br>* 16S rRNA amplicons covering variable regions V3 to V4 were generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3') incorporating Roche 454 FLX Titanium adapters (Branford, CT) and a sample barcode sequence<br>|
| NYU<br>New York University (NYU) Human Microbiome and Colorectal Tumor study | Diagnostic Test: Mobio PowerSoil DNA Isolation Kit<br>* 16S rRNA amplicons covering variable regions V3 to V4 were generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3') incorporating Roche 454 FLX Titanium adapters (Branford, CT) and a sample barcode sequence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and relative abundance of selected fecal microbial taxa | Quantitative polymerase chain reaction | 2 Days |