linjc16/ctgov huggingface dataset:
Smoking Treatment of Prisoners

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of a 10-week smoking cessation therapy combined with NicoDerm CQ for smoking cessation among female prisoners.

Detailed Description
-----------------
This is a randomized controlled trial utilizing a wait-list control group to examine 10-week group therapy and nicotine replacement compared to wait-list for smoking cessation among female prisoners.

Official Title
-----------------
Smoking Treatment of Prisoners: Project STOP

Conditions
-----------------
Tobacco Use Cessation, Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: 10-week smoking cessation group therapy combined with NicoDerm CQ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) current smoker and (2) seeking group treatment to quit smoking. Exclusion Criteria: (1) non-english speaking, (2) housed in segregation, (3) presence of active, severe mental illness as defined by active psychosis, manic episode, or imminently suicidal/homicidal, (4) mental retardation such that they cannot provide informed consent, and (5) due to be released or transferred to another facility within the next year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: 10-week smoking cessation group therapy combined with NicoDerm CQ|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking cessation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine dependence
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.

Detailed Description
-----------------
Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study Visit #2 in two weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro

Official Title
-----------------
Clinical Study of the Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment

Conditions
-----------------
Asthma, Asthma in Children

Intervention / Treatment
-----------------
* Diagnostic Test: Vivatmo pro FeNO Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 7 to 80 years of age. Has asthma Has been identified as a candidate for inhaled corticosteroid (ICS) treatment Is willing and able to perform Vivatmo pro™ testing Exclusion Criteria: Subject has used corticosteroids prior to enrollment. Subject has other current serious medical conditions Subject has not been clinically stable for at least 2 weeks prior to the study Subject is unwilling or unable to perform Vivatmo pro testing

Ages Eligible for Study
-----------------
Minimum Age: 7 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Cohort<br>Subjects age 7 to 80 with asthma | Diagnostic Test: Vivatmo pro FeNO Test<br>* Breath gas analysis<br>* Other names: Fractional exhaled nitric oxide (FeNo);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FeNO Value | Change in FeNO value before and after inhaled corticosteroid treatment | 14 days |
SARS Cov-2 in Conjunctival Secretion in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19 patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant systemic clinical conditions.

Detailed Description
-----------------
Since February 2020, Coronavirurus Disease 2019 associated to a severe acute respiratory syndrome started in China and rapidly spread all over the world and in particular in northern Italy. There are many reasons to justify this rapid diffusion in Italian Lombardia region as the high population density with more possibilities of interpersonal contact, high prevalence of respiratory pathologies, in particular in elderly people, due to pollution, high number of contacts with Chinese population for travelling and business reasons, and at last the non-windy temperate climate conditions, that increases the persistence of virus in the environment. At now, more than eighty thousand citizens from Lombardia Region have been officially affected by the disease with a high death toll, also considering that actual numbers are certainly much underestimated. The aim of the present study was to evaluate the prevalence of SARS COV-2 virus in tears collected from COVID-19 patients by rtPCR analysis directed to target sites of viral RNA, and to correlate virus presence to concomitant systemic clinical conditions

Official Title
-----------------
SARS Cov-2 in Conjunctival Secretions in an Italian Lombardia Cohort of Patients

Conditions
-----------------
Sars-CoV2, Tear

Intervention / Treatment
-----------------
* Diagnostic Test: Tears swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized COVID 19 patients Exclusion Criteria: Patients with respiratory support that interferes with tears sampling

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID 19 Patients<br>hospitalized patients with COVID 19 | Diagnostic Test: Tears swab<br>* rtPCR on tears swabs samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virus presence in COVID 19 patients tears | prevalence of SARS CoV 2 virus on tears | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance to Naso-Pharingeal Swab | Evaluation of concordance with Naso-Pharingeal testing | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID 19, EYE, Tears
Self-Expanding Multi-Layered Partially Resorbable Lightweight Polypropylene Mesh Device (Proceed Ventral Patch® Or Pvp®) For The Treatment of Small and Medium Umbilical Ventral Hernias

Study Overview
=================
Brief Summary
-----------------
Meshes-devices using dual-sided mesh technology have been developed for the specific indication of small ventral hernias. The design of these meshes allows introduction of a mesh of appropriate size to cover the hernia defect, through a small incision. This technique is very attractive for the surgeon and the patients because the mesh usually can be introduced through a nearly invisible scar in the umbilicus. The avoidance of fixation sutures omits the pain related to these sutures. Short-term results and patient satisfaction are very favorable, encouraging the surgeons to continue with the technique, although long-term results of these meshes in good quality studies are lacking.

Detailed Description
-----------------
The aim of this study is to evaluate the safety and efficacy at 12 months after repair of small and medium ventral hernias using PVP™. All patients operated between March 2009 and February 2011 at the participating centers, will be evaluated and described. Patients will be evaluated by clinical investigation, questioning and ultrasound. The investigators' main focus will be the incidence of complications related to the use of the device, during the first year. Also the investigators look at recurrence rate at 12 months, occurrence of pain at 12 months and foreign body feeling. The trial can be seen as a quality control of a cohort of patients treated with an innovative mesh device. No sponsoring from the company J&J will be asked or accepted.

Official Title
-----------------
Multicenter Prospective Clinical Registry To Evaluate The Safety And Efficacy Of A Self-Expanding Multi-Layered Partially Resorbable Absorbable Lightweight Polypropylene Mesh Device (Proceed Ventral Patch® Or Pvp®) For The Treatment Of Small And Medium Umbilical Ventral Hernias

Conditions
-----------------
Umbilical Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients that were treated at the participating centres with a PVP™ for the repair of an umbilical hernia or another abdominal wall hernia before February 2011. Exclusion Criteria: no informed consent from the patient. patients lost to follow up.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Umbilical Hernia Repair, PVP Mesh
The Impact of Interactive, Multifaceted Approach Education on Congenital Cataract

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of a health education program on parental anxiety, the comprehension-memorization of the information and their satisfaction.

Detailed Description
-----------------
Prospective study including parents of congenital cataract, randomized in two groups: health education program with an interactive, multifaceted approach versus conventional follow-up. A health education module consisting of a lecture and workshop was incorporated into a health-care course. A non-validated survey assessed knowledge. Parental stress was assessed using self-questionnaires before and after training .At each moment we evaluated the level of anxiety, satisfaction of information quality and the comprehension-memorization of the data.

Official Title
-----------------
The Impact of Interactive, Multifaceted Approach Education on Parental Anxiety, Knowledge and Satisfaction for Congenital Cataract: A Randomized, Controlled Trial

Conditions
-----------------
Congenital Cataract

Intervention / Treatment
-----------------
* Other: interactive, multifaceted approach
* Other: conventional approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with regulated cataract surgery Exclusion Criteria: difficulty in understanding the language uncompleted questionnaires or badly filled in by two different people

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interactive, multifaceted approach<br>A health education module consisting of a lecture and workshop was incorporated into a health-care course. | Other: interactive, multifaceted approach<br>* A health education module consisting of a lecture and workshop was incorporated into a health-care course.<br>|
| Sham Comparator: conventional approach<br>conventional follow-up with oral healthy education | Other: conventional approach<br>* conventional follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting stress | Parenting stress was assessed using the Parenting Stress Index (PSI) | 12 months |
Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation

Study Overview
=================
Brief Summary
-----------------
Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve replacement, it is still restricted to high surgical risk patient who are frail. The aim of the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and functional recovery after TAVR

Detailed Description
-----------------
Primary objective: identify geriatric biomarkers associated with vital/functional status after TAVR. Primary outcome measure is altered functional status at six month follow-up defined as an absolute decrease of 15 points of the Barthel Index. Secondary outcome measures are: Barthel index and survival at 6, 9 and 12 months follow-up. QOL during follow-up

Official Title
-----------------
Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation. Multicenter Observational Study

Conditions
-----------------
Symptomatic Aortic Stenosis

Intervention / Treatment
-----------------
* Procedure: TAVR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥75 Symptomatic aortic stenosis Prior geriatric evaluation Patient who agreed to answer the telephone follow-up to 6, 9 and 12 months Patient given his non-opposition to using his data Patient affiliated to the French social security. Exclusion criteria:

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: TAVR|Percutaneous aortic valve replacement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of Barthel | Maintaining of the same Score | at 6, 9 and 12 months | 
| Maintain or improve the quality of life score at 6 months, defined as a score of SF-12 scale at 6 months |  | at 6 months | 
| Survival rate at 6 months, 9 months, 12 months |  | at 6, 9 and 12 months | 
| Survival time after TAVI during the study |  | up to 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic stenosis, TAVR, Frailty, Elderly
Accuracy of Acoustic Rainbow Monitoring (ARM) Sensor

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to conduct a side by side comparison of the accuracy of the respiratory rate (RR) between our Acoustic Rainbow Monitoring (ARM) sensor and the Oridian Microcap Capnograph in healthy adults. Our hypothesis was that the ARM sensor would have comparable or a better performance than the capnograph.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: ARM sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult volunteers Exclusion Criteria: under age of 18

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>The subjects will be enrolled into the test group and will receive ARM sensor. | Device: ARM sensor<br>* Acoustic Monitoring sensor that monitors respiratory rate<br>* Other names: RAS-125c;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Respiratory Rate determination | Accuracy is calculated using ARMS analysis | 40 minutes |
Post Operative Visual Acuity for DSAEK and UT-DSAEK

Study Overview
=================
Brief Summary
-----------------
To study the correlation between graft size in DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) and UT (ultra thin)-DSAEK type corneal transplants to the visual acuity 6 months postoperatively.

Official Title
-----------------
Post Operative Visual Acuity for Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and UT-DSAEK

Conditions
-----------------
Corneal Transplant

Intervention / Treatment
-----------------
* Procedure: DSAEK type corneal transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent DSAEK surgery Patients in department of ophthalmology between february 2012 and june 2017 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 |
| --- | --- |
| UT-DSAEK<br>With graft 6 months thick less than 100 µm | Procedure: DSAEK type corneal transplant<br>* All surgeries were performed by the same surgeon and according to the same protocol<br>|
| DSAEK<br>With graft thicker than 100 µm | Procedure: DSAEK type corneal transplant<br>* All surgeries were performed by the same surgeon and according to the same protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative visual acuity | postoperative visual acuity in logmar | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pachymetry | Measurement of the thickness of the cornea | Month 6 |
Validation and Characterization of Signal Decrease on an Oximeter in COPD (They Have Chronic Obstructive Pulmonary Disease) Patients During Deep Inhalation (

Study Overview
=================
Brief Summary
-----------------
The objective is to verify that there is a decrease in the pulsed oxygen saturation with the digital sensor. That is, the drop in oxygen saturation in COPD patients during inhalation is real and not due to an artifact of the measuring tool, because oximeters need a quality pulsatile signal to properly measure oxygen saturation

Official Title
-----------------
Validation and Characterization of Signal Decrease on an Oximeter in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Pulmonary Disease, Copd

Intervention / Treatment
-----------------
* Other: Measurements of oxygen saturation and finger pressure during deep inspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
healthy arm Inclusion Criteria: Healthy adults volunteers are recruited from students with normal lung function. Exclusion Criteria: abnormal lung function COPD Arm Inclusion Criteria: Adults with Chronic Obstructive pulmonary disease Exclusion Criteria: cardiovascular disease The subjects selected are selected on a voluntary basis among the patients coming to the pulmonary consultation. They have Chronic Obstructive Pulmonary Disease.

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: half healthy subject, half COPD patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Volunteers<br>oxymetry and finger pressure in Healthy subjects | Other: Measurements of oxygen saturation and finger pressure during deep inspiration<br>* Measurements during deep inspiration of oxygen saturation with pulse oximeter and finger pressure with pressure cuff<br>|
| Experimental: COPD patients<br>oxymetry and finger pressure in COPD patients | Other: Measurements of oxygen saturation and finger pressure during deep inspiration<br>* Measurements during deep inspiration of oxygen saturation with pulse oximeter and finger pressure with pressure cuff<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drop in oxygen saturation during deep inspiration in COPD | saturation is measured in percentage (SPO2) | from the intervention to 3 minutes after the start of the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD