linjc16/ctgov huggingface dataset:
An Age-Stratified Data Collection Study in Adult Males and Females, Ages 18 and Above to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II

Study Overview
=================
Brief Summary
-----------------
To collect three dimensional retinal measurements of the optic disc and the macula lutea on healthy normal subjects using the 3D OCT-1000 Mark II for the purpose of developing a normative database that is stratified by age.

Official Title
-----------------
An Age-Stratified Data Collection Study in Adult Males and Females, Ages 18 and Above to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Females at least 18 years of age; Must be a member of one of the 3 ethnic groups: Caucasian, Hispanic or African American. Asians, Eastern Indians, and Native Americans have been excluded from this study; Signed, written informed consent obtained for the study; BSCVA of 20/40 or better in both eyes; Intraocular pressure (IOP) ≤ 21 mm Hg in both eyes. Exclusion Criteria: Ocular disease; Cataract on slit lamp exam with a corresponding loss of BSCVA worse than 20/25; Corneal surface disruption precluding imaging; Prior ocular surgery except uncomplicated phacoemulsification or strabismus surgery; Prior corneal refractive surgery of any type; Family history of glaucoma among first generation relatives; Current history of an acute or chronic disease or illness that would confound the normative outcome(s) of the study; Current use of systemic medications that may confound the outcome of the study; Nystagmus or any other condition that would prevent a steady gaze during study tests or measurements; Current history of inflammation or infection of the eye or eyelids; injury to the eye.

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 |
| --- | --- |
| Normal Healthy Volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A normative dataset containing a statistical description of expected norms of retinal nerve fiber layer (RNFL) and macula lutea thickness, stratified by age. |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of catecholamine excess on brown fat. To evaluate the effect of brown fat on energy expenditure and lipid and glucose metabolism

Official Title
-----------------
Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue

Conditions
-----------------
Pheochromocytoma, Adrenal Incidentaloma

Intervention / Treatment
-----------------
* Procedure: Removal of adrenal tumor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10 patients with pheochromocytoma 5 patients with incidentaloma without hormone production Age > 18 years Exclusion Criteria: - None

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 |
| --- | --- |
| Pheochromocytoma patients<br>Pheochromocytoma patients | Procedure: Removal of adrenal tumor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [18F]FDG uptake in brown adipose tissue |  | 3 months |
LCoMotion. Learning, Cognition and Motion. Effect of a Four Month School-based Cluster-randomized Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of a four months school-based physical activity intervention on cognition, academic achievement, physical activity and aerobic fitness in 12-15 year old adolescents.

Conditions
-----------------
Cognitive Function

Intervention / Treatment
-----------------
* Behavioral: Physical activity intervention
* Behavioral: Usual practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: six or seventh grader in a Danish public school participating in normal math lessons Exclusion Criteria: private school receiving extra math lessons because of special needs

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity intervention<br>60 minutes of physical activity on every school day | Behavioral: Physical activity intervention<br>* Physical activity during recess, in academic subjects, active transportation and PA home work<br>|
| Active Comparator: Control<br>Usual practice | Behavioral: Usual practice<br>* Normal curriculum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive function accuracy | Executive function (part of cognitive function) measured by a modified computer-based flanker-test | Up to 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Academic achievement | A standardized math test | November 2013 -June 2014 | 
| Physical activity | Measured with accelerometers for one week both pre- and post-intervention and supplemented with a questionnaire | November 2013-June 2014 | 
| Aerobic fitness | Measured with an intermittent running test (Andersen test) | November 2013 - June 2014 | 
| Anthropometric measures | Body height, body weight, waist circumference and puberty status (self-assessed) | November 2013 - June 2014 | 
| Questionnaire | To students and parents. SES, family diseases, physical activity, sport participation | November 2013 - June 2014 |
Pooled Analysis of NHANES I/II--Race, Gender, and CHD

Study Overview
=================
Brief Summary
-----------------
To conduct a pooled analysis of NHANES I/II data on race, gender, and coronary heart disease.

Detailed Description
-----------------
BACKGROUND: Over the last 25 years, a sustained and marked decline in death rates from coronary heart disease (CHD) has occurred for all major segments of the U.S. population. Recently, however, the decline has proceeded less rapidly in blacks than in whites, and in women than men. These trends have focused further attention on possible heterogeneity in the risk factor patterns among the demographic sub-groups. Previous studies of CHD risk factors in blacks and whites using the First National Health and Examination Survey Epidemiologic Follow-up Study (NHEFS-I, 11-year follow-up), including this group's own work, demonstrate its potential strengths, while at the same time foundering on the problem of low statistical power. With the extension of the follow-up of NHANES-I cohort (1971-1974) to 1987 (14 years) and the completion of 14-year follow-up for NHANES II cohort (1976-1980), a strong rationale exists to undertake a pooling project. The resulting data set would provide optimal characterization of CHD risk at the national level. DESIGN NARRATIVE: The study sought to determine whether data from NHANES I and NHANES II could be pooled. To accomplish this, the distribution of baseline measures was assessed and a determination was made whether the same logistic prediction equations fitted both studies. Also, gender-race differences were examined in individual exposure-outcome relationships, patterns of co-morbidity, and population attributable risks. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases

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

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational research study is to examine how point-of care ultrasound affects the workup and management of perioperative complications for specific clinical scenarios of low blood pressure (hypotension), low blood oxygen (hypoxemia), in the post- anesthesia care unit (PACU).

Official Title
-----------------
Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit- A Collaborative Observational Study Between UCLA and Loma Linda University Medical Centers

Conditions
-----------------
Hypotension, Hypoxemia, Altered Mental Status, Urine Output Low, Chest Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the post-anesthesia care unit with the following events Mean arterial blood pressure <60 mmHg or <20% of pre-operative baseline mean arterial blood pressure,) hypoxemia (pulse oximetry saturation <95% or Pao2 <80), altered mental status, decreased urine output, chest pain/EKG changes, or to confirm endotracheal Lube placement. Exclusion Criteria: Patients who are not able to have a point of care ultrasound examination in the post anesthesia recovery area.

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 |
| --- | --- |
| Point of Care Ultrasound (POCUS) group<br>When the provider in charge of covering the post-anesthesia care unit, they would apply POCUS examinations in their PACU assessment as per the study protocol of hypotensive and hypoxic events. | |
| No Point of Care Ultrasound (POCUS) group<br>When the provider in charge of covering the post-anesthesia care unit, they would apply routine bedside examination techniques in their PACU assessment as per the study protocol of hypotensive and hypoxic events. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post anesthesia care (PACU) unit length of stay (minutes) | The primary outcome marker for the study was post anesthesia care (PACU) unit length of stay (minutes), with a hypothesis that patients receiving a POCUS examination for the cardiovascular or pulmonary event would have a shorter PACU LOS. | during year of the study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of diagnosis before and after assessment | Additional markers include a POCUS report completed by the performing attending anesthesiologist that included POCUS findings and the number of potential diagnoses to explain the acute event (hypoxia and/or hypotension) before and after the POCUS exam was performed.. | during of the study enrollment |
Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a percutaneous coronary intervention (PCI). A select number of sites will also participate in a substudy where eligible patients will undergo an additional procedure;cardiac magnetic resonance imaging.

Official Title
-----------------
Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction

Conditions
-----------------
Myocardial Infarction, Cardiovascular Diseases, Pathologic Processes

Intervention / Treatment
-----------------
* Drug: KAI-9803


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute STEMI and has a planned emergent primary PCI procedure Continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset Exclusion Criteria: Persistent systolic blood pressure < 90 mm Hg

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1: KAI-9803<br> | Drug: KAI-9803<br>* STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo<br>|
| Experimental: A2: KAI-9803<br> | Drug: KAI-9803<br>* STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo<br>|
| Experimental: A3: KAI-9803<br> | Drug: KAI-9803<br>* STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo<br>|
| Placebo Comparator: A4: Placebo<br> | Drug: KAI-9803<br>* STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of KAI-9803 on infarct size as assessed by CK-MB AUC |  | During the index hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias |  | Within the first 3 months after Myocardial Infarction | 
| The safety and tolerability of KAI-9803 by IV infusion to acute STEMI |  | Within the first 3 months after Myocardial Infarction | 
| Assess left ventricular function by imaging |  | Within the first 3 months after Myocardial Infarction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Diseases, Myocardial Ischemia, Infarction, Myocardial Infarction
Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of AL-39256 in patients with open-angle glaucoma or ocular hypertension.

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: AL-39256 Ophthalmic Suspension, 1%
* Drug: Latanoprost Ophthalmic Solution, 0.005%
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with open-angle glaucoma or ocular hypertension. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential. Other protocol-defined exclusion criteria may apply.

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: AL-39256<br>AL-39256 Ophthalmic Suspension, 1%, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks. | Drug: AL-39256 Ophthalmic Suspension, 1%<br> <br> |
| Active Comparator: XALATAN<br>Latanoprost Ophthalmic Solution, 0.005%, 1 drop in the study eye(s) at 8 PM from the evening bottle (morning bottle contained vehicle and was dosed 1 drop in the study eye(s) at 8 AM) for 4 weeks. | Drug: Latanoprost Ophthalmic Solution, 0.005%<br> <br> * Other names: XALATAN®;Drug: Vehicle<br>* Inactive ingredients used as a placebo comparator<br>|
| Placebo Comparator: Vehicle<br>Inactive ingredients, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks. | Drug: Vehicle<br>* Inactive ingredients used as a placebo comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in IOP |  | Week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open Angle Glaucoma, Ocular Hypertension
The Success of Pediatric Percutaneous Nephrolithotomy

Study Overview
=================
Brief Summary
-----------------
Between June 1997-June 2018, 573 pediatric patients underwent PCNL for renal stone disease by senior surgeons. Data was disunited into 2 groups. The study showed that PCNL is an operator-dependent procedure, with the improvement of outcomes over time, presumably due to increased operator experience and the involvement of a team member with substantial prior experience During 20 years, by gaining experience and with the development of new tools and optics, fluoroscopy time, operation time, blood loss and complication rates decreased and stone-free rates increased.

Official Title
-----------------
Which Factor Affect the Success of Pediatric PCNL?: Single Center Experiences, Over 20 Years: Cohort Study

Conditions
-----------------
Nephrolithiasis

Intervention / Treatment
-----------------
* Procedure: Percutaneous nephrolitotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with kidney stone Exclusion Criteria: Patients with a solitary kidney

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: the data into two groups. In group-1, PCNL was performed in the first 10 years period (1997-2007); in group-2, PCNL was performed in the second ten years period from 2008 to the present.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Years 1997-2007<br>Group-1, PCNL was performed in the first 10 years period (Years 1997-2007); | Procedure: Percutaneous nephrolitotomy<br>* Pediatric PCNL<br>|
| Experimental: 2008- to the present<br>The PCNL was performed in the second ten years period from 2008 to the present. | Procedure: Percutaneous nephrolitotomy<br>* Pediatric PCNL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy of clinical experience of Percutaneous nephrolitotomy | The duration of clinical experience affects complication rates, success rates. Intraoperative and postoperative data was contained, preoperative and postoperative GFR (calculated with Cockcroft Gault equations), changing hemoglobin levels, transfusion rate, complications according to the Clavien classification. | over 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing of complications managements | Rate of and changing of Management of complications in pediatric patients | Over 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urolithiasis, Pediatrics, Percutaneous
Effects of High Protein Intake With Intense Exercise and Energy Deficit

Study Overview
=================
Brief Summary
-----------------
A four week intervention will take place with the participants. They will undergo 6 days a week of high intensity training. They will also be at a 40% energy deficiency. One group will have a normal intake of protein, 1.2g/kg, while the other will have 2.4g/kg. It is our thesis that the participants with the higher protein will retain more lean mass.

Official Title
-----------------
Effects of High Protein Intake With Intense Exercise and Energy Deficit

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: High Protein
* Dietary Supplement: Low Protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-30 males Healthy Exclusion Criteria: more than 15% body fat 35-50ml/kg/min VO2 BMI grater than 27

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

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

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: High Protein<br>High Protein | Dietary Supplement: High Protein<br>* 2.4g/kg of protein<br>|
| Placebo Comparator: Low Protein<br>Low Protein | Dietary Supplement: Low Protein<br>* 1.2g/kg of protein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | To compare the effect of normal protein intake (1.2 g/kg per day) and increased protein intake (2.4 g/kg per day) on body composition over a 4 week period of energy restriction in young males (18-30), with intense exercise training. Body composition will be measured via DXA, Bod Pod, Bio-impedance, skin folds. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological state | To compare the psychological state of the participants, before, during and after the intervention. To see if the mind will grow with the body as high intensity exercise is performed, or whether the mind will tire and scores will be reduced. Measurement tactics will in include POMS, and PANAS questionnaires for mood, and stroop, isometric hand grip, operation span test, and vigilance task. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle, Protein, Diet, Exercise