linjc16/ctgov huggingface dataset:
Outcomes of Patients With COVID-19 in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit. A Multicenter Observational Study.

Detailed Description
-----------------
As of 23 March 2020, a cumulative total of 332,930 confirmed cases of coronavirus disease 2019 (COVID-19) were reported in 189 countries and territories worldwide. As of this time, there had been 367 total confirmed cases of COVID-19, including four deaths in Mexico. The clinical manifestations of patients with COVID-19 are wide, asymptomatic infection, mild upper respiratory tract illness, and approximately 5% of critically ill patients with COVID-19 have presented rapidly progressive respiratory failure, development of acute respiratory distress syndrome (ARDS), and intensive care unit (ICU) admission. On March 24, 2020, the Secretary of Health of Mexico, formally declared the beginning of phase 2. It has been estimated that many confirmed cases of COVID-19 would occur, thus would result in a significant increase of hospital and ICU admissions.

Official Title
-----------------
Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)

Conditions
-----------------
Coronavirus Infections, COVID-19, Viral Pneumonia Human Coronavirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed case: Critically ill patient who meets the operational definition of a suspected case and who has a confirmed diagnosis by the National Network of Public Health Laboratories recognized by the Institute of Epidemiological Diagnosis and Reference (Indre) (Mexico). Exclusion Criteria: If a negative for SARS-CoV-2 result is obtained from a critically ill patient with a high index of suspicion for COVID-19 virus infection. Patients who had participated in another observational study in the last 30 days prior to inclusion.

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 |
| --- | --- | --- |
| Hospital mortality | Mortality 30 days following hospital admission | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the intensive care unit | The number of calendar days from the day of admission (counted as 1 day) to day of intensive care unit discharge | Through study completion, an average of 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intensive care unit, Critical care, Outcomes, Epidemiology
Assessment of Intracerebral Hematoma

Study Overview
=================
Brief Summary
-----------------
The study will assess acute intracerebral hematoma expansion within the first 48 hours from the onset using transcranial duplex sonography in patients who have acute intracerebral hematoma , and will also assess the correlation between the transcranial duplex sonography measurements and the clinical outcome of these patients .

Official Title
-----------------
Assessment of Intracerebral Hematoma Using Transcranial Duplex _ Hospital Based Study

Conditions
-----------------
Intracerebral Hematoma

Intervention / Treatment
-----------------
* Device: transcranial duplex sonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first ever non traumatic supratentorial primary intracerebral haemorrhage on non contrast CT brain admitted within 24 hours of symptom onset Exclusion Criteria: blood diseases, decompansated hepatic or renal impairment, or encephalopathy caused by electrolyte disturbance on anticoagulant treatment if devolped major complications during hospitalization ( e.g sever chest infection, hypoxia, or deep venous thrombosis ) comorbid neurological or psychiatric disorders

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients assessed by transcranial duplex sonography<br> | Device: transcranial duplex sonography<br>* it is an imaging device that will measure the intracerebral hematoma expansion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in volume of intracerebral hematoma |  | at baseline, then 24 hour after the baseline, and finally 48 hours after the baseline |
Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Study Overview
=================
Brief Summary
-----------------
This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.

Detailed Description
-----------------
Infections, chemical injury, and other diseases result in acute or chronic corneal ulcer, which may damage corneal stroma and may lead to permanent corneal scars and blindness. Corneal transplantation is standard method for corneal ulcer, but severe shortage of donor corneas limits its application. Acellular porcine corneal matrix is similar to the native cornea, especially with the biological property and microstructure. Recently, this matrix has been proved to be safe when transplanted to animal subjects and will not be rejected by the recipient. In animal lamellar keratoplasty experiments, acellular corneal matrix showed that they can integrate into the corneal wound bed and help reconstruction of the lamellar integrity of corneal stroma. This study will investigate its healing effect on human corneal ulcer. It will provide a potential corneal substitute for this disease.

Official Title
-----------------
Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Conditions
-----------------
Corneal Ulcer

Intervention / Treatment
-----------------
* Device: acellular corneal matrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged between 18 and 75 yrs. Corneal ulcer. Informed consent. Exclusion Criteria: Corneal perforation. Other ocular diseases. The presence of systemic connective tissue diseases Severe allergic constitution Pregnancy The presence of chronic disease, such as significant cardiovascular illness The patients who received clinical experiments for other medicine or medical devices within 3 months prior to the transplantation. Any patient that is not suitable for recruitment, in the judgment of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acellular corneal matrix<br> | Device: acellular corneal matrix<br>* Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty.<br>* Other names: ACM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rejection evaluation |  | 30 days following transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal wound healing |  | 90 days following transplantation |
Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure

Study Overview
=================
Brief Summary
-----------------
This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.

Official Title
-----------------
An Open Label, Non-randomised Study to Explore Safety/Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 in Patients With Stable Heart Failure

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

Intervention / Treatment
-----------------
* Drug: LCZ696


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with documented heart failure (NYHA class II-IV) Exclusion Criteria: Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stable heart failure patients<br> | Drug: LCZ696<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696 |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of LCZ696 and its metabolites |  | 14 days | 
| Pharmacodynamics of LCZ696 |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, LCZ696
Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Liver transplantation (LT) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (HHT) with severe hepatic involvement. The investigating team provides a long-term evaluation of graft status after LT for HHT with a focus on the risk of recurrence. The present study included all patients prospectively followed up after LT for HHT in the Lyon Liver Transplant Unit from 1993 to 2010 with a survival of more than 1 year.

Official Title
-----------------
Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation: Clinical Implications and Physiopathological Insights.

Conditions
-----------------
Hereditary Haemorrhagic Telangiectasia, Liver Transplant

Intervention / Treatment
-----------------
* Other: Data collection from standard follow-up after liver transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant for HHT Exclusion Criteria: Patient who died in the year following transplantation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver transplant in Hereditary Hemorrhagic Telangiectasia<br>Hereditary Hemorrhagic Telangiectasia (HHT) patients who underwent a liver transplant in Lyon between 1993 and 2010, and who survived more than 1 year after transplantation. | Other: Data collection from standard follow-up after liver transplant<br>* All patients underwent regular follow-up every 6 to 12 months after the first year post-liver transplant (LT). Complete laboratory investigations were performed at each visit. Doppler ultrasonography was performed every 1 to 3 years after LT. Computed tomography (CT) scan and/ or magnetic resonance imaging (MRI) was performed at 1, 5, 10, 15, and 20 years after LT, or when clinically indicated. All available radiological material was reviewed. Cardiac evaluation was performed regularly in patients who received transplant for cardiac failure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in graft status after liver transplant for Hereditary Haemorrhagic Telangiectasia (HHT) (risk of recurrence) | Recurrent clinical examinations (including laboratory, histological and radiological investigations) | Every 6 months after transplantation up to 5 years |
Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell Transplantation: a Pharmacokinetic Study

Study Overview
=================
Brief Summary
-----------------
A study of pharmacokinetics of daily intravenous busulfan

Detailed Description
-----------------
A study of pharmacokinetics of daily intravenous busulfan

Official Title
-----------------
Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell

Conditions
-----------------
Hematologic Malignancy

Intervention / Treatment
-----------------
* Drug: intravenous busulfan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing transplantation Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 70 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: intravenous busulfan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic data |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, transplantation, busulfan
CARTO 3 Human Patch Study

Study Overview
=================
Brief Summary
-----------------
The Purpose of this clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. During the study the adhesiveness properties of the patches will be evaluated.

Official Title
-----------------
CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case

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

Intervention / Treatment
-----------------
* Device: ACL Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Subject Informed Consent Form Healthy subject Age Range: 20 - 50 years BMI - half o the subjects 18-25 and half >25 Chest cage normal anatomy and dimensions No history of skin contact patch allergy, of any kind Exclusion Criteria: Chest cage bony deformity Known skin allergies to patches, or dermatological conditions requiring therapy Presence of any active skin lesion on chest or back Any condition that preclude subject from lying down for six hours with minimal movement Pregnancy Subjects with devices, such as pace makers, IC, loop recorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| ACL Patch<br> | Device: ACL Patch<br>* Observe and characterize the changes in relative conductivity between the six ACL patches over period of six hours. Investigation only involves passive data collection on pressure impact and adhesiveness properties of ACL patches.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites. |  | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACL Patch Placement
Clinical Acceptability of I-GEL® in Pediatric Patients: Comparison of Clinical Performance With Classic-LMA™

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether a functional difference exists between the laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received neuromuscular blockade.

Conditions
-----------------
Endotracheal Intubation

Intervention / Treatment
-----------------
* Device: i-gel airway (Intersurgical Ltd., Wokingham, England)
* Device: Laryngeal Mask Airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary Exclusion Criteria: Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status upper airway abnormality

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 9 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

| Intervention/Treatment |
| --- |
|Device: i-gel airway (Intersurgical Ltd., Wokingham, England)|supra-glottic airway device|
|Device: Laryngeal Mask Airway|supra-glottic airway device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway leak pressure | Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached. | within 5 min of insertion of each device |
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of Vitreosolve® in diabetic retinopathy patients.

Official Title
-----------------
A Phase 3 Safety and Efficacy Study of Vitreosolve® for Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Vitreosolve
* Drug: Vitreosolve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a history of systemic diabetes(type I,or II) Subject with a documented history of Non- proliferative Diabetic Retinopathy(NPDR) Subjects with no or partial PVD at baseline exam in study eye. Exclusion Criteria: Subjects with retinal pathology in the study eye other then (NPDR) Subjects with high myopia in the study eye Subjects who have monocular vision or central lateral vision of 20/200 or worse BCVA in the non-study eye. Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less then 6 months prior to study enrollment. Subjects that have either vitrectomy surgery, intavitreal injections, or laser treatments in the study eye.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitreosolve I<br>Intravitreal injection | Drug: Vitreosolve<br>* intravitreal injection<br>|
| Experimental: Vitreosolve<br>Intravitreal injection | Drug: Vitreosolve<br>* intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound, OCT, and clinical exam |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound ,OCT ,Safety, and Clinical Exam |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Retinopathy