linjc16/ctgov huggingface dataset:
Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents.

Official Title
-----------------
A Centre-Randomized, Open-Label, Cross-Over Study to Compare the Pharmaco-Economic Consequences of an Ultiva (Remifentanil Hydrochloride) Based Regimen With Conventional Sedative Based Regimens in ICU Subjects Requiring Short-Term Mechanical Ventilation With Analgesia and Sedation

Conditions
-----------------
Sedation

Intervention / Treatment
-----------------
* Drug: midazolam
* Drug: lorazepam
* Drug: fentanyl
* Drug: morphine
* Drug: remifentanil
* Drug: propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation. Exclusion criteria: ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: midazolam|nan|
|Drug: lorazepam|nan|
|Drug: fentanyl|nan|
|Drug: morphine|nan|
|Drug: remifentanil|nan|
|Drug: propofol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Outcome: Duration of time on mechanical ventilation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Outcome: length of stay in ICU, in hospital, requirement of opioid and sedative agents, duration of extubation process. Safety: haemodynamics and adverse events. Efficacy: sedation and pain scores |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU mechanical ventilation analgesia sedation
Effect of 3 Years of Exercise on Development of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This is a substudy of Generation 100. In that study, 4000 healthy persons between 70 and 75 will be randomised to a moderate intensity training group, a high intensity training group or control group, with 3 years of exercise. The investigators will follow these persons and register all who develop atrial fibrillation during these 3 years, and at follow-up after ended intervention to see if there is differences in the number of persons who develop atrial fibrillation in the 3 groups.

Official Title
-----------------
Effect of 3 Years of Exercise on Development of Atrial Fibrillation - A Generation 100 Substudy

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Behavioral: High intensity exercise
* Behavioral: Moderate intensity exercise
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participating in the Generation 100 study Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity exercise<br>High intensity exercise(Borg 16) in intervals. | Behavioral: High intensity exercise<br> <br> |
| Experimental: Moderate intensity exercise<br>Moderate intensity exercise 3 times a week. | Behavioral: Moderate intensity exercise<br> <br> |
| Experimental: Control group<br>Exercise on their own. Follow current guidelines. | Behavioral: Control<br>* Advised to follow current guidelines for physical activity, but exercise on their own.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of persons who develop atrial fibrillation during the 3 year intervention period | People who already have the diagnosis before randomisation will not be counted. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of persons who develop atrial fibrillation during the 6 years after randomisation |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Prevention, Exercise
Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair

Study Overview
=================
Brief Summary
-----------------
It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.

Official Title
-----------------
Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair

Conditions
-----------------
Paraumbilical Hernia

Intervention / Treatment
-----------------
* Procedure: Onlay mesh Hernioplasty
* Procedure: Sublay Mesh Hernioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both sexes and age 20 years and above with paraumblical hernia Defect size 3 to 6cm in greatest diameter Exclusion Criteria: defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or strangulated hernia Uncontrolled diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Onlay Mesh Hernioplasty<br>In this group patients with paraumbilical hernia are treated with onlay mesh hernioplasty in which we placed mesh on the anterior rectus sheath | Procedure: Onlay mesh Hernioplasty<br>* Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath<br>|
| Active Comparator: Sublay Mesh Hernioplasty<br>In this group patients with paraumbilical hernia are treated with sublay mesh hernioplasty in which we placed mesh in the retromuscular space | Procedure: Sublay Mesh Hernioplasty<br>* Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients presenting with recurrence of hernia | Recurrence (defined as appearance of swelling in operative site with positive cough impulse) of hernia after surgery | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain from score 1 to 10 | Postoperative pain measured with visual analog score after surgery with 1 being the minimum and 10 being the maximum | 3 days | 
| Hospital Stay duration in days | hospital stay (duration of patient from surgery to discharge) after surgery | 1 week |
Endtidal Ethanol in Sclerotherapy

Study Overview
=================
Brief Summary
-----------------
During the ethanol sclerotherapy procedure, the investigators will record doses of and time of ethanol injections and record ethanol concentrations in endtidal breath every 5 minutes. Furthermore after every ethanol injection the concentration will be measured every minute for 5 minutes. To do so, the investigators will attach a breath alcohol testing device to the expiratory carbon dioxide measuring unit. Since this is the new standard of the university hospital Berne all patients undergo the same procedure. There is no study specific intervention. In this study the investigators will only document the breath alcohol levels, doses and timing of ethanol injections. All other data will be obtained from the anesthesia information system. During the two months of the study, the investigators will also record endtidal ethanol concentration after anesthesia in the postoperative care unit discharge from the unit. The intention is to show the correlation between injected ethanol doses and measured endtidal ethanol concentration over the entire time of the intervention.

Official Title
-----------------
Endtidal Ethanol in Sclerotherapy

Conditions
-----------------
Ethanol Concentration

Intervention / Treatment
-----------------
* Device: Alcomed 3011®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing ethanol sclerotherapy at the university hospital Berne Exclusion Criteria: under the age of 18

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Alcomed 3011®|Endtidal ethanol measurement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endtidal ethanol concentrations in mg/dl over time |  | 1 year 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloodpressure in mmHg over time |  | 1 year 2 months | 
| Bloodpressure in mmHg over injected peripheral ethanol volume |  | 1 year 2 months | 
| Pulse rate in beats er minute over time |  | 1 year 2 months | 
| Pulse rate in beats er minute over injected peripheral ethanol volume |  | 1 year 2 months | 
| Endtidal ethanol concentrations in mg/dl over injected ethanol volume |  | 1 year 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sclerotherapy, ethanol, pulmonal hypertension
Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers

Study Overview
=================
Brief Summary
-----------------
Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly unpredictable spontaneous seizures. The occurrence of the seizure in patients without any forewarning is the most debilitating aspect of the disease. The Epicall system is intended for early detection of seizure related life threatening events by monitoring per-seizures biomarkers. The system is based on a sticker placed on the side of the face. The external sticker incorporates EOG (electrooculograph electrode) and PPG (photoplethysmograph electrode) sensors for continuous monitoring of: Heart Rate (base line, increase, decrease, asystole). Extra ocular eye movement (blinking, eye deviation, roving eye movements).

Official Title
-----------------
Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers

Conditions
-----------------
Seizure

Intervention / Treatment
-----------------
* Device: Epicall


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age 1 year -18 years old. Hospitalized patient who is diagnosed with epilepsy. Patient's parents/care giver able to comprehend and give informed consent for participation in this study. Patient's parents/care giver must commit to both screening and monitoring visits. Patient's parents/care giver must sign the Informed Consent Form. Exclusion Criteria: Patient with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in monitoring electrode area General weakness. Patient's parents/care giver objects to the study protocol. Concurrent participation in any other clinical study. Physician objection.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- |
| Epicall group<br>patients will be connected to Epicall sensor | Device: Epicall<br>* The Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lack of adverse events |  | 1-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epicall feasibility for monitoring pre-seizure biomarkers | Feasibility of using the Epicall for monitoring pre-seizure biomarkers will be established by the correlation between Epicall and ECG heart rate measurements. | 1-2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seizure early detection
FRench-speAking Icu (Intensive Care Unit) Nutritional Survey

Study Overview
=================
Brief Summary
-----------------
Assessment of nutritional practices in french intensive care units.

Detailed Description
-----------------
Assessment of nutritional practices in french intensive care units.

Official Title
-----------------
FRench-speAking Icu (Intensive Care Unit) Nutritional Survey

Conditions
-----------------
Intensive Care Units (ICUs)

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults hospitalized patients in intensive care units for an expected period of stay> 3 days Exclusion Criteria: Refuse to participate in the Protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Patients hospitalised in ICU<br>Patients hospitalised in ICU | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patients receiving parenteral nutrition within the first 10 days after ICU admission |  | 10 days |
To Study the Changes in Protein in Lung Cells of Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the changes in protein in lung cells of Asian patients with advanced non small cell lung cancer.

Detailed Description
-----------------
A molecular epidemiology study in Asian patients with advanced NSCLC of adeno histology to assess EGFR mutation status.

Official Title
-----------------
A Molecular Epidemiology Study in Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC) of Adeno Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation Status

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Testing for mutation status


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytologically confirmed advanced Non small cell lung cancer of adeno histology NSCLC treatment naive Availability of cancer tissue or cytology sample Exclusion Criteria: Involvement in the planning and/or conduct of the study Previous enrollment in the present study

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

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>EGFR mutation testing | Procedure: Testing for mutation status<br>* EGFR mutation test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGFR mutation status of Asian patients with advanced NSCLC |  | Samples will be tested after informed consent. Mutation results will be available within 1-3 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, EGFR mutation
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

Study Overview
=================
Brief Summary
-----------------
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years

Official Title
-----------------
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study

Conditions
-----------------
Japanese Encephalitis

Intervention / Treatment
-----------------
* Biological: Japanese Encephalitis purified inactivated vaccine (IC51)
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Written informed consent obtained prior to study entry Exclusion Criteria: Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine History of any previous JE vaccination (e.g. JE-VAX®) Immunodeficiency including post-organ-transplantation or immunosuppressive therapy A family history of congenital or hereditary immunodeficiency History of autoimmune disease Any acute infections within 2 weeks prior to enrollment Known or suspected HIV Infection Pregnancy, lactation or unreliable contraception in female subjects

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IC51 | Biological: Japanese Encephalitis purified inactivated vaccine (IC51)<br>* IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28<br>|
| Placebo Comparator: 2<br>Placebo | Biological: Placebo<br>* Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability up to Day 56 | calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs) | Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Serious Adverse Events and Medically Attended Adverse Events |  | until Day 56 | 
| Changes in Laboratory Parameters |  | until Day 56 | 
| SCR and GMT of Subjects With Concomitant Vaccinations |  | until Day 56 |
Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft

Study Overview
=================
Brief Summary
-----------------
Reperfusion of renal graft in kidney transplantation can change the pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of urine output during surgery may change the PKPD parameters of the drugs, including elimination rate. The goal of this study is to characterize the PKPD model of rocuronium during kidney transplantation and establish a basis for adequate dosage of rocuronium in kidney transplantation. Through PKPD modeling, the changes during reperfusion of the renal graft will be evaluated. Furthermore, the factors related to the changes will be assessed. Adjusting the infusion rate according to the step of kidney transplantation will lead to stable muscle relaxation and fast recovery.

Official Title
-----------------
Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft During Kidney Transplantation

Conditions
-----------------
End Stage Renal Disease, Transplantation

Intervention / Treatment
-----------------
* Drug: Rocuronium bromide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for elective living donor kidney transplantation end stage renal disease with oliguria or anuria normal BMI (BMI 18.5   25) obtained informed consent Exclusion Criteria: patient with underlying neuromuscular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocuronium bolus<br>rocuronium bromide 1st bolus 0.1mg/kg, rocuronium bromide 2nd bolus 0.4mg/kg | Drug: Rocuronium bromide<br>* Pharmacokinetic-pharmacodynamic modeling blood sampling and Rocuronium bromide concentration measure muscle relaxation evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rocuronium plasma concentration (mcg/ml) | PKPD modeling from measuring plasma rocuronium concentration and excreted urine rocuronium amount | 0, 1, 3, 5, 10, 30, 60, 90, 120 minutes after rocuronium second bolus injection | 
| acceleromyography data (TOF ratio %) | Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation. | intraoperative |