linjc16/ctgov huggingface dataset:
Biochemical Predictors of Delirium in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Delirium is a common neurologic complication after cardiac surgery occuring in 30-50% of patients. The occurence of this complication is associated with worse outcomes, including prolonged length of stay in the ICU and hospital, increased morbidity and mortality. Considering great clinical significance of this complication, the search for early predictors of postoperative delirium remains an urgent task. The purpose of this prospective observational study is to test the hypothesis that metabolomic changes before and after cardiac surgery could be served as early predictors of this complication.

Official Title
-----------------
Biochemical Predictors of Delirium in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass

Conditions
-----------------
Postoperative Delirium

Intervention / Treatment
-----------------
* Diagnostic Test: Metabolomic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgery under cardiopulmonary bypass Age > 60 years CABG surgery or valve surgery (repair/replacement) Exclusion Criteria: urgent surgery surgery on aorta combined procedures (CABG+valves) significant stenosis of carotid arteries Parkinson's disease liver cirrhosis use of anticholinergic drugs, antidepressants, antiepileptic or chemotherapy drugs

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 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 |
| --- | --- |
| Study cohort<br>Patients undergoing surgery under cardiopulmonary bypass | Diagnostic Test: Metabolomic analysis<br>* Blood will be collected in all patients blood before surgery and after surgery (postoperative day 1). Our study is based on a polar metabolomics profiling of plasma and/or serum using hybrid triple quadrupole mass spectrometer coupled with chromatographic system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium | Postoperative delirium will be diagnosed with CAM-ICU (confusion assessment method - intensive care unit) | 5 days after surgery |
Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography

Study Overview
=================
Brief Summary
-----------------
Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator. These records will help to assess the agreement between the detection of asynchronies using electromyography of the respiratory muscles (technique of reference) and the diaphragmatic echography. We will also compare the respective performance of two techniques of diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of Ultrasound technique of at least 90% will be interpreted as a satisfactory index of concordance.

Official Title
-----------------
Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography

Conditions
-----------------
Diaphragm, Ultrasonography

Intervention / Treatment
-----------------
* Other: Creation and detection of patient-respirator asynchronies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer (male or female) Free and Informed Consent Exclusion Criteria: Known pregnancy, parturient or nursing mother Minor under 18 years of age Major incapable Non-affiliation to the social security scheme Any history of respiratory pathology

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

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

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

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: Healthy volunteers<br> | Other: Creation and detection of patient-respirator asynchronies<br>* The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchronies detection with diaphragm ultrasonography | Evaluation of the agreement between asynchronous subject-ventilator detection using diaphragm ultrasonography and detecting the same events in using the electromyogram of the respiratory muscles (as a reference technique. | thirty minutes |
EMI and CIED: Is High Power Charging of Battery Electric Car Safe?

Study Overview
=================
Brief Summary
-----------------
It is not known if the use of high power charging systems for electric vehicles may interfere with the functionality of implanted pacemakers and cardioverter-defibrillators.

Detailed Description
-----------------
The use of electric cars for public and private transport is increasing all over the world. Moreover the charging technique is improving and enables very fast charging with the use of high power. It is not known if the use of high volume charging systems interfere with cardiac implantable electronic devices. The study evaluates different types of high volume charging systems connected to different full electric vehicles with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.

Official Title
-----------------
Assessment of Electromagnetic Interference Between Cardiac Implantable Electronic Devices and High Power Charging Systems for Battery Electric Cars

Conditions
-----------------
Pacemaker, ICD

Intervention / Treatment
-----------------
* Other: Electromagnetic Field Exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: implanted cardiac implantable electronic device with regular function Exclusion Criteria: implanted cardiac implantable electronic device with irregular function

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Exposure of patients with pacemaker or ICD to the electromagnetic fields of high power charging systems
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional arm<br>Participants were charging full electric cars, using high power charging systems | Other: Electromagnetic Field Exposure<br>* All participants were exposed to the electromagnetic field of 4-5 different high power charging systems, charging 4-5 different, commercially available full electric cars<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromagnetic interference | Occurence of electromagnetic interference during an exposure time of up to 5 minutes | during the intervention, i.e. when participants are exposed to the electromagnetic field of the high power charging column | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromagnetic fields | Measuring the electromagnetic fields while super-charging along the charging cable, the column and the car connector | during the intervention |
Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota

Study Overview
=================
Brief Summary
-----------------
To design and understand the mechanism of action of different combinations of nutraceuticals coupling bacteria, fibers and polyphenols, which can act on the 4 pillars simultaneously via an innovative ex-vivo model approach coupled with functional and quantitative metagenomics.

Detailed Description
-----------------
The objective of the study is to collect fresh stools from 4 healthy volunteers, in order to study the mechanism of action of probiotic strains, polyphenols and fibers, alone or in combinations. These fresh stools will be cultured in vitro in fermenters, and the samples taken at different culture times will be analyzed in terms of microbial composition (shotgun metagenomic analysis) and their cellular activity (functional metagenomic analysis).

Official Title
-----------------
Stool Collection From Healthy Donors for the ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota: Bacteria / Host Interaction Model

Conditions
-----------------
Microbial Colonization

Intervention / Treatment
-----------------
* Other: Probiotic strains
* Other: Polyphenols
* Other: Fibers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person with a low fiber diet (<17g / day). Exclusion Criteria: Taking antibiotics and / or transit modulators in the 3 months preceding the sample; Colonoscopy in the last 3 months; Person under legal protection measure (curators, tutors, etc.).

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

| Intervention/Treatment |
| --- |
|Other: Probiotic strains|Fresh stools will be cultured in vitro in fermenters with adjunction of probiotic strains|
|Other: Polyphenols|Fresh stools will be cultured in vitro in fermenters with adjunction of polyphenols|
|Other: Fibers|Fresh stools will be cultured in vitro in fermenters with adjunction of fibers|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial growth | Change about the bacterial growth after 15 days of incubation | Day 1 to Day 15 | 
| PH evolution | Change about the PH evolution after 15 days of incubation | Day 1 to Day 15 | 
| Quantity of Co2 production | Change about the quantity of Co2 production after 15 days of incubation | Day 1 to Day 15 |
A MRI Study of Visual and Motor Pathways in Premature Infants

Study Overview
=================
Brief Summary
-----------------
Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the US. These babies often have motor and/or visual problems when they grow up. It is very important to identify high risk ELBW infants as early as possible, so that the investigators can treat them earlier to prevent poor development. Neurological examination at early age is not good enough to identify high risk ELBW infants. One the other hand, some magnetic resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at a very early age to predict long-term outcome and to identify infants who are at high risk of having motor and/or visual problems when they grow up.

Conditions
-----------------
Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ELBW infants with birth weight 401-1000 g (gestational age <30 weeks) Exclusion Criteria: Complex congenital anomalies Central nervous system malformations, Chromosomal abnormalities, or hydrops fetalis

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 5 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ELBW infants<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI |  | 0 |
The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.

Official Title
-----------------
The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Exparel
* Procedure: TAP Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 years w Elective laparoscopic colorectal resection. Exclusion Criteria: Patients under 18 years. Patients unable to provide informed consent Patients undergoing emergency surgery. Pregnant women Severe liver or kidney disease (GFR 15-29 ml/min)

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP Block Experal<br>Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally. | Drug: Exparel<br>* In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.<br>Procedure: TAP Block<br>* no intervention will be done to this arm.<br>|
| No Intervention: No TAP Block<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain Score | Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience. | participants will be followed for the duration of hospital stay, an expected average of 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Narcotic Use | Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups. | participants will be followed for the duration of hospital stay, an expected average of 4 days |
AVL200 IOL for Treatment of Cataract and Presbyopia

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the performance of the AVL200 IOL in terms of visual function improvement over a range of focal points. Participants meeting eligibility criteria will undergo cataract surgery with implantation of the AVL200 intraocular lens (IOL), then be followed through 1 year postoperatively. Postoperative assessments include safety and visual function.

Official Title
-----------------
A Prospective, Open-label, Single-center Study of the Atia™ AVL200 Modular Intraocular Lens System for Treatment of Cataract and Presbyopia

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: AVL200 IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visually significant cataract Best corrected distance visual acuity between 20/40 and 20/200 Potential distance visual acuity of 20/32 or better Corneal astigmatism ≤ 1.5 diopters Exclusion Criteria: Use of medication that could affect accommodation Previous corneal surgery or significant corneal abnormalities Ocular pathology or degenerative disorder having potential to impair visual acuity Pupil abnormality Intraoperative cataract surgery complications that could affect IOL implantation or positioning

Ages Eligible for Study
-----------------
Minimum Age: 40 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: AVL200 IOL<br>The AVL200 is a modular fluid-filled, shape-changing intraocular lens (IOL) designed to restore visual function across a range of focal points | Device: AVL200 IOL<br>* The AVL200 is an intraocular lens surgically implanted in the eye after cataract surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in monocular best corrected distance visual acuity | Best-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart | 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in monocular distance-corrected near visual acuity | Distance-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart | 3 months postoperative |
MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)

Study Overview
=================
Brief Summary
-----------------
The clinical study evaluates the efficacy and safety of MK0476 in adult patients with allergic rhinitis.

Official Title
-----------------
Mk0476 Phase II Dose Finding Study -Allergic Rhinitis-

Conditions
-----------------
Rhinitis Allergic

Intervention / Treatment
-----------------
* Drug: MK0476, montelukast sodium / Duration of Treatment: 2 Weeks
* Drug: Comparator: placebo / Duration of Treatment: 2 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with seasonal allergic rhinitis Exclusion Criteria: Patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection and those disease severe enough to interfere with assessment of effectiveness Patients who have rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilia rhinitis) Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0476, montelukast sodium / Duration of Treatment: 2 Weeks|nan|
|Drug: Comparator: placebo / Duration of Treatment: 2 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis |  |  |
3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenia (CM)

Study Overview
=================
Brief Summary
-----------------
Lambert-Eaton Myasthenic Syndrome (LEMS) is a rare autoimmune disorder which affects the nerve-muscle junction. The major symptoms of LEMS are progressive muscle weakness. Many patients experience other symptoms like dry mouth or impotence. Congenital Myasthenia (CM) is an inherited disorder with similar affects and symptoms. 3,4-Diaminopyridine (DAP) is an experimental drug that has improved strength in some subjects with (LEMS). There are no other accepted treatments for LEMS and DAP has relatively few side effects.

Detailed Description
-----------------
Subjects with clinically confirmed LEMS or CM will receive 3,4-diaminopyridine (3,4 DAP) by mouth in slowly increasing doses. Treatment will begin with 5-10 mg three times a day. A common final dosage is 15-20 mg four or five times a day, as clinically needed, and if tolerated. The upper limit is a total of 100 mg/day. Subjects will be monitored for strength and side effects via routine clinic visits at intervals of one month for the first three months, then every three months for the first year, and at least every six months thereafter. Treatment will be continued indefinitely if a good clinical response is achieved and side effects are tolerable.

Official Title
-----------------
3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenia

Conditions
-----------------
Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenia (CM)

Intervention / Treatment
-----------------
* Drug: 3,4-diaminopyridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of LEMS or CM If female and over the age of 9, must have a negative pregnancy test, and, if premenopausal, must be willing to practice an effective form of birth control. Must be tested and found by ECG not to have a prolonged Q-Tc syndrome. Must agree to have a second ECG at the time of peak drug effect. Exclusion Criteria: Known to have sensitivity to 3,4-DAP History of clinical seizures or evidence of seizure activity on screening EEG History of severe asthma

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 3,4-diaminopyridine|10mg tablets for up to 100mg per day|

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
-----------------
3,4DAP, LEMS, CM