linjc16/ctgov huggingface dataset:
Effect of Yoga Vs. Stretching on Chronic Back Pain

Study Overview
=================
Brief Summary
-----------------
This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.It will also for physical, psychological and physiological factors associated with improvement in back pain.

Official Title
-----------------
Effect of Yoga Vs. Stretching on Chronic Back Pain

Conditions
-----------------
Chronic Non-specific Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Yoga
* Behavioral: Exercise
* Behavioral: Self-care book recommendations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group Health Cooperative enrollee Uncomplicated low back pain At least moderate pain levels Exclusion Criteria: Sciatica persisting 3 or more months after physician visit History of cancer (other than nonmelanoma skin cancer) Severe disk problems Unstable medical conditions Back surgery within past 3 years Physically unable to do the yoga or exercise classes and homework Unable to attend classes Currently doing yoga Taken yoga or exercise class for back pain within past year Currently in litigation for back pain Seeking other treatment for back pain

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Yoga<br>* Yoga for back pain<br>|
| Active Comparator: 2<br>Exercise | Behavioral: Exercise<br>* exercises for back pain<br>|
| Active Comparator: 3<br>Self-care book recommendations | Behavioral: Self-care book recommendations<br>* Self-care book for back pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back-related function |  | 6 months | 
| Pain |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Low Back Pain, Yoga
Artisan Aphakia Lens for the Correction of Aphakia in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.

Official Title
-----------------
Artisan Aphakia Lens for the Correction of Aphakia in Children

Conditions
-----------------
Aphakia

Intervention / Treatment
-----------------
* Device: Artisan Aphakia Intraocular Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2 to 21 years of age Have a visually significant cataract or need IOL replacement surgery Compromised capsular bag prohibiting implantation of standard posterior IOL Subject or parent/guardian must be able to comply with visit schedule and study requirements Subject's legal representative must be able to sign the Informed Consent Exclusion Criteria: Under 2 years of age Unable to meet Postoperative evaluation requirements No useful vision or vision potential in fellow eye Mentally retarded patients History of corneal disease Abnormality of the iris or ocular structure ACD less than 3.2 mm Uncontrolled glaucoma IOP > 25 mmHg Chronic or recurrent uveitis Preexisting macular pathology that may complicate the ability to assess the benefit of this lens Retinal detachment or family history Retinal disease that may limit visual potential Optic nerve disease that may limit visual potential Diabetes mellitus Pregnant, lactating or plan to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artisan Aphakia Intraocular Lens<br>Implantation of an Artisan intraocular lens to correct aphakia in children | Device: Artisan Aphakia Intraocular Lens<br>* Implantation of an intraocular lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected distance visual acuity at 12 months postoperative | Determination of the ability of the lens to correct refractive error caused by aphakia | 5 years follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aphakia, secondary intraocular lens, congenital cataract, marfan syndrome, pediatric cataract, ectopia lentis, subluxated lens
Greater Trochanter Epiphysiodesis In Hip Pathology

Study Overview
=================
Brief Summary
-----------------
One of the most common problems in the treatment of pediatric patients with various disorders of the hip joint is the formation of deformity of the proximal femur, such as abnormal growth of the greater trochanter, which causes it to be positioned high in relation to the femoral head. This condition is called relative overgrowth of the greater trochanter (ROGT).

Official Title
-----------------
Outcomes of The Greater Trochanter Epiphysiodesis In Treatment Of Children With Hip Pathology

Conditions
-----------------
Orthopedic Disorder

Intervention / Treatment
-----------------
* Procedure: Greater Trochanter epiphysiodesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: emerging deformities of the proximal femur with a high position of the greater trochanter, in which its apex was located above the center of the femoral head but below its superior pole; changes in the structure of the femoral neck, accompanied by its shortening; functioning growth zone of the greater trochanter at the time of intervention; and patients without surgical treatment history Exclusion Criteria: hip dislocation upon examination; patients with varus deformity of the femoral neck (neck-shaft angle <120°), patients with complications of surgical interventions, trauma, rickets, and rheumatoid arthritis; and patients with neurological disorders and Refusal to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GT overgrowth group<br>pediatric patients with greater trochanter overgrowth | Procedure: Greater Trochanter epiphysiodesis<br>* epiphysiodesis by cortical screw and washer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological measurments | articulo-trochanteric distance | 12 month |
Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
Manual Lymphatic Drainage is a widely used technique for lymphedema. However, the analgesic effects of this technique could be potentially useful for managing pain in patients with generalized widespread chronic pain, including patients with fibromyalgia.

Official Title
-----------------
Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Other: Manual Lymphatic Drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with diagnosis of Fibromyalgia. Exclusion Criteria: Women with heart failure.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 Years

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

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

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 |
| --- | --- |
| Experimental: Manual Lymphatic Drainage<br> | Other: Manual Lymphatic Drainage<br>* Manual lymphatic drainage is a technique that through gentle passes facilitates the flow of lymph through manual therapy techniques based on Vodder therapy. This technique is being studied to know its effectiveness in pain and for this reason we want to carry out this research.<br>|
| No Intervention: No intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain pressure threshold | Kg/cm2 | Baseline | 
| Pain pressure threshold | Kg/cm2 | Immediately after the intervention | 
| Pain pressure threshold | Kg/cm2 | Up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | 0-10 | Baseline | 
| Visual Analogue Scale | 0-10 | Immediately after the intervention | 
| Visual Analogue Scale | 0-10 | Up to 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Manual Lymphatic Drainage, Randomized clinical trial, Pain
Association Between Lipid Profiles and Cardiovascular Events

Study Overview
=================
Brief Summary
-----------------
KORLIPID (Study on the Association between Lipid Profiles and Cardiovascular Events) registry enrolled 4234339 subjects who underwent general health check-ups provided by National Health Insurance Service in 2009.

Detailed Description
-----------------
Subjects who underwent general health check-ups provided by National Health Insurance Service in 2009 were included in KORLIPID study. Demographic data, anthropometric data and medical information from general health check-ups were collected. In addition, medical records in National Health Insurance Service between 2002 and 2018 were also collected.

Official Title
-----------------
Study on the Association Between Lipid Profiles and Cardiovascular Events: Analysis From the Korean Nationwide Health Insurance Database

Conditions
-----------------
Dyslipidemias, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Measurement of lipid profiles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who underwent general health check-ups in 2009 Exclusion Criteria: Age less than 30 years Age 75 years or more

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 74 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Measurement of lipid profiles|Measured: total cholesterol, high-density lipoprotein cholesterol, and triglyceride Calculated: low-density lipoprotein|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction | acute myocardial infarction demanding hospitalization | until 2018 after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | acute ischemic stroke demanding hospitalization | until 2018 after inclusion | 
| Heart failure | acute heart failure demanding hospitalization | until 2018 after inclusion | 
| Death | all cause mortality | until 2018 after inclusion |
Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents

Study Overview
=================
Brief Summary
-----------------
In patients treated for exudative age-related macular degeneration (AMD), diabetes, retinal venous occlusion (OVR), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (IVT) are widely used both for their anti-angiogenic action. Patients often have injections for many years, sometimes monthly or every 2 months. The discontinuation of treatment with repeated injections of anti-angiogenic agents, linked to the COVID-19 coronavirus pandemic will potentially impact the visual acuity, the ophthalmological state and the quality of life of the patients concerned, therefore it is relevant to analyze the consequences the breakdown of usual care in this population.

Official Title
-----------------
Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents

Conditions
-----------------
Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Procedure: Questionnaire
* Other: Data collection up to 1 year


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ocular pathology requiring repeated IVT treatment of anti-angiogenic drugs (exudative AMD, diabetic macular edema or secondary to retinal venous occlusion ...) Beginning of IVT treatment repeated before 10/01/2019 (6 months before the start of French confinement) Exclusion Criteria: Refusal to participate

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with IVT before COVID19 pandemia<br>Treatment started at least 6 months before the French confinement for COVID19 (15th march 2020) | Procedure: Questionnaire<br>* At inclusion : Questionnaire collecting data concerning the interruption of IVT treatment<br>Other: Data collection up to 1 year<br>* Data collection up to 1 year after resumption of follow-up: visual acuity, OCT : optical coherence tomography, IVT treatment, complications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of visual acuity in patients treated with repeated IVT anti-angiogens during the COVID-19 epidemic | Change from baseline (last visual acuity before confinement) and visual acuity 6 months after resumption of follow-up | Baseline (Before confinement) and 6 months after resumption of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravitreal Injections, Anti-angiogenics, COVID19
Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This is a 96-week extension study of open-label simufilam 100 mg b.i.d. for mild-to-moderate Alzheimer's disease subjects who completed the Phase 2 study, PTI-125-04. The study will evaluate safety and long-term treatment. Safety will be assessed by AE monitoring, clinical labs, urinalysis, vital signs, ECGs, and C-SSRS.

Detailed Description
-----------------
This is an open-label 96-week extension study of open-label simufilam 100 mg b.i.d. for subjects who completed the Phase 2 study, PTI-125-04. All subjects will provide consent to enroll into this study. Simufilam will be administered as coated oral tablets. The last study visit, Month 24, from the PTI-125-04 study will be used for the Study Day 1 visit assessments in this extension study. Clinic visits will occur every 12 weeks ±10 days. A complete physical examination will be performed at Study Day 1, Week 48 and Week 96. Subjects will return to the clinic every 12 weeks for safety assessments of vital signs, AE monitoring, C-SSRS, and drug dispensation and accountability. Blood draws for clinical laboratory testing, urine collection for urinalysis, and ECGs will be performed at Study Day 1 and Weeks 24, 48, 72, and 96. Safety will be evaluated by adverse event monitoring, vital signs, clinical labs, and the Columbia Suicide Severity Rating Scale (C-SSRS).

Official Title
-----------------
An Open-Label Extension of the PTI-125-04 Study Evaluating the Safety and Long-Term Treatment of Simufilam in Mild-to-Moderate Alzheimer's Disease Patients

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: simufilam


Participation Criteria
=================
Eligibility Criteria
-----------------
• Subjects must have completed the PTI-125-04 study.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label extension study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simufilam 100 mg<br>simufilam 100 mg oral tablets, b.i.d. | Drug: simufilam<br>* simufilam 100 mg oral tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Monitoring | Adverse Event Monitoring | Baseline to 96 Weeks |
Smoke Inhalation Injury in Patients Admitted to Intensive Care

Study Overview
=================
Brief Summary
-----------------
Many Studies have shown that the smoke-inhalation injury is responsible for a high mortality mainly related to the systemic effects of carbon monoxide and cyanide. Respiratory lesions induced by smoke inhalation, is one of predictive factors of mortality. The aim of the study is to identify the clinical and epidemiological characteristics of smoke-inhalation injury and to identify prognostic factors among these patients .

Detailed Description
-----------------
The study is a monocentric, retrospective, descriptive and analytical study , betwen december 1997 and september 2018 in intensive care unit of university of hospital. All patients aged over 18 year and who had received a diagnosis of smoke- inhalation injury and were admitted to the ICU of Medical University Hospital , a referral center in Paris providing HBO therapy , were potentially eligible for inclusion in this investigation. Criteria used for recommending HBO therapy to a patient with transient or prolonged unconsciousness, abnormal neurologic findings on physical examination. Data were analyzed to identify independent factors that may influence mortality.

Official Title
-----------------
Prognostic Factors for Smoke Inhalation Injury in Patients Admitted to Intensive Care

Conditions
-----------------
Smoke Inhalation Injury, Morality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Men or women over the age of 18 Hyperbaric oxygen therapy between 1997 and 2018 Exclusion Criteria Patients under 18 years old. Patient opposed to the use of his data Patients not treated with hyperbaric oxygen

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | survival study for the search of prognostic factors | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidemiologic characteritics | description of quantitative and qualitative data | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognostic Factors, intensive care unit
Computerized Evaluation of the Endometrial Myometrial Junction During a Natural Menstrual Cyle.

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the width of the endometrial myometrial zone in participants during natural menstrual cycle by using specific computerized application on 3 dimensions sonographic images of their uteri.

Detailed Description
-----------------
The uterine endometrium and the uterine myometrium have different acoustic characterization in transvaginal ultrasound(TVS).TVS can also demonstrate the interface between these tissues - the endometrial myometrial zone(EMJ) .This is optimally achieved in 3 dimensions images in a coronal section of the uterus.A specific computerized algorithm was developed in our unit by using MATLAB software for the quantitative measurements of the EMJ width in different uterine planes.The investigators aim to evaluate changes in the width of the EMJ in different uterine planes in participants during natural menstrual cycle .

Official Title
-----------------
The Investigators Aim to Evaluate the Width of the Endometrial Myometrial Zone in Participants During Natural Menstrual Cycle by Using Specific Computerized Application on 3 Dimensions Sonographic Images of Their Uteri

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: Transvaginal sonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:patients with regular menstrual cycles - Exclusion Criteria:patients on contraceptive pills.patients after uterine surgery -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transvaginal sonography|Transvaginal sonography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the width of the EMJ during natural cycle |  | 30 days |