linjc16/ctgov huggingface dataset:
Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.

Official Title
-----------------
Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy Versus Standard Colonoscopy

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Device: Device Assisted Colonoscopy
* Device: Standard Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing first screening colonoscopy Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies. Ability to provide informed consent. Exclusion Criteria: Previous surgical resection of any part of the colon history of colon cancer history of inflammatory bowel disease use of antiplatelet agents or anti-coagulants that precluded removal of polyps Poor general condition History of polyposis syndrome or hereditary nonpolyposis colorectal cancer Inability to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Assisted Colonoscopy<br>Device assisted colonoscopy (DAC) is a technique of attaching disposable devices like Endocuff or Transparent cap at tip of colonoscope to improve mucosal visualization and stability. | Device: Device Assisted Colonoscopy<br>* This will be similar to the standard colonoscopy except the endocuff device will be used.<br>|
| Active Comparator: Standard Colonoscopy<br>Standard colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a camera on a flexible tube passed through the anus. | Device: Standard Colonoscopy<br>* No endocuff device will be used on the study participants undergoing standard colonoscopy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate (ADR) as determined by Colonoscopy |  | intraoperative | 
| Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal Intubation Rate (CIR) |  | intraoperative |
Postoperative Troponin in Children With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the value of postoperative troponin in the prediction of mid term and long term mortality and morbidity in children with congenital heart disease undergoing cardiac surgery.

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all children with congenital heart disease between 0-10 years admitted for elective or emergency corrective or palliative cardiac surgery Exclusion Criteria: parental refusal children older than 10 years

Ages Eligible for Study
-----------------
Maximum Age: 10 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 |
| --- | --- |
| children with congenital heart disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity and mortality and length of stay in the PICU and in the hospital |  | in hospital; 3 months; 6 months |
ADenoVirus Initiative Study in Epidemiology in Italy

Study Overview
=================
Brief Summary
-----------------
The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Detailed Description
-----------------
Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in Italy. The planned duration of the study is one year from the first patient visit to the last patient visit.

Official Title
-----------------
Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis

Conditions
-----------------
Viral Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms. Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data. No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components). Exclusion Criteria: Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result. Previous enrolment in the present study. Any direct involvement with the study conduct at site or any family link with study site staff.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Frequency of patients with adenovirus conjunctivitis | The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis. | During the visit to the ophthalmologist (one visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions

Study Overview
=================
Brief Summary
-----------------
Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be the first choice.

Detailed Description
-----------------
To compare the diagnostic accuracy of chromoendoscopy indigo carmine or acetic acid and NBI for differentiating neoplastic from non-neoplastic colorectal lesions, differentiating adenomas from carcinomas, and differentiating early carcinomas from invasive ones. Included colorectal lesions consecutively distribute in a 1:1 ratio to 2 groups.

Official Title
-----------------
Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions Using Magnifying Colonoscopy With Narrow Band Imaging, Indigo Carmine, and Acetic Acid Staining

Conditions
-----------------
Colorectal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with more than one lesion ≧ 6mm . Exclusion Criteria: Patients with chronic inflammatory bowel disease, advanced cancer, insufficient bowel preparation, familial adenomatous polyposis (FAP) Lesions ≦ 5mm and submucosal tumor (SMT).

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
narrow band imaging（NBI）, indigo carmine, acetic acid, colorectal lesions, predicting histology
Telephone Interview Study for Men and Women With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The telephone interviews will be conducted to gather information on goal setting and goal attainment from men and women with osteoarthritis.

Detailed Description
-----------------
Interview data used to develop a new self-administered questionnaire

Official Title
-----------------
Observational Telephone Interview Study for Men and Women With Osteoarthritis

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 40 and 80 years of age Have moderate to severe pain Diagnosed with osteoarthritis of the hip and/or knee at least 6 months ago Currently receiving treatment for osteoarthritis Able to speak and read English US resident Willing to share your thoughts and experiences in a 45-minute telephone interview Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, arthritis
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.

Official Title
-----------------
A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical diagnosis of COPD Current or prior history of cigarette smoking Exclusion Criteria: Medical diagnosis of asthma Chest X-ray diagnostic of significant disease other than COPD Significant condition or disease other than COPD

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Formoterol Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of lung function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function, as well as vital signs |  |  | 
| Physical Exam results, Adverse event reporting, etc |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, COPD, formoterol
Compassion Training and Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether compassion training will improve the physical and psychological well-being of patients with chronic pain. The investigators also want to determine whether any benefit of compassion training in the patients spreads to significant others with whom the patient has a close relationship.

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

Intervention / Treatment
-----------------
* Behavioral: Compassion Cultivation Training Course


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18+ and chronic pain for >6months Pain over the last month Ability to read, write, and converse in English If being treated for pain condition, then stable treatment regimen. For significant others: 1)18 years of age or older 2)Ability to read, write, and converse in English Exclusion Criteria: For patients and significant others: 1)Current or history of a psychological disorder that would interfere with study procedures, at the discretion of the researcher. For patients only: prior compassion meditation experience on going legal action or disability claim currently pregnant or planning to become 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compassion cultivation training<br> | Behavioral: Compassion Cultivation Training Course<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Pain Inventory | Intensity - pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable | Baseline and end of 9-week treatment protocol | 
| Change in Chronic Pain Acceptance Questionnaire |  | Baseline and end of 9-week treatment protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Pain Inventory | Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes | Baseline to end of 9-week treatment protocol |
Sulfasalazine and Endothelial Function

Study Overview
=================
Brief Summary
-----------------
Experimental studies suggest that systemic inflammation leads to endothelial dysfunction and atherosclerosis. This study will examine the effects of the anti-inflammatory drug sulfasalazine on endothelial function in patients with coronary artery disease. Subjects will be treated with sulfasalazine or to placebo for six weeks. After a two-week rest period, subjects will cross over to the alternative treatment. Endothelium-dependent flow-mediated dilation of the brachial artery will be studied before and after each drug. We hypothesize that anti-inflammatory therapy will reverse endothelial dysfunction in patients with coronary artery disease.

Official Title
-----------------
Effect of Sulfasalazine on Endothelial Function

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Sulfasalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of coronary artery disease Exclusion Criteria: G6PD deficiency defined by red blood cell G6PD activity assay Sulfa allergy Aspirin allergy Allergy to furosemide (lasix), hydrochlorthiazide, sulfonylureas, acetazolamide (Diamox) or other carbonic anhydrase inhibitors SGOT, SGPT, alkaline phosphatase, total bilirubin greater than 2 times the upper limit of normal WBC less than 4.0 or greater than 11.0 K/UL Platelet count less than 150 K or greater than 450K Hematocrit less than 30% 7 Serum creatinine greater than 1.5 mg/dl Unstable angina or acute MI within 2 weeks Warfarin treatment Immunosuppressive treatment (methotrexate, cyclosporine, etc.) Digoxin treatment Phenytoin (Dilantin) treatment Methenamine (Mandelamine, Urex) treatment Probenecid or sulfinpyrazone (Anturane, Aprazone) treatment Porphyria Symptomatic GI obstruction GU obstruction (not including clinical evidence of benign prostatic hypertrophy) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfasalazine|sulfasalazine 2 grams daily for 6 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery flow-mediated dilation |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum markers of inflammation |  | 6 weeks |
Study of Bleeding With Extended Administration of an Oral Contraceptive

Study Overview
=================
Brief Summary
-----------------
This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.

Official Title
-----------------
Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Norethindrone 1 mg / ethinyl estradiol 20 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women Age 25-40 History of regular cycles Exclusion Criteria: Current or recent (within 2 months) users of hormonal contraceptives Contraindications for use of hormonal contraception Conditions which affect the absorption or metabolism of steroid hormones BMI > 35

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

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: Norethindrone 1 mg / ethinyl estradiol 20 mcg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bleeding/spotting days/episodes per treatment cycle |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception
The Comparison Between the PVAM and CPVI for the Patients of PAF

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.

Detailed Description
-----------------
This is a single centre, prospective control study. The study will enroll 180 patients with 2:1 grouped.

Official Title
-----------------
The Comparison Between the Pulmonary Vein Antrum Modification by SmartTouch Ablation Catheter With Contact Force Monitoring and Circumferential Pulmonary Vein Isolation by That Without Contact Force Monitoring Plus Lasso Catheter for the Patients of Paroxysmal Atrial Fibrillation: a Randomized Controlled Trial

Conditions
-----------------
Atrial Fibrillation, Pulmonary Vein Isolation

Intervention / Treatment
-----------------
* Procedure: pulmonary vein antrum modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with paroxysmal atrial fibrillation refractory to drugs with consent Exclusion Criteria: LVEF<50% history of cardiac surgery valvular heart disease abnormal thyroid function left atrial thrombus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PVAM<br>pulomonary vein antrum modification with contact force monitoring for AF | Procedure: pulmonary vein antrum modification<br> <br> |
| Active Comparator: Control arm<br>pulmonary vein isolation without contact force | Procedure: pulmonary vein antrum modification<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any recorded atrial arrhythmias proved by 7-day holter | sustained at least 30s | at least 18 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time | time that the patient spend in the procedure room | time during patient enrollment | 
| x ray time | x ray spent during the procedure | time during patient enrollment | 
| adverse event |  | at least 18 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, pulmonary vein isolation, Contact Force, antrum