linjc16/ctgov huggingface dataset:
Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

Study Overview
=================
Brief Summary
-----------------
Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.

Official Title
-----------------
A 3-Week, Single-Blind, Placebo-Controlled, Within-Patient, Randomized Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: pimecrolimus active cream
* Other: placebo base cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American children aged 2 to 17 years mild to moderate atopic dermatitis Exclusion Criteria: m-EASI less than 3 at baseline allergy to Elidel or components use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study. previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment. active skin infections. immunocompromised patients. previous history of skin cancer or lymphoma any hypopigmentation in study areas pregnant or breastfeeding participation in another investigational trial

Ages Eligible for Study
-----------------
Minimum Age: 2 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pimecrolimus<br>Pimecrolimus 1% cream | Drug: pimecrolimus active cream<br>* Pimecrolimus 1% cream apply to affected study area twice daily for 21 days<br>* Other names: Elidel 1% cream Novartis Pharmaceuticals;|
| Placebo Comparator: 2<br>Placebo cream over affected study area | Other: placebo base cream<br>* apply to affected study area twice daily for 21 days<br>* Other names: by Novartis Pharmaceuticals;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis |  | at baseline, one week and three weeks following treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified IGA score |  | at baseline, one week and three weeks following initiation of therapy | 
| hypopigmentation scale score |  | baseline, one and three weeks following initiation of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
African American children
Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm

Study Overview
=================
Brief Summary
-----------------
This study is aimed to analyze the outcomes after conventional endoscopic submucosal dissection (ESD) and optimized ESD with snaring (oESD-S) for colorectal neoplasm that is more than 20 mm in diameter of laterllay spreading tumor or flat elevated lesion without stalk. Optimized ESD with snaring means submucosal dissection followed by snaring when narrowed circumference of the remained submucosal tissue beneath the lesion is less than 5 mm in diameter with snaring, then resected by using an electric current. The investigators expect optimized ESD with snaring can provide more time-saving procedure with comparable en-bloc resection rate and perforation rate, when compared with the conventional ESD method.

Official Title
-----------------
Comparison of Coventional Endoscopic Submucosal Dissection and Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm

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

Intervention / Treatment
-----------------
* Procedure: Optimized ESD with snaring
* Procedure: Conventional ESD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colorectal laterally spreading tumor that is more than 20 mm in diameter other elevated or flat colorectal neoplasm without stalk, that is more than 20 mm in diameter Exclusion Criteria: colorectal neoplasms that are proven or suspected to be invaded more than submucosal invasion colorectal neoplasms that have severe fibrosis beneath the target lesion patient's refusal to participate this study less than 18 years old subjects who cannot consent voluntarily due to the communication difficulty

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional ESD<br>Conventional ESD arm indicates the group in which conventional ESD method is applied for the dissection of colorectal neoplasm. | Procedure: Conventional ESD<br> <br> |
| Experimental: Optimized ESD with snaring<br>Optimized ESD with snaring arm indicates the group in which optimized ESD with snaring method is applied for the dissection of colorectal neoplasm. | Procedure: Optimized ESD with snaring<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time |  | 8 months | 
| En Bloc resection rate |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histologic complete resection rate |  | 8 months | 
| complication rate | perforation rate, bleeding rate | 8 months |
Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry

Study Overview
=================
Brief Summary
-----------------
Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design, affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea.

Official Title
-----------------
Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must provide written informed consent to participate in the study. Adult male or female subjects over 18 years of age who have or have not been diagnosed with OSA. Subjects claiming no history of OSA should take the Epworth questionnaire and obtain a result less than 10. Subjects must satisfy the study investigator about their fitness to participate in the study. Subjects must be available to complete the study. Exclusion Criteria: Subjects not compliant with the instructions for use of the stepped mouthpiece and the study procedures. Subjects who have participated in a clinical trial in the previous month.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| To measure the impact of different horizontal mandibular advancements, achieved through a stepped mouthpiece design, on the size of the upper airways in subjects with and without Obstructive Sleep Apnea (OSA). |  | one 60 minute session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth |  | one 60 minute session | 
| Measurement of the upper airways through acoustic pharyngometry during slow and deep breathing while the subject uses a stepped mouthpiece. The acoustic pharyngometry measurement will be performed at mid inhalation |  | one 60 minute session | 
| Assessment of the most comfortable position when using the stepped mouthpiece during both tidal and slow and deep breathing. The scoring of the comfortable position will be performed through a Likert-style questionnaire |  | one 60 minute session | 
| The most comfortable position established as outlined above will be evaluated for comfort while holding that position for 3 minutes. After the 3 minutes, the subject's level of comfort will be re-evaluated through a Likert-style questionnaire |  | one 60 minute session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To evaluate the effect of advancing Jaw on airway dimension
Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection

Study Overview
=================
Brief Summary
-----------------
Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.

Detailed Description
-----------------
Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not sufficient for the development of cervical cancer. Additional factors correlated with HPV persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and, more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of anaerobic bacterial species. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.

Official Title
-----------------
Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection and Cervical Cytological Abnormalities.

Conditions
-----------------
Papillomavirus Infections

Intervention / Treatment
-----------------
* Biological: Human Papillomavirus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of HR-HPV results. Exclusion Criteria: Clinical diagnosis of vaginitis, immune disease, malignancy History of cervical lesions Pregnancy Clinical diagnosis of other serious systemic primary diseases, such as severe liver and kidney dysfunction Severe mental illness

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 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 |
| --- | --- |
| Group A<br> | Biological: Human Papillomavirus<br>* women with high-risk Human Papillomavirus or not<br>|
| Group B<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal microbiota and HR-HPV infection | The persistence vaginal organism in HPV infection participants | 12 months | 
| Vaginal microbiota and the cervical lesion | The cervical cytology, HPV and the vaginal microbiota were evaluated | 12 to 36 months |
Urinary Catheter Exchange on Admission of Septic Elderly With Permanent Catheter Before Initiation of Antibiotics

Study Overview
=================
Brief Summary
-----------------
In the era of emerging antibiotics resistant microbiology, we look for better outcome in the treatment of infections in the elderly. We look for guidelines to manage an elderly who has a permanent urinary catheter, admitting to E.R. with Fever/Sepsis. We assume that exchanging the permanent urinary catheter prior to the Urine Culture sample as well as for initiating antibiotic treatment will improve the outcome of the patients.It could help the day-to-day fight for the proper antibiotics treatment to avoid resistance.

Conditions
-----------------
Fever, Heart Rate, Blood Pressure, C-Reactive Protein, Erythrocyte Sedimentation Rate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >65 years Permanent Urinary Catheter FEVER or Septic State Exclusion Criteria: Supra-Pubic Aspiration Catheters Septic Shock I.V. Antibiotics Initiated before admission

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 95 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 |
| --- | --- | --- |
IMAGE-HF: Project IIa Canadian CArdiomyopathy Registry for Device Therapy

Study Overview
=================
Brief Summary
-----------------
Delayed enhanced MRI in patients (of either ischemic or non-ischemic cause) being referred for primary prevention ICD

Detailed Description
-----------------
Device therapy using defibrillators and cardiac resynchronization therapy (CRT) is an important advance in the care of patients with acquired heart disease and heart failure. In specific groups these devices appear to significantly reduce the risk of sudden cardiac death and progression of heart failure. However, our ability to identify ideal candidates, and those who are most likely to respond and benefit from this therapy, is poor. Preliminary studies using specialized Magnetic Resonance Imaging (MRI) appears to be one of the more valuable ways of predicting response to device therapy and holds substantial promise for patients with cardiomyopathy. Large, prospective registries are necessary to explore its real-world utility for risk prediction across a broad spectrum of patients. Can-CARD MR is a national, multi-centre registry designed to address this particular need.

Official Title
-----------------
IMAGE-HF: Project IIa - Canadian CArdiomyopathy Registry for Device Therapy (CanCARD-MR)

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: .Any patient accepted for primary prevention ICD (+/-) CRT) Exclusion Criteria: Known contra-indications to MRI. Recent myocardial infarction or revascularization procedure within the past 3 months. GFR (glomerular filtration rate) ≤ 30 ml. / min/ m2.
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a)appropriate ICD therapy (shock or anti-tachycardia pacing (ATP)) or sudden cardiac death | Occurrence of a)appropriate ICD therapy (shock or anti-tachycardia pacing (ATP)) or sudden cardiac death | 1 year |
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly

Study Overview
=================
Brief Summary
-----------------
Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects previously vaccinated with Fluarix or the influenza adjuvanted vaccine, will receive a booster dose with the 2006-2007 season's formulations of either Fluarix or the adjuvanted vaccine.

Official Title
-----------------
A Phase II, Open, Controlled Study to Evaluate the Reactogenicity and the Immunogenicity of GlaxoSmithKline Biologicals' Adjuvanted Influenza Vaccine in Elderly Adults Previously Vaccinated With Either Fluarix™ or the Adjuvanted Vaccine.

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Fluarix and adjuvanted influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subjects must be healthy elderly >/= 67 years and previously vaccinated with Fluarix or the adjuvanted vaccine. Exclusion Criteria: Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immunemodifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, have a history of influenza infection since previous vaccination, or if subjects have acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination

Ages Eligible for Study
-----------------
Minimum Age: 67 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Fluarix and adjuvanted influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine, during 21 days following administration of the vaccine. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the humoral immune response & cell-mediated immune response 21 days after revaccination with candidate vaccine. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, improved vaccine, elderly
Rectus Musle Reapproximation During Cesarean Section

Study Overview
=================
Brief Summary
-----------------
During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

Detailed Description
-----------------
Pfannenstiel incision will be done under general or spinal anesthesia. The abdomen will be opened and fetus and placenta will be delivered. Then the abdomen will be closed. In Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

Official Title
-----------------
Intraoperative and Postoperative Results of Rectus Musle Reapproximation During Cesarean Section

Conditions
-----------------
Cesarean Section Complications

Intervention / Treatment
-----------------
* Procedure: Cesarean Section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40 years old women undergoing cesarean section Exclusion Criteria: grandmultiparas

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: reappoximation of rectus muscle<br>During Cesarean Section rectus muscle will be reapproximated with interrupted sutures. | Procedure: Cesarean Section<br>* Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed.<br>|
| Active Comparator: no reappoximation of rectus muscle<br>During Cesarean Section rectus muscle will not be closed. | Procedure: Cesarean Section<br>* Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain: Visual Analog Score | Visual Analog Scores, minimum score is 0, maximum score is 10. Score 10 represents highest pain score. | 24 hours after the procedure | 
| Postoperative interrectus distance | Distance between the margins of the rectus muscles in centimeters will be measured with ultrasonography | 6 weeks after the procedure |