linjc16/ctgov huggingface dataset:
Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical ventilation in ICU patients

Detailed Description
-----------------
Many new mechanical ventilation modes are proposed without clinical evaluation. Among them, dual-controlled modes, as AutoFlow, are supposed to improve patient-ventilator interfacing, and could led to lesser alarm. This study is a long term clinical evaluation of AutoFlow during assist-controlled ventilation, focusing on its efficacy (on gas exchange and outcome) and on ventilator alarms.

Official Title
-----------------
Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients

Conditions
-----------------
Ventilation, Mechanical

Intervention / Treatment
-----------------
* Device: AutoFlow mode on Evita 4 Dräger ventilators
* Device: Evita 4 Dräger ventilators


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients under assist-controlled ventilation with an Evita 4 ventilator (Dräger, France) for an expected duration of more than two days Exclusion Criteria: coma ventilation longer than 12 hours prior to inclusion pregnancy inclusion in another study

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With AutoFlow<br>Assist-controlled ventilation with activation of AutoFlow mode | Device: AutoFlow mode on Evita 4 Dräger ventilators<br>* Activation of AutoFlow mode during assist-controlled ventilation<br>|
| Active Comparator: Without AutoFlow<br>Assist-controlled ventilation without activation of AutoFlow mode | Device: Evita 4 Dräger ventilators<br>* Assist-controlled ventilation without activation of AutoFlow mode<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gas exchange |  | daily during mechanical ventilation | 
| sedation length |  | ICU discharge | 
| ventilator alarm rates |  | daily during mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of mechanical ventilation |  | ICU discharge | 
| ventilator asssociated pneumonia rate |  | ICU discharge | 
| SOFA score |  | daily during mechanical ventilation | 
| death rate |  | ICU discharge | 
| cumulative sedation drugs dosage |  | ICU discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiration Artificial, Positive-Pressure Respiration, Critical Care, Intensive Care Units
Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to check blood and urine levels to further define markers/tests in the blood and urine that would be useful in following patients with obstructive sleep apnea and then to see if by wearing CPAP every night, these markers can be reduced. This research is being done because currently there are no effective blood or urine markers to determine how well CPAP is working.

Detailed Description
-----------------
The goal of this study is to further define biomarkers that would be useful in following patients with obstructive sleep apnea and examining their response to compliance to therapy with CPAP. To date no correlation between biomarkers of oxidative stress and compliance to CPAP has been measured. CPAP is the most effective treatment for obstructive sleep apnea and has been show to reduce blood pressure and decrease oxidative stress.

Official Title
-----------------
Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance

Conditions
-----------------
Sleep Apnea, Obstructive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women over 18 years suspected of having sleep apnea Exclusion Criteria: Those under 18 years or not suspected of having sleep apnea

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 |
| --- | --- |
| Sleep apnea<br>Those suspected of sleep apnea and scheduled for polysomnography and treated with CPAP therapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining biomarkers for polysomnography characteristics before and after CPAP treatment | The primary objective of this pilot study will determine the biomarkers for polysomnography characteristics with CPAP treatment from baseline to 6 months in patients with obstructive sleep apnea. The results will guide biomarker selection for full scale studies. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea
DePuy Attune Total Knee Arthroplasty RSA Study

Study Overview
=================
Brief Summary
-----------------
The DePuy Attune knee system incorporates several key features aimed at improving kinematics of the knee joint, range of motion, and smoothness of use compared to existing total knee replacement technologies. As this is a newly approved medical device, clinical testing in patients using high precision diagnostics is important to evaluate the stability of implant fixation and in vivo function. We propose a multi-centre consecutive series study examining the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be utilized to identify the micromotion of the tibial tray with respect to the surrounding bone. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at follow-up intervals.

Official Title
-----------------
Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: DePuy Attune posterior stabilized fixed bearing total knee replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty Between the ages of 21 and 80 inclusive Patients willing and able to comply with follow-up requirements and self-evaluations Ability to give informed consent Exclusion Criteria: Active or prior infection Medical condition precluding major surgery

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 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 |
| --- | --- |
| Other: DePuy Attune TKA<br>DePuy Attune posterior stabilized fixed bearing total knee replacement | Device: DePuy Attune posterior stabilized fixed bearing total knee replacement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant migration |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional range of motion |  | 2 years | 
| Self-reported health status | EQ-5D score | 2 years | 
| Self-reported joint status |  | 2 years |
Evaluation of Inhaled Treatment in Sinusitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether inhaled corticosteroid (specially nebulized) could be a good alternative to oral corticosteroid and whether they are effective in the treatment of sinusitis

Official Title
-----------------
Evaluation of Inhaled Corticosteroid Treatment in Sinusitis

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Drug: methylprednisolone
* Drug: Budesonide
* Drug: Budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nasal/Sinus polyps Exclusion Criteria: Previous sinus surgery Age under 18y Use of antibiotics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral<br>Oral drug (methylprednisolone) administration | Drug: methylprednisolone<br>* Oral 32mg/8d-16mg/4d-8mg/4d<br>|
| Experimental: Metered dose inhaler<br> | Drug: Budesonide<br>* Budesonide by metered dose inhaler<br>|
| Experimental: Nebulized<br> | Drug: Budesonide<br>* Budesonide by nebulization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sniffin' Sticks Test |  | Baseline and day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific quality of life questionnaire (Snot 20) |  | Baseline and day 15 | 
| Retro Olfaction Test |  | Baseline and day 15 |
Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After CABG

Study Overview
=================
Brief Summary
-----------------
Postoperative Atrial Fibrillation (POAF) is one of the most common complications following coronary artery bypass grafting (CABG) occurring to 20% - 40% of patients. It is associated with prolonged hospitalization, increased hospital costs, increased complications and mortality rate. Despite the use of Beta Blockers, approximately 20% of patients develop atrial fibrillation following CABG surgery, suggesting a role for polymorphism in the genes The aim of the present study is to determine the minor allele frequency of some of the genes that affect the beta blockers' response and to determine the association between polymorphism in these genes and the occurrence of postoperative atrial fibrillation after coronary artery bypass grafting in Egyptian patients receiving perioperative beta blockers.

Official Title
-----------------
Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After Coronory Artery Bypass Grafting (CABG) Surgery in Egyptian Patients Receiving Beta Blockers

Conditions
-----------------
Coronary Bypass Graft Surgery, Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Beta blocker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years. Candidates for CABG surgery without a concurrent valve surgery. Patients receiving perioperative beta blockers before new onset of postoperative AF. Exclusion Criteria: Patients who have either persistent or permanent AF, atrial flutter or atrial tachycardia on ECG obtained on the day of the operation. Serum creatinine >2 mg/dL before the surgery. Uncontrolled thyroid disease. Recent treatment with amiodarone before the occurrence of POAF

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| POAF group<br>Patients who will experience AF at any time during the first six days after the operation. | Drug: Beta blocker<br>* perioperative beta blockers<br>|
| Non POAF group<br>Patients with a sinus rhythm during the first six days after the operation. | Drug: Beta blocker<br>* perioperative beta blockers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Atrial fibrillation | Atrial fibrillation based on postoperative electrocardiogram. AF diagnostic criteria will include absence of discrete P waves, the RR intervals follow unrepetitive form and the ranges of ventricular rate usually between 90 and 170 beats/min. | within 6 days after the operation |
Target Planning for Placement of DBS-electrodes and Follow-up of the Clinical Efficacy of Stimulation

Study Overview
=================
Brief Summary
-----------------
Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's disease and other indications. A common target for stimulation is the subthalamic nucleus (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical improvement. The project aims to describe the variability of target coordinates in the patient group and to relate it to clinical outcome as documented in standardized questionaires. Trial with surgical intervention

Detailed Description
-----------------
Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's disease and other indications. A common target for stimulation is the subthalamic nucleus (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical improvement. The project aims to describe the variability of target coordinates in the patient group and to relate it to clinical outcome as documented in standardized questionaires.

Official Title
-----------------
Target Planning for Placement of DBS-electrodes and Follow-up of the Clinical Efficacy of Stimulation

Conditions
-----------------
Movement Disorders, Epilepsy

Intervention / Treatment
-----------------
* Procedure: deep brain stimulation (DBS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients fullfill all criteria for implantation of deep brain stimulation (DBS) electrodes Patients are able to give informed written consent Exclusion criteria: Patients do not their give informed written consent

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: deep brain stimulation (DBS)|deep brain stimulation (DBS) is in itself not part of this study but a clinical indication. The study aims at documenting DBS parameters and outcome|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological outcome | UPDRS | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
All indication for deep brain stimulation (DBS)
Ascending Aortic Dilation in BiAV After TAVR

Study Overview
=================
Brief Summary
-----------------
This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).

Detailed Description
-----------------
The growth rate of ascending aorta was calculated as annual growth rate using baseline and the last echocardiography. The difference in ascending aorta growth rates between the two groups (BiAV and TAV) were analyzed by independent t-test.

Official Title
-----------------
Changes in Ascending Aorta Size After Transcatheter Aortic Valve Replacement in Severe Bicuspid Aortic Stenosis: A Pilot Study With Echocardiographic Follow-up

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Other: diagnosed as bicuspid aortic valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe AS who underwent TAVR Exclusion Criteria: ascending aorta more than 50mm

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BiAV<br>Bicuspid aortic valve | Other: diagnosed as bicuspid aortic valve<br> <br> |
| TAV<br>Tricuspid aortic valve | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in dimension of ascending aorta | the annual growth rate of ascending aorta(mm/year) using echocardiography | baseline and 1year after TAVR |
Current Scope of Practice of Today's Hepatopancreatobiliary Surgeons: A Survey of AHPBA Members

Study Overview
=================
Brief Summary
-----------------
The development of multiple training pathways to foster competent hepatopancreatobiliary (HPB) surgeons has led to a diverse group of surgical subspecialists. The objective of our study was to determine the current scope of practice of today's HPB surgeons. An online survey was sent to all the Americas Hepato-Pancreato-Biliary Association's members to assess the current scope of practice of today's HPB surgeons. We found very few surgeons run a solo HPB practice, so changes may be needed in HPB training to provide uniformity and enhance the scope of practice for future HPB surgeons.

Official Title
-----------------
The Current Scope of Practice of Today's Hepatopancreatobiliary Surgeons: A Survey of Americas Hepato-Pancreato-Biliary Association Members

Conditions
-----------------
Scope of Practice of Today's Hepatopancreatobiliary Surgeons

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Member of Americas Hepato-Pancreato-Biliary Association Exclusion Criteria: No or non-functioning email address

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Survey|Survey was sent to all the Americas Hepato-Pancreato-Biliary Association's members|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey outcome 1 | Response to survey | December 2014 - February 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
survey, AHPBA
Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.

Official Title
-----------------
Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent

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

Intervention / Treatment
-----------------
* Drug: Indobufen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 19 to 50 years at screening. Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9. Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol. Exclusion Criteria: Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study. Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100mg<br>Wild type UGT1A : 3 / Variant type UGT1A : 3 | Drug: Indobufen<br>* Single Oral Dose of<br>|
| Experimental: 200mg<br>Wild type UGT1A : 3 / Variant type UGT1A : 3 | Drug: Indobufen<br>* Single Oral Dose of<br>|
| Experimental: 400mg<br>Wild type UGT1A : 3 / Variant type UGT1A : 3 | Drug: Indobufen<br>* Single Oral Dose of<br>|
| Experimental: 800mg<br>Wild type UGT1A : 3 / Variant type UGT1A : 3 | Drug: Indobufen<br>* Single Oral Dose of<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | AUC, Cmax | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics | Platelet Aggregation Test | 24 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Indobufen, healthy volunteers