linjc16/ctgov huggingface dataset:
Sustaining Women's Smoking Cessation Postpartum

Study Overview
=================
Brief Summary
-----------------
To conduct a five-year demonstration and education project to sustain smoking cessation postpartum by women who had stopped smoking in pregnancy.

Detailed Description
-----------------
BACKGROUND: The results from this study were expected to demonstrate the effectiveness of a practical program to protect women and their families from direct and indirect smoke exposure and to contribute longitudinal data on change processes involved in smoking cessation, especially those over the maintenance, relapse, and recycling stages, in a relatively complete population through a critical transition. DESIGN NARRATIVE: The TLC Program, unique in its focus on the postpartum period, used a researched model of behavior change that matched messages and skill training with the woman's stage of change. It also addressed the whole family to create a supportive environment for individual change, included other steps for families to protect children from passive smoke and negative modeling, and focused on smoking and smoke exposure directly as well as through self-care and child-care messages. The program used innovative materials, including videotapes and intervention. The study took place in two multi-ethnic health-care sites where the research team had conducted previous studies. The study used a randomized mixed design with 500 women who smoked regularly before pregnancy and who had been abstinent for > 30 days at their 28th week of pregnancy. The primary outcome was abstinence at one year postpartum. Secondary outcomes were partner smoking status and exposure of the index baby. Self report was validated biochemically in samples of mothers and babies. The study design separated data collection from the experiments by enrolling subjects in a university-sponsored study of new mothers' health-care site.

Conditions
-----------------
Lung Diseases, Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions

Study Overview
=================
Brief Summary
-----------------
The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%. Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this. There is currently no score established for the colo-rectal endoscopic submucosal dissection. To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital. Allow to obtain an estimation of number of patients required for a larger study.

Official Title
-----------------
Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays

Conditions
-----------------
Polyp of Colon

Intervention / Treatment
-----------------
* Procedure: endoscopic submucosal dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering of lesion relevant of endoscopic submucosal dissection treatment: Lesions for which en bloc resection with snare EMR is difficult to apply i/LST-NG, particularly LST-NG (PD) ii/ Lesions showing a VI-type pit pattern iii/ Carcinoma with shallow T1 (SM) invasion Large depressed-type tumors iv/ Large protruded-type lesions suspected to be carcinoma Mucosal tumors with submucosal fibrosis Sporadic tumors in conditions of chronic inflammation such as ulcerative colitis Local residual or recurrent early carcinomas after endoscopic resection Local res Les lésions de plus Male or female patients aged ≥ 18 years old Patients able to fill in questionnaires written in French Exclusion Criteria: Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris O-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: endoscopic submucosal dissection|endoscopic submucosal dissection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital. |  | From 2016 to 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allow to obtain an estimation of number of patients required for a larger study |  | From 2016 to 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic Submucosal Dissection
Compliance and Administration Technique in Topical Drug Therapy of Glaucoma

Study Overview
=================
Brief Summary
-----------------
Clinic-based evaluation of patients compliance with topical medications in the treatment of glaucoma. Also assessing effectiveness of delivery techniques among these patients.

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glaucoma 18 years of age or older Exclusion Criteria: Recent ocular surgery

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Compliance, Therapy, Administration technique
The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults

Study Overview
=================
Brief Summary
-----------------
The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study

Detailed Description
-----------------
Epilepsy is a common neurological condition. Unfortunately, just over 30% of patients with epilepsy (PWE) do not become seizure free with anti-epileptic drugs. Some patients may be suitable for epilepsy surgery. Alternative established treatments include vagal nerve stimulation and the ketogenic diet in children. The evidence base for the use of ketogenic diet in adults is limited. There are a few prospective studies and no randomised control trial to date. This study is a prospective observational cohort study for adult patients with drug resistant epilepsy who are not suitable for resective epilepsy surgery. The intervention is a modified ketogenic diet. The carbohydrate load will be between 20-30gm per day. Blood ketones and blood sugars will be monitored. The primary outcome measure is seizure frequency at 12 months. There are a number of secondary outcome measures including tolerability, seizure severity, quality of life, lipid profiles and health care utilisation.

Official Title
-----------------
The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: Modified Ketogenic Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
The study will have no formal inclusion/exclusion criteria as it is purely observational and it will be the clinical team's decision as to whether or not people are seen by the dietary clinic based on established dietary clinic protocols.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Modified Ketogenic Diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% responder rate |  | Twelve months |
Detection of Minimal Change Esophagitis by I-scan

Study Overview
=================
Brief Summary
-----------------
Study design and objective The primary outcome of this prospective cohort study was to identify the endoscopic findings that have diagnostic value for the prediction of NERD (minimal change esophagitis) by using HD endoscopy with i-scan. The secondary outcome was to evaluate the response to proton pump inhibitor (PPI) in GERD patients with or without minimal change esophagitis.

Detailed Description
-----------------
Background and aims Majority of patients with gastro-esophageal reflux disease (GERD) were non-erosive reflux disease (NERD). High definition (HD) endoscopy with i-scan could enhance visualization of mucosal and vascular pattern and might identify changes that were invisible at standard endoscopy. This study aimed to evaluate the endoscopic findings that may have diagnostic value for the prediction of NERD by using HD endoscopy with i-scan. Methods Patients with typical GERD symptoms and healthy control without GERD symptoms were included and 2 validated GERD questionnaires were completed. The endoscopist was blinded to the presence of reflux symptoms and distal esophagus was examined using standard white light endoscopy followed by i-scan. Mucosal morphology at squamocolumnar junction (SCJ) observed by i-scan were compared between GERD patients and controls.

Conditions
-----------------
Gastro-esophageal Reflux Disease, Non-erosive Reflux Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years of age and had ability to provide written informed consent Exclusion Criteria: pregnancy, cirrhosis or presence of gastroesophageal varices, gastrointestinal hemorrhage, angina pectoris, allergy to PPI, high risk or contraindication for endoscopy, chronic cough,laryngitis, asthma.

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
with or without GERD symptoms, presenting to gastrointestinal clinic of Maharaj Nakorn Chiangmai Hospital, November 2009 to November 2010, GERD, NERD
Optimal Time for Staple/Dressing Removal

Study Overview
=================
Brief Summary
-----------------
The medical literature does not provide sufficient information or recommendation regarding the optimal time to remove the staples and the bandage after a cesarean section. The goal of this study is to compare 5 groups of patients: staple removal on POD 4 and dressing removal on Post Operative Day (POD)1 staple removal on POD 4 and dressing removal on Post Operative Day (POD)4 staple removal on POD 7 and dressing removal on Post Operative Day (POD)1 staple removal on POD 7 and dressing removal on Post Operative Day (POD)7 staple removal on POD 4 and dressing removal on Post Operative Day (POD)7 Since there is no definite protocol for staple and dressing removal, we will adapt the above protocol each for a 3-4 month period of time. Patients will be contacted to either return for a follow up visit or to answer a telephone survey.

Official Title
-----------------
The Influence of the Timing of Staple and Dressing Removal After Cesarean Section on the Surgical Incision Healing

Conditions
-----------------
Surgical Wound Healing, Surgical Wound Infection, Patient Satisfaction

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing a cesarean section at our facility Exclusion Criteria: patients lost to follow up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| staple removal day 4 dressing removal day 1<br>early staple removal and early dressing removal | Other: questionnaire<br> <br> |
| staple removal day 4 dressing removal day 4<br>early staple removal and day 4 dressing removal | Other: questionnaire<br> <br> |
| staple removal day 7, dressing removal day 1<br>late staple removal and early dressing removal | Other: questionnaire<br> <br> |
| staple removal day 7, dressing removal day 7<br>late staple removal and late dressing removal | Other: questionnaire<br> <br> |
| staple removal day 7, dressing removal day 4<br>late staple removal and day 4 dressing removal | Other: questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Wound infection and complications |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caesarian section, Surgical Wound
Toxins and Delivery in e-Cigarette Users

Study Overview
=================
Brief Summary
-----------------
Electronic cigarettes or e-cigarettes (EC) may have a potential public health benefit as a safer alternative to smoking and possibly also as an aid in tobacco dependence treatment. However, there are concerns about their safety and whether they can deliver nicotine consistently and in doses necessary for such effects. To be able to consider the safety of ECs and their potential in harm reduction, data are needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional cigarettes, users of EC, and people who use both products at the same time. To accurately assess EC nicotine delivery, data are needed from people who use them regularly, as there is some evidence of higher and faster nicotine absorption in experienced users compared with naïve users who try them once in an artificial laboratory setting. This study will provide information on both of these issues. Forty smokers will be given EC to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of acrolein and nicotine will be measured before and after 4 weeks of EC use.

Official Title
-----------------
Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Other: e-Cigarette


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smokers who want help in quitting Aged 18 or over Exclusion Criteria: Women who are pregnant or breastfeeding People with any current serious illness

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 |
| --- | --- |
| e-Cigarette<br>Smokers attempting to quit with behavioural support and e-Cigarettes. | Other: e-Cigarette<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes. | Change in urinary 3HPMA levels (a metabolite of acrolein) after 4 weeks use of electronic cigarettes, in both individuals who have stopped smoking conventional cigarettes and those who are still using them. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nicotine levels after 4 weeks use of electronic cigarettes (EC) | Change in blood nicotine levels obtained from using an EC after 4 weeks use of electronic cigarettes (10 participants only). | 4 weeks | 
| Electronic cigarette acceptability | Participants' views on electronic cigarettes | 6 months | 
| Use of electronic cigarettes | Participants' use of electronic cigarettes | 6 months |
Peer Mentors for Adolescents in HIV Affected Families

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of a peer mentoring program designed for youths ages 9 to 15 whose parents or guardians are HIV infected. The program will focus on the youths' mental health, school performance, alcohol and drug use, personal and social behaviors, and behaviors that might expose them to HIV. The study is expected to enroll predominantly minority youth.

Detailed Description
-----------------
This study will conduct an efficacy trial of peer mentoring for a high-risk, predominantly minority population of 9- to 15-year-old youths whose parents are HIV infected. The study will also determine mechanisms (mediating variables) through which peer mentoring improves outcomes for the mentees, for example, consistency and continuity of relationship, teaching/role modeling, emotional support/empathy, advocacy, and behavioral reinforcement. After the conclusion of the efficacy trial, the study will continue through naturalistic longitudinal research for an additional 2 years in order to examine the long-term outcomes of peer mentoring. Participants are randomized to either the peer mentoring program or a control condition (a recreation program). Surveys are conducted at entry into the study, at 6 months, 1 year, and then annually for 2 years. Youths will also participate in focus groups. The surveys and focus groups will assess the youths' psychological functioning, academic adjustment, alcohol and drug use, HIV risk behaviors, delinquent/violent behaviors, peer relationships, prosocial activities, and coping/problem-solving skills. The study will also evaluate family outcomes, including parent/guardian functioning and improved permanency planning.

Official Title
-----------------
Peer Mentors for Early Adolescents in HIV-Affected Families

Conditions
-----------------
Adolescent Behavior, Health Behavior, HIV Seronegativity

Intervention / Treatment
-----------------
* Behavioral: Peer mentoring program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria HIV infected parent or guardian No previous involvement in the mentoring program Adolescent assent Parental consent

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 15 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Peer mentoring program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| substance use; association with substance using peers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health behavior, adolescent behavior, peer mentoring
A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.

Official Title
-----------------
A Partially Masked, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Latanoprost-PPDS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 yrs of age with ocular hypertension or open-angle glaucoma Subjects who have a best corrected visual acuity of 20/100 or better Exclusion Criteria: Subjects who wear contact lenses. Uncontrolled medical conditions Subjects requiring chronic topical artifical tears, lubricants and/or requiring any other chronic topical medications Subjects who have a history of chronic or recurrent inflammatory eye disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Punctal Plug<br> | Drug: Latanoprost-PPDS<br>* Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change from baseline |  | 6 weeks |