linjc16/ctgov huggingface dataset:
Comparison of the Effects of Sevoflurane and Midazolam Used for the Maintenance of Anaesthesia on the Levels of Postoperative Cardiac Troponin I in Pediatric Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two different anaesthetic agent effect on postoperative Troponin I levels in pediatric cardiac surgery

Conditions
-----------------
Myocardial Injury, Anaesthetic Preconditioning

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective pediatric surgery Patients written informed consent for study participation Exclusion Criteria: Redo surgery History of myocarditis Renal failure Pulmonary embolism Hypothyroidism

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 6 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam<br>Used for maintenance anaesthesia (0.2 mg/kg/saat continuous infusion) | Drug: Midazolam<br>* 0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia<br>|
| Active Comparator: Sevoflurane<br>Used for the maintenance for anaesthesia (% 0.5-8 end tidal concentration) | Drug: Sevoflurane<br>* end tidal concentration of % 0,5-8<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial protective effect of sevoflurane | Postoperative troponin I levels | postoperative 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic and respiratory data | Arterial pressure, heart rate, blood gas analysis, extubation time, | Postoperative 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial protection, Myocardial injury, Anaesthetic preconditioning, Pediatric cardiac surgery, Troponin I, Sevoflurane, Midazolam
Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy

Study Overview
=================
Brief Summary
-----------------
Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate GERD. On-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. However, whether on-demand PPI therapy achieves similar efficacy of symptom control is uncertain. The aim of this study is to compare the efficacy and quality of life of on-demand and maintenance PPI regimens in long-term management of non-erosive GERD patients. The investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.

Official Title
-----------------
Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months Exclusion Criteria: Erosive esophagitis Concomitant peptic ulcer disease Use of NSAID in recent 4 weeks (Low dose aspirin < 300 mg is allowed) Pregnant or lactating female Illiterate patient (who cannot administer questionnaire) Known hypersensitivity to PPI

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure |  | 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score |  | 26 weeks | 
| Quality of Life |  | 1 year | 
| Number of days off treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD
Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.

Official Title
-----------------
Study of the Level of Mannose Binding Lectin (MBL) as a Predictor of the Onset of a Invasive Fungal Infection (IFI) During Chemo-induced Aplasia in Patients With Acute Leukemia (AL)

Conditions
-----------------
Acute Leukemia, Invasive Fungal Infection

Intervention / Treatment
-----------------
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : persons who have provided written consent Patients with national health insurance cover Patients with malignant hemopathy who have been treated with chemotherapy able to induce profound neutropenia (PN < 500 / mm3) lasting more than 10 days. Patients with malignant hemopathy who have received an autologous bone marrow graft Patients with severe idiopathic medullar aplasia (PN < 500 / mm3) who need to be hospitalized for at least 10 consecutive days (with or without treatment with immunosuppressants) Exclusion Criteria: Patients who have received an bone marrow PSC allograft (as such patients have a risk of aspergillosis, which appears in most cases after medullar recovery; they will not be included in the study). Patients who have received an autologous PSC graf (as the duration of neutropenia is in most cases less than 10 days). Patients whose neutropenia, retrospectively assessed, lasted less than 10 days.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients who develop a fungal infection<br> | Biological: blood sample<br> <br> |
| patients without fungal infection<br> | Biological: blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia |  | 1st day of the period of aplasia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of MBL during an episode of aplasia for both groups of patients studied |  | Every day except Saturday and Sunday for roughly 3 weeks |
10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain a prospective database which will allow analysis of total knee outcomes.

Detailed Description
-----------------
A prospective database was set up in October 1998. Patient details are collected pre-operatively, intra-operatively and immediately post operatively. Patients are then followed up in a dedicated knee clinic at 6 months, 18 months, 3 years and 5 years. Data such as SF12 and the American knee society score has been done at each visit.

Official Title
-----------------
10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis

Conditions
-----------------
Total Knee Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing total knee replacement in Fife
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 |
| --- | --- | --- |
| Clinical outcome of the Sigma knee at 10 years | Patient satisfaction scores SF 12 and Oxford American Knee society score | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic outcomes at 10 years | looking for failure by identitying lucent lines and osteolysis | 10 years |
The Effect of Relaxation Response Training on Declarative Memory and Salivary Cortisol in Older Adults

Study Overview
=================
Brief Summary
-----------------
To evaluate whether a 5-week relaxation response intervention influences the learning, memory or attention of healthy older adults.

Official Title
-----------------
The Effect of Relaxation Response Training on Declarative Memory and Salivary Cortisol in Older Adults

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

Intervention / Treatment
-----------------
* Behavioral: Relaxation Response


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 to 80 years od age No prior or current psychiatric or neurological condition. score above 24 on the Mini-Mental State Exam (MMSE)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Relaxation Response|Relaxation training|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate whether a RR training program would decrease anxiety levels, improve attention, declarative memory performance in healthy older adults. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate whether a RR training program would decrease salivary cortisol levels in healthy older adults. |  | 8 weeks |
The Effect of Head Positioning on the Cross-sectional Area of the Subclavian Vein.

Study Overview
=================
Brief Summary
-----------------
In the present study, the cross-sectional area of subclavian vein, the distances of subclavian vein   subclavian artery and subclavian vein   pleura are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) in spontaneous breathing adults.

Official Title
-----------------
The Effect of Head Positioning on the Cross-sectional Area of the Subclavian Vein

Conditions
-----------------
Normal Volunteers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Exclusion Criteria: Medication affecting vascular elasticity History of central venous catheterization or clavicle fracture History of lung surgery, operation of chest cage

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-sectional area of subclavian vein |  | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depth of subclavian vein from skin |  | through study completion, an average of 1 year | 
| Distance of subclavian vein   subclavian artery |  | through study completion, an average of 1 year | 
| Distance of subclavian vein   pleura |  | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subclavian vein
Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome

Study Overview
=================
Brief Summary
-----------------
The primary aims of this study are: To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS); To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness; To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness; To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Detailed Description
-----------------
To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Neurosciences Intensive Care Unit in patients with DOC or LIS; To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness; To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Official Title
-----------------
Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome

Conditions
-----------------
Consciousness Disorders, Locked-In Syndrome

Intervention / Treatment
-----------------
* Device: mindBEAGLE EEG-based brain-computer interface


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 Diagnosis of coma Vegetative state Minimally conscious state Confusional state Locked-in state Exclusion Criteria: • History of developmental, neurologic, or major psychiatric disorder resulting in functional disability

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: patients Arm 2: healthy controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface | Device: mindBEAGLE EEG-based brain-computer interface<br> <br> |
| Experimental: Healthy Controls<br>Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface | Device: mindBEAGLE EEG-based brain-computer interface<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Diagnosis of Level of Consciousness (LoC) | LoC will be defined using the Coma Recovery Scale-Revised behavioral evaluation (score range 0-23). Higher scores are generally associated with a higher level of consciousness. | on the day of intervention |
Autonomic Nervous System and Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
Sickle cell disease (SCD) children and adults with asthma have an increased rate of vaso-occlusive crisis, acute chest syndrome episodes, and premature mortality when compared to those without asthma. We hypothesised that either asthma diagnosis and/or bronchodilator treatment may aggravate SCD via their modulating effect on autonomic nervous system.

Detailed Description
-----------------
Heart rate variability during pulmonary function tests (spirometry, static volumes, DLCO/DLNO, exhaled NO at multiple flow rates) including salbutamol administration will be evaluated in patients with SCD (n=60) receiving asthma treatment or not, as compared to asthmatic children without SCD (n=30) matched for ethnicity

Official Title
-----------------
Effect of Salbutamol on Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease

Conditions
-----------------
Heart Rate Variability (ANS Function)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age from 8 to 16 years (≥ 8 years and < 16 years) (spirometry and DLCO study feasible) Sub-Saharan African or Caribbean ethnic origin. child with sickle cell disease referred for monitoring of respiratory function in the framework of its sickle cell disease and whether or not it presents a possible disease asthmatic (asthma treatment prescribed in the past year) or asthmatic child (typical functional signs + history of exacerbation severe hospitalized or reversible obstructive pulmonary disorder) not sickle cell addressed for respiratory function monitoring Exclusion Criteria: Refusal to participate (lack of consent) Sickle cell child of North African origin

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sickle cell patients<br> | |
| Asmathic patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of salbutamol administration on ANS in these SCD children (with and without asthma) and in control asthmatics (without SCD) | heart rate variability after salbutamol administration | cross-sectional, one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess ANS functions in patients with SCD receiving asthma treatment or not, as compared to asthmatic children without SCD matched for ethnicity | baseline heart rate variability | cross-sectional, one hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sickle cell disease; asthma; beta-agonist; hear rate variability
Real-time Attended Home-polysomnography Through Telematic Data Transmission

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop an efficient home-based polysomnography device, which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the hospital, in order to decrease the failure rate of home-based recordings.

Official Title
-----------------
Real-time Attended Home-polysomnography Through Telematic Data Transmission

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

Intervention / Treatment
-----------------
* Device: polysomnograph Dream and Sleep Box


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical suspicion of OSA 18 y old Exclusion Criteria: restrictive respiratory disorders distance home-hospital exceeding 30 Km.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telematic attended polysomnography<br> | Device: polysomnograph Dream and Sleep Box<br>* Portable polysomnograph will be placed at home around 7:00PM. The Sleep Box (wireless monitoring device) will be left near the patient, to allow real-time GPRS transmission of recorded sleep parameters to the sleep lab.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Polysomnographic Recordings | Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep apnea, polysomnography, telemedicine