linjc16/ctgov huggingface dataset:
Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population

Study Overview
=================
Brief Summary
-----------------
Narrow-Band Imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect oesophageal squamous cell carcinoma (SCC) and appears more specific than Lugol chromoendoscopy in expert centres but its specificity in current practice is not known. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy to detect oesophageal SCC and high-grade dysplasia (HGD) in current practice (including tertiary care centres, local hospitals and private clinics).

Official Title
-----------------
Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population: a Randomised Controlled Multicentre Trial

Conditions
-----------------
FRENCH STUDY

Intervention / Treatment
-----------------
* Diagnostic Test: UPPER ENDOSCOPY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had a history or current SCC Exclusion Criteria: NONE

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NBI PATIENT<br> | Diagnostic Test: UPPER ENDOSCOPY<br>* UPPER ENDOSCOPY<br>|
| LUGOL PATIENT<br> | Diagnostic Test: UPPER ENDOSCOPY<br>* UPPER ENDOSCOPY<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPECIFICITY OF THE TWO DIAGNOSTIC STRATEGIES |  | 4 years |
Clinical Study of the Tympanostomy Tube Delivery System

Study Overview
=================
Brief Summary
-----------------
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

Official Title
-----------------
A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media (inVENT)

Conditions
-----------------
Otitis Media With Effusion

Intervention / Treatment
-----------------
* Device: Acclarent Tympanostomy Tube Delivery System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion. Either male or female Exclusion Criteria: History of sensitivity or reaction to anesthesia chosen for the procedure Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane Otitis externa Active acute otitis media Otitis media pathology Stenosed ear canal
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: Tympanostomy Tube Delivery System (TTDS)<br>Tympanostomy tube placement with Acclarent tube delivery system | Device: Acclarent Tympanostomy Tube Delivery System<br>* A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects). | At procedure visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-Over to Manual Myringotomy and Tube Placement | Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure. | at procedure visit | 
| Tube Retention | Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects). | two weeks post-procedure |
The Viscoelastic Properties of Lower Extremity's Muscles

Study Overview
=================
Brief Summary
-----------------
This study aims to create normative values for stiffness, tonus and elasticity in the lower extremity muscles and to determine age and gender differences.

Official Title
-----------------
The Mechanical Characteristics of Lower Extremity Muscles in Healthy Individuals Using Myotonometric Assessment

Conditions
-----------------
Muscle Loss

Intervention / Treatment
-----------------
* Diagnostic Test: Myotonometric evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals without any systemic or metabolic diseases, psychological illnesses, or drug abuse; those without any diseases that could cause muscle disease or muscle atrophy; and those who had not undergone any surgery in the musculoskeletal system during the past 3 months were included Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: men<br> | Diagnostic Test: Myotonometric evaluation<br>* Vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.<br>|
| Experimental: women<br> | Diagnostic Test: Myotonometric evaluation<br>* Vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myotonometric evaluation | The muscle tone, stiffness and elasticity of participants are assessed with myoton device for creating normative data | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle tone, viscoelastic properties, aging
A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder

Official Title
-----------------
A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder

Conditions
-----------------
Autistic Disorder

Intervention / Treatment
-----------------
* Drug: Placebo of Aripiprazole
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder (defined in DSM-IV-TR) and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. Inpatient or outpatient status Others Exclusion Criteria: The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome. Patients who fall under a contraindication listed in the ABILIFY package insert Others

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>administered orally once daily | Drug: Placebo of Aripiprazole<br>* administered orally once daily<br>|
| Experimental: Aripiprazole<br>administered orally once daily | Drug: Aripiprazole<br>* Flexibly dose administered orally once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score | The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition. | baseline, 8 weeks after dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autistic Disorder, children and adolescents, Aripiprazole, Double-blind, Randomized, children and adolescents
Contraceptive Choice Center

Study Overview
=================
Brief Summary
-----------------
The Contraceptive Choice Center will use an innovative-model of contraceptive care which was developed as a part of the Contraceptive CHOICE Project (CHOICE). This delivery model will deliver high-quality family planning services for women and reduce unintended pregnancies and births. This intervention will result in improved health for women, improved health care, and reduced costs to Medicaid. The Center will provide care to women ages 14-45 years of age.

Detailed Description
-----------------
The Center will provide high-quality contraceptive care using the innovative model of the Contraceptive CHOICE Project. Specifically, the model will provide the following components: 1) Structured, evidence-based contraceptive counseling; 2) education of providers about long-acting reversible contraceptive (LARC) methods and evidence-based guidelines for contraceptive provision; 3) removal of patient barriers to family planning services; and 4) post-visit contraceptive support. The model addresses the barriers to contraceptive uptake.

Official Title
-----------------
The Center for Contraceptive Excellence: an Innovative Health Services Delivery and Payment Model

Conditions
-----------------
Unintended Pregnancy, Contraception, Family Planning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Childbearing-age seeking family planning services Negative pregnancy test Willing and able to undergo informed consent Exclusion Criteria: Current participation in a research study that would interfere with the conduct of this study Currently pregnant

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women seeking family planning services<br>Women seeking family planning and gynecological services will be enrolled in our study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of unintended pregnancy | Reduce unintended pregnancy by 10% - # of pregnancies that are unintended per 1000 reproductive-age women (14-45 years) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of unintended births | Reduce unintended births and associated costs by 15% - # of births that are unintended per 1000 reproductive age women | 24 months |
A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and tolerability of single doses of odanacatib (MK0822) when administered with a light breakfast.

Official Title
-----------------
A Double-Blind, Randomized, 2-Period Crossover, Placebo Controlled Study to Asses the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MK0822

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: odanacatib
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is male and between the ages of 18 and 45 Subject is within 25% of ideal body weight and weighs between 55 and 95 kg Subject is in generally good health Subject is a nonsmoker Exclusion Criteria: Subject has multiple or severe allergies to food or medications Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates Subject has any infections, including HIV Subject has donated blood or taken another investigational drug in the last month Subject consumes excessive amounts of caffeine or alcohol Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Odanacatib | Drug: odanacatib<br>* A single oral dose of 100 mg odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.<br>* Other names: MK0822;|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: Placebo<br>* A single oral dose of Placebo to odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of MK0822 based on clinical and laboratory adverse experiences |  | Throughout the study | 
| Effect of a low-fat meal on pharmacokinetics of MK0822 |  | Through 240 hours post-dose |
Changes in Intracuff Pressure of a Cuffed Endotracheal Tube During Prolonged Surgical Procedures.

Study Overview
=================
Brief Summary
-----------------
To date, there are no data in the literature regarding changes in the intracuff pressure during prolonged surgical procedures. It is possible that the pressure will increase over time related to gas expansion during equilibration to body temperature. If this is the case, these patients may be at risk for tracheal damage. This is a prospective study to evaluate the changes in intracuff pressure over time during prolonged surgical procedures.

Conditions
-----------------
Surgical Procedure, Unspecified

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in whom a cuffed endotracheal tube is to be used for surgical procedures of more than 4 hours. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac patients<br>Patients undergoing cardiac surgery | Other: Cuff pressure<br>* Measuring endotracheal tube (ETT) cuff pressure<br>|
| Non-cardiac patients<br>Patients undergoing any surgery other than cardiac surgery | Other: Cuff pressure<br>* Measuring endotracheal tube (ETT) cuff pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intracuff Pressure |  | 1 day |
Diabetic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Diabetes represents one of the 10 leading causes of death in the world and concerns 5% of the French population (> 3.3 million patients). About 30% of diabetic patients will develop heart failure. The specific and early identification of diabetic cardiomyopathy at a subclinical stage (asymptomatic patients with normal LVEF) will thus make it possible to predict the risk of the onset of heart failure and to strengthen their monitoring and further adapt their treatment.

Official Title
-----------------
Diabetic Cardiomyopathy: Diagonostic Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 Diabetic Patients

Conditions
-----------------
Diabetic Cardiomyopathies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (≥18 years old) Type 2 diabetic and hypertensive subjects, cardiac asymptomatic, without myocardial ischemia documented by Dobutamine stress ultrasound (ESD), having at least 1 additional CV risk factor among: dyslipidemia, active or stopped smoking for less than 3 years, family history (1st degree relationship) of major CV accident before age 60, obliterating arteriopathy of the lower limbs and / or carotid atheroma, or proteinuria. Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. Exclusion Criteria: Patient who expressed his opposition to participating in the study Valvular heart disease (moderate to severe valve disease), hypertrophic or dilated (MVGi> 95 g / m2 in women and MVGi> 115 g / m2 in men), chronic pulmonary; History of cardiotoxic chemotherapy; Subject under legal protection, under guardianship or under guardianship.

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 |
| --- | --- | --- |
| Analysis of Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 of diabetic Patients |  | The files analysed retrospectily from April 15, 2015 to April 30, 2019 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Cardiomyopathy, Diabetic Cardiomyopathies, Type 2 diabetes, Echocardiography, Left ventricle, strain 2D and 3D
Esthetic Outcome of Isolated Advancement Genioplasty With and Without Submental Liposuction in Treatment of Skeletal Chin Deficiency

Study Overview
=================
Brief Summary
-----------------
This study is to measure the eshetic outcome of of isolated advancement genioplasty with and without submental liposuction in treatment of skeletal chin deficiency in double chin patients

Detailed Description
-----------------
Many methods used to treat skeletal chin deficiency in double chin patients, the aim of this study is to measure the advancement genioplasty with and without submental liposuction

Official Title
-----------------
Measuring the Eshetic Difference Between Advancement Genioplasty With and Without Submental Liposuction in Treatment of Skeletal Chin Deficiency in Double Chin Patients

Conditions
-----------------
Receding Chin

Intervention / Treatment
-----------------
* Procedure: Submental liposuction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: skeletal chin deficiency double chin patients Ages from 18 to 45 systemic free Exclusion Criteria: body mass index greater than 28 ages greater than 45 systemically diseased

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Skeletal chin deficiency<br>Advancement genioplasty with submental liposuction | Procedure: Submental liposuction<br>* Advancement Genioplasty With Submental Liposuction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patient satisfaction | scale of units/discrets | 6 months postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Submental liposuction, Advancement genioplasty, Double chin patients