linjc16/ctgov huggingface dataset:
Effects of a Chewing Gum Containing POs-Ca and Fluoride on Enamel

Study Overview
=================
Brief Summary
-----------------
There were no differences in the degree of enamel remineralization of subsurface lesions among the chewing gums containing or not containing POs-Ca and fluoride.

Official Title
-----------------
Effects of a Chewing Gum Containing POs-Ca and Fluoride on Remineralization of Enamel Subsurface Lesions in Situ

Conditions
-----------------
Enamel Subsurface Lesion

Intervention / Treatment
-----------------
* Dietary Supplement: chewing gum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult subjects More than 22 permanent teeth Exclusion Criteria: Alcohol addiction Smoking Active caries Periodontal pockets Low-saliva flow (less than 0.3ml/min)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 31 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Dietary Supplement: chewing gum<br>* chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions<br>|
| Active Comparator: POs-Ca<br> | Dietary Supplement: chewing gum<br>* chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions<br>|
| Active Comparator: POs-Ca+F<br> | Dietary Supplement: chewing gum<br>* chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mineral content of enamel | Mineral content of bovine enamel blocks inserted into the subject mouth during chewing of the gums was assessed. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chewing-gum, enamel subsurface lesion, calcium additives, fluoride, in situ
Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation in Children With Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to map regions of brain activation following rectal stimulation in children with irritable bowel syndrome (IBS) and healthy controls.

Detailed Description
-----------------
Our first aim is to compare the brain areas activated rectal stimulation in boys and girls with IBS and healthy children. Our second aim is to compare the anatomic regions of the brain activated during rectal stimulation in pre and post-pubertal male and female subjects between 10-18 yrs of age.

Official Title
-----------------
Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation Following Rectal Stimulation in Children With Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 10 years to 18 years who provide written assent and whose parents provide written permission for participation English-speaking Subjects in the IBS group will meet Rome III criteria for IBS as determined by a pediatric gastroenterologist. Exclusion Criteria: Other pain-related diseases, functional gastrointestinal disorders, or somatization disorder Mental retardation or pervasive developmental disorder or epilepsy Psychosis Genetic or chromosomal disorders Currently receiving psychoactive drug treatment Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning Inability to lie still in the scanner Claustrophobia (Inability to lie still in the scanner) Pregnancy Subjects who admit to substance abuse during screening Orthodontic braces

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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 |
| --- | --- |
| IBS<br>Children between the ages of 10 and 18 who meet Rome III criteria for IBS as determined by a pediatric gastroenterologist. | |
| Control<br>Healthy children between the ages of 10 and 18. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We intend to measure the degree of brain activation following rectal stimulation |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fMRI, IBS, Brain Activation
Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the effect of addition of an adsorber during cardio pulmonary bypassin patients with infective endocarditis undergoing valve surgery, and if it will decrease the use of vasoactive drugs postoperatively.

Official Title
-----------------
Does Whole Blood Adsorber During CPB Reduce the Amount of Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery? -a Randomized Controlled Study

Conditions
-----------------
Infective Endocarditis

Intervention / Treatment
-----------------
* Device: CytoSorb


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infected endocarditis patients undergoing heart valve surgery. Age over 18 years. Exclusion Criteria: 1 Declines participation

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Addition of whole blood adsorber to CPB circuit | Device: CytoSorb<br>* Addition of a hemofilter to the cardiopulmonary bypass circuit<br>|
| No Intervention: Control<br>Standard treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of vasoactive substances | Use of norepinephrine in ICU | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Milrinone use | Amount of milrinone used 24 and 48 hours postoperatively | 48 hours | 
| Chest tube bleeding | Chest tube output in ml | 48 hours | 
| Blood transfusions | Transfusion of red blood cells, plasma and platelets | 48 hours |
Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.

Official Title
-----------------
Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: nortriptyline
* Drug: transdermal nicotine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-70, smoking > 10 cigarettes per day, no current major depression, no concurrent psychiatric medications Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: 1<br>Transdermal nicotine plus nortriptyline | Drug: nortriptyline<br>* Dose titrated to 75 mg daily as tolerated combined with transdermal nicotine 21 mg<br>|
| Active Comparator: 2<br>Transdermal nicotine plus placebo | Drug: transdermal nicotine<br>* Transdermal nicotine 21 mg, titrated down plus placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated smoking cessation |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation
Immune Responses to the Flu Shot During Pregnancy

Study Overview
=================
Brief Summary
-----------------
This study will examine effects of everyday life stress and obesity on immune responses to influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody levels against influenza (the flu) increase. Higher antibody levels indicate better immune protection from influenza. In addition to providing protection from the flu for yourself, being vaccinated during pregnancy may protect your baby from the flu during the first six months of life during which time infants cannot be vaccinated. Our primary goals are to determine whether greater life stress and obesity reduce 1) antibody responses to the flu shot in women and 2) antibody levels in the newborn at the time of delivery.

Official Title
-----------------
Immune Responses to the Flu Shot During Pregnancy

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Biological: influenza virus vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less than 29 weeks pregnant ages 18-42 planning to deliver at The Ohio State University Wexner Medical Center Exclusion Criteria: prior serious adverse reaction to seasonal influenza vaccine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 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 |
| --- | --- |
| Flu Shot<br>pregnant women receive a seasonal influenza virus vaccination | Biological: influenza virus vaccination<br>* comparison of immune responses to the flu vaccine in obese and non-obese populations<br>* Other names: flu vaccine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal HAI Antibody Titers | Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay | 30-days after influenza vaccination | 
| Maternal HAI Antibody Titers | Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant HAI Antibody Titers | Infant influenza antibody titers from hemagglutination inhibition (HAI) assay | cord blood at delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnant, flu shot, influenza, vaccine
Platelet Response During the Second Cycle of Decitabine Can Predict Response and Survival for Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of decitabine and identify predictors for response to decitabine therapy.

Detailed Description
-----------------
Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications Survival and response Analysis Response rate Overall survival Leukemia free survival

Official Title
-----------------
Retrospective Study for Predictive Marker for Decitabine Treament in MDS Patients

Conditions
-----------------
Myelodysplastic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications

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 |
| --- | --- |
| MDS patients<br>MDS patients who were treated with decitabine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | International Working Group (IWG) response criteria | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | measured from the date of decitabine therapy to the date of death or the last follow-up visit | 1 year | 
| Leukemia free survival | the date of decitabine therapy to the date of death or leukemic transformation | 1 year |
Evaluation of Breast Reduction Techniques

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to retrospectively evaluate breast reduction techniques in terms of complications, functionality, patient satisfaction, and cosmetic outcomes.

Detailed Description
-----------------
A breast reduction is a common operation with a fairly high complication rate as large incision techniques require undermined skin flaps to be closed under tension. This study is evaluation the open incision breast reduction technique to a liposuction assisted breast reduction. This study will evaluate these two breast reduction techniques in terms of complication rates, functionality, patient satisfaction, and cosmetic outcomes. Participants will be asked to complete the BREAST-Q survey regarding their breast reduction postoperatively.

Official Title
-----------------
Breast Reductions: Retrospective Evaluation of Suction Assisted Breast Reduction With Peri-Areolar Mastopexy Compared to Longer Incision Pedicle Breast Reduction Techniques

Conditions
-----------------
Breast Reductions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent a breast reduction between 2013 and 2019 All patients who underwent a liposuction assisted or layered skin incision pedicled technique breast reduction. Exclusion Criteria: Patients who underwent additional procedures simultaneously at the time of the breast reduction.

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 |
| --- | --- |
| Liposuction Assisted Breast Reduction<br> | |
| Open Incision Breast Reduction<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complication Rate | To determine if liposuction assisted breast reduction has a lower postoperative complication rate as opposed to open incision breast reduction | Postoperative Period (Average of 1 year following surgery) | 
| Breast Reduction Success Rate | To determine if liposuction assisted breast reduction has a higher success rate as opposed to open incision breast reduction based on postoperative outcomes. | Postoperative Period (Average of 1 year following surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Reductions
Information and Anaesthesia in Paediatrics

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy. Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention. Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.

Official Title
-----------------
Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Other: Information with comics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female children between 6 to 16 years and 11 month old. Children scheduled to have a craniotomy or orthopaedic surgery (multi-level surgery, spinal decompression, osteosarcoma resection, column surgery , fibroid curettage, Nuss bar procedure, hip varus surgery) or visceral and urologic surgery (intestinal continuity restoration, hypospadias surgery, bladder malformation, sarcoma). Children with a high, normal or light level of verbal comprehension (normal academic level or less than two repeating). Children coming with their parents. Exclusion Criteria: Previous surgery. Unwillingness to participate (parents or child)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Information of children with comic leaflet | Other: Information with comics<br>* Information of children with comic leaflet<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of anxiety scale (STAIC-S) |  | before preanaesthesia consultation and after preanaesthesia consultation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension) |  | before preanaesthesia consultation | 
| Level of anxiety scale (STAIC-T) |  | Before preanaesthesia consultation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, anaesthesia, child, Elective surgery, RCT
Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere, France

Study Overview
=================
Brief Summary
-----------------
This study evaluates the relation between sens of coherence and primary dysmenorrhea. Aself-questionnaire is completed by a sample of girls aged between 14 and 19, schooled in Finistère (France).

Detailed Description
-----------------
Primary dysmenorrhea affects more than 60% of adolescent girls. Menstrual pain increases absenteeism and lowers self-esteem and academic performance. Moreover, dysmenorrheal women suffer more depression and anxiety. Sense of coherence (SOC) is composed of three items: comprehensibility: what the person understands about his illness manageability: what the person does to cope meaningfulness: what the disease means to the person. A high SOC score is related to good mental and physical health. The aim of this study will be to determine if there is a relationship between primary dysmenorrhea and the sense of coherence. A self-questionnaire composed of the SOC-13 and a scale evaluating dysmenorrhea will be proposed in the voluntary high schools of Finistère (France) to the girls of the classes chosen at random.

Official Title
-----------------
Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere: Cross-sectional Observational Study

Conditions
-----------------
Primary Dysmenorrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: student in high schools aged 14 and 19 years with menstrual cycle Exclusion Criteria: Illiteracy student and parents opposition

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 Years

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

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 |
| --- | --- | --- |
| Presence / absence of dysmenorrhea | Presence / absence of dysmenorrhea objectified by Visual Analogue Scale (EVA) from 0 to 10 indicating the average pain over the last 3 cycles (if greater than 3 without treatment = primary dysmenorrhea) | Inclusion - Day 0 | 
| Sense of coherence | Sense of coherence measured by the self-administered French SOC-13 questionnaire (Likert scale). | Inclusion - Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sens of coherence, Primary dysmenorrhea, Salutogenesis, Teenagers