linjc16/ctgov huggingface dataset:
Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient

Conditions
-----------------
Pediatric Urologic Surgeries

Intervention / Treatment
-----------------
* Other: Pressure-controlled ventilation
* Other: Volume-controlled ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery. Exclusion Criteria: parent refusal clinically significant respiratory disease ③ congenital airway abnormalities, oropharyngeal or facial pathology ④ risk of aspiration

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 7 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: PCV group<br>After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in pressure-controlled mode. | Other: Pressure-controlled ventilation<br> <br> |
| Active Comparator: VCV group<br>After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in volume-controlled mode. | Other: Volume-controlled ventilation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography. |  | 1 min after I-gel insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oropharyngeal leak pressure |  | 1 min after caudal block | 
| FOB grade | grade 1= only the vocal cords visible, 2= vocal cords and epiglottis visible, 3= only the epiglottis visible, 4= vocal cords and epiglottis not visible | 1 min after I-gel insertion | 
| peak airway pressure |  | 1 min after I-gel insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric insufflation, I-gel, Peak airway pressure, Pressure-controlled ventilation, Volume-Controlled Ventilation, pediatric patient
Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the hypothesis that acetaminophen will reduce lipid peroxidation and isoprostane formation during reperfusion after percutaneous revascularization for acute myocardial infarction.

Official Title
-----------------
Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients presenting with STEMI Exclusion Criteria: Duration of symptoms > 12 hours Suspected LM or proximal LAD occlusion (based on EKG interpretation) Hemodynamic instability Acetaminophen use in prior 24 hours Use of dipyridamole, or Aggrenox, a formulation of aspirin and extended-release dipyridamole, within 48 hours Current use of the following medications: phenytoin, valproic acid, phenobarbital, topiramate, rifampin, carbamazepine, cyclophosphamide, ritonavir, efavirenz, St. John's Wort Chronic heavy alcohol use Chronic liver disease (other than non-alcoholic fatty liver infiltration) Severe valvular heart disease Stroke in the past 60 days Active major bleeding Major surgery in the past 30 days Ongoing treatment for active malignancy Life expectancy less than 12 months as determined by the patient's attending physician Pregnancy asthma or severe COPD active wheezing on presentation allergy or prior adverse reaction to adenosine

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetaminophen<br> | Drug: Acetaminophen<br>* single dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma isoprostane level |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index of microcirculatory resistance |  | Average 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial Infarction, Percutaneous Coronary Intervention, Acetaminophen, Lipid Peroxidation
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

Study Overview
=================
Brief Summary
-----------------
General - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery Laparoscopic surgery at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm) with or without anchoring transparietal sutures or double crown technique

Official Title
-----------------
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh
* Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent from the patient or his/her legal representative ventral hernia requiring elective surgical repair Exclusion Criteria: no written informed consent 'hostile' abdomen; open abdomen treatment contraindication to pneumoperitoneum emergency surgery (incarcerated hernia) parastomal hernia

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Laparoscopic Ventral hernia repair by heavy weight mesh | Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh<br>* Laparoscopic Ventral hernia repair by heavy weight mesh<br>|
| Experimental: 2<br>Laparoscopic Ventral hernia repair by lighter weight mesh | Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh<br>* Laparoscopic Ventral hernia repair by lighter weight mesh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate |  | after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity rate |  | perioperative | 
| quality of life |  | after 1 year | 
| postoperative pain |  | within 1 week | 
| long term complication rate |  | after 1 year |
Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate Laparoscopic Sleeve Gastrectomy in the treatment of morbidly obese patients pre and post-operatively after 3 months, 6 months, and 1-year follow-up and assess the volumetric changes of the gastric reservoir 1 year after LSG using multi-slice computer tomography.

Official Title
-----------------
Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy: Effect of the Pouch Size on Excessive Weight Loss and Weight Regain

Conditions
-----------------
Bariatric Surgery Candidate, Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI of > 40 kg/m 2 or > 35 kg/m2 with comorbidities e.g. hypertension and type 2 DM. All patients failed in supervised conservative management for obesity for at least 2 years. Exclusion Criteria: BMI > 60 previous bariatric surgery symptomatic reflux oesophagitis disease, gastric pathology (tumor, active peptic ulcer) Significant psychological disorder, active alcohol or substance abuse severe eating disorders (bulimia) severe systemic disease making anesthesia or surgery prohibitively risky (American Society of Anesthesiologists (ASA) class IV

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sleeve gastrectomy followed by volumetric assessment<br> | Procedure: sleeve gastrectomy<br>* Laparoscopic sleeve gastrectomy had evident therapeutic effects on preexisting obesity-related comorbidities. All patients were referred for abdominal MSCT with a volumetric assessment of gastric pouch within 1 month of surgery and 1 year postoperatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric volume after surgery | gastric reservoir volume after performance of laparoscopic sleeve gastrectomy | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric reservoir, Multi-slice computer tomography, Laparoscopic Sleeve Gastrectomy
Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

Study Overview
=================
Brief Summary
-----------------
To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

Detailed Description
-----------------
Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

Official Title
-----------------
Determine the Effects of COL-101 Administered Once Daily With Metronidazole Topical Gel, 1% Versus Doxycycline Hyclate 100 mg Administered Once Daily With Metronidazole Topical Gel, 1% in Patients With Moderate to Severe Rosacea

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: doxycycline
* Drug: doxycycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 8-40 total lesions erythema telangiectasia Exclusion Criteria: non-pregnant, non-lactating achlorhydric gastric by-pass surgery allergy to study medications drug/alcohol abuse use of proton pump inhibitors

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1: doxycycline<br>Vibramycin plus metronidazole | Drug: doxycycline<br>* COL-101, QD plus metronidazole<br>* Other names: Vibramycin, 100 mg, QD plus metornidazole;|
| Active Comparator: Cohort 2<br>Oracea® delayed release plus metronidazole | Drug: doxycycline<br>* 40 mg with metronidazole QD<br>* Other names: Oracea® 40 mg plus metronidazole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total lesion count from Baseline at the study endpoint |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Investigator's Global Assessment from Baseline at the study endpoint |  | 16 weeks | 
| Change in Clinician's Erythema Assessment score from Baseline at the study endpoint |  | 16 weeks | 
| Change in total lesion count (papules + pustules + nodules) from Baseline at each visit |  | 4 weeks, 8 weeks, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rosacea
PREdicting RENAL Injury In Patient After Hip Fracture Surgery

Study Overview
=================
Brief Summary
-----------------
To determine whether MALDI, a type of Mass-Spectometry, can use protein pattern detection within urine to predict postoperative (after an operation) kidney damage in adults who have undergone emergency hip fracture surgery?

Detailed Description
-----------------
The PRE-RENAL study is a prognostic accuracy study testing the ability of the MALDI-MS assay to predict incident acute kidney injury after fractured neck of femur surgery. The study aims to validate the findings of a urinary peptide panel previously developed and validated on a cohort of septic patients. Kidney injury following surgery or as a part of severe illness is an important complication, because it can delay and reduce the chances of recovery. A reliable early test for kidney injury would be useful so that treatments to prevent or minimise it can be started as early as possible. This study, based with a group of medical researchers working with chemists, will analyse clinical urine specimens from patients undergoing major orthopaedic (bone) surgery. We will explore whether patterns of proteins in the urine could be used as an early warning that kidney injury is present before existing tests demonstrate it.

Official Title
-----------------
The Use of Urinary MALDI-MS in Predicting Post-Operative Acute Kidney Injury in Patients After Fixation of Fractured Neck of Femur.

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fractured Neck of Femur Age >50 Informed consent Exclusion Criteria: Refusal of Consent

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| Acute Kidney Injury | Defined by KDIGO Criteria | Within 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mass Spectometry, Observational, Urine
Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to characterize the metabolism and excretion (ADME) of a single oral dose of [14C]varespladib methyl.

Official Title
-----------------
An Open-Label, Single-Dose, Study to Assess the Metabolism and Elimination of Varespladib After Oral Administration of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: varespladib methyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedure Healthy males, 19 to 55 years of age Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive Exclusion Criteria: History or presence of any clinically significant disease or disorder in the opinion of the investigator Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, or vital signs at baseline in the opinion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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: varespladib methyl<br> | Drug: varespladib methyl<br>* 500 mg oral suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the varespladib blood levels and radioactivity in blood, urine and fecal samples |  | 1 hour prior to drug, and post dose: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, and 120 hours after drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADME, Healthy volunteers
Postoperative Complication After Free Flap Reconstruction for Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
This study was designed to investigate the outcome of free-flap reconstruction surgery following head and neck cancer resection between primary and recurrent head and neck cancer patients.

Official Title
-----------------
The Impact of Operation Time and Operators on Postoperative Complication After Free Flap Reconstruction for Patients With Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer, Recurrent Cancer, Surgery--Complications

Intervention / Treatment
-----------------
* Other: Reconstruction group
* Other: Recurrent group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with head and neck cancer who underwent tumor wide excision and primary free flap reconstruction or secondary free flap reconstruction between March 2008 and February 2017 Age: 20 100 years old Exclusion Criteria: patients with missing or unvalidated data patients less than 20 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| head and neck cancer with free flap reconstruction<br>patients with head and neck cancer who underwent tumor wide excision and primary free flap reconstruction or secondary free flap reconstruction between March 2008 and February 2017 | Other: Reconstruction group<br>* Patients with primary tumor which underwent free flap reconstruction group.<br>Other: Recurrent group<br>* Patients with recurrent tumor which underwent free flap reconstruction group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure or success flap | The condition of the reconstruction flap is failure or success. | 2 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | such as wound infection rate, fistula, hematoma, and partial necrosis of the flap | 2 months after surgery |
Advanced Diffusion Tensor MRI for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to evaluate the accuracy of the BIT-Motion (Breast Imaging Tensor-Motion) software with non-contrast MRI scanning to detect breast cancer.

Detailed Description
-----------------
The goal of this study is to answer the question: what is the ability of the BIT-Motion (Breast Imaging Tensor-Motion) software to detect and discriminate between benign and malignant breast lesions that are identified on mammogram (MG) and ultrasound (US) examinations. Women over the age of 18 who have a breast lesion that is seen on MG or US will be eligible to enroll. Participation in this study will involve one non-invasive non-contrast MRI scan of the breasts.

Official Title
-----------------
Advanced Diffusion Tensor MRI for Breast Cancer

Conditions
-----------------
Breast Cancer, Breast Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Evaluation of BIT-Motion software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female scheduled for ultrasound or stereotactic guided breast biopsy > 18 years of age able to tolerate up to 90 minutes in the MRI scanner Exclusion Criteria: Male Has a medical condition that, in the opinion of the investigator, puts the subject at significant risk Has any contraindication to the MRI examination as determined by standard NorthShore University Health System relative to MRI safety Cannot comprehend or complete the Informed Consent Form

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with breast lesions<br>Women with an identified breast lesion have a non-invasive non-contrast MRI scan prior to biopsy. | Diagnostic Test: Evaluation of BIT-Motion software<br>* Software program to discern benign versus malignant breast lesions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic diagnosis | MRI scans evaluated with BIT-Motion software will be compared to definitive pathologic diagnosis | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Diffusion Tensor Imaging