linjc16/ctgov huggingface dataset:
Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of post-voiding urine residue.

Detailed Description
-----------------
Secondarily, we will evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of acute urine retention (first voiding volume > 500cc) and on post-partum bacteriuria rates.

Official Title
-----------------
Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study

Conditions
-----------------
Postpartum Women

Intervention / Treatment
-----------------
* Procedure: Catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paturient women admitted to the delivery room Exclusion Criteria: Patients who have been catheterized during the third trimester of the current pregnancy History of surgery on the urinary tract

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before group<br>Women in this group are included before the implementation of a strategy of systematic catheterization (they will not be catheterized). | |
| After group<br>Women in this group are included after the implementation of a department-wide strategy of systematic catheterization. Intervention: catheterization | Procedure: Catheterization<br>* Women in this group will be systematically catheterized before leaving the delivery room.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of a post-voiding residue | Assessed just after the first post-partum voiding. | Day 0 to Day 2 (just after first voiding) |
Additive Effects of Pravastatin and Valsartan

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.

Conditions
-----------------
Hypertension, High Cholesterol

Intervention / Treatment
-----------------
* Drug: pravastatin, valsartan, pravastatin+valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension and low-density lipoprotein cholesterol levels >100 Exclusion Criteria: Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pravastatin<br> | Drug: pravastatin, valsartan, pravastatin+valsartan<br>* pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment<br>|
| Active Comparator: valsartan<br> | Drug: pravastatin, valsartan, pravastatin+valsartan<br>* pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment<br>|
| Active Comparator: pravastatin combined with valsartan<br> | Drug: pravastatin, valsartan, pravastatin+valsartan<br>* pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation |  | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance |  | 8 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance, hypertensive, hypercholesterolemic patients
Covered Versus Uncovered Biliary Stents for Biliary Malignancies

Study Overview
=================
Brief Summary
-----------------
Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.

Detailed Description
-----------------
Consecutive patients with malignant strictures of the extra-hepatic biliary tree considered unfit for surgical excision Placement of covered or uncovered metal stents in patients with and without gallbladder on the basis of a computer-generated randomization list Evaluation of clinical outcome, survival, complications, and quality of life. Evaluation of the cost and efficacy of the two types of metal stents.

Official Title
-----------------
Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial

Conditions
-----------------
Biliary Tract Cancer

Intervention / Treatment
-----------------
* Device: covered biliary stents
* Device: uncovered biliary stents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree not eligible for surgical intervention able to provide informed consent Exclusion Criteria: benign biliary obstruction previous surgery of the biliary tract life expectancy < 3 months

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: covered stents<br>endoscopic placement of covered biliary stents | Device: covered biliary stents<br>* endoscopic placement of covered biliary stents<br>* Other names: Taewoong Medical NITI-S Covered;|
| Active Comparator: uncovered biliary stents<br>endoscopic placement of uncovered biliary stents | Device: uncovered biliary stents<br>* endoscopic placement of uncovered biliary stents<br>* Other names: Taewoong Medical NITI-S Uncovered;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of malignant biliary obstruction | Clinical assessment | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost/effecacy | cost and effectiveness of covered versus uncovered biliary stents | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal malignancy of the extra-hepatic biliary tract, metallic biliary stents, covered biliary stents, uncovered biliary stents
Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire

Study Overview
=================
Brief Summary
-----------------
The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life. The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to evaluate disease activity. It has the advantage of being inexpensive, easy to use in large cohorts and has been used in several studies. It has never been validated in French. The Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is specific to systemic lupus erythematous; it was developed from interviews with patients. This tool, validated in a British population, has never been validated in French.

Official Title
-----------------
Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire

Conditions
-----------------
Lupus

Intervention / Treatment
-----------------
* Other: SLA Questionnaire
* Other: Lupus Qol Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous. Patients able to understand written and spoken French. Patients who have been informed about the research Exclusion Criteria: Severe mental retardation. Any impairment of ability to understand making self-evaluation impossible. Age < 18 years. Age > 75 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Lupus<br> | Other: SLA Questionnaire<br> <br> Other: Lupus Qol Questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ) |  | Evolution of answers between D0, D15, M3 and M6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Answers in French to the Lupus Quality of Life (Lupus QoL) questionnaire |  | Evolution of answers between D0, D15, M3 and M6 |
Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)

Study Overview
=================
Brief Summary
-----------------
Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.

Official Title
-----------------
Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)

Conditions
-----------------
Patent Ductus Arteriosus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational less than 28 weeks Postnatal age less than 12 hours

Ages Eligible for Study
-----------------
Maximum Age: 28 Weeks

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Small ductus<br> | |
| Experimental: Large ductus ibuprofen<br>Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life | Drug: Ibuprofen<br>* Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life<br>|
| Placebo Comparator: Large ductus placebo<br>Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life | Drug: Placebo<br>* Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year survival without cerebral palsy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASQ (Ages and Stages Questionnaire) score at 2 years |  | 2 years | 
| Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal) | To compare the outcome between the large and the small ductus groups | 2 years | 
| Comparison of outcome according to the McNamara stage at surgical ligation |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prematurity, patent ductus arteriosus, ibuprofen
Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke

Study Overview
=================
Brief Summary
-----------------
Stroke is one of main causes of death and impairment worldwide. Objective of this study is to analyze serum High Sensitivity C-Reactive Protein in acute phase stroke in patients attended at Petróleos Mexicanos Hospital Central Sur de Alta Especialidad and to correlate with stroke extension and clinical features.

Official Title
-----------------
Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke

Conditions
-----------------
Stroke, National Institutes of Health Stroke Scale, Serum High Sensitivity C-Reactive Protein

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected of acute phase stroke who arrive to emergency room at our hospital Patients affiliated to Petróleos Mexicanos medical system Patients of any gender Patients between 18 and 80 years old Exclusion Criteria: Stroke provoked by angiographic procedure Pregnancy Patient under chemotherapy or radiotherapy Recently surgery or trauma among last 30 days Heparin usage Stroke and/ or thrombolysis history Active infection Liver disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stroke<br>Patients admitted to hospital who are diagnosed with stroke will be treated as usually a our center by observation, venous or arterial thrombolysis depending on extension, condition, thrombolysis feasibility. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of serum High sensitivity C-Reactive Protein level | Serum levels of serum High sensitivity C-Reactive Protein will be measured in patients with suspicion of stroke at the emergency room within the first 8 hours of arrival at our hospital | within the first 8 hours since admission to hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale | clinical impact of stroke will be determined by neurology and neurosurgery department at admission to emergency room of our hospital | within the first 4 hours since admission to emergency room | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, National Institutes of Health Stroke Scale, Serum high sensitivity C-Reactive Protein
Effect of Subcision and Suction on Acne Scars

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine whether the use of standard treatment in conjunction with suction will improve acne scars compared to a standard treatment alone.

Official Title
-----------------
Pilot Split Face Randomized, Evaluator Blinded Study on the Effect of Subcision and Suctioning With a Microdermabrasion Device on Rolling Acne Scars

Conditions
-----------------
Acne Scars

Intervention / Treatment
-----------------
* Procedure: Suction
* Procedure: Subcision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and over Have bilateral rolling acne scars Are in good health Subject has the willingness and ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. Exclusion Criteria: Under 18 years of age Pregnancy or lactation Unable to understand the protocol or give informed consent Has mental illness Recent Accutane use in the past 6 months Prone to hypertrophic and keloidal scarring

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subcision & Suction<br>Standard treatment for acne scars followed by suction. | Procedure: Suction<br> <br> Procedure: Subcision<br> <br> |
| Active Comparator: Subcision<br>Standard treatment for acne scars only | Procedure: Subcision<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in acne scarring compared to baseline after treatments | The change in acne scarring is measured using a global scarring grading system to compare baseline scarring to the treatments. | Baseline and 4 months |
High Flow Nasal Cannula and Diaphragmatic Function

Study Overview
=================
Brief Summary
-----------------
Prospective randomized study investigating the effect of postoperative oxygen delivery on diaphragmatic function. Two different modalities of oxygen delivery will be compared: high flow nasal cannula versus standard oxygen therapy with facial mask

Official Title
-----------------
Effect of High Flow Nasal Cannula vs Standard Oxygen Therapy on Diaphragmatic Function After Thoracic Surgery

Conditions
-----------------
Diaphragm Injury, Postoperative Complications

Intervention / Treatment
-----------------
* Device: High flow nasal cannula
* Device: Facial mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective thoracic surgery Exclusion Criteria: ASA score >3 Body mass index > 35 kg/m2 History of neuromuscular disease History of thoracic surgery Phrenic nerve paisy

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high flow nasal cannula<br>Two hours after extubation patients will received high flow nasal cannula oxygenation therapy for 24 hours | Device: High flow nasal cannula<br>* A device able to delivery high flow oxygen therapy<br>|
| Active Comparator: Standard oxygen therapy<br>Two hours after extubation patients will received standard oxygenation therapy for 24 hours | Device: Facial mask<br>* standard oxygen therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diaphragmatic dysfunction | Ultrasound evaluation of diaphragmatic dysfunction | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complication | Incidence of postoperative pulmonary complication | 7 days after surgery |
Intraoperative Monitoring (IOM) Patient Registry

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the optimal management of the surgical patient.

Detailed Description
-----------------
Prospective reports will be collected on approximately 10,000 patients undergoing lumbar or cervical spinal surgery using intraoperative monitoring. Patients will be enrolled in registry after signing informed consent. Data will be collected prior to surgery, during surgery, immediately following surgery and 4 to 6 weeks post surgery. The registry will serve as a database for surgeries using IOM. Specific outcome measures will be: neurological assessment, length of hospital stay, pain intensity, and complications.

Official Title
-----------------
Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM

Conditions
-----------------
Intraoperative Monitoring, Spinal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing lumbar or cervical surgery Utilization of IOM Understand and sign informed consent Exclusion Criteria: There are no specific 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumbar<br>Patients undergoing lumbar surgery | |
| Cervical<br>Patients undergoing cervical surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Neurological Assessment at 24 hours | Motor, Reflex, and Sensory testing will be assessed for change from baseline and 24 hours after surgery | baseline and 24 hours from time of surgery | 
| Change in Pain Intensity from Baseline at 24 hours | Pain intensity will be measured by Visual Analogue Scale (VAS) for change from baseline and 24 hours after surgery | baseline and 24 hours from time of surgery | 
| Complications |  | At time of surgery | 
| Change from baseline in Neurological Assessment at 6 weeks | Motor, Reflex, and Sensory testing will be assessed for change from baseline, within 6 weeks but not less than 4 weeks | baseline and 6 weeks | 
| Change in Pain Intensity from Baseline at 6 weeks | Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks | baseline and 6 weeks | 
| Complications |  | 24 hours after surgery | 
| Complications | within 6 weeks after surgery but not less than 4 weeks | 6 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spine, IOM, IONM, Intraoperative Monitoring, Intraoperative Neuromonitoring, Lumbar, Cervical