linjc16/ctgov huggingface dataset:
To Advance the New Disability Evaluation System in Taiwan

Study Overview
=================
Brief Summary
-----------------
Before 2007, the disability evaluation was based on the medical model in Taiwan. According to the People with Disabilities Rights Protection Act announced on 11 July 2007, the assessment of a person's eligibility for disability benefits has to be determined as suffering one of eight malfunction categories based on the International Classification of Functioning, Disability, and Health (ICF) framework. People with disabilities want to issue a disability identification and other welfare & services need processes of evaluation & assessment based on the ICF framework for the evaluation report and result of living need by the committee composed of professionals from medicine, social work, special education and employment counseling and evaluation. In this year, investigators planed the project with the Taiwan Society of ICF to develop the evaluation form. The experts from various disciplines of the ICF Office convened internal integration meetings to reach a consensus for developed the ICF evaluation form, add the code of pain and sleep and the items from Short-Form 12 for quality of life to the questionnaire. The results were used to analysis other relevant factors affecting the disability evaluation. And then add the core set from World Health Organization to both physical and mental disorders linked coding group, compared the new disability evaluation system and evaluate the living need of people with disability to provide suggestion for core set.

Conditions
-----------------
Motor Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: comply with a standard of the disability evaluation Exclusion Criteria: no

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Assessment of Quality of life by disability evaluate system |  | One day when patients came first | 
| Pain intensity on the Numerical Rating Scale |  | One day when patients came first | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disability Evaluation System, SF-12, ICF model
Investigation of the Uterine Cervix Using CervicalMD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the CervicalMD device's ability to collect digital imagery suitable for a colposcopy examination.

Official Title
-----------------
Investigational Study: Imaging the Uterine Cervix Using C30 Investigational Device

Conditions
-----------------
Colposcopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Negative Pregnancy test Abnormal Pap smear 18 years and older Presence of a cervix Exclusion Criteria: Pregnant Absence of a cervix Less than 18 years old Male

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colposcopy, Cervical intraepithelial neoplasia, cervical cancer, cervical precancer
Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information. Traditional culture methods of throat swab and sputum samples can only identify the most prevalent bacteria in samples, those of which there are over about 5 million bacteria per teaspoon. A recently developed method has been found to be more sensitive and can detect up to several hundred bacterial species in throat swab or sputum sample of individual CF patients.

Detailed Description
-----------------
This study does not include testing of any investigational drugs and this is a noninvasive study requiring only a sputum/swab sample paired with information contained in the routine clinic letters and laboratory results your CF physicians obtain at your regular clinic visits.

Official Title
-----------------
Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 1-16 upon enrollment Diagnosis of Cystic Fibrosis Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 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 |
| --- | --- | --- |
| To identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF). |  | 2 years |
Evaluation Of The Pharynx in Patients Undergoing Lateral Pharyngoplasty

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for treatment of obstructive sleep apnea through MRI, before and 6 months after surgery.

Official Title
-----------------
Evaluation of the Pharynx Through MRI in Patients Undergoing Lateral Pharyngoplasty for Treatment of Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Procedure: LATERAL PHARYNGOPLASTY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of obstructive sleep apnea syndrome Exclusion Criteria: MRI contraindications

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lateral pharyngoplasty<br>lateral pharyngoplasty | Procedure: LATERAL PHARYNGOPLASTY<br>* tonsilectomy and lateral pharyngoplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expansion of pharynx |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea, Obstructive, Magnetic Resonance Imaging, Pharyngeal Muscles
Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Investigate efficacy and safety of Vardenafil in patients with spinal cord injury

Official Title
-----------------
A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Vardenafil (Levitra, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period. Stable heterosexual relationship for at least 1 month. Exclusion Criteria: Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy Other exclusion criteria apply according to US Product Information or Summary of Product Characteristics

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Vardenafil (Levitra, BAY38-9456)<br>* 5mg, 10mg or 20mg taken 1 hour prior to sexual intercourse<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function-Erectile Function domain |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Encounter Profile Question 2 |  | 12 weeks | 
| Sexual Encounter Profile Question 3 |  | 12 weeks | 
| Other diary based variables |  | 12 weeks | 
| Safety and tolerability |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Traumatic spinal cord injury, Vardenafil
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy For Locally Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study is being done to help the investigators determine how accurate the sentinel lymph node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant chemotherapy in patients presenting with locally advanced breast cancer.

Official Title
-----------------
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients Presenting With Locally Advanced Breast Cancer: A Prospective Study

Conditions
-----------------
Breast Cancer, Locally Advanced Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Sentinel Lymph Node Biopsy (SLNB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients over 18 years of age with biopsy-proven breast cancer Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging studies Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam Exclusion Criteria: Patients with a prior history of ipsilateral breast cancer Pregnant patients Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam Patients not consenting to ALND

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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This will be a prospective single-arm study design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinel Lymph Node Biopsy (SLNB)<br>The patients will undergo SLNB with dual tracer mapping using technetium-99m sulfur colloid and isosulfan blue dye, as is standard practice at our institution for cN1 patients. Than the SLNB procedure will be performed | Procedure: Sentinel Lymph Node Biopsy (SLNB)<br>* Sentinel Lymph Node Biopsy Patients with locally advanced breast cancer will undergo SLNB with dual tracer mapping followed by completion axillary lymph node dissection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sentinel Lymph Node Biopsy, 17-384
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy

Study Overview
=================
Brief Summary
-----------------
To evaluate the survival impact of extensive lymphadenectomy as part of debulking surgery in stage IVB ovarian cancer with supradiaphragmatic lymph node metastasis.

Official Title
-----------------
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy on Stage IVB Ovarian Cancer With Supradiaphragmatic Lymph Node Metastasis

Conditions
-----------------
Ovarian Cancer Stage IV, Lymph Node Metastases

Intervention / Treatment
-----------------
* Procedure: debulking surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically diagnosed ovarian, fallopian tubal, primary peritoneal cancer Patients suspected of metastatic lymph nodes in the cardiophrenic, internal mammary, and/or supraclavicular lymph node by CT (size larger than 5mm) Patients clinically diagnosed FIGO stage IVB ovarian, fallopian tubal, primary peritoneal cancer Patients underwent debulking surgery (primary debulking surgery or interval debulking surgery) at Seoul National University Hospital from January 2010 to January 2020 Patients age 18-90 Exclusion Criteria: Borderline or benign ovarian disease Patient didn't undergo debulking surgery Non-epithelial ovarian cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: debulking surgery|debulking surgery as primary debulking surgery or interval debulking surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | the time interval from the treatment start date to disease recurrence or progression date | From date of treatment until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 120 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the time interval from the treatment start date to death or end of study date | From the date of treatment start date until death due to any cause, assessed up to 120 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
internal mammary lymph node, supraclavicular lymph node, cardiophrenic lymph node
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.

Official Title
-----------------
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: WaveWriter
* Other: Conventional Medical Managament


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Chronic low back pain, with or without leg pain, for at least 6 months Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy) If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening Subject signed a valid, IRB-approved informed consent form (ICF) provided in English Key Exclusion Criteria: Primary pain complaint of vascular origin (e.g. peripheral vascular disease) Require implantation of lead(s) in the cervical epidural space Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Spinal Cord Stimulation<br>To receive Spinal Cord Stimulation programming | Device: WaveWriter<br>* To receive Spinal Cord Stimulation programming<br>|
| Other: Conventional Medical Management<br>To receive conventional medical management | Other: Conventional Medical Managament<br>* To receive conventional medical management<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate | Proportion of subjects with 50% or greater reduction in pain | 3 months post-activation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Stimulation
Central Venous Access Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to document clinicians variation in practice in comparison to standard guidelines by the Medical Center's approved Evidence-based Practice (EBP) guidelines, policies, and procedures for CVCs, PICCs and HD catheters by way of a structured retrospective review of the Electronic Medical Record (EMR) system.

Detailed Description
-----------------
This will be a single site retrospective (non-experimental) study utilizing the electronic medical record, both descriptive and correlational methods. There will be two outcomes: The outcomes associated with the management of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter in adherence with hospital approved Evidence-based Practice guidelines for Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter. The mechanical/technical, thrombotic, and other adverse outcomes (Heparin induced coagulopathy) associated with central venous catheters due to variation in insertion and management practices of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter.

Official Title
-----------------
The CentrAl VenouS Catheter Access DocumEntation (CASCADE) Study

Conditions
-----------------
Central Line Catheters

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Adult patients in Medical Intensive Care Unit (MICU), Coronary Care Unit (CCU), Cardiac Surgical Intensive Care Unit (CSICU), Surgical Intensive Care Unit (SICU) with either CVCs, PICCs, or HD catheters. Exclusion Criteria: • Pediatric (including neonates), obstetric and gynecology, medical-surgical, and oncology 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Clinicians Interventions and Management in adherence and not in adherence with Hospital Approved EBP guidelines for CVCs, PICCs, and HD catheters | To document number of mechanical/technical, thrombotic, and other adverse outcomes associated with CVCs, PICCs and HD catheters | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Number of variation in practices in clinical management of CVCs PICCS, and HD catheters associated with Catheter Complication | To document number of variation in practices in clinician management of CVCs, PICCs, and HD catheters associated with CVCs, PICCs and HD catheters | 1 year |