linjc16/ctgov huggingface dataset:
Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501B in Glabellar lines.

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Single-center Phase I Trial to Investigate the Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines

Conditions
-----------------
Glabellar Lines

Intervention / Treatment
-----------------
* Drug: CKDB-501B
* Drug: Botox®50U


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS) Exclusion Criteria: Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function History of facial nerve paralysis or ptosis Significant facial asymmetry Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Interventional Model Description: Active-controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKDB-501B<br> | Drug: CKDB-501B<br>* Intramuscular injection CKDB-501B<br>|
| Active Comparator: Botox® 50U<br> | Drug: Botox®50U<br>* Intramuscular injection Botox®50U<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Severity and frequency of reported adverse events | [Time Frame: up to week 12] |
IRM Cognition in Patients With Head Trauma

Study Overview
=================
Brief Summary
-----------------
Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period.

Detailed Description
-----------------
The following data are collected in 3 months, 12 months then 24 months after the accident with followed data collection : Clinical, neuropsychological assessments Diffusion magnetic resonance imaging (MRI) for the reconstruction of anatomical pathways Functional imaging data.

Official Title
-----------------
Longitudinal Descriptive Study of the Correlation Between Cognitive Functions, White Matter Anatomical Pathways and Functional Magnetic Resonance Imaging Activations in Patients With Moderate to Severe Head Trauma.

Conditions
-----------------
Brain-damaged Patients

Intervention / Treatment
-----------------
* Other: Cognitive rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, over the age of 18. Mild traumatic brain injury (Initial Glasgow score between 9 and 12) Severe brain injury (Initial Glasgow score between 3 and 8), Diffuse axonal injury and/or focal lesions. Exclusion Criteria: Patients with MRI contraindications, Antecedents of brain lesions, Important lesions of the lobes and cortex on cerebral CT, Anoxic lesions related to cardiorespiratory arrest, Must be able to perform neuropsychological tests, Visual and auditory impairments. Aphasia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Traumatic brain injury population<br>Defined population : traumatic brain injury population | Other: Cognitive rehabilitation program<br>* Rehabilitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Baseline standardized volume of the white matter fascicles | determined on the iplan software. Baseline measured at 3 months after brain traumatic injury. | at 3, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the volume of activations clusters | during functional MRI for attention, motor, working memory, language tasks. | at 3, 12 and 24 months | 
| Location of activation clusters | during functional MRI for attention, motor, working memory, language tasks. | at 3, 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Craniocerebral injury, Mild and severe brain traumatic injury, Neuropsychological abilities, Clinical assessment, Anatomical and functional imaging
Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery

Study Overview
=================
Brief Summary
-----------------
Today there are few studies in the literature involving patients in an ICU following major visceral surgery. There are thus few results about the prognostic value of pulmonary extravascular water in this population of patients, but also the prognostic value of pulmonary extravascular water measured at the bedside using pulmonary ultrasound. In addition, pulmonary ultrasound will be combined with echocardiography to measure left ventricular function (LVEF) and to study the profile of the mitral valve to assess filling pressure in patients with immediate post-operative ventilation. This will make it possible to distinguish between increases in pulmonary extravascular water associated with high filling pressure and increased pulmonary water associated with low filling pressure: characteristic of lesional oedema. The aim of this study is to determine the prognostic value of extravascular pulmonary water (PEVW) diagnosed using pulmonary ultrasound in patients admitted to an ICU following scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.

Official Title
-----------------
Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery: Prognostic Value of Pulmonary Extravascular Water Revealed by Pulmonary Ultrasound.

Conditions
-----------------
Digestive Surgery, Urinary Surgery

Intervention / Treatment
-----------------
* Other: pulmonary ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing scheduled or emergency visceral surgery and admitted to an ICU following the intervention. Exclusion Criteria: Chest surgery ASA (American Society of Anesthesiologists) 4 or more Refusal of the patient Pregnant women Spontaneously-breathing patients

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

| Intervention/Treatment |
| --- |
|Other: pulmonary ultrasound|Collect the aeration profile for each lung quadrant: profile A, profile B1, profile B2, profile C. Calculate the aeration score from O to 36 (LUS (Lung ultrasound) score).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of post-operative acute respiratory distress |  | 28 days |
A Post Breastfeeding Follow-Up Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study which is to evaluate the benefits of lactation support intervention, in conjunction with maternal nutritional supplementation during the last trimester to 12 weeks postpartum in comparison to pre- and postnatal care on 1) breast feeding practices (primary objective), and 2) cognitive development in children within 28 months 16 days - 32 months 30 days (secondary objective).

Detailed Description
-----------------
This is an observational study involving mothers and their child at 30 months old as a follow up to the breastfeeding intervention study that they have participated in and completed during the period from the last trimester to 12 weeks postpartum. The assessors will be blinded to subject's treatment group assignment from the intervention phase. There are no products given to any subject. The primary variable is duration of any breastfeeding from birth.

Official Title
-----------------
A Post-Breastfeeding Intervention Observational Follow-Up Study

Conditions
-----------------
Breast Feeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother and child pair was enrolled in and completed the breastfeeding intervention (AL08) study. Age of child is within the allowable window (28 months 16 days - 32 months 30 days). Subject's parent/Legally Acceptable Representative (LAR) is willing and able to follow study procedures. Subject's parent/LAR has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study. Exclusion Criteria: Child has a diagnosis of developmental disorders e.g. cerebral palsy that require medical intervention prior to enrollment in this study.

Ages Eligible for Study
-----------------
Minimum Age: 28 Months
Maximum Age: 32 Months

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

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 |
| --- | --- | --- |
| Duration of any breastfeeding from birth | The primary variable, which is the duration of any breastfeeding from birth, will be assessed in all mothers recruited for this study. A questionnaire will be used to capture information on the age of the child (in months/weeks) in which the mother stopped breastfeeding. This information will be used to derive any breastfeeding duration from birth onwards. | 32 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive outcomes | Bayley Scales (BSID-III) of Infant and Toddler Development | 32 months | 
| Language/Communication outcomes | Age & Stages Questionnaire (ASQ-3) | 32 months |
Study of Myopia Acquisition and Prevention

Study Overview
=================
Brief Summary
-----------------
Purpose: To determine whether the use of reading glasses blocks the near work mediated increased incidence of myopia in healthy school children. Methods: SMART enrolled 115 emmetropic children (ages 7-9 years). The children were recruited in the Principality of Liechtenstein. They were randomly assigned to either the control group (n=52) or to receive reading glasses with a lens power of +2.0 dioptres (n=63). The primary outcome measure was progression towards myopia as determined by autorefraction after cycloplegia. The secondary outcome measure was change in biometry measurements of corneal curvature, axial length, anterior chamber depth, crystalline lens thickness, and vitreous chamber depth using partial coherence interferometry.

Official Title
-----------------
Study of Myopia Acquisition and Prevention in a Randomised Trial

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Behavioral: Wearing of reading glasses during prolonged near work


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emmetropia Exclusion Criteria: Ametropia

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 9 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

| Intervention/Treatment |
| --- |
|Behavioral: Wearing of reading glasses during prolonged near work|nan|

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
-----------------
Myopia, Prevention
Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume and Cardiac Output

Study Overview
=================
Brief Summary
-----------------
Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.

Detailed Description
-----------------
Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace. The Cardiac MRI will be received  1-4 days after the measurement is completed. The data will be compared with data collected from the Necklace and the reference device during the study.

Official Title
-----------------
Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume, Cardiac Output, Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to undergo Cardiac MRI Exclusion Criteria: Sensitivity to electrodes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Men/Women between 18 & 85<br>Accepting both healthy and non-healthy subjects. A portion of the subjects will have a fluid management issue or heart failure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume |  | Retrospective up to 6 months after study completion |
The Differences Between Gonadal and Extra-gonadal Malignant Teratomas

Study Overview
=================
Brief Summary
-----------------
A tumor comprising of different types of tissues (such as hair, muscle, bone, etc.) is known as a teratoma. It is a type of germ cell (cells that make sperm or eggs) tumor. When these germ cells have rapid cancerous growth, then such a teratoma is called a malignant teratoma. We have studied the differences between gonadal and extra-gonadal malignant teratomas and the effects of chemotherapy in both genders. Methods: The samples of 3799 male and 1832 female patients with malignant teratoma samples, between the ages of 1 and 85+ years, were selected from the years 1973 to 2014. Trends in incidence, estimated prevalence, incidence rates, and frequency were calculated in gonadal and extra-gonadal tumors with age adjustment. The fiveyear observed, expected, and relative survival rates were analyzed to study the prognosis.

Official Title
-----------------
The Differences Between Gonadal and Extra-gonadal Malignant Teratomas in Both Genders and the Effects of Chemotherapy

Conditions
-----------------
SEER Database

Intervention / Treatment
-----------------
* Other: survival rates


Participation Criteria
=================
Eligibility Criteria
-----------------
The registry used in our study was the SEER 9 registries Custom Data (with additional treatment fields), Nov 2016 Submission (1973-2014) < Katrina/Rita Population Adjustment> - Linked to County Attributes -Total United States, 1969-2015 Counties, National Cancer Institute, DCCPS (Division of Cancer Control and Population Sciences), Surveillance Research Program, released April 2017, based on the November 2016 submission.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| gonadal<br> | Other: survival rates<br>* survival rates<br>|
| extra-gonadal<br> | Other: survival rates<br>* survival rates<br>|
| chemotherapy<br> | Other: survival rates<br>* survival rates<br>|
| without chemotherapy<br> | Other: survival rates<br>* survival rates<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rates |  | 1973-2014 |
Language in Primary Progressive Aphasia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to further define the neurological and linguistic deterioration in primary progressive aphasia.

Detailed Description
-----------------
The Language in Primary Progressive Aphasia (PPA) aims to understand the behavioral, anatomical and physiological changes in people with PPA throughout the course of the illness. The researchers in this study want to increase awareness of PPA, educate others about this unique disorder, and to encourage more research to eventually develop therapies. During the three-day research program, participants will be asked to undergo neuropsychological testing (paper and pencil tests that evaluate cognition), advanced imaging (MRI and PET), cognitive experiments, and other computer and language testing batteries. Participants may be asked to return every two years to complete the same measures. For participants not living near Chicago, IL, flights and accommodations (for both the person with PPA and their companion) will be covered by the study.

Official Title
-----------------
Asymmetric Neurodegeneration and Language in Primary Progressive Aphasia

Conditions
-----------------
Primary Progressive Aphasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary progressive aphasia Right-handed Native English speaker Visual acuity of 20/30 corrected Adequate hearing to follow conversation Safe for an MRI scan Exclusion Criteria: Left-handedness Claustrophobia Presence of significant medical illness that initially or in the future could interfere with continued participation in the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PPA (Primary Progressive Aphasia)<br>Individuals with primary progressive aphasia | |
| Control<br>Individuals with no diagnosis of any type of dementia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological variables |  | Immediately after testing and at two years post-testing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
frontotemporal dementia, primary progressive aphasia, semantic dementia, progressive nonfluent aphasia, progressive aphasia, frontotemporal lobar degeneration
Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.

Official Title
-----------------
Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR

Conditions
-----------------
Foetal Growth Problem, Small for Gestational Age

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10 Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age Normal response to GH stimulation test (greater than 10 ng/mL) Exclusion Criteria: Diabetes Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders) Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy Previous or ongoing growth hormone therapy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 14 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height gain according to birth group, age of onset, the treatment and Tanner stage |  | during 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height SDS for bone age |  | during 12 months of treatment | 
| Height velocity SDS for bone age |  | during 12 months of treatment | 
| Height velocity for chronological age |  | during 12 months of treatment |