linjc16/ctgov huggingface dataset:
A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children With Torticollis

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children with torticollis. The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children with torticollis.

Official Title
-----------------
Ajou University School of Medicine

Conditions
-----------------
Anesthesia, Endotracheal

Intervention / Treatment
-----------------
* Device: McGrath MAC videolaryngoscopy
* Device: Macintosh Laryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: orotracheal intubation under general anesthesia torticollis Exclusion Criteria: •oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mcgrath group<br>Orotracheal intubation with McGrath MAC videolaryngoscopy | Device: McGrath MAC videolaryngoscopy<br>* Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction<br>|
| Placebo Comparator: Macintosh group<br>Orotracheal intubation with Macintosh laryngoscopy | Device: Macintosh Laryngoscopy<br>* Orotracheal intubation with Macintosh Laryngoscopy after anesthetic induction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Time interval between laryngoscopy passing the teeth to the confirming of end tidal CO2 | through intubation completion, an average of 30 second | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of glottic exposure as assessed by Cormack and Lehane Grade | Grade 1: full view of glottis, grade 2: Partial view of glottis, grade 3:only epiglottis seen, grade 4:neither glottis nor epiglottis seen | Up to 5 second after laryngoscopy passing the teeth |
Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)

Study Overview
=================
Brief Summary
-----------------
BMS-275183 given orally twice weekly to patients pretreated for locally advanced or metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the patients enrolled: Cohort I: Patients previously treated with one taxane containing regimen. Cohort II: Patients previously treated with a platinum based but non-taxane containing regimen. Cohort III: Patients previously treated with both a chemotherapy regimen and one EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound. Patients in cohorts I and II should have not been treated with a prior EGFR-TKI compound. Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR inhibitor.

Official Title
-----------------
A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: BMS-275183 (oral taxane)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, age >= 18 years Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen. Exclusion Criteria: Concomitant medication with a cytochrome P450 (CYP) 3A4 inhibitor or inducer

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BMS-275183 (oral taxane)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population |  |  | 
| Assess the response duration |  |  | 
| Assess the progression free survival time |  |  | 
| Assess the overall survival time |  |  | 
| Assess the pharmacokinetics (PK) of BMS-275183 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locally advanced or metastatic non-small cell lung cancer
An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

Official Title
-----------------
An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diagnosis of rheumatoid arthritis RA subjects 18 years or older Currently taking etanercept in pre-filled syringes for at least 4 weeks Subjects must give written informed consent Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception Subject is pregnant or breast feeding Significant concurrent medical diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-Arm<br>Open-lable Single Arm Study | Drug: Etanercept<br>* Intervention type was to study the drug delivery method.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects. |  | 22 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects. |  | 22 Days | 
| To determine the rate of failed drug deliveries (as opposed to device failures). |  | 22 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Device, Auto-injector, SureClick, Enbrel, Etanercept
Endocrine Outcome of Surgery for Pituitary Adenoma

Study Overview
=================
Brief Summary
-----------------
Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.

Detailed Description
-----------------
The main aim of the study is to compare microsurgical and endoscopic transsphenoidal surgery and to determine endocrine outcome. Secondary extent of resection and quality of life will be evaluated.

Official Title
-----------------
Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI

Conditions
-----------------
Pituitary Adenoma

Intervention / Treatment
-----------------
* Procedure: Endoscopic resection
* Procedure: Microsurgical resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected symptomatic or progressively growing pituitary adenoma Informed consent Exclusion Criteria: Prolactinoma No follow-up possible Emergency surgery without informed consent or without intraoperative MRI

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
Interventional Model Description: prospective randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: microsurgical technique<br> | Procedure: Microsurgical resection<br>* Transsphenoidal microsurgical resection of pituitary adenoma<br>|
| Active Comparator: endoscopic technique<br> | Procedure: Endoscopic resection<br>* Transsphenoidal endoscopic resection of pituitary adenoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endocrine function | Testing of pituitary function with insulin-hypoglycemic test, results will be dichotomized as satisfactory or not satisfactory. Satisfactory outcome is defined, if pituitary function improves or is stable, if compared to preoperative testing. | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of resection | Volumetric analysis of tumor volume before the surgery, intraoperatively and 3 months after surgery will be performed. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences | tumor volume before the surgery, 3 months after surgery | 
| Quality of Life, EQ-5D | EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year. | 3 months and 1 year after surgery |
A Pilot Study Non-Invasive Guidance for Therapeutic Ultrasound Treatment of Lower Back Muscle Injuries

Study Overview
=================
Brief Summary
-----------------
Back injuries are the most common reason people seeking for effective treatment. One of the most common treatments in sports medicine for muscular injuries is therapeutic ultrasound, which is designed to heat the injured tissue and increase the flow of blood to promote healing.

Detailed Description
-----------------
Researchers at Beckman Laser institute, using a technology developed at University of California, Irvine. The device call Diffuse Optical Spectroscopy, this device developed with harmless light that can measures and detect the change of blood flow, oxygen level, temperature and muscle tissue in lower back during therapeutic ultrasound therapy treatment. The researchers can provide information in real-time tissue change before, during, and after treatments that can determine the effectiveness of the treatment and speed up recovery time.

Official Title
-----------------
A Pilot Study to Investigate Non-Invasive Metabolic Guidance for Improving Therapeutic Ultrasound Treatment of Lower Back Muscle Injuries

Conditions
-----------------
Injury; Muscle, Back, Lower

Intervention / Treatment
-----------------
* Device: Diffuse Optical Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female over 18 years of age, No back injuries, No plan treatment Currently diagnose with back injuries, with plan treatment of therapeutic ultrasound Exclusion Criteria: Minors Obese Pregnant

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Musculoskeletal injuries<br>Diffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment | Device: Diffuse Optical Spectroscopy<br>* Diffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal lower back muscle | Diffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment | 4 weeks |
Phase II Proof of Concept Study in Uncomplicated UTI

Study Overview
=================
Brief Summary
-----------------
A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, MultiCenter Study of the Efficacy and Safety of MPC-SHRC for the Relief of Symptoms Associated With Uncomplicated Urinary Tract Infections

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Drug: MPC-SHRC
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection On adequate birth control Normal ECG Exclusion Criteria: Participated in any other trial within 30 days of visit 1 Known or suspected allergy to investigational drug Narrow angle glaucoma Recovering from chicken pox or flu-like symptoms History of peptic ulcer, gastrointestinal bleeding, gastrointestinal surgery, or gastrointestinal dysfunction which could interfere with drug absorption Taken any drugs for within past 24 hours for symptoms associated with uncomplicated urinary tract infections Currently taking prohibited drugs Taken an antibiotic within 7 days of Visit 1 Are ineligible to receive an antibiotic History of urinary retention History of interstitial cystitis History of impaired renal function History of impaired hepatic function Diagnosis or suspicion of complicated urinary tract infection or systemic infection History of substance abuse

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPC-SHRC<br>oral tablet four times a day for 3 days | Drug: MPC-SHRC<br>* Oral tablet four times a day for 3 days<br>|
| Placebo Comparator: Placebo<br>oral tablet four times a day for 3 days | Drug: Placebo Oral Tablet<br>* Oral tablet four times a day for 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on assessment instrument | Patient reported outcome | 6 hours after the first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on assessment instruments | Patient reported outcome | Three hour intervals after first dose of study drug | 
| Change from baseline on Pain Scale | Patient reported outcome | Three hour intervals after first dose of study drug |
A PK Study GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers

Detailed Description
-----------------
GL2702 GLARS-NF1 tablet is controlled released formulation which is invented by GL Pharm Tech Corp.

Official Title
-----------------
A Randomized, Open-label, Single-dose, Four-sequence, Four -Period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: GL2702 GLARS-NF1
* Drug: Omix Ocas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 45 years old, Healthy Adult Male Subject Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20% Exclusion Criteria: ALT or AST > 1.25 times (Upper Normal Range) Total Bilirubin > 1.5 times (Upper Normal Range) CPK > 2 times (Upper Normal Range) BUN or Creatinine > Normal Range Systolic BP > 160mmHg or < 80mmHg, Diastolic BP > 100mmHg or < 50mmHg

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GL2702 GLARS-NF1 , fasted<br>Tamsulsoin 0.4mg | Drug: GL2702 GLARS-NF1<br>* 0.4mg once a day<br>* Other names: Tamsulosin;|
| Active Comparator: Omix Ocas® , fasted<br>Tamsulsoin 0.4mg | Drug: Omix Ocas<br>* 0.4mg once a day<br>* Other names: Tamsulosin;|
| Experimental: GL2702 GLARS-NF1, after meal<br>Tamsulsoin 0.4mg | Drug: GL2702 GLARS-NF1<br>* 0.4mg once a day<br>* Other names: Tamsulosin;|
| Active Comparator: Omix Ocas®, after meal<br>Tamsulsoin 0.4mg | Drug: Omix Ocas<br>* 0.4mg once a day<br>* Other names: Tamsulosin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Pharmacokinetic parameter of tamsulosin 0.4mg | 48 hours | 
| AUClast | Pharmacokinetic parameter of Tamsulosin 0.4mg | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Pharmacokinetic parameter of Tamsulosin 0.4 mg | 48 hours | 
| t1/2 | Pharmacokinetic parameter of Tamsulosin 0.4 mg | 48 hours | 
| Vz/F | Pharmacokinetic parameter of Tamsulosin 0.4 mg | 48 hours | 
| CL/F | Pharmacokinetic parameter of Tamsulosin 0.4 mg | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tamsulosin,controlled release formulation
Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?

Study Overview
=================
Brief Summary
-----------------
The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.

Official Title
-----------------
Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?

Conditions
-----------------
Barlow's Disease, Prolapse; Mitral

Intervention / Treatment
-----------------
* Procedure: Right minithoracotomy
* Procedure: Sternotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011 Exclusion Criteria: Age inferior to 18 years

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 |
| --- | --- |
| MT-Right<br> | Procedure: Right minithoracotomy<br>* Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space<br>|
| Sternotomy<br> | Procedure: Sternotomy<br>* Longitudinal resection of the sternum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Death | The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk | 12 years | 
| Severe MR | The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk | 12 years |