linjc16/ctgov huggingface dataset:
Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized double-blind study is to evaluate in which anatomical layer (AF versus BF) continuous wound infusion of local anesthetics combined with NSAIDs through a multiorifice catheter has the best effectiveness during the first 48 hours on postoperative pain intensity after elective cesarean delivery.

Official Title
-----------------
Evaluation of Optimal Anatomical Layer for Continuous Wound Infusion of Local Anesthetics Combined With NSAIDs Through a Multiorifice Catheter for Postoperative Pain Intensity After Elective Cesarean Delivery

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Procedure: Continuous wound infusion
* Procedure: Continuous wound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective Cesarean Section under spinal anesthesia over37 weeks' gestation Exclusion Criteria: allergy to NSAIDs ASA III or higher refusal to participate

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous wound infusion above the fascia<br> | Procedure: Continuous wound infusion<br> <br> |
| Active Comparator: Continuous wound infusion below the fascia<br> | Procedure: Continuous wound<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative intravenous morphine consumption |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain intensity at rest and mobilization |  | admission, 3,6,12,24,36,48h | 
| adverse effects (nausea, vomiting, itching, sedation) |  |  |
Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures.

Conditions
-----------------
Urethral Stricture

Intervention / Treatment
-----------------
* Procedure: Internal urethrotomy
* Drug: Mitomycin C - local injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male urethral stricture suitable for internal urethrotomy Stricture length less than 10 mm Exclusion Criteria: Stricture length over 10 mm Benign prostate enlargement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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: 1. Internal urethrotomy<br> | Procedure: Internal urethrotomy<br> <br> |
| Experimental: 2. Internal urethrotomy + mitomycin C<br> | Procedure: Internal urethrotomy<br> <br> Drug: Mitomycin C - local injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urethral stricture recurrence |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urethral stricture, Mitomycin C, Internal Urethrotomy
Phase 1 Study of URC102 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the food effect on PK.

Official Title
-----------------
A Phase I, Placebo-controlled, Randomized, Double Blind, Single or Multiple Dose Study of URC102 in Healthy Male Volunteers of Korean and Caucasian to Assess Safety, Pharmacokinetics and Pharmacodynamics

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

Intervention / Treatment
-----------------
* Drug: URC102
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers Exclusion Criteria: Received other investigational drug within 12 weeks prior to the first dose of study drug

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |
| Active Comparator: URC102<br>URC102 | Drug: URC102<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with AE |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma URC102 concentration |  | 1 week | 
| Blood uric acid |  | 1 week |
Perfusion CT Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether coronary perfusion computed tomography is effective in the treatment of coronary artery disease.

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age greater than or equal to 20 Patient who has a coronary perfusion computed tomography Exclusion Criteria: Unwillingness or inability to give informed consent

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of coronary perfusion computed tomography | Positive predictive value Negative predictive value Sensitivity Specificity | 5year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between coronary perfusion computed tomography and fraction flow reserve |  | 5year | 
| Relationship between coronary perfusion computed tomography and SPECT(nuclear imaging) |  | 5year | 
| occurrence of the event after coronary perfusion computed tomography | Death Myocardial infarction coronary angiography Revascularization | 5year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perfusion computed tomography, coronary artery disease
Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.

Official Title
-----------------
An Open-label, Two-period, Multi-center, Single Dose Study to Assess the Pharmacokinetics of AEB071 in de Novo Liver Transplant Patients

Conditions
-----------------
de Novo Liver Transplantation

Intervention / Treatment
-----------------
* Drug: AEB071


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary liver transplant recipients. Transplanted liver functioning at an acceptable level by 24 h post-transplant Patients started on tacrolimus therapy within 12 h post-transplant Exclusion Criteria: Previous transplantation or multiple organs transplantation Acute rejection Non-heart beating donor Other protocol-defined inclusion/exclusion criteria may apply.

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AEB071 | Drug: AEB071<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Pharmacokinetic of AEB071 & its primary metabolite, AEE800 at predose & up to 72 hours post-operatively -Safety & tolerability (vital signs,ECGs,clinical lab evaluations,seroius/adverse events) -AEB071,AEE800 & tacrolimus in blood for both Periods |  | at predose & 16 timepoints post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Pharmacokinetics of tacrolimus in presence of AEB071 -Biliary excretion of AEB071 & primary metabolite (AEE800) from patients with a T-tube -Relationship of free drug concentration, α-1 acid glycoprotein concentration & pharmacokinetics AEB071 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Organ transplant, liver, pharmacokinetics, AEB071, immunosuppression
Do Patients Suffering a Cardiac Arrest Present to the Ambulance Service With Symptoms in the Preceeding 48hrs?

Study Overview
=================
Brief Summary
-----------------
A cardiac arrest is often preceeded by a varying period of physiological deterioration which if acted upon may prevent the cardiac arrest. We aim to review patients presenting to the ambulance service with cardiac arrest so see if they had contacted the ambulance service in the preceeding 48 hrs to understand if warning symptoms were missed or not acted upon appropriately.

Detailed Description
-----------------
The UK ambulance services are called to attend 60,000 out-of-hospital cardiac arrests (OHCA) each year. Hospital studies have shown that many patients who suffer an in-hospital cardiac arrest (IHCA) have been deteriorating for the preceeding 48 hrs and suggest that many IHCA are potentially avoidable if this deterioration is identified and actued on promptly. No similar study has been performed to see if patients suffering OHCA have also presented with warning signs in the preceeding 48 hrs that were overlooked.

Official Title
-----------------
Do Patients Suffering an Out-of-hospital Cardiac Arrest Present to the Ambulance Service With Symptoms in the Preceeding 48hrs?

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Diagnostic Test: NEWS2 score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • All patients seen by SCAS ambulance crews and suffering a cardiac arrest within the following 48 hrs Exclusion Criteria: • None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Out-of-hospital cardiac arrest<br>Patients suffering an out-of-hospital cardiac arrest to who the ambulance service was requested to attend. | Diagnostic Test: NEWS2 score<br>* Patients seen by ambulance crews within the preceeding 48 hrs of their cardiac arrest will have a NEWS2 score performed to assess the level of physiological deterioration at the time of thei intial assessment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Out-of-hospital cardiac arrest | Cardiac arrest following ambulance assessment | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac arrest, Ambulance, Triage, Deterioration
Oxygen Level and Safe Emergence From Anesthesia

Study Overview
=================
Brief Summary
-----------------
Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the postoperative area of atelectasis without desaturations becoming more common.

Official Title
-----------------
Emergence From General Anesthesia With Laryngeal Mask Airway and Increased End-expiratory Pressure Using 30% Oxygen is as Safe as With 100% Oxygen But Reduces the Area of Post Operative Atelectasis.

Conditions
-----------------
Focus of Study is Postoperative Pulmonary Atelectacis

Intervention / Treatment
-----------------
* Procedure: 30% oxygen
* Procedure: 100% oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No sign of difficult airway or intubation Day case surgery in total intravenous anesthesia with laryngeal mask airway without adding regional anesthesia of plexus brachialis or muscle relaxant. Body mass index less than 35. American Society of Anesthesiologists physical status (ASA) class I-III Exclusion Criteria: Body mass index 35 or higher Increased risk of aspiration Obstructive sleep apnea syndrome Procedures during surgery making a former easy airway a difficult airway Need for opioids after extubation Hypothermia

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100% oxygen during extubation<br>In this arm the intervention will consist of 100 % oxygen. | Procedure: 100% oxygen<br> <br> |
| Experimental: 30% oxygen during extubation<br>In this arm the intervention will consist of 30 % oxygen. | Procedure: 30% oxygen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of atelectasis | The area of atelectasis is investigated by computed tomography of the lungs postoperatively | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral oxygen saturation (SpO2) | SpO2 is continuously assessed postoperatively. | 3 hours |
Role of markErs in the progreSsion of dIabeteS in Obese paTIeNts

Study Overview
=================
Brief Summary
-----------------
Obese patients will be enrolled from 2006 to 2014. The progression of diabetes mellitus will be observed (if any). Anthropometric and biochemical parameters will be evaluated.

Official Title
-----------------
Role of Some Markers in the Progression of Diabetes in Obese Patients: a 8-year Observational Study

Conditions
-----------------
Obese Patients

Intervention / Treatment
-----------------
* Other: Progression of diabetes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obesity (body mass index >/= 30 Kg/m2 Normal blood glucose (glycemia < 100 mg/dl) Exclusion Criteria: No exclusion criteria

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 |
| --- |
|Other: Progression of diabetes|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of diabetes | evaluation of glycemia during 8 years | 8 years | 
| Anthropometric parameters | Weight | 8 years | 
| Anthropometric parameters | Waist circumference; hip circumference; abdominal circumference | 8 years | 
| Markers of progression of diabetes | Adiponectin | 8 years | 
| Markers of progression of diabetes | Resistin | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Diabetes Mellitus
Docosaexahenoic Acid and Gross Motor Milestones in Infants

Study Overview
=================
Brief Summary
-----------------
To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3 (400 IU) alone. Primary outcome measure: time of achieving gross motor development milestones. Secondary outcome measure: time of achieving early fine motor development milestones and language.

Official Title
-----------------
RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.

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

Intervention / Treatment
-----------------
* Dietary Supplement: Docosahexaenoic acid (DHA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: weight at birth equal or above 2500 g; gestational age between 37 and 42 completed weeks; single birth; absence of neonatal or birth abnormalities; Apgar score greater than or equal to 7 at 5 m; white parents. Exclusion Criteria: presence of neonatal diseases requiring hospitalisation for longer than 7 days; unknown father; parents unable to understand the protocol requirements and to fill out the infants diary; infant already enrolled or selected for another clinical study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br> | Dietary Supplement: Docosahexaenoic acid (DHA)<br>* DHA 20 mg per day through 12 months of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of achieving the four gross motor development milestones |  | 4, 8 and 12 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of achieving early fine motor milestones and language |  | 4, 8 and 12 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Performance of motor skills
Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test

Study Overview
=================
Brief Summary
-----------------
postoperative outcomes were evaluated by using inBody test

Detailed Description
-----------------
postoperative outcomes were evaluated by using inBody test

Official Title
-----------------
Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: inbody


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgically treated patients Exclusion Criteria: a body weight loss of >10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease

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 |
| --- |
|Behavioral: inbody|Body fluid composition|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term outcomes | overall survival rate | 5year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short-term outcomes | postoperative complications | up to 24 weeks |
Liraglutide in Spinal Fluid

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate transfer of liraglutide from blood to cerebrospinal fluid.

Official Title
-----------------
Liraglutide in Spinal Fluid

Conditions
-----------------
Liraglutide Blood-brain Transfer

Intervention / Treatment
-----------------
* Procedure: Lumbar puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes treated with liraglutide 1.8 mg for 1 month and 5% weight loss Exclusion Criteria: -

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide treated patients<br> | Procedure: Lumbar puncture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebrospinal fluid concentration of liraglutide |  | time 60 minutes |