linjc16/ctgov huggingface dataset:
Dural Puncture Epidural Technique Versus Conventional Epidural Techmique

Study Overview
=================
Brief Summary
-----------------
This study will be conducted on 50 patients of ASA grade I and II aged from 25 to 55 years and presented for laparoscopic hysterectomy. Patients will be divided into two equal groups; group A control group for conventional epidural technique(n=25) and group B for 25G dural puncture epidural with 25G pencil point Whitacre spinal needle (n=25). Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.

Official Title
-----------------
Comparative Study Between Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Laparoscopic Hysterectomy

Conditions
-----------------
Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial Anesthesia

Intervention / Treatment
-----------------
* Procedure: Conventional Epidural Technique
* Procedure: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II Height(150-170 cm) Exclusion Criteria: patient refusal hypersensitivity to local anesthetic drugs bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Epidural Technique<br> | Procedure: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle<br>* 25G Dural Puncture Epidural Block at L2-3 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.<br>|
| Active Comparator: Dural Puncture Epidural technique using pencil-point 25G Whitacre needle<br> | Procedure: Conventional Epidural Technique<br>* Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L2-3 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of bilateral sacral blockade | Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 minutes) | Up to 30 minutes after local anesthetic injection |
Zenith® Low Profile AAA Endovascular Graft

Study Overview
=================
Brief Summary
-----------------
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.

Official Title
-----------------
Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft

Conditions
-----------------
Abdominal Aortic Aneurysms, Iliac Aneurysms, Aortoiliac Aneurysms

Intervention / Treatment
-----------------
* Device: Zenith Low Profile AAA Endovascular Graft and ancillary components


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has at least one of the following Aortic or aortoiliac aneurysm Iliac aneurysm Aneurysm with a history of growth Exclusion Criteria: Less than 18 years of age Inability or refusal to give informed consent Disease considerations that would compromise patient safety or study outcomes Pregnant of breastfeeding or planning on becoming pregnant with 60 months Unwilling to comply with the follow-up schedule

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular Graft<br>The Zenith Low Profile AAA Endovascular Graft and ancillary components | Device: Zenith Low Profile AAA Endovascular Graft and ancillary components<br>* Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Without Major Adverse Events Within 30 Days | Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation | 30 days | 
| Number of Patients With Device Success | Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Profile, Abdominal Aortic Aneurysms, Endovascular
Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery

Study Overview
=================
Brief Summary
-----------------
Risk factors for cardiac arrest during spine surgery have been well defined, including lumbar fusion, age over 65 years, obesity, cardiovascular disease, ethnicity and ASA status. Bradycardia and asystole have been described under general anaesthesia in combined surgical cohorts: Proposed mechanisms include unopposed parasympathetic activation, enhanced vasovagal response to decreased venous return, and psychiatric stressors. The investigators prospectively will review patients candidates for spine surgery to explore potential incidence, contributory factors and outcomes to unexpected transient intraoperative haemodynamic instability, arrhythmia, and cardiac arrest during spine surgery as these data are needed to aid risk stratification and improve decision making for spine care teams.

Official Title
-----------------
Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery

Conditions
-----------------
Spine Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged more than 18 Gender: both. ASA grade I-II (American society of anesthiologists). Prepared to spine surgery under general anesthesia Exclusion Criteria: Ischemic heart patients Hypertensive patients Patients with atrial fibrillation or any previous history of attack of arrhythmias Patients on B.B ( beta-blockers) Chronic use of neuropsychiatric medications Renal Impairment Liver Dysfunction. Any complications during the procedure as massive hemorrhage Surgery for traumatic spinal cord

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Haemodynamic Instability during Spine Surgery | To calculate Incidence of Haemodynamic Instability during Spine Surgery | allover one year | 
| Risk factors of Haemodynamic Instability during Spine Surgery | To analyze risk factors of Haemodynamic Instability during Spine Surgery | allover one year | 
| outcomes of Haemodynamic Instability during Spine Surgery | To calculate the rate of mortality of Haemodynamic Instability during Spine Surgery | allover one year | 
| Incidence of cardiac arrest during Spine Surgery | To calculate Incidence of cardiac arrest during Spine Surgery | allover one year | 
| Risk factors of cardiac arrest during Spine Surgery | To analyze risk factors of cardiac arrest during Spine Surgery | allover one year | 
| outcomes of Cardiac Arrest during Spine Surgery | To calculate the rate of mortality of cardiac arrest during Spine Surgery | allover one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spine surgery , bradycardia , cardiac arrest
Topera C-FIRM Registry

Study Overview
=================
Brief Summary
-----------------
This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard routine of the center. Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.

Detailed Description
-----------------
Prospective and retrospective enrollment possible

Official Title
-----------------
Control for EU (European Union) Focal Impulse and Rotor Modulation Registry - Topera C-FIRM Registry-

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication Exclusion Criteria: women who are pregnant As this is a registry only data of patients will be included who have been treated according to the current AF guidelines and the daily routine of the center.
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 |
| --- | --- | --- |
| Number of Participants With Acute Success | Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure | day of procedure | 
| Number of Participants With 12-Month Effectiveness | Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period. | 12 months after initial AF ablation | 
| Number of Participants With Acute Safety Success | Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation | 7 days after initial AF ablation | 
| Number of Participants With 12-Month Safety Success | 12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure | 12-months after index procedure |
To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)
* Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 54 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.) | Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)<br> <br> |
| Active Comparator: 2<br>Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare) | Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 41 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressant
Health Effects of CLA Versus Industrial Trans Fatty Acids

Study Overview
=================
Brief Summary
-----------------
The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food. The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins, inflammatory markers, blood pressure and insulin status in human volunteers relative to industrial trans fatty acids and to oleic acid.

Detailed Description
-----------------
It will be a double-blind randomized multiple cross-over trial with 3 treatments: CLA; Industrial trans fatty acids (as a positive control); Oleic acid (Cis 18:1, the monounsaturated fatty acid in unhydrogenated vegetable oils) as a reference fat. Each volunteer receives each diet for three weeks, in random order, for a total of 9 weeks. Three weeks is sufficient to reach new stable lipoprotein levels.

Official Title
-----------------
Health Effects of CLA Versus Industrial Trans Fatty Acids in Healthy Volunteers (CLARINeT-Study)

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

Intervention / Treatment
-----------------
* Procedure: Consumption of CLA enriched food


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65 years healthy Exclusion Criteria: serum total cholesterol >= 6,5 mmol/L serum triglycerides > 2,3 mmol/L chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction) use of cholesterol lowering medication use of blood pressure lowering medication high alcohol intake BMI > 30 pregnant and lactation women unusual dietary requirements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Consumption of CLA enriched food|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol |  |  | 
| HDL cholesterol |  |  | 
| LDL cholesterol |  |  | 
| Apo B |  |  | 
| Triglycerides |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin status markers : HOMA; QUICKY |  |  | 
| Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg |  |  | 
| Fatty acid composition of cholesteryl esters and erythrocytes |  |  | 
| proteomics |  |  | 
| iso-prostanes |  |  | 
| blood pressure and heart rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLA, Industrial trans fatty acids, Oleic acid, Controlled dietary trial
Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies

Study Overview
=================
Brief Summary
-----------------
Elastography is a emerging imaging technique that has demonstrated high reliability in the assessment of tissues stiffness and quantification of fibrosis particularly in adult's livers. This ultrasound exploration has no secondary effects. There is no study published in the pediatric population concerning the role of ultrasound elastrography in kidney. The aim of this study is to look for a correlation between the elastography's results and the kidney fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential diagnostic and/or prognostic role in the management of these patients which would limit invasive biopsy procedures.

Official Title
-----------------
Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies

Conditions
-----------------
RENAL FIBROSIS

Intervention / Treatment
-----------------
* Procedure: Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male children or feminine from 5 to 18 years old to whom is indicated a renal biopsy by the néphrologue paediatrician whatever is the initial pathology, whatever are one or several current or previous treatments and whatever is their associated comorbidity Exclusion Criteria: Children of less than 5 years old or more than 18 years Children for whom a draining renal biopsy is not or more indicated by néphrologues Refusal or withdrawal of the consent lit by the holders of the exercise of the parental authority or by the child if he is capable of receiving the information Contraindication in the realization of a draining renal biopsy (current infection, disorder of the coagulation.)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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: Elastography<br> | Procedure: Elastography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the elastography | to study a link enters the elasticity of the kidney estimated by the élastographie and the classification of the renal fibrosis estimated and quantified from the histology by draining renal biopsy. | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dosage of the créatininémie |  | 30 months | 
| the debit of filtration glomérulaire at the child |  | 30 MONTHS |
Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL

Study Overview
=================
Brief Summary
-----------------
Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract calculi; however, the vast majority of patients do not tolerate the procedure without analgesia and sedation. Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine cream). The quadratus lumborum block was first described by Blanco. QL block is performed as one of the perioperative pain management procedures for abdominal surgery. QL block provides anesthesia and analgesia on the anterior and lateral wall of the abdomen.

Official Title
-----------------
Is Painless ESWL Possible? Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During Extracorporeal Shockwave Lithotripsy

Conditions
-----------------
Pain, Acute

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadratus Lumborum Block<br>Ultrasound guided Quadratus Lumborum Block with 10 ml %0.5 bupivacaine and 10 ml %2 lidocaine | Drug: Bupivacaine<br>* 10 ml %0.5 bupivacaine<br>Drug: Lidocaine<br>* 10 ml %2 lidocaine<br>|
| No Intervention: Group Control<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Score | Visual Analog Pain Score at 5.,10.,15., 20., 25., 30. minutes | Intraoperative 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Opioid consumption at 5.,10.,15., 20., 25., 30. minutes | Intraoperative 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal Shockwave Lithotripsy, Quadratus Lumborum Block, bupivacaine, lidocaine