linjc16/ctgov huggingface dataset:
The Study of Human Atherosclerosis by Polarization-Sensitive Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
Atherosclerosis is unquestionably the leading cause of morbidity and mortality in developed countries, and the world-wide importance of acute vascular syndromes is increasing. Rupture of atherosclerotic plaque has been identified as the proximate event in the majority of cases of acute ischemic syndromes. Therefore, modalities capable of characterizing the atherosclerotic lesion may be helpful in understanding its natural history and detecting lesions with high risk for acute events. Optical coherence tomography (OCT) is a powerful tool capable of tomographic imaging based on low coherence interferometry. It is analogous to ultrasound imaging except that it uses infrared light instead of sound. Polarization-sensitive optical coherence tomography (PS-OCT) combines the advantages of OCT with additional image contrast of the sample. The added contrast is based on the ability of PS-OCT to detect the birefringent properties of a sample (phase retardation and fast-axis orientation) simultaneously. The goals of this project are: 1) to examine whether PS-OCT is an acceptable tool for the characterization of typical plaque constituents; and 2) to explain the correlation between birefringence and forming or rupture of a plaque; and 3) to establish a quantitative PS-OCT image criteria for atherosclerotic plaque characterization in vitro.

Detailed Description
-----------------
Optical Coherence Tomography (OCT) is a promising new class of diagnostic medical imaging technology that utilizes advanced photonics and fiber optics to obtain images and tissue characterization on a scale never before possible within the human body. OCT combines the principles of ultrasound with the imaging performance of a microscope and a form factor that is familiar to clinicians. Whereas ultrasound produces images from backscattered sound echoes, OCT uses infrared light waves that reflect off the internal microstructure within the biological tissues.

Conditions
-----------------
Pathological Conditions, Anatomical

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart transplantation, atherosclerosis Exclusion Criteria: Infection

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
atherosclerosis, optical coherence tomography, polarization, phase retardation, birefringence
BAY 77-1931 Long-term Extension From Phase II Study

Study Overview
=================
Brief Summary
-----------------
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis

Official Title
-----------------
A Long-term, Open Label Extension, Non-controlled Study to Assess the Efficacy and Safety of BAY 77-1931 (Lanthanum Carbonate) for Hyperphosphatemia in Patients Undergoing Hemodialysis

Conditions
-----------------
Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: BAY 77-1931


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least Exclusion Criteria: Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: BAY 77-1931<br>* Lanthanum Carbonate (BAY 77-1931)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pre-dialysis serum phosphate levels |  | Every 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL) |  | Every 4 weeks | 
| Changes in corrected serum calcium level |  | Every 4 weeks | 
| Changes in the product of serum calcium and phosphate |  | Every 4 weeks | 
| Changes in serum intact-PHT levels |  | Every 4 weeks | 
| Changes in bone metabolism markers |  | Every 4 weeks |
Neonatal Outcomes in Instrumental Delivery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the impact of instrumental delivery on newborn head mark and newborn comfort over the impact of non-instrumental delivery. It is also to evaluate how mothers age, Body Mass Index, instrumental extraction indication, extractor type, variety and height of the fetal presentation, operator, time of birth (day or night) and birth weight impact on head mark existence and newborn comfort.

Official Title
-----------------
Neonatal Outcomes in Instrumental Delivery: Newborn Head Mark and Comfort.

Conditions
-----------------
Instrumental Delivery; Nec, Affecting Fetus or Newborn

Intervention / Treatment
-----------------
* Other: instrumental delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term infant non-opposition of the newborn parent Exclusion Criteria: outborn child premature newborn newborn transferred

Ages Eligible for Study
-----------------
Minimum Age: 12 Hours
Maximum Age: 72 Hours

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>newborns who were delivered with an extractor | Other: instrumental delivery<br>* the birth was assisted with an extractor.<br>|
| Controls<br>newborns who were not delivered with an extractor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head mark or injury | Any mark or injury (skin erosion, wound, hematoma, fracture, paralysis, etc.) on the newborn head will be described (type, color, size, position) and documented (photo) | 12 to 72 hours of age | 
| Newborn comfort | assessed using Newborn Pain and Discomfort Scale (EDIN) (DEBILLON et al. Development and initial validation of the EDIN scale, a new tool for assessing prolonged pain in preterm infants. Arch Dis Child Neonatal Ed 2001;85:36-41) | 12 to 72 hours of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic use | Any analgesic administration to the newborn will be reported | 0 to 72 hours of age | 
| Length of hospitalisation after childbirth | The day out for home of the newborn will be reported | First month of life |
Parent Mentor Interventions for Early Childhood Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to identify the most effective strategy for intervention to change behaviors and affect weight status in obese children 2-5 years of age within the context of early childhood education centers.

Detailed Description
-----------------
The primary aim is to test an intervention to disseminate and promote the adoption of positive deviance behaviors among parents of obese Hispanic children using peer mentors. This trial will evaluate the efficacy and feasibility of this approach in reducing adiposity among a high-risk population of children. Our central hypothesis is that children randomized to the intervention with a parent mentor using positive deviance methods with have a greater reduction in adiposity as measured by body mass index (BMI) compared with a parent mentor using traditional education or a control receiving usual education.

Official Title
-----------------
Parent Mentor Interventions for Early Childhood Obesity

Conditions
-----------------
Obesity, Childhood

Intervention / Treatment
-----------------
* Behavioral: Parent Mentor with Standard Education
* Behavioral: Parent Mentor with Positive Deviance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2-5 years of age child, Hispanic ethnicity, attends the Head Start facility Exclusion Criteria: any major medical disorder impairing growth or development

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br> | |
| Placebo Comparator: Parent Mentor<br> | Behavioral: Parent Mentor with Standard Education<br>* Parent mentors will provide coaching based on the current guidelines around diet and physical activity<br>|
| Active Comparator: Parent Mentor with Positive Deviance<br> | Behavioral: Parent Mentor with Positive Deviance<br>* Parent mentors will provide coaching based on findings from the positive deviance study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMIz | standardized BMI for age and sex | 6 months post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy | Parenting self-efficacy around specific topics | 6 months post-enrollment |
Non-insulino-dependant Diabetes in Infants and Teenagers

Study Overview
=================
Brief Summary
-----------------
The incidence of diabetes in children, which is constantly increasing worldwide is estimated in mainland France at about 15/100 000 per year with a wide disparity between countries and a north gradient South. In Reunion island, about 30 children a year seem to reveal diabetes before the age of 18 years but no precise data has ever been published on this subject. Indeed, while type 1 diabetes (insulin-dependent autoimmune) represents historically the majority of cases of diabetes revealed at pediatric age (about 90%), since a little more than 10 years other types of diabetes seem emerge at pediatric age. This is particularly the case of type 2 diabetes in connection with the global epidemic of obesity. The purpose of the investigator's study is the exhaustive prospective collection of all cases of diabetes revealed before the age of 18 in the Reunion region over a period of 5 years.

Official Title
-----------------
Evaluation of the Incidence of Diabetes Revealed at Pediatric Age in Reunion

Conditions
-----------------
Diabetes, Pediatric Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child or adolescent residing in the territory of the reunion island with a diagnosis that revealed diabetes according to criteria defined by WHO (World Health Organization) before 18 years of age Parents who signed the participation consent Exclusion Criteria: Patient not residing in the usual way in Reunion island

Ages Eligible for Study
-----------------
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 |
| --- | --- | --- |
| Average annual number of new cases of diabetes according to World Health Organization (WHO) criteria |  | 5 years |
Study of Late-foetal Human Organ Development

Study Overview
=================
Brief Summary
-----------------
Knowledge about abnormal organ development is important to understand pathology and to develop novel treatment approaches for individuals with congenital and acquired disease. Most of our current understanding is based on examination of tissues from the embryo and early fetus, collected from women undergoing termination of pregnancy in the first trimester (third) of pregnancy. There is very little known about normal and abnormal organ development from a developmental perspective during the crucial last two-thirds of pregnancy when much remodelling of fetal tissues occurs. We aim to collect tissue from a variety of developing fetal organs in the last two-thirds of pregnancy from women who decide to undergo a termination of pregnancy and who wish to undergo a clinical fetal postmortem (PM) examination.

Official Title
-----------------
Study of Late-foetal Human Organ Development

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old pregnant women who attend the Fetal Medicine Unit for concerns about a fetal abnormality where they decide to proceed to termination of pregnancy Exclusion Criteria: Screening labs positive for maternal HIV, Hepatitis B and Hepatitis C, Chlamydia and Herpes. Subject unable to make an informed decision about termination of pregnancy.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular maturity | Immunofluorescence staining | Immediately after tissue collection |
Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy.

Study Overview
=================
Brief Summary
-----------------
Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We compared the efficacy and duration of the spinal block with two different bupivacaine baricities. Group I: low dose isobaric group GroupII: Low dose hyperbaric group

Detailed Description
-----------------
Patients undergoing TURP were randomly allocated into two groups. Group I: Received fentanyl 20 µgr (0.4ml),heavy bupivacaine 0.5% (1.5 ml)and normal saline % 0.9 NaCl ( 1.1ml) Group II: Received fentanyl 20 µgr (0.4 ml), plain bupivacaine 0.5%(1.5 ml) normal saline 0.9% NaCl (1.1 mL) in total bupivacaine 0.25% (3ml) intrathecally. Onset and duration of the sensory block, the degree of the motor block, side - effects and perioperative analgesic requirement assesed.

Official Title
-----------------
Low Dose, Low Concentration Different Baricity Bupivacaine for Transuretral Prostatectomy.

Conditions
-----------------
Benign Prostate Hyperplasia

Intervention / Treatment
-----------------
* Drug: Heavy Bupivacaine
* Drug: Isobaric Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50-85 years ASA 1-4 BENİGN PROSTAT HYPERPLASİ Exclusion Criteria: Allergy of study drugs Morbid obesity Spinal anesthesia contrindications Bleeding dyscrasias

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heavy Bupivacain, Local anesthetic, Amp<br>Heavy bupivacaine 7.5 mg (1.5 ml), 20 microgram fentanyl(0.4 ml), 1.1 ml saline , Total 3 ml | Drug: Heavy Bupivacaine<br>* 7,5 mg intrathecal hyperbaric bupivacain,<br>* Other names: marcaine heavy;|
| Active Comparator: Isobaric spinal, Local anesthetic, Amp<br>7,5 mg isobaric bupivacaine, 20 microgram (0.4 ml)fentanyl, 1.1 ml saline, Total 3 ml | Drug: Isobaric Bupivacaine<br>* 7.5 mg intratecal isobaric bupivacain<br>* Other names: Marcain flakon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal Block Quality | Sensory block assesment with pinpric test. | 15 minute after intrathecal injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal block regression | Sensory block assesment with pinprick test | 5 minute after arrival at PACU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low dose, different baricity, spinal anesthesia
Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
This cohort study compares immune response induced in two groups of small HCC patients treated by ablation (group1 RFA, group 2 MWA). Patients will benefit for tumoral and non tumoral biopsies prior to treatment and stepped peripheral blood samples juste before ablation and during the first month after.

Official Title
-----------------
Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven HCC for less than 3 months before ablation Decision of ablation treatment in multidisciplinary meeting Exclusion Criteria: Fibrolamellar HCC Hepatocholangiocarcinoma

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RFA<br>Patient with HCC and decision of treatment with ablation | Procedure: Percutaneous ablation<br>* Hepatic Percutaneous Ablation with radiofrequency or microwave<br>|
| MWA<br>Patient with HCC and decision of treatment with ablation | Procedure: Percutaneous ablation<br>* Hepatic Percutaneous Ablation with radiofrequency or microwave<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare induced immunomodulation by RFA and MWA in HCC patients | Comparison of modulation of immune cells (frequency, activity, function) between the two groups. Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T) before and after the treatment (day 0, day 2, day 7, day 30) | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate early induced immunomodulation after RFA in HCC patients | Differences of frequencies, activities, functions of immune cells before and after the RFA treatment (day 0, day 2, day 7, day 30). Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T) | one month | 
| To evaluate early induced immunomodulation after MWA in HCC patients | Differences of frequencies, activities, functions of immune cells before and after the MWA treatment (day 0, day 2, day 7, day 30). Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T) | one month |
Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions

Study Overview
=================
Brief Summary
-----------------
This is a follow-up study of a multi-center, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5 years of age and health outcomes through 5.5 years of age in participants who received one of two staged study formulas through one year of age.

Official Title
-----------------
Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions

Conditions
-----------------
Cognitive Ability, General

Intervention / Treatment
-----------------
* Dietary Supplement: Enriched Protein Fractions
* Dietary Supplement: Protein Fraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant who previously consumed study formula through one year of age in MJN Project 6027 5.5 years of age (i.e. when child turns 5 years and 6 months old ± 2 months) at Visit 1 Signed informed consent obtained for child's participation in the study Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 64 Months
Maximum Age: 68 Months

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 |
| --- | --- |
| Experimental: Enriched Protein Fractions<br>This group was given Infant formula with enriched protein fractions | Dietary Supplement: Enriched Protein Fractions<br>* Enriched protein fractions<br>|
| Active Comparator: Protein Fractions<br>This group was given Infant formula with protein fractions | Dietary Supplement: Protein Fraction<br>* Protein fractions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV) |  | At 5.5 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dimensional Change Card Sort (DCCS) |  | At 5.5 years of age | 
| Stroop Task |  | At 5.5 years of age | 
| Functional Near Infrared Spectroscopy (fNIRS) |  | At 5.5 years of age | 
| Child Behavior Checklist (CBCL) |  | At 5.5 years of age | 
| Body weight |  | At 5.5 years of age | 
| Body height |  | At 5.5 year of age | 
| Health history outcomes |  | At 5.5 years of age |