linjc16/ctgov huggingface dataset:
Near-Infrared Spectroscopy Comparison Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to determine which modality best correlates with jugular venous oxygen saturation

Official Title
-----------------
Validation of Near-Infrared Spectroscopy for Neuromonitoring During Moderate Hypothermic Circulatory Arrest for Total Aortic Arch Replacement: A Comparison of Two Technologies With Jugular Venous Bulb Oximetry

Conditions
-----------------
Total Aortic Arch Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent from patient or legally authorized representative before surgery Adult patients 18-65 years of age Presenting for elective or urgent total aortic arch repair under moderate hypothermic circulatory arrest (Nasopharyngeal temperature 20 - 24 ºC) with selective antegrade cerebral perfusion - Exclusion Criteria: Patients will be excluded from this study if they are age less than 18 Are undergoing an emergent procedure Have a history of insulin-dependent diabetes mellitus Have a history of stroke Are undergoing a redo sternotomy during which major bleeding occurs necessitating transfusion of > 4 units of packed red blood cells prior to the institution of circulatory arrest Patients in whom a left jugular venous bulb cannula cannot successfully be placed

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 |
| --- | --- |
| Cardiac Disease<br>Total Aortic Arch Replacement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear correlation between absolute value of cerebral oxygen saturation (rSO2) compared to Jugular Venous Oxygen Saturation (SjvO2). Sensitivity and specificity to detect < 60% desaturation. |  | At the end of the surgical case approximately 6 to 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near Infrared Spectroscopy, Neuromonitoring, Aortic Arch Replacement
Changes of Transforming Growth Factor b1 and Procollagen III in Patients With Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
Transforming Growth Factor-b1 (TGF-b1) is involved in the development of acute lung injury and in the fibroproliferation during acute respiratory distress syndrome (ARDS). Procollagen III Peptide (PIIINP) is a validated marker of fibroproliferation. PIIINP is associated with death in ARDS patients. The simultaneous changes of TGF-b1 and PIIINP were never studied in patients with ARDS. The relationships between TGF-b1 and the outcome of ARDS are unknown. The aim of the study is to analyse the changes of TGF-b1 and PIIINP during ARDS and to show the relationships between TGF-b1 - PIIINP and the outcomes of ARDS.

Detailed Description
-----------------
Primary outcome: To analyse the changes of Transforming Growth Factor b1 and Procollagen III during the acute respiratory distress syndrome.

Official Title
-----------------
Changes of Transforming Growth Factor b1 and Procollagen III in Patients With Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS with a PaO2/FIO2 < 200 mmHg at a positive end-expiratory pressure (PEEP) ³ 5 cm H2O ARDS criteria from less than 24 hours Informed consent Exclusion Criteria: Pregnancy Chronic interstitial or fibrosis lung diseases Hepatic chronic disease Neutropenia £1 G/l Corticosteroid (more than 200 mg/day of hydrocortisone or equivalent, less than 2 weeks before inclusion) Immunosuppressive therapy within the last 30 days Participation in any investigational drug or devices study within 30 days prior study entry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
Tracheobronchomalacia: Treatment Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).

Detailed Description
-----------------
TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM. Our study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM.

Official Title
-----------------
Tracheobronchomalacia: Treatment Outcomes

Conditions
-----------------
Tracheomalacia, Tracheobronchomalacia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspicion of symptomatic tracheal and/or bronchial collapse during bronchoscopy or Dynamic Computed Tomographic study. Chronic Obstructive Pulmonary Disease (regardless of severity) and suspicion of tracheal and/or bronchial collapse Exclusion Criteria: inability to follow commands Focal extrinsic compression of the trachea/bronchi by mass or other

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia. |  | At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status. |  | At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tracheomalacia, Tracheobronchomalacia, Airway Stabilization, Bronchoscopy, Stent Placement, Tracheobronchoplasty, COPD
A Multi-Center Observational Surveillance Study of VAP Causing Bacteria

Study Overview
=================
Brief Summary
-----------------
Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by the bronchoalveolar lavage (BAL) method.

Detailed Description
-----------------
Any patient admitted into the chosen ICU will be a potential patient for this study. One of the main purposes of this study is to discover the various types of bacteria that cause VAP, and their frequency of occurrence. In order to obtain accurate and applicable results, as many subjects should be tested as possible. Approximately 500 patients will be included in this study. VAP is defined as any lower respiratory tract infection that developed after 2 day of MV. The criteria for clinical suspicion of pneumonia are as follows: Presence of a new or persistent lung opacity on chest radiographs, plus two of the following items: Fever > 38.3ºC or hypothermia < 36ºC; WBC count > 10,000/mm3 or < 5,000/mm3, and/or purulent endoctracheal aspirate; Purulent endotracheal aspirate. Every patient suspected of having pneumonia will undergo fiberoptic bronchoscopy to obtain samples by means of a bronchoalveolar lavage (BAL). VAP will be diagnosed based on results of BAL where BAL cultures yielding > 104 cfu/ml.

Official Title
-----------------
A Multi-Center Observational Surveillance of VAP Causing Bacteria Study

Conditions
-----------------
Ventilator Associated Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients hospitalized and mechanically ventilated for more than 48 hours are eligible for the study. Fever > 38.3ºC or hypothermia < 36ºC or WBC count > 10,000/mm3. Presence of a new or persistent lung opacity on chest radiographs. Willing to provide informed legal consent. If the patient is a minor or incapacitated, legal consent may be given by a legal guardian or representative. Exclustion: Patients whose antibiotic strategy had been changed during the 3 days preceding the diagnostic procedure will not be included.
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
-----------------
VAP
Video Game Playing on Lunch-time Food Intake in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this experiment is to investigate the effect of video game playing for 30 minutes on food intake and subjective appetite. The investigators hypothesize that video game playing will affect food intake in children. Food intake will be measured at 30 minutes following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg Sucralose® in 250ml of water) beverage with or without video game playing. Subjective appetite will be measured at 0, 20, 35 and 65 minutes.

Official Title
-----------------
The Effect of Sedentary Video Game Playing Before a Mixed Meal on Subjective Appetite and Satiety Signals From a Glucose Preload in Normal Weight and Overweight/Obese Boys

Conditions
-----------------
Exogenous Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Glucose Beverage
* Behavioral: Video Game Playing
* Dietary Supplement: Control Beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy boys with no emotional, behavioral or learning problems Exclusion Criteria: girls

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose beverage<br>Glucose beverage | Dietary Supplement: Glucose Beverage<br> <br> |
| Experimental: Control beverage and video game playing<br>Control beverage and video game playing | Behavioral: Video Game Playing<br> <br> |
| Experimental: Glucose beverage and video game playing<br>Glucose beverage and video game playing | Behavioral: Video Game Playing<br> <br> |
| Experimental: Control beverage<br>Control beverage | Dietary Supplement: Control Beverage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Intake (kcal) |  | at 30 min after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite (mm) | Subjective appetite (in mm) determined by visual analogue scale will be determined at 0, 20, 35 and 65 minutes. | 0-65 min |
Capnography Data Collection From Healthy Participants

Study Overview
=================
Brief Summary
-----------------
Capnography is the non-invasive monitoring of the concentration or partial pressure of carbon dioxide (CO2) in the expired respiratory gases; it is thus a non-invasive monitoring technique which allows fast and reliable insight into ventilation, circulation and metabolism. The capnogram is a direct monitor of the inhaled and exhaled concentration or partial pressure of CO2, and an indirect monitor of the CO2 partial pressure in the arterial blood. The purpose of this study is to create a waveform library by collecting CO2 waveform data from healthy volunteers.

Official Title
-----------------
The Capnography Library: Data Collection From Healthy Participants

Conditions
-----------------
Healthy Volunteers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consent to participate in the trial by volunteer themself or by their legal guardian Exclusion Criteria: Any individual who does not consent themselves or their legal guardian does not grant consent to participate in the trial A medical history of heart disease, lung disease, smoking, hypertension, pregnancy, diabetes or any other illness that excludes the participant from enrolling in the trial in the opinion of the PI

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

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 |
| --- | --- |
| Healthy volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To gather data received from monitoring healthy participants as reference for the creation of a capnography waveform library. | Participants will put on the capnography monitoring device (a simple tube with prongs that fit in the nostrils, similar in design to the oxygen delivering device nasal cannula) and this device will be hooked up to a computer. The participants will be asked to do very simple activities, such as sit, stand, eat and drink. The changes in their CO2 waveforms during these activities will be recorded in order to build a library of reference waveforms. | One hour |
Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP).

Detailed Description
-----------------
To perform a randomized, controlled, study on patients that undergo PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.

Official Title
-----------------
A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

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

Intervention / Treatment
-----------------
* Drug: Intravitreal dexamethasone implant
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with vitreous hemorrhage undergoing PPV for PDRP Exclusion Criteria: Previous PPV Vitreous hemorrhage of non-PDRP origin

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Sham Comparator: Sham<br>Vitrectomy only | Procedure: Vitrectomy<br>* Vitrectomy only<br>|
| Active Comparator: Intravitreal Ozurdex<br>Intravitreal Ozurdex after vitrectomy | Drug: Intravitreal dexamethasone implant<br>* Intravitreal Ozurdex after vitrectomy<br>* Other names: OZURDEX® (dexamethasone intravitreal implant);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation | The proportion of patients that, due to re-bleeding within 12 months, have a second PPV | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding | The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PDRP, vitreous hemorrhage, vitrectomy
Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in vernal keratoconjunctivitis

Detailed Description
-----------------
The objective of this pilot study is to evaluate the clinical and biological efficacy of preservative free NAAGA eyedrops in VKC -by in particular the levels of ECP and MPO in tears- comparatively to the activity of levocabastine eyedrops.

Official Title
-----------------
Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis

Conditions
-----------------
Keratoconjunctivitis, Vernal

Intervention / Treatment
-----------------
* Drug: N-acetyl-aspartyl-glutamate (NAAXIA Sine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with vernal keratoconjunctivitis, mild or moderate : clinical score >3 and <= 14, calculated from 4 major symptoms (itching, tearing, photophobia, foreign body sensation) and 6 major clinical signs (conjunctival erythema, conjunctival chemosis, discharge, papillae, limbal infiltrates and corneal epithelial disease) age >= 4 years old Exclusion Criteria: no occurrence of ocular trauma or infection (within the 3 months preceding the study), no ocular medical treatment (topical or not) within the 5 days preceding the study, no ocular laser (within the 3 previous months), no ocular surgery (within the previous year), patient who signs the informed consent form (or his/her parents or legal guardian in the case of underage patient).

Ages Eligible for Study
-----------------
Minimum Age: 4 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: N-acetyl-aspartyl-glutamate (NAAXIA Sine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECP tear concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance |  |  |
Automated Chest Physiotherapy to Improve Outcomes in Neuro

Study Overview
=================
Brief Summary
-----------------
Following current standard-of-care, subjects data (brain pressure) will be recorded for 1 hour and include 10-minutes of data during which the subject recieves chest physiotherapy (CPT). The hypothesis is that CPT is not harmful to brain pressure.

Detailed Description
-----------------
The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice. The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice. The study will include only patients who currently have intracranial pressure monitoring devices in place (intraventricular and intraparenchymal). The study will last 1-hour and all subjects in the study will receive 10-minutes of CPT. The 10-minute CPT episode will be randomly assigned to occur 10, 20, 30 or 40-minutes into the study. ANCOVA using SAS will be used to explore for within and between group differences in ICP. This study observes current standard practice, there are no additional risks to the subject.

Official Title
-----------------
Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study

Conditions
-----------------
Intracranial Hypertension, Brain Injury

Intervention / Treatment
-----------------
* Other: Chest Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented episode of elevated ICP ICP monitoring in situ neurological/neurosurgical diagnosis currently on a specialy bed Exclusion Criteria: spinal cord injury such that CPT is not desired

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>All subjects act as their own contral | Other: Chest Physiotherapy<br>* 10-minutes of chest physiotherapy using programmed parameters that are components of the specialty beds used in ICU<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial pressure |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain Injury, Intracranial hypertension, Human subjects, Nursing care