linjc16/ctgov huggingface dataset:
Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow Up Study

Study Overview
=================
Brief Summary
-----------------
A specified version of the Apgar-Score, that can be used in newborns under resuscitation, was developed and its value to predict chronic damage in preterm infants will be tested.

Detailed Description
-----------------
Specifications of the individual items of the original Apgar score were suggested. These specifications slightly changed the Apgars' perspective, but did not alter the number of its components. The specified Apgar should therefore be easily applicable to every delivery room around the world. As a result of these specifications, the Apgar score will not express the efforts of the infant but describe its condition, independently of the requirements needed to achieve this condition. The advantage of the proposed definitions is the applicability in all infants, regardless of resuscitative efforts or gestational age. To validate the accuracy of the specified version to predict neonatal mortality and long term neurological outcome in preterm infants the present prospective, observational study is planned. The study will test the hypothesis that the specified APGAR-score predicts mortality and morbidity better at 2 years of age than the conventional Apgar-score. Furthermore, the predictive reliability of the specified Apgar can be improved in combination with perinatal data respectively with the expanded Apgar version of the AAP/ACOG. The primary outcome condition at 2 years of age is composed of death and a major neurological deficit. In this case neurological deficit is defined by the presence of one of the followings characteristics: index of mental development (Bayley Scale II) <85, blindness, deafness, cerebral palsy.

Official Title
-----------------
Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow-Up Study

Conditions
-----------------
Premature Birth, Mortality, Apgar Score

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: All preterm infants included in the TEST-APGAR Study Exclusion Criteria: Missing parental Consent

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 2 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
-----------------
Neurodevelopmental Impairment, Intraventricular hemorrhage, Retinopathy of prematurity, Mortality, Apgar Score
Prospective Analysis of Genotype-phenotype Correlations Observed in a Large Cohort of Patients With Hereditary Retinal Dystrophies - GEPHIRD

Study Overview
=================
Brief Summary
-----------------
This study will carry out a detailed descriptive analysis of a large population of patients with hereditary retinal dystrophies (HRD): clinical, paraclinical and genetic data. The information drawn from these analyzes will provide a better understanding of the pathophysiology of these rare diseases and this may ultimately impact the medical management of patients (targeted therapy).

Official Title
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Prospective Analysis of Genotype-phenotype Correlations Observed in a Large Cohort of Patients With Hereditary Retinal Dystrophies - GEPHIRD

Conditions
-----------------
Hereditary Retinal Dystrophies

Intervention / Treatment
-----------------
* Procedure: OCT-A
* Procedure: Visual acuity (ETDRS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized for suspicion of hereditary retinal dystrophy Benefiting as part of the care of a genetic analysis Exclusion Criteria: - Patient under a measure of legal protection

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspicion of hereditary retinal dystrophy<br> | Procedure: OCT-A<br>* Optical coherence tomography angiography (OCT-A)<br>Procedure: Visual acuity (ETDRS)<br>* Visual acuity tested with ETDRS score (Early Treatment Diabetic Retinopathy Study)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the phenotypic characteristics of patients with hereditary retinal dystrophies. | Phenotypic diagnosis of the type of retinal dystrophy based on all the examinations performed as part of the usual care and examinations added by the research (OCT-Angiography - Optical coherence tomography, and visual acuity with ETDRS scale : Early Treatment Diabetic Retinal Study, ETDRS). | Baseline | 
| Description of the genotypic characteristics of patients with hereditary retinal dystrophies. | Determination of the genetic mutations responsible for retinal dystrophy in order to confirm the phenotypic diagnosis and identify correlation between the phenotypic and genotypic characteristics | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hereditary retinal dystrophies
Expectant Management of Ectopic Pregnancy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the efficacy and safety of expectant management in the treatment of tubal ectopic pregnancy and identification of different factors that can be used to predict its success.

Official Title
-----------------
Evaluation of Expectant Management in Women Diagnosed With a Tubal Ectopic Pregnancy at Ain-Shams University Maternity Hospital Over the Period From January 1, 2016 to December 31, 2020

Conditions
-----------------
Ectopic Pregnancy

Intervention / Treatment
-----------------
* Diagnostic Test: qualitative hCG levels and ultrasound criteria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - all women who underwent expectant management as the first line of management offered after optimal counseling during the period from January 1, 2016 to December 31, 2020. Hemodynamically stable with confirmed diagnosis of ectopic pregnancy on ultrasound scan. No significant pelvic pain. No hemoperitoneum. No fetal heart in the ectopic pregnancy. HCG level <5000 IU/L. Expectant management was the first line of management offered to the patient after optimal counseling. Exclusion Criteria: all women with non tubal ectopic pregnancy all women with tubal ectopic pregnancy that recieved medical or surgical treatment as 1st line treatment
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: qualitative hCG levels and ultrasound criteria|detect upper limit of qualitative hCG levels associated with successful expectant management of ectopic pregnancy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolution of hCG level | hCG levels measured every week till negative less than (<20 IU/l) up to 12 weeks | up to 12 weeks |
Genetic Epidemiology--Development of Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
To determine how genetic and environmental factors influence the co-occurrence of obesity and hypertension during development and to identify cardiovascular risk factors in adolescence that will predict cardiovascular disease in adults.

Detailed Description
-----------------
BACKGROUND: Obesity and hypertension are two of the major risk factors for cardiovascular disease (CVD) and those with obesity have a greater risk of hypertension. In children and adolescents, high body mass index correlates with elevated blood pressure. Genetic factors make a significant contribution to the variation of obesity and hypertension. DESIGN NARRATIVE: Anthropometric, cardiovascular, physiologic and physical fitness data were used to investigate a series of critical issues about the etiology, heterogeneity, comorbidity and developmental trajectories of CVD risk factors, including obesity, hypertension and cardiovascular health. Using the two datasets, the main questions of the study were addressed. How do genes and environment act and interact to create covariation between obesity and hypertension, and were the genetic and environmental factors the same at all ages (from childhood to late adolescence and adulthood) in both sexes? Areas of research included the following: causes of individual differences in anthropometric and cardiovascular characteristics, their covariation and developmental change or continuity in adolescence, parent-offspring transmission, prediction of cardiovascular risk, and sex, race and population differences in genetic and environmental contributions on cardiovascular risk factors.

Conditions
-----------------
Obesity, Cardiovascular Diseases, Hypertension, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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 |
| --- | --- | --- |
DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation

Study Overview
=================
Brief Summary
-----------------
1.1. Primary Objectives To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant. We will also validate whether DWIBS-MRI ADC values can be used to accurately differentiate benign from malignant lesions. Additionally, because it is not known whether tumor type or growth rate (Ki67 values) will affect our results, we will include these parameters in our analysis. Once we validate the use of DWIBS-MRI ADC values to determine malignancy, can we establish an ADC threshold value to decrease the number of false positive biopsies that are performed while still maintaining a zero false negative rate? This study will also assess the correlation between ADC values and the Ki-67 proliferative index of malignant lesions.

Official Title
-----------------
DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient will be eligible for inclusion in this study if she meets all of the following criteria: >30 years of age Genetic Female Suspected diagnosis of BIRADS 4 or BIRADS 5 masses and/or asymmetries greater than 1 centimeter based on standard 2D/3D mammogram and ultrasound imaging. Exclusion Criteria: A patient is ineligible for inclusion in this study if she meets any of the following criteria: Prior biopsy of suspicious lesion Breast implants Prior history of breast cancer Patient has a pacemaker Contraindications to use of MRI imaging (metal implants, etc.) Woman pregnant or lactating Calcifications as only findings present for a suspicious lesion

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI DWIBS Accuracy | • To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant. | 1 month | 
| Validate DWIBS-MRI | • We will also validate whether DWIBS-MRI ADC values can be used to accurately differentiate benign from malignant lesions. Additionally, because it is not known whether tumor type or growth rate (Ki67 values) will affect our results, we will include these parameters in our analysis. | 1 month |
Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.

Official Title
-----------------
Study of the Pharmacodynamics of NGM282 on Colonic Transit, Bile Acid Homeostasis, and Fecal Fat in Subjects With Functional Constipation and Healthy Individuals

Conditions
-----------------
Functional Constipation

Intervention / Treatment
-----------------
* Biological: NGM282
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functional constipation confirmed by modified Rome III criteria or Healthy Volunteer Exclusion Criteria: Structural or metabolic diseases/conditions that affect the GI system Diagnosis of dyspepsia, IBS, or significant gastrointestinal symptoms

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

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

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

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: NGM282 Dose 1<br>NGM282 | Biological: NGM282<br> <br> |
| Experimental: NGM282 Dose 2<br>NGM282 | Biological: NGM282<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on Colon Transit, as measured by the movement of food through the colon |  | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Laboratory Assessments |  | 14 days |
The Effect of Elemental Diet on Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been speculated as a cause of aspiration pneumonia. Elemental diet may facilitate gastric emptying in PEG patients as compared with regular liquid enteral nutrients, resulting in the prevention of aspiration pneumonia.

Official Title
-----------------
The Comparative Study of Elemental Diet and Regular Liquid Diet on Gastric Emptying in Patients With Percutaneous Endoscopic Gastrostomy

Conditions
-----------------
Postprocedural Delayed Gastric Emptying

Intervention / Treatment
-----------------
* Other: Elental


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: percutaneous endoscopic gastrostomy patients Exclusion Criteria: history of abdominal surgery
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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Elemental diet<br> | Other: Elental<br>* 200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients<br>|
| Placebo Comparator: Liquid nutrient<br> | Other: Elental<br>* 200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of gastric emptying | Two kinds of liquid test meals (Elemenal diet or regular liquid nutrient ) (200kcal/200ml) labeled with 100 mg(13C sodium acetate) are administered for 15 min and after that 13C breath test performed during the 4 hours | Four hours (from 7:30 am to 11:30 am) |
Timing of Prophylactic Antibiotics for Cesarean Sections

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blinded placebo controlled trial of cefazolin timing before cesarean section fo infection prophylaxis. Subjects are randomized to cefazolin either 30 minutes prior to skin incision or at time of cord-clamping. Primary outcome is infectious morbidity including wound infections and endometritis.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled Trial of Cefazolin Given Either 30 Minutes Prior to Cesarean Section or at Cord Clamping

Conditions
-----------------
Endometritis, Wound Infection

Intervention / Treatment
-----------------
* Drug: Cefazolin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant 24-43 weeks gestation > 18 years old Requiring cesarean section - Exclusion Criteria: Receiving antibiotics < 18 years old Allergy to cefazolin -

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cefazolin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined infectious morbidity - endometritis + wound infection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal sepsis |  |  | 
| Allergic reactions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean section, Antibiotic prophylaxis, Cefazolin
Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744c 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS

Study Overview
=================
Brief Summary
-----------------
Primary objective: to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions. Secondary objectives: to assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population. to document SSR149744C plasma level during the study.

Official Title
-----------------
Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 100 OR 300 mg for the Prevention of Ventricular Arrhythmia-Triggered ICD Interventions

Conditions
-----------------
Arrhythmia, Tachycardia, Ventricular, Ventricular Fibrillation

Intervention / Treatment
-----------------
* Drug: SSR149744C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with an ICD implanted during the previous year for documented spontaneous life-threatening ventricular arrhythmia OR implanted with an ICD and with at least one appropriate ICD therapy (shock or anti-tachycardia pacing) for ventricular tachycardia or ventricular fibrillation in the previous year. Left ventricular ejection fraction measured by 2D-echocardiography must have been documented to be less than 40% in the last 6 months. Exclusion Criteria: MAIN CRITERIA (non-exhaustive list): Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, severe associated conditions.

Ages Eligible for Study
-----------------
Minimum Age: 21 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

| Intervention/Treatment |
| --- |
|Drug: SSR149744C|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint is time to all ventricular tachycardia or ventricular fibrillation arrhythmia leading to any ICD intervention (anti-tachycardia pacing or ICD shock). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to all arrhythmia episodes leading to at least one documented ICD shock. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tachycardia, Ventricular, Ventricular Fibrillation, Defibrillators Implantable, Arrhythmia, Anti-arrhythmia agents