linjc16/ctgov huggingface dataset:
Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors : a Cross-sectional Study

Study Overview
=================
Brief Summary
-----------------
Several types of gingival phenotype can be diagnosed in the general population and their evaluation is an essential clinical criterion in periodontal practice, whether the periodontal therapies are preventive or curative, non-surgical or surgical. Moreover, several authors have shown that the gingival phenotype varies from one dental sector to another, hence the interest of a meticulous and targeted diagnostic approach in relation to the established therapeutic objectives. To date, the gingival phenotype has been not studied extensively in the mandibular incisal area. Therefore, it seems relevant to conduct an observational cross-sectional study on a cohort of patients in good general health and with a healthy and intact periodontium to assess the prevalence of the gingival phenotype in this area. The secondary objective is to highlight the associated intrinsic and extrinsic risk factors for thin gingival phenotype, to anticipate a risk of gingival recession and to propose an early personal therapy.

Official Title
-----------------
Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors in French Dental Students Population : a Cross-sectional Study

Conditions
-----------------
Gingival Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age (18 years old or older) dental student on the university hospital of Nice social security affiliate systemically healthy healthy and intact periodontium informed consent. Exclusion Criteria: pregnancy under any regular medical treatment active periodontal disease presence of plaque enduring orthodontic treatment periodontal surgery in the mandibulary anterior region non consent patient patient under judgment trials.

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 |
| --- | --- |
| Main Cohort<br>Dental students on the university hospital of Nice | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival phenotype prevalence | Assessment of gingival thickness (Kan et al 2015) and keratinised tissue height of the lower incisors with UNC-15 periodontal probe (Hu-Freidy, USA) and clinical photography. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated risk factors for thin gingival phenotype | Age, gender, smoking habit, orthodontic background, oral hygiene habit, oral ventilation, dysfunction, facial typology, chin shape, visibility of vascularisation and root convexity through the gum, gingival recession (Cairo), frenal insertion and skin type. | 18 months |
E-health Literacy and Healthy Lifestyle Behaviors of University Students Studying Health Education in Turkey

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the relationship between e-health literacy and healthy lifestyle behaviors of university students receiving health education in Turkey.

Official Title
-----------------
Relationship Between E-health Literacy and Healthy Lifestyle Behaviors of University Students Studying Health Education in Turkey

Conditions
-----------------
E-health Literacy, Healthy Lifestyle Behaviors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteering to participate in the study, being at least an associate degree student in the study area of health education Exclusion Criteria: having any vision and hearing problems

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 27 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 |
| --- | --- | --- |
| E-health literacy | The E-Health Literacy Scale will used to determine the participants' e-health literacy.The scale consists of 2 items related to internet use and 8 items measuring internet attitude. The scale items are organized as 1= strongly disagree, 2= disagree, 3= undecided, 4= agree, 5= strongly agree with a 5-point Likert-type scaling method. The lowest score is 8 points and the highest score is 40 points. A high score obtained from the scale indicates a high level of e-health literacy. | baseline | 
| Healthy lifestyle behavior | Participants' healthy lifestyle behaviors were assessed with the Healthy Lifestyle. Behaviors Scale II The scale consists of 52 items and six factors. These are health responsibility, physical activity, nutrition, spiritual development, interpersonal relationships and stress management. The scale is scored on a scale of never=1, sometimes=2, often=3, regularly=4. A high score indicates relatively positive healthy living behaviors. The lowest score for the whole scale is 52 and the highest score is 208. The score of the whole scale gives the score of the healthy lifestyle behaviors. Higher scores indicate that the person practices the specified health behaviors at a high level | baseline |
CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.

Official Title
-----------------
Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: CDK4/6 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥18 and older Confirmed diagnosis of hormone receptor-positive breast cancer. Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy. Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease. ECOG 0-2 Adequate organ function Exclusion Criteria: Subjects disable to swallow pills. History of immunodeficiency 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients have received or plan to receive CDK4/6 inhibitors for advanced disease.<br> | Drug: CDK4/6 inhibitor<br>* CDK4/6 inhibitors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first. | From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival is defined as the time from starting CDK4/6 inhibitor to death from any cause. | From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years | 
| Adverse events | Adverse events during CDK4/6 regimen will be assessed according to the NCI CTCAE v5.0. | From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locoregionally Recurrent, Metastatic, CDK4/6 Inhibitors
The TALK for Black Male Adolescent Sexual Health

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to construct the first nurse-led web-based intervention, The TALK, a parent-centered, adolescent-involved health promotion intervention for Black male adolescents and young adults (AYA). Through the use of entertainment videos and educational modules, investigators will provide parents with resources and tools for communicating with their adolescents about sexual health and experiences of racial discrimination, and how these experiences impact sexual health.

Official Title
-----------------
The TALK; A Novel Nurse-led, Family-based Web-based Application Marketed in Barbershops and Beauty Salons for Black Fathers and Mothers to Promote Sexual Health Among Black Male Adolescents and Young Adults in the United States

Conditions
-----------------
Sexuality Education

Intervention / Treatment
-----------------
* Behavioral: The Talk Web-based resources


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identified as a parent, parent figure, or caregiver of a Black or African American male adolescent between the ages of 13-17 years, able to speak and read English. Adolescents of these parents will also be recruited along with their parents. Adolescents recruited will be required to sign additional consent forms. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The TALK intervention for Black male adolescents and young adults (AYA)<br>The TALK, a parent-centered, adolescent-involved health promotion intervention for Black male adolescents and young adults (AYA). Through the use of entertainment videos and educational modules, investigators will provide parents with resources and tools for communicating with their adolescents about sexual health and experiences of racial discrimination, and how these experiences impact sexual health. | Behavioral: The Talk Web-based resources<br>* Educational videos and podcasts for parents and their sons<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Usability of The TALK as measured by number of website uses | 6 months | 
| Acceptability | Acceptability of The TALK as measured by participant survey feedback | 6 months | 
| Communication Frequency | Frequency of parent-adolescent sexual health communication measured by survey feedback | 6 months | 
| Communication Quality | Quality of parent-adolescent sexual health communication as measured by survey feedback | 6 months |
An App to Reduce Cannabis Use Among Emerging Adults

Study Overview
=================
Brief Summary
-----------------
This study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as cannabis. This study will help researchers learn about ways of delivering this information that is both appealing and helpful to young adults who use mobile apps.

Official Title
-----------------
Pilot Project 1. Feasibility Pilot of a JITAI to Reduce Cannabis Use Among Emerging Adults

Conditions
-----------------
Cannabis Use

Intervention / Treatment
-----------------
* Other: Just-In-Time-Adaptive-Intervention (JITAI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reside in the US Speak and read English Have a smartphone on which the app can be downloaded Screen positive for cannabis use 3 or more times each week over the past month Report motivation to change cannabis as 1 or higher (using scale of 0-10) Meet Study verification criteria (i.e., use of CAPTCHA, IP address checks) Exclusion Criteria: Use of Medical Cannabis Failure to meet study verification criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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: JITAI<br>Experimental: Within-participant micro-randomization Twice daily in the study, a participant is assigned to receive a message or no message. The micro-randomization will be performed by a reinforcement learning algorithm based on the participant's engagement with the intervention. | Other: Just-In-Time-Adaptive-Intervention (JITAI)<br>* Behavioral: MiWaves behavioral messages Participants will be using the MiWaves mobile app for 30 days. When a participant is assigned to receive a message, a message will be randomly selected from a pool of intervention message sets. Messages are based in motivational interviewing and include affect management and behavioral economic strategies.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| App Feasibility | % of participants who consented to the study who download the MiWaves app. | 1 month | 
| App Acceptability | Participants will complete acceptability ratings for the MiWaves app within their post-test assessment (percent with positive rating). | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cannabis Use, Marijuana, Substance-Related Disorders, Mental Disorders
Evaluation of Patient Information in Interventional Radiology.

Study Overview
=================
Brief Summary
-----------------
Interventional radiology is developing. Patient information modalities are also evolving, in particular information videos. The aim of this work is therefore the evaluation of patient information in interventional radiology

Official Title
-----------------
Evaluation of Patient Information in Interventional Radiology.

Conditions
-----------------
Patient Satisfaction

Intervention / Treatment
-----------------
* Other: Questionary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who receives a consultation before an interventional procedure. Exclusion Criteria: None

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient who receives a consultation before an interventional procedure<br>Any patient who receives a consultation before an interventional procedure will be included. Questionary will be administrated. | Other: Questionary<br>* Questionary will be administrated to evaluated the information for patients on interventional radiology (dedicated consultation, information posters, explanatory video, information form, etc.).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate effectiveness of each patient information tool by Consultation with the interventional radiologist | Analysis results of questionary. | Year : 2 | 
| To evaluate Effectiveness of each patient information tool by Consultation with another doctor who explained the procedure | Analysis results of questionary. | Year : 2 | 
| To evaluate Effectiveness of each patient information tool by Explanatory videos | Analysis results of questionary. | Year : 2 | 
| To evaluate Effectiveness of each patient information tool by Patient information sheet | Analysis results of questionary. | Year : 2 | 
| To evaluate Effectiveness of each patient information tool by Posters in the consultation room | Analysis results of questionary. | Year : 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interventional radiology, Information, videos
Clinical Relevance of Small Airways Disease in Severe Asthma Patients Treated With Anti-InterLeukin-5 Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of this research is to investigate the extent and clinical relevance of small airways disease in severe eosinophilic asthma patients treated with anti-IL5/5R therapy.

Official Title
-----------------
Clinical Relevance of Small Airways Disease in Severe Asthma Patients Treated With Anti-InterLeukin-5 Therapy

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe asthma patients treated with anti-IL5/5R therapy (i.e. mepolizumab, benralizumab, reslizumab) for at least 4 months. Exclusion Criteria: No information about lung function at baseline, or after both 4 months and 12 months. No information about clinical response (i.e. number of exacerbations, reduction of mOCS/ maintenance oral corticosteroid dose, ACQ, AQLQ) after both 4 months and 12 months. Treatment with another anti-IL5/5R therapy before
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 |
| --- | --- | --- |
| Is change in FEF25-75 during anti-IL5/5R treatment associated with change in asthma control (measured with the asthma control questionnaire -ACQ-) in severe eosinophilic asthma patients after 4 months and after 12 months treatment? | Is change in FEF25-75 during anti-IL5/5R treatment associated with change in asthma control (measured with the asthma control questionnaire -ACQ-) in severe eosinophilic asthma patients after 4 months and after 12 months treatment? | 4 months and 12 months |
Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

Detailed Description
-----------------
The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

Official Title
-----------------
Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis-A Randomized Controlled Trial

Conditions
-----------------
Pancreatectomy

Intervention / Treatment
-----------------
* Drug: Indomethacin suppository
* Other: Standard Medical Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: *All patients planned to undergo pancreatectomy. Exclusion Criteria: asthma allergic reactions to NSAIDs CKD internal hemorrhoids anti-platelet medications

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment | Drug: Indomethacin suppository<br>* 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia<br>Other: Standard Medical Treatment<br>* Standard Medical Treatment<br>|
| Active Comparator: Group B<br>Standard Medical Treatment | Other: Standard Medical Treatment<br>* Standard Medical Treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-pancreatectomy Acute Pancreatitis |  | 2 weeks after pancreatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic Fistula |  | 30 days after pancreatectomy | 
| Peripancreatic abscess |  | 30 days after pancreatectomy | 
| Length of hospital stay |  | 30 days after pancreatectomy |
Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

Study Overview
=================
Brief Summary
-----------------
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure to remove stones from the kidney by a small puncture wound through the skin. Patients receiving lidocaine infusion had lower pain scores, reduced postoperative analgesic requirements and decreased intraoperative anesthetic requirements. Erector spinae plane block (ESPB) seems to be effective when compared with no block or a placebo block.

Official Title
-----------------
Intravenous Lidocaine Infusion Versus Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

Conditions
-----------------
Postoperative Analgesia

Intervention / Treatment
-----------------
* Drug: Intravenous lidocaine infusion
* Other: Erector spinae plane block (ESPB)
* Other: Intravenous infusion of normal saline
* Other: ESPB with normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) score I-II.. Body mass index < 35 kg/m2. Exclusion Criteria: Patient's refusal. Known coagulopathy. Known peripheral neuropathy or neurological deficits. Chronic pain disorders. Known allergy to study drugs

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous lidocaine infusion<br> | Drug: Intravenous lidocaine infusion<br>* Intravenous lidocaine infusion<br>|
| Active Comparator: Erector spinae plane block (ESPB)<br> | Other: Erector spinae plane block (ESPB)<br>* Unilateral erector spinae plane block<br>|
| Placebo Comparator: Intravenous infusion of normal saline and ESPB with normal saline<br> | Other: Intravenous infusion of normal saline<br>* Intravenous infusion of normal saline<br>Other: ESPB with normal saline<br>* Unilateral ESPB with normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first rescue analgesia | Time to first rescue analgesia | 24 hours postoperatively |