linjc16/ctgov huggingface dataset:
The Safety and Adverse Reaction Study of Neonatal to Inhaled Carbon Monoxide

Study Overview
=================
Brief Summary
-----------------
Based on the study about carbon monoxide in human inflammatory and other beneficial physiological function , now we'll be going to research its application in neonates .Phase 1 Study as a foundation for the further test is, the safety and Adverse reaction study of newborn to inhaled CO

Detailed Description
-----------------
Previous studies have demonstrated that, carbon monoxide has showed the effectiveness such as in inflammation ,apoptosis as well as relaxation of smooth muscle of the body. Now we have a hypothesis to use carbon monoxide in pulmonary hypertension of the newborns, to observe whether it will decrease pulmonary artery hypertension on newborns. Phase 1 study is ,the safety and Adverse reaction study of newborn to inhaled CO , after this,we can master the application of carbon monoxide dose

Official Title
-----------------
Phase 1 Study of Inhaled Carbon Monoxide on the Effectiveness of Neonatal Pulmonary Hypertension

Conditions
-----------------
Miscellaneous Disorders in the Fetus or Newborn

Intervention / Treatment
-----------------
* Other: Inhaled Carbon Monoxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The newborn whose physiological function is healthy or close to healthy Exclusion Criteria: Clinical considerations cannot survive or no treatment value of newborn Diagnosis of congenital or hereditary diseases, or children with heart diseaseCentral pulmonary vascular malformations in children

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 1 Month

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: Safety and Adverse Reaction in CO<br>Inhaled Carbon Monoxide | Other: Inhaled Carbon Monoxide<br>* Inhaled Carbon Monoxide in newborn<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | up to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbon monoxide, safety, Adverse Reaction, newborn
Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Detailed Description
-----------------
Ceftazidime is a third generation cephalosporins that should be reserved for severe bacterial infections. Substitution of the brand ceftazidime with a generic ceftazidime raised some concerns. The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Official Title
-----------------
Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: ceftazidime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in surgical intensive care unit who require ceftazidime treatment Exclusion Criteria: less than 1 year old

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 95 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 |
| --- |
|Drug: ceftazidime|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adverse drug reactions of ceftazidime |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of ceftazidime |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ceftazidime, safety, infection
Hepatocyte Transplantation as a Life Support Bridge

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain knowledge about the result of infusing liver cells, carefully matched to blood type, into a subject's body. The hope is that this procedure will aid functions of the liver and prevent death, enable a transplant procedure to be carried out if a donated liver becomes available, and lessen complications in postoperative recovery. There is no guarantee that any of these benefits will be re eived, but even if they are not, the hope is that knowledge gained by using this procedure will be of future benefit to others who also suffer from liver disease.

Detailed Description
-----------------
Adult and pediatric patients eligible for liver transplantation who require intensive care unit admission for multisystem organ failure in addition to liver failure, without systemic sepsis, are eligible for liver cell transplantation regardless of race, sex or financial support. Failure of 3 or more organ systems are the criterion used to select patients with as close to 100% mortality as possible without solid organ transplant. Hepatocytes, isolated from excess liver tissure from reduced liver transplant procedures or from donor livers not used for transplantation, are prepared by a complex process and then are infused, guided by radiology into the splenic artery or portal vein of the patient. Patients must be on immunosuppression therapy for as long as the hepatocytes are living and beneficial to the patient.

Official Title
-----------------
The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure

Conditions
-----------------
Fulminant Liver Failure

Intervention / Treatment
-----------------
* Procedure: Hepatocyte Infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to VCU Health System ICU in fulminant Liver Failure in addition to multisystem organ failure Exclusion Criteria: Patients with Sepsis -
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 |
| --- |
|Procedure: Hepatocyte Infusion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to liver transplantation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Function Normalization |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocytes
Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals' dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.

Official Title
-----------------
Open, Booster Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Administered to Healthy Chinese Children 6-8 Years of Age.

Conditions
-----------------
Tetanus, Diphtheria, Acellular Pertussis

Intervention / Treatment
-----------------
* Biological: Boostrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female between, and including, 6-8 years of age at the time of vaccination, Written informed consent obtained from the parent or guardian of the subject, Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, Exclusion Criteria: subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate Subjects with history of diphtheria, pertussis or tetanus diseases can not participate

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Boostrix|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uncontrolled
Epidemiological Study of the Prevalence of Age-Related Macular Degeneration in Portugal

Study Overview
=================
Brief Summary
-----------------
This is an epidemiological study to assess the the prevalence of Age-Related Macular (ARM) Degeneration in Portugal.

Official Title
-----------------
Epidemiological Study of the Prevalence of Age-Related Macular Degeneration in Portugal

Conditions
-----------------
Age-Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with 55 years-old Exclusion Criteria: None

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

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 |
| --- | --- | --- |
| ARM | Signs of Age-Related Macular Degeneration | 1 month after the screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other ocular disease | Signs of other ocular disease such as: diabetic retinopathy, glaucoma, cataract, etc. | 1 month after screening |
Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in maintenance heart transplant recipients with impaired renal function.

Official Title
-----------------
A One-year Multicenter, Randomized, Open-label Study of the Safety and Efficacy of Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

Conditions
-----------------
Heart Transplantation

Intervention / Treatment
-----------------
* Drug: Everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipients of primary heart transplant Reduced renal function (serum creatinine > 1.7 ng/mL over 2 months or more) at 6 months or more after heart transplantation Patients with current immunosuppressive therapy consisting of cyclosporine microemulsion and mycophenolate mofetil Exclusion Criteria: Patients who are recipients of multiple organ transplants Patients who have previously received an organ transplant Patients with serum creatinine > 3.5 mg/dl Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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 |
| --- |
|Drug: Everolimus|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
-----------------
everolimus, cyclosporine microemulsion, renal function
A Study to Evaluate Effectiveness and Safety of Surgeries in Elderly NSCLC Patients

Study Overview
=================
Brief Summary
-----------------
The trial was designed to compare effectiveness and safety of surgeries in the patients with non-small cell lung cancer

Detailed Description
-----------------
The trial is a multi-centre, real-world, non-interventional, observational study. The Chinese elderly pathologically diagnosed patients with early-stage non-small cell lung cancer enrolled from 2015 to 2017 who received lobectomy or segment/wedge dissection were included and the study data on patient demographic/tumor biological characteristics, and clinical treatments were retrospectively collected to evaluate effectiveness and safety of the surgeries.

Official Title
-----------------
A Multi-centre Real-world Non-interventional Observational Study to Evaluate Effectiveness and Safety of Surgeries in the Chinese Early-stage Patients With Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Surgeries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received surgeries from 2014 to 2017; Patients who received lobectomy or segment/wedge dissection; Pathologically diagnosed patients with non-small cell lung cancer; Patients with age >=65 years old. Exclusion Criteria: Patients who received neoadjuvant therapy prior to surgery.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Patients with surgeries<br>Pathologically diagnosed elderly early Chinese patients with non-small cell lung cancer who received lobectomy or segment/wedge dissection | Procedure: Surgeries<br>* Lobectomy or segment/wedge dissection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | 2015-2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chinese, real-world evidences, NSCLC, surgeries
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning

Study Overview
=================
Brief Summary
-----------------
Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown whether this can be used in retinal vascular occlusive diseases. The purpose of the present study is to examine whether the autoregulation of retinal vessel diameters in normal persons change after remote ischemic conditioning.

Official Title
-----------------
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning

Conditions
-----------------
Retinal Artery Occlusion, Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Procedure: Remote ischemic conditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal persons Exclusion Criteria: Present or previous eye disease Use of medications except anti-conceptive Epilepsy Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemic conditioning<br> | Procedure: Remote ischemic conditioning<br>* Briefly reversible restricting of blood flow to upper limb in four cycles of 5 minutes of inflation at 200mm Hg followed by 5 minutes of deflation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter change of retinal vessel |  | immediate |
Sleep Apnea After Extubation

Study Overview
=================
Brief Summary
-----------------
Sleep apnea is common after extubation, approximately 71%, and is independently associated with hypertension and metabolic disease contributing to increased morbidity and mortality. Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the management of more symptomatic patients with obstructive sleep apnea. The aim of this study is to evaluate the prevalence of sleep apnea after extubation by respiratory polygraphy.

Official Title
-----------------
Sleep Apnea After Extubation

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Device: Respiratory polygraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients after extubation Exclusion Criteria: pregnant non-consciousness received continuous positive airway pressure (CPAP)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Respiratory polygraphy|The respiratory polygraphy consisted of continuous polygraphical recordings for a whole night from 22:00 h to 07:00 h with standardised equipment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sleep apnea after exutbation |  | during first to second night following extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea, Respiratory polygraphy, Extubation
Time Trend Analysis of PE Diagnosis With SPECT V/Q: a Single Institution Observational Study

Study Overview
=================
Brief Summary
-----------------
Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. However, PE prevalence was high (28%), which may seem a bit high as compared with other recent studies. The hypothesis was that the use of SPECT V/Q may be responsible for an overdiagnosis of PE, especially at the implementation phase of the test. The aim of this study was to perform a time trend analysis of the evolution over the years of PE diagnosis with SPECT V/Q.

Official Title
-----------------
Time Trend Analysis of Pulmonary Embolism Diagnosis With SPECT V/Q: a Single Institution Observational Study From 2011 to 2016

Conditions
-----------------
Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016 Exclusion Criteria: Patient under legal or judicial protection Patient opposed to the use of his medical data for research.

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 |
| --- | --- | --- |
| Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE | positive, negative, or non-conclusive | April 2011 to December 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of thromboembolic events (i.e. objectively confirmed pulmonary embolism or proximal deep vein thrombosis) during the 3-month follow-up period in patients left untreated based on a negative SPECT V/Q. |  | up to 3 Months following the date of the SPECT V/Q scan |
Evaluation of the Quality of the NovoSeven (rFVIIa) Tratment Practice at Rigshospitalet, Copenhagen University Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose is to evaluate and improve NovoSeven treatment practice done according to our guidelines

Conditions
-----------------
Hemorrhage, Shock

Intervention / Treatment
-----------------
* Procedure: NovoSeven treatment according to guideline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for NovoSeven treatment according to our guideline Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: NovoSeven treatment according to guideline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |