linjc16/ctgov huggingface dataset:
Driving Pressure and Postoperative Pulmonary Complications

Study Overview
=================
Brief Summary
-----------------
This study aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.

Official Title
-----------------
Driving Pressure Limited Ventilation Decreases Postoperative Pulmonary Complications in One-Lung Ventilation: Randomized Controlled Study

Conditions
-----------------
One-Lung Ventilation, Postoperative Respiratory Complications, Driving Pressure

Intervention / Treatment
-----------------
* Other: Driving Pressure Limited Ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults greater than or equal to 19 years Patient who undergoes one-lung ventilation for thoracic surgery Exclusion Criteria: The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4 Patient who is contraindicated with application of positive end expiratory pressure Patient who rejects being enrolled in the study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Protective Ventilation<br>The control arm receives existing conventional protective ventilation with tidal volume of 6mL/kg of ideal body weight and positive end expiratory ventilation of 5cmH2O during one-lung ventilation | |
| Experimental: Driving Pressure Limited Ventilation<br>The intervention arm receives driving pressure limited ventilation during one-lung ventilation | Other: Driving Pressure Limited Ventilation<br>* Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 2 to 10 cmH2O during one-lung ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative pulmonary complications | Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale. | within the first 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial pressure of oxygen in arterial blood |  | during surgery | 
| The ratio of partial pressure arterial oxygen and fraction of inspired oxygen | The ratio will be obtained from the first arterial blood gas analysis on the first postoperative day. | on the first postoperative day |
Patients With NMDA Biomarker Data Following Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this current retrospective study is to perform follow-up analysis on the 22 children from the study # 621-2004 It is important to examine whether an elevated biomarker of brain ischemia before and/or following cardiac surgery has any clinical or functional implications as the child ages.

Detailed Description
-----------------
The N-Methyl-D-Aspartate (NMDA) receptor is unique to the brain. With brain injury or ischemia, fragments of the NMDA receptor (NR2) break off and appear in the bloodstream. These NR2 fragments generate an antibody response (NR2 ab) from the body. A recently developed blood test (CIS-Biotech, Inc) is able to measure these fragments (NR2) and the antibody (NR2 ab) response. In adult patients who suffer from ischemic stroke, elevated blood levels of NR2 ab correlate with the amount of brain damage on brain magnetic resonance imaging. The purpose of the past prospective study, Blood Markers of Brain Injury from Cardiopulmonary Bypass and Deep Hypothermic Circulatory Arrest in Infants and Children, Emory #621-2004, was to observe the expression of blood markers of brain ischemia, NMDA receptor fragment (NR2) and antibody (NR2 ab) in infants with congenital heart disease before and after cardiac surgery. Our intent is to review hospital medical records, the cardiothoracic surgical database and neurological database at Children's Healthcare of Atlanta to assess their clinical and functional outcomes. We will review surgery information, clinic visits to Sibley Heart Center Cardiology, and echo, MRI and neurological testing results as well as mortality for these patients. No patient will be contacted. This retrospective study is important as a follow-up to the initial prospective pilot study as it will provide information regarding the clinical outcome of the patients.

Official Title
-----------------
Retrospective Review of 22 Patients With NMDA Biomarker Data Following Cardiac Surgery

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participated in previous 621-2004 blood marker study for infants and children having open-heart surgery with cardiopulmonary bypass with or without hypothermic circulatory arrest Exclusion Criteria: Those who do not meet inclusion criteria

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, cardiac, pediatric, blood markers
Effect of Non Surgical Periodontal Therapy on Inflammatory Markers in Chronic Periodontitis Patients

Study Overview
=================
Brief Summary
-----------------
The current study was performed to study levels of Il-17 and Il-18 in aggressive periodontitis patients before and after non surgical periodontal therapy

Detailed Description
-----------------
Background:host defense factors are involved in pathogenesis of chronic periodontitis so, the current study is assessing levels of Il-17 and Il-18 in chronic periodontitis patients versus periodontally healthy controls. Subjects and methods: Fifty subjects were included; twenty five of them are diagnosed with chronic periodontitis patients and twenty five are periodontally healthy subjects. Probing depth (PD), clinical attachment level (CAL), plaque index (PI) and gingival index (GI) were recorded for all the enrolled subjects. GCF levels of Il-17 and IL-18 were analyzed by enzyme-linked immunosorbent assay (ELISA).

Official Title
-----------------
Effect of Non Surgical Periodontal Therapy on Levels of Il-17 and Il-18 in Chronic Periodontitis Patients Versus Periodontally Healthy Individuals

Conditions
-----------------
Aggressive Periodontitis

Intervention / Treatment
-----------------
* Procedure: non surgical periodontal therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically free subjects . both genders . age range between 30 to 60 years old . Exclusion Criteria: Subjects with periodontal surgeries in the last 6 months. Subjects with prior use of antibiotics in the last 6 months. Smokers. Pregnant and lactating females were excluded. Lactating females.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| chronic periodontitis<br>scaling and root planing | Procedure: non surgical periodontal therapy<br>* Scaling and root planing<br>|
| Periodontally healthy individuals<br>no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure levels of Il-17 and Il-18 in chronic periodontitis patients | measure levels of Il-17 and Il-18 in GCF of chronic periodontitis patients | Change from Baseline Il-17 andIl-18 at 3 months |
BEOVU in the Treatment of Dystrophy-related Macular Neovascular Degeneration

Study Overview
=================
Brief Summary
-----------------
Dystrophy-Related macular neovascularization degeneration occur is a vision threatening condition.The investigators evaluate the efficacy of BEOVU intravitreal treatment.

Detailed Description
-----------------
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included intravitreal injection of Brolucizumab (BEOVU®, Genen-tech, South Francisco, CA)

Official Title
-----------------
Brolucizumab-dbll (BEOVU®) Intravitreal Injection in the Treatment of Dystrophy-related Macular Neovascular Degeneration

Conditions
-----------------
Dystrophy, Retinal

Intervention / Treatment
-----------------
* Drug: Brolucizumab-Dbll


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dystrophy-Related macular neovascularization degeneration Exclusion Criteria: age related macular degeneration , other causes of macular neovascularization degeneration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEOVU<br>Intravitreal injection of BEOVU 3 loading injections ( monthly) then every 3 months | Drug: Brolucizumab-Dbll<br>* intravitreal injection of Brolucizumab (BEOVU)<br>* Other names: BEOVU;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity (BCVA) | Change in BCVA in LOG MARS(logarithm minimum angle of resolution) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optical coherence tomography (OCT) foveal thickness | change in foveal thickness measured in micrometer | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular degeneration, BEOVU, RETINAL DYSTROPHY
Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver Elastography ratio) during normal pregnancy

Official Title
-----------------
Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks

Conditions
-----------------
Pregnant Woman

Intervention / Treatment
-----------------
* Other: lung and liver elastography measurement of fetus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major pregnant women singleton pregnancy Exclusion Criteria: foetus: fetal pulmonary disease fetal liver disease chromosome fetal abnormalities fetal growth restriction mother: BMI>30 in beginning of pregnancy premature ruptured membranes high blood pressure pre-eclampsia gestational diabetes

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

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

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: Pregnant women with a normal pregnancy<br>Assesment of fetal lung and liver stiffness with 2D Ultrasounds Shear Wave Elastography | Other: lung and liver elastography measurement of fetus<br>* Other: lung and liver elastography measurement of fetus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Lung to liver Elastography ratio (LLE ratio) between 24 and 39 weeks of amenorrhea | Evolution of the fetal lung elasticity coefficient measured in kilopascals (kPa) compared to the fetal liver elasticity | measurements at: 24, 28, 32, 36, 39 weeks of amenorrhea (WA) |
Hemodynamic Optimization Based on a Dynamic Elastance Protocol

Study Overview
=================
Brief Summary
-----------------
In this study investigators explore the effects of a dynamic elastance guided protocol compared to a stroke volume variation fluid therapy on lactate levels during major abdominal surgery. Hence investigators created two groups: in the intervention group fluids are given in fluid-responders (SVV > 13%) based on high value of dynamic elastance (ie. Eadyn > 0.9). In the standard group fluids are administered when SVV > 13%.

Official Title
-----------------
Intraoperative Fluid Optimization Based on a Dynamic Elastance Protocol During Major Abdominal Surgery: a Randomised Control Trial

Conditions
-----------------
Fluid Management

Intervention / Treatment
-----------------
* Behavioral: Elastance Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients enrolled for major abdominal surgery - Exclusion Criteria: end-stage renal disease severe heart dysfunction heart rhythm alterations

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: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br> | Behavioral: Elastance Group<br>* Fluids are given based on dynamic elastane value<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactate levels |  | at the end of surgery |
The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients

Study Overview
=================
Brief Summary
-----------------
Obese patients may have difficulty in airway management.Patients who have body mass index > 35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of difficult airway.This study is designed to evaluate the differences and the effects of different laryngoscopes.

Official Title
-----------------
The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients

Conditions
-----------------
Difficult Airway, Videolaryngoscopes

Intervention / Treatment
-----------------
* Device: c-mac laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index> 35 Exclusion Criteria: emergency airway

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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 |
| --- | --- |
| c-mac used for intubation<br>obese patients intubated with c-mac videolaryngoscope | Device: c-mac laryngoscope<br>* type of laryngoscopes<br>* Other names: mc-grath laryngoscope;|
| mc-grath used for intubation<br>obese patients intubated with mc-grath videolaryngoscope | Device: c-mac laryngoscope<br>* type of laryngoscopes<br>* Other names: mc-grath laryngoscope;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation difficulty | the management of airway | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway assesment | evaluating the airway | 1 minute |
Measurement Skin Temperature During Pulsed Laser Exposure

Study Overview
=================
Brief Summary
-----------------
Lasers are the treatment modality of choice for Port Wine Stain birthmarks.The epidermis is not totally spared due to partial absorption of energy therein by melanin that presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.

Detailed Description
-----------------
The researchers want to establish a correlation between non-invasive skin temperature measurements and the minimum laser energy during skin laser treatment using cryogen spray cooling. This study would eliminate the need for test pulses to estimate the safe and acceptable radiant exposure prior to laser treatment.

Official Title
-----------------
Phase II Clinical Trial is to Compare Epidermal Temperature Measurements During 1.Laser Treatment at Standard Treatment Energies 2.Cryogen Spray Cooling (CSC) Plus Laser Treatment. 3.Contact Cooling Plus Laser Treatment.

Conditions
-----------------
Port-Wine Stain

Intervention / Treatment
-----------------
* Procedure: cooling spray during laser treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 7 years of age and older with diagnosis of port wine stain birthmark 18 years of age and older with no port wine stain non-pregnant women apparent good health Exclusion Criteria: age less than 7 years old pregnant women history of photodermatoses or skin cancer current use of photosensitizing drugs

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 75 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: cooling spray<br>cooling spray during laser treatment | Procedure: cooling spray during laser treatment<br>* skin temperature measurement<br>* Other names: laser treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin temperature during laser treatment |  | 90 days |
Treatment With SU11248 in Patients With Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.

Official Title
-----------------
A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Drug: Sunitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven diagnosis of carcinoid tumor or pancreatic islet cell tumor. Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST). ECOG performance status 0 or 1 Exclusion Criteria: Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell carcinoma, or any other second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri. Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted.

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: A<br> | Drug: Sunitinib<br>* Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity<br>* Other names: Sutent, SU011248;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic objective disease response |  | From screening until disease progression or discontinuation of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety (adverse events and lab abnormalities) |  | From screening until patient death or discontinuation of study | 
| To assess patient-reported outcomes and treatment-related symptoms |  | From screening until patient death or discontinuation of study | 
| To assess pharmacokinetics and biomarkers |  | From screening until patient death or discontinuation of study | 
| To assess overall survival at 1 year |  | From screening until patient death or discontinuation of study | 
| To assess other measures of antitumor efficacy including TTP and survival |  | From screening until patient death or discontinuation of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuroendocrine tumor, advanced disease, sunitinib, Phase 2