linjc16/ctgov huggingface dataset:
Cuff Pressure in LMS

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective observational study is to investigate minimum cuff pressure to prevent gas leakage during mechanical ventilation in laryngomicrosurgery.

Detailed Description
-----------------
It has been well known that cuff pressure should be adequately limited to prevent ischemic injury of tracheal mucosa, which is about 20-30 mmHg. However, higher cuff pressure that 20-30 mmHg might be required to prevent gas leakage during general anesthesia for laryngomicrosurgery. The hypothesis of this study is that the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery, and there will be no damage from the required cuff pressure because of short time of surgery.

Official Title
-----------------
Minimum Cuff Pressure to Prevent Gas Leakage During Mechanical Ventilation in Laryngomicrosurgery - Pilot Study -

Conditions
-----------------
Laryngomicrosurgery

Intervention / Treatment
-----------------
* Procedure: Cuff pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule Exclusion Criteria: Who doesn't agree to enroll do not use a reinforced tracheal tube of internal diameter of 5.5 mm for male patient do not use a reinforced tracheal tube of internal diameter of 5.0 mm for female patient

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| female<br>female patient who is scheduled for laryngomicrosurgery | Procedure: Cuff pressure<br>* observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery<br>|
| male<br>male patient who is scheduled for laryngomicrosurgery | Procedure: Cuff pressure<br>* observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cuff pressure | the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery | intraoperative | 
| post operative complication | any postoperative symptoms associated with cuff pressure such as hoarsness, dyspnea | from end of surgery to 1-2 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cuff pressure, laryngomicrosurgery
Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia

Study Overview
=================
Brief Summary
-----------------
This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.

Detailed Description
-----------------
Objective: To compare the laparoscopic Keyhole repair with the modified Sugarbaker repair in a nonrandomised case-controlled prospective study of consecutive patients with parastomal hernia. Summary Background Data: Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim. Methods: In two time periods 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and ePTFE with a self-cut slit, 1997- 2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009-2015). The patients in the two groups matched with regard to age, gender, ASA score, colostomy or ileostomy hernia, previous repairs, size of fascial defect and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma re-siting, mesh removal, death, or last non-event visit

Official Title
-----------------
Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia: A Long Term Case-controlled Prospective Study of Consecutive Patients.

Conditions
-----------------
Parastomal Hernia

Intervention / Treatment
-----------------
* Procedure: Laparascopic repair of parastomal hernia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of parastomal hernia and indication for surgical treatment - Exclusion Criteria: None -

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 |
| --- | --- |
| Keyhole rapair<br>74 patients who undervent parastomal hernia repair with keyhole technique 1997-2009 | Procedure: Laparascopic repair of parastomal hernia<br>* Laparascopic repair of parastomal hernia<br>|
| Sugarbaker repair<br>61 patients who undervent parastomal henia repair a.m. Sugarbaker 2009-2015 | Procedure: Laparascopic repair of parastomal hernia<br>* Laparascopic repair of parastomal hernia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Recurrence of parastomal hernia | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesh-related morbidity | Late mesh-related morbidity | 3 years | 
| Postoperative complications | Early postoperative complication | 30 days after surgery |
Risk Factors for Glaucoma in Musicians

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the impact of playing wind instruments for the development of ocular hypertension and glaucoma, together with investigating the prevalence of visual problems and eye diseases in (professional) musicians.

Official Title
-----------------
Risk Factors for Glaucoma in Musicians

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All full time or part time professional players of participating symphony or wind orchestras, including guest players. Retired players, if possible. Exclusion Criteria: Difficulty in reading or speaking Dutch.
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 |
| --- | --- |
| (Wind) musicians<br>Members of (professional) orchestras, especially wind instrument players. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP levels, including IOP peaks occurring during or directly after playing, and prevalence of glaucomatous field loss in players of wind instruments. |  | One hour. | 
| IOP peaks and variations during continuous IOP monitoring | Several high-risk participants will be asked their permission to perform continuous IOP monitoring during 24 hours with a sensing contact lens. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for glaucoma and the prevalence of visual problems and eye disease among (professional) musicians | Participants of orchestras will be asked to fill in a questionnaire to collect demographic data together with data on musical history,ophthalmologic history and family history on glaucoma and ocular hypertension. From these participants, a selection will be invited for further screening. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Wind instruments
Rapid Evaluation of Amantadine for Treatment of Cocaine Abuse/Dependence - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, amantadine is tested.

Detailed Description
-----------------
16-week participation plus a 2 weekk lead-in period. Participants are assigned randomly to placebo or amantadine. Participants attend group meeting 3 times/week

Official Title
-----------------
Rapid Evaluation of Cocaine Pharmacotherapies (Amantadine)

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Amantadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F, ages 18-65. cocaine dependence according to DMS-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of the study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy, history of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amantadine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention |  |  | 
| Cocaine use |  |  | 
| Cocaine craving |  |  | 
| Psychosocial progress |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amantadine, Cocaine, Pharmacotherapy, Outpatient
Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Goal is to physiologically detect unsuspected small airways obstruction in children and adults with treated heterozygous and homozygous cystic fibrosis. Unsuspected refers to normal routine pre bronchodilator spirometry including normal FEV1(L), FVC (L). and FEV1/FVC%. This is a retrospective study.

Detailed Description
-----------------
The current study is based on current investigators previously published patho-physiologic and lung CT studies in small airways intrinsic obstruction, emphysema, and asthma. Current investigators have demonstrated that despite the presence of normal routine spirometry including normal FEV1(L), FVC (L), and FEV1/FVC% that unsuspected small airways obstruction, and emphysema can be detected. This has been achieved by presence of isolated abnormal expiratory airflow limitation at low lung volumes on the maximal expiratory flow volume curves. This includes abnormal expiratory airflow at 75% and 80% expired lung volume. Current investigators believe investigators will be able to detect unsuspected small airways intrinsic obstruction, and peripheral airway bronchiectasis proven by lung CT, in patients with cystic fibrosis despite presence of pre bronchodilator normal routine spirometry.

Official Title
-----------------
The Measurement and Analysis of Maximal Expiratory Flow Volume Loops at Low Lung Volumes in Children With Cystic Fibrosis and Normal Routine Lung Function.

Conditions
-----------------
Cystic Fibrosis in Children

Intervention / Treatment
-----------------
* Diagnostic Test: spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heterozygote or homozygote patients with cystic fibrosis with normal routine pre bronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1/FVC%. Exclusion Criteria:Heterozygote or homozygote patients with cystic fibrosis with ABNORMAL routine pre bronchodilator spirometry -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: spirometry|measure spirometry and lung CT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis | Retrospective analysis of pre bronchodilator spirometry, and lung CT study to detect abnormal FEF75% in the presence of normal spirometry and FEF25-75. Detect isolated abnormal pre bronchodilator spirometry at 75%FVC | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung CT, abnormal FEF75, bronchiectasis
Visualase Visualization Database (VIVID-1)

Study Overview
=================
Brief Summary
-----------------
The purpose of the VIVID-1 data collection study is to establish a database of clinical images and associated technical files from commercial cases using the Visualase Thermal Therapy System (VTTS). All data collected will be de-identified. No safety or effectiveness assessments will be completed.

Official Title
-----------------
Visualase Visualization Database (VIVID-1)

Conditions
-----------------
Epilepsy, Tumor, Other

Intervention / Treatment
-----------------
* Device: Visualase Thermal Therapy System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patient correlating with the de-identified data set to be collected received standard of care treatment using the Visualase System prior to the date of site activation. Exclusion Criteria: Patient correlating with the de-identified data set to be collected is a minor (less than 18 years old, or as defined by local policy) that is not allowed to participate in this type of research project (eg, IRB approval with waiver of consent) per IRB policy Patient correlating with the de-identified data set to be collected is enrolled in the Medtronic SLATE trial
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VTTS as standard of care<br>VTTS as standard of care. | Device: Visualase Thermal Therapy System<br>* Patients who have previously received treatment with VTTS when used as intended.<br>* Other names: VTTS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image assessment | Identify pathologies and tissue types prescribed Visualse Thermal Therapy | During the Procedure |
Evaluation of the Baha SoundArc in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather clinical performance data on the Baha SoundArc

Detailed Description
-----------------
Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.

Official Title
-----------------
Evaluation of the Baha SoundArc in Pediatric Patients

Conditions
-----------------
Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral

Intervention / Treatment
-----------------
* Device: SoundArc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:• Existing recipients using a Baha sound processor on a Softband for at least three months Subjects aged 5 through 12 years of age Subjects should be able to perform clinical testing adapted for age and developmental status, (Threshold sound field audiometry and basic monosyllabic word test, PBK) Willingness on behalf of the subject's parent or guardian to complete study questionnaire Exclusion Criteria:• Subject's inability to perform requisite test measures as described in the study protocol -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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: Experimental SoundArc study group<br>all subjects will receive the SoundArc intervention | Device: SoundArc<br>* non-surgical attachment method for wearing a bone conduction hearing system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Survey | To evaluate patient experience when using the Baha SoundArc after a one month take-home trial, compared to the existing Baha Softband on the Participant Take Home questionnaire (strongly agree, Agree, Neutral, disagree, strongly disagree) | one month post fitting | 
| Percentage Correct on Word Identification Task | one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct. | 4 weeks post fitting |
Efficacy and Safety of DA-3002 in Short Children Borns SGA.

Study Overview
=================
Brief Summary
-----------------
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.

Official Title
-----------------
Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age.

Conditions
-----------------
Infant, Small for Gestational Age

Intervention / Treatment
-----------------
* Drug: DA-3002
* Drug: Genotropin®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronological Age ≥ 4 Before the adolescence, Tuner stage I (breast) Height <3rd percentile for age Normal thyroid function Exclusion Criteria: Growth hormone was administered for 12 months or longer in the past Treated with estrogen or adrenal androgens for 12 months or longer in the past Malignancy, CNS Trauma, Psychiatric Disorder endocrine and/or metabolic disorders growth failure caused by other disorders

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 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: DA-3002<br>1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week). | Drug: DA-3002<br> <br> |
| Active Comparator: Genotropin®<br>1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week). | Drug: Genotropin®<br> <br> |
| Other: Non-treatment control group<br>After no treatment for 26 weeks, 1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week). | Drug: DA-3002<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized height velocity(cm/year) after 52 weeks. | Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized height velocity(cm/year) after 26 weeks. | Height velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate. | 26 weeks | 
| Changes in height standard deviation score after 52 weeks |  | 52 weeks | 
| Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks |  | 52 weeks | 
| Changes in IGF-1 after 52 weeks |  | 52 weeks | 
| Changes in IGFBP-3 after 52 weeks |  | 52 weeks |
Duration and Force Variations in Applied Kinesiology Manual Muscle Testing

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of duration of Applied Kinesiology manual muscle testing on strong versus weak result of the test.

Official Title
-----------------
Duration and Force Variations in Applied Kinesiology Manual Muscle Testing

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age, willing to participate Exclusion Criteria: Major injury or conditions which would prevent muscle testing of the shoulder.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force over time during a manual muscle test and a maximal voluntary isometric contraction |  | 1 to 6 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facilitated (strong) or inhibited (weak) rating of muscle |  | 1 to 6 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Manual muscle testing