linjc16/ctgov huggingface dataset:
Clinical Outcomes of Transvaginal Mesh Procedures for Cystocele Repair: Comparisons of Uphold and Perigee Systems

Study Overview
=================
Brief Summary
-----------------
Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

Detailed Description
-----------------
Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. Traditional vaginal surgery with native tissue is associated with high recurrence rate. Thus, synthetic meshes were introduced into POP surgery and became the mainstream. Several transvaginal mesh procedures, such as Uphold system (Boston Scientific) and Perigee system (American Medical Systems Inc), have been used for cystocele repair. Perigee system is a trans-obturator four-arm mesh device attached to proximal and distal arcus tendineus fasciae pelvis. Nonetheless, Uphold system, is a single incised, two-arm anterior sacrospinous mesh fixation system. Both systems can be used for cystocele repair, despite Uphold system can be used for concomitant repair of apical prolapse. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

Official Title
-----------------
Far Eastern Memorial Hospital

Conditions
-----------------
Pelvic Organ Prolapse, Surgical Mesh

Intervention / Treatment
-----------------
* Procedure: Uphold
* Procedure: Perigee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vaginal anterior wall prolapse greater than or equal to second phase of POP-Q Underwent Uphold or Perigee procedures Exclusion Criteria: nil

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Uphold<br>Patients who underwent Uphold procedure | Procedure: Uphold<br>* Uphold system in treating women with cystocele<br>|
| Perigee<br>Patients who underwent Perigee procedure | Procedure: Perigee<br>* Perigee system in treating women with cystocele<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of pelvic organ prolapse | Compare the recurrence rate of Uphold system and Perigee system in treating women with cystocele. | 10 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Compare the complication rate (such as mesh extrusion, dyspareunia, pelvic pain, voiding difficult, etc) of Uphold system and Perigee system in treating women with cystocele. | 10 years |
Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study

Study Overview
=================
Brief Summary
-----------------
In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function (see below). The twice-daily (8 AM and 4 PM) regimen is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect during the night. To this end, a higher dose is used in the morning, with a lower dose in the afternoon.

Official Title
-----------------
Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study

Conditions
-----------------
Nephrolithiasis, Calcium Oxalate, Nephrolithiasis, Calcium Phosphate

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of calcium oxalate or calcium phosphate stone. Good renal function Exclusion Criteria: History of hypo-or hypernatremia. History of hypotension or orthostatic dizziness. Clinical history of congestive heart failure.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tolvaptan first, then Placebo<br>Tolvaptan twice daily in first intervention period and placebo twice daily in second intervention period. (after washout period) | Drug: Tolvaptan<br>* Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).<br>* Other names: Samsca;Drug: Placebo<br>* Patients will receive daily dose at 8 AM and at 4 PM.<br>|
| Experimental: Placebo first, then Tolvaptan<br>Placebo twice daily in first intervention period and Tolvaptan twice daily in second intervention period. (after washout period) | Drug: Tolvaptan<br>* Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).<br>* Other names: Samsca;Drug: Placebo<br>* Patients will receive daily dose at 8 AM and at 4 PM.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary calcium oxalate supersaturation (SS) | Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers. | Baseline to 3 weeks | 
| Change in Calcium phosphate SS | Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers. | Baseline to three weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney stone, Calcium oxalate, Calcium phosphate
Clinical Reminders in Test Reports to Improve Guideline Compliance

Study Overview
=================
Brief Summary
-----------------
This study examines the impact of adding a statement to the echocardiography report that advises anyone reading the report regarding if and when a follow-up study is recommended.

Conditions
-----------------
Echocardiography

Intervention / Treatment
-----------------
* Other: Statement
* Other: No Statement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing echocardiography where the physician creating the report feels a comment is appropriate regarding when follow-up should or should not occur. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statement<br>A statement is added to the echocardiography report describing if and when a follow-up echocardiogram is recommended. The statement may be positive (e.g. follow-up recommended in 6 months) or negative (e.g. no follow-up recommended). | Other: Statement<br> <br> |
| Experimental: No Statement<br>No statement is added to the echocardiography report | Other: No Statement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inappropriate follow-up | Performance of a follow-up echocardiogram when it was not indicated or not performing for a follow-up echocardiogram when it was indicated. | 1 year |
Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery

Study Overview
=================
Brief Summary
-----------------
To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.

Official Title
-----------------
An Evaluation of the Prophylactic Efficacy and Safety of the Administration of the Combination Formulation of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops in Inflammation and Infection Post-cataract Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≧18 years of age able to sign an informed consent and complete all required visits intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL) Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg) Exclusion Criteria: Uncontrolled glaucoma or IOP use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye use of steroid during the study or within 14 days prior to enrollment

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 |
| --- | --- |
| Experimental: Vigadexa eye drops<br>Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops | Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops<br>* 1 drop every 6 hours into the study eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. | The percentage of patients with a score of zero for Anterior chamber cells. Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm). Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon | Day 15 after cataract surgery | 
| The Percentage of Patients With no Ocular Pain |  | Day 15 after cataract surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract
Bone UltraSonic Scanner (BUSS): Validation Study

Study Overview
=================
Brief Summary
-----------------
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.

Detailed Description
-----------------
Study will conduct measurements in a group of postmenopausal women and use their DXA examination data as a control. BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.

Official Title
-----------------
Portable Bone Ultrasonometer for Osteoporosis Assessment

Conditions
-----------------
Osteoporosis, Osteopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal Age 50-90 years Any race or ethnicity DXA spine and hip exam within one year Exclusion Criteria: Open wounds or rashes on the testing area Active skin infection Recent tibia surgery Abnormal tibia anatomy Body Mass Index > 34.9 kg/m2 Current or previous tibial fracture on side of testing Stroke or with total or partial paralysis with residual disability lasting more than 3 months Current or recent (within past 6 months) use of bone-active drugs: Bisphosphonates Calcitonin Estrogens or selective estrogen receptor modulator (SERM) Therapeutic doses of fluoride (> 2mg/day) Teriparatide used currently or within past 3 months Drugs under research protocols, and Unstudied or unapproved drugs Presence of metabolic bone disease

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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 |
| --- | --- | --- |
| BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, ultrasound, sonometer, DXA
Attentional Bias Modification in Patients With Posttraumatic Stress Disorder

Study Overview
=================
Brief Summary
-----------------
Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder.

Official Title
-----------------
Effects of Attentional Bias Modification on Attentional Bias and Symptoms of Posttraumatic Stress Disorder

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Attentional Bias Modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Posttraumatic Stress Disorder Exclusion Criteria: Diagnosis of psychosis, drug- or alcohol dependency/abuse; Unable to fill in questionnaires in Dutch; Color blindness (Stroop test).

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>9 sessions of attentional bias modification (computerized training program) | Behavioral: Attentional Bias Modification<br>* computerized training to reduce attentional bias in posttraumatic stress disorder<br>* Other names: Attentional Training;|
| Placebo Comparator: 2<br>Attentional control condition (placebo training program) | Behavioral: Attentional Bias Modification<br>* computerized training to reduce attentional bias in posttraumatic stress disorder<br>* Other names: Attentional Training;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale (CAPS) |  | End of Trial + 3 week Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptoms (self-report) |  | end of trial + 3wk Follow Up | 
| Attentional Bias (dot-probe test) |  | End of trial + 3wk Follow-up | 
| Emotional Stroop Interference |  | End of trial + 3wk Follow Up |
Smart Vision Labs Autorefractor

Study Overview
=================
Brief Summary
-----------------
The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor.

Conditions
-----------------
Ocular Refraction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy young adults ages 18-35 year male and female Exclusion Criteria: presence of ocular disease refractive surgery amblyopia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- | --- |
| refractive errors |  | 4 months |
Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare two strategies of early enteral nutrition in terms of efficacy and complications in mechanically ventilated patients.

Official Title
-----------------
Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

Conditions
-----------------
-Mechanically Ventilated Patients

Intervention / Treatment
-----------------
* Device: enteral nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (> 18 ans) Mechanical ventilation for > 72 hours Planned enteral nutrition Informed consent Exclusion Criteria: Body Mass Index < 20 kg/m2 Enteral nutrition non indicated (ileus, splanchnic ischemia..) Shock (use of catecholamines, arterial blood pressure < 90 mmHg, peripheral hypoperfusion, elevation of lactates > x 1,5 normal value) Contraindications for gastric tube Pregnancy Previous enrollment in the present study

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: enteral nutrition|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nutrition failure (diarrhea, ileus, vomiting, aspiration pneumonia, elevated residual gastric volume) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Measured nutrition amount when compared to theorical nutrition during ICU stay |  |  | 
| -Measured nutrition amount when compared to theorical nutrition during the first three days |  |  | 
| -Influence of prokinetic drugs on nutrition quality |  |  |
A Clinical Trial to Evaluate Pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in Healthy Male Volunteers Under Fed Condition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.

Official Title
-----------------
Phase 1 Study of Daewon-ES(A) & Daewon-ES(B) in Healthy Male Volunteers Under Fed Condition

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

Intervention / Treatment
-----------------
* Drug: megace
* Drug: DW-ES(A)
* Drug: DW-ES(B)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 20 to 55 years at screening. No significant congenital/chronic disease. No symptoms in physical examination. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation. Exclusion Criteria: History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion. History of known hypersensitivity to drugs including valsartan and pitavastatin.

Ages Eligible for Study
-----------------
Minimum Age: 20 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Megace<br>800mg | Drug: megace<br>* 800mg<br>|
| Active Comparator: DW-ES(A)<br>625mg | Drug: DW-ES(A)<br>* 625mg<br>|
| Active Comparator: DW-ES(B)<br>625mg | Drug: DW-ES(B)<br>* 625mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
megesterol
Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study

Study Overview
=================
Brief Summary
-----------------
Using bedside ultrasound, the investigators will examine gastric content in non-fasting patients assigned to rapid sequence intubation (RSI). The procedure will be done immediately before intubation. The percentage of non-fasting patients who actually have gastric content will be determined. Identifying gastric content is critical because presence increases the risk of pulmonary aspiration during intubation.

Detailed Description
-----------------
Quantitative gastric content will be registered by measuring the cross section area of antrum using bedside ultrasound. The area and the patients age will be applied to estimate gastric volume.

Official Title
-----------------
Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study

Conditions
-----------------
Non-fasting Patients, Rapid Sequence Intubation, Anesthesia Intubation Complication

Intervention / Treatment
-----------------
* Other: Bedside ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults scheduled for surgery Adults over 18 years old that are assigned to general anesthesia with rapid sequence intubation (RSI) Exclusion Criteria: Body mass index over 40 Pregnant women Patients earlier underwent gastric surgery Critically ill patients where spending time on ultrasound would cause a major disadvantage for the patients

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 |
| --- | --- |
| Non-fasting patients<br>We will examine non-fasting patients using bedside ultrasound. First we examine the gaster in a supine position. Then we repeat the procedure in a right lateral position. | Other: Bedside ultrasound<br>* Checking for gastric content using bedside ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High risk of aspiration | Detection of solids, or more than 1,5 mL/kg clear fluid in the gaster | Immediately before intubation | 
| Low risk of aspiration | Detection of empty stomach, or less than 1,5 mL/kg clear fluid in the gaster | Immediately before intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, Gastric content, Non-fasting, Rapid Sequence Induction, Gastric volume