linjc16/ctgov huggingface dataset:
Effect of Music Therapy Intervention on Pain After Gynecological Surgery

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of musical therapy before and after gynecological surgeries on pain relief following surgery. The hypothesis is that musical therapy is effective in pain relief following surgical procedures.

Detailed Description
-----------------
The intention with the study is to focus on the first postoperative phase in a case of pain upon gynecologic abdominal surgery. The literature search revealed studies reporting that participates who had pre-operative session of music intervention for relaxation experienced a greater level of reducing pain levels both pre and post their operation than in the participates in the control group. It is therefore a decision to include one pre operative session of intervention with music therapy in the design. The study will carry out at the Gynecologic Unit, in Rambam Hospital, Israel.

Official Title
-----------------
Effect of Music Therapy Intervention on Pain After Gynecological Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: Music therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women are schedule to undergo gynecological surgeries Exclusion Criteria: Neuropathy Neurological conditions Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music therapy and Behavioral therapy<br>Music and behavioral therapy | Behavioral: Music therapy<br>* Music therapy will be given to patients 24 hours prior and for the first 48 hours after surgery<br>|
| Active Comparator: Music only<br>Music therapy without behavioral therapy | Behavioral: Music therapy<br>* Music therapy will be given to patients 24 hours prior and for the first 48 hours after surgery<br>|
| No Intervention: Control<br>Patients will not listen to music neither will get music therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level following surgery | VAS will be used for the evaluation of pain level | 48 hours following suegery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Music therapy, pain, gynecological surgeries
Effects of Maternal Obesity on Offspring Brain Development

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development.

Detailed Description
-----------------
This study will recruit pregnant women who are either obese or normal weight and otherwise healthy. We will measure their body composition, food intake and other characteristics during pregnancy. When their babies are born, we will evaluate the brain development of their babies using magnetic resonance imaging and electroencephalography at age two weeks. We will then compare the findings and see if their are differences.

Official Title
-----------------
Effects of Maternal Obesity on Offspring Brain Development

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18.5-25 or >30 with early OB visit medical records accessible singleton pregnancy about 36wks of pregnancy at least 18 years of age Exclusion Criteria: hypertension, diabetes, or other preexisting medical conditions medications known to influence fetal growth recreational drugs, nicotine or tobacco use of alcohol use while pregnant pregnancy conception with assisted fertility treatment medical complications developed during pregnancy

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 |
| --- | --- |
| Obese pregnant women<br>BMI >30 with early OB visit medical records accessible | |
| Normal weight pregnant women<br>BMI 18.5-25 with early OB visit medical records accessible. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether maternal obesity correlates with abnormal brain development in newborns | Brain will be imaged at 2wks using an MRI | 2 weeks |
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC

Study Overview
=================
Brief Summary
-----------------
The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on gestational weight gain (GWG) in a low-income population.

Official Title
-----------------
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)

Conditions
-----------------
Gestational Weight Gain

Intervention / Treatment
-----------------
* Behavioral: Nutrition and physical activity intervention
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15-20 weeks gestational age and 18 years of age or older at time of recruitment body mass index (BMI) of 25-45 kg/m2 in the first trimester possession of a cellular phone with the ability to receive text messages without a charge Exclusion Criteria: conditions requiring a special diet multiparous pregnancies unable to consent to participate unwilling to be randomized

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

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition and physical activity intervention<br> | Behavioral: Nutrition and physical activity intervention<br>* Messages sent on nutrition and physical activity in pregnancy<br>|
| Other: Control<br> | Behavioral: Control<br>* Messages sent on general health during pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change between pre-pregnancy weight and last weight taken before delivery | Total weight gained during pregnancy | From date of randomization until delivery of child (e.g. up to 25 weeks) |
Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether a standardized intervention in the health center and based on hygienic dietary measures and physical exercise, supplemented with a polyphenol extract in patients, achieves a greater benefit in the reduction of LDL cholesterol in dyslipidemias in the short term.

Official Title
-----------------
Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

Conditions
-----------------
Cholesterol; Metabolic Disorder, Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Olive polyphenols
* Dietary Supplement: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with dyslipidemia without the need for pharmacological treatment, but with annual follow-up of their dyslipidemia and with baseline LDL-cholesterol values. Patients to whom the annual analysis will be carried out for control of the lipid profile and who agree to postpone it during the month of the health education study. Patients who undergo hygienic-dietetic intervention and exercise. Patients willing to ingest the nutritional supplement of polyphenols that will be supplied to them. Signed the informed consent. Exclusion Criteria: <18 years old. High cardiovascular risk. With pharmacological treatment. With some previous chronic disease. With some allergy to the compounds of the product and placebo according to the technical specifications.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olive polyphenols<br> | Dietary Supplement: Olive polyphenols<br>* The amount of polyphenols to be supplied is within the ranges of absolute biosecurity food described by different authors and used in different studies.<br>|
| Placebo Comparator: Control<br> | Dietary Supplement: Control<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterols levels | TC, HDL-C, LDL-C and TG. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (kg/m2) | Weight and height will be combined to report BMI in kg/m^2 | 1 month | 
| Blood pressure | SBP and DBP. | 1 month | 
| Waist circumference (cm) |  | 1 month |
Evaluating Adapted Structured Clinical Management for People With a Diagnosis of Personality Disorder

Study Overview
=================
Brief Summary
-----------------
Camden and Islington NHS Foundation Trust in London has a Personality Disorder Service (PDS) which offers a number of evidence-based interventions to people with a diagnosis of Personality Disorder. One team in the PDS, the Community Team, offers an adapted form of Structured Clinical Management (SCM; Bateman and Kravitz, 2013). As these adaptations are novel, this study aims to formally explore the effectiveness of this intervention, through a sample of clients under the team, with outcomes (proxy measures of distress such as inpatient admissions) pre- and post- intervention.

Official Title
-----------------
Evaluating Adapted Structured Clinical Management for People With a Diagnosis of Personality Disorder

Conditions
-----------------
Personality Disorders

Intervention / Treatment
-----------------
* Other: Adapted Structured Clinical Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allocated to a care coordinator at the PDS for greater than one year (a reasonable time period for therapeutic rapport to form and the effect of the intervention to manifest). Exclusion Criteria: No existing notes for one year prior to allocation. No primary diagnosis of Personality Disorder.

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 |
| --- | --- |
| Clients under PDS Community Team<br>27 adult clients under PDS Community Team | Other: Adapted Structured Clinical Management<br>* Adapted form of a previous Evidence Based Treatment- adapted to local context, in light of input from service-users and commissioners.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proxy measures of client distress | Inpatient admissions, safeguarding concerns, crisis centre contacts, crisis house admissions, criminal justice contacts. | One year pre-referral and one year post-allocation |
Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects.

Detailed Description
-----------------
Aim: To study the effect of low dose aspirin on exhaled breath inflammatory mediators To compare the change to that seen in diseased states such as asthma and Lymphangioleiomyomatosis (LAM) We will interview healthy volunteers to confirm that they do not have any major underlying medical conditions such as heart disease, diabetes, stroke and bleeding disorders. We will collect breath condensate before and after two weeks of low dose over the counter enteric coated aspirin 81 mg/day therapy. Side effects are extremely rare at this dose, but include bleeding, heart burn and allergic reaction.

Official Title
-----------------
Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects

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

Intervention / Treatment
-----------------
* Drug: aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults Exclusion Criteria: any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspirin<br>Low dose daily aspirin in healthy volunteers for two weeks | Drug: aspirin<br>* 81 mg orally daily for two weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Exhaled Inflammatory Mediator Levels | Descriptive statistics | baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy volunteers, aspirin, Normal healthy subjects
Epidemiology of Injuries During Crossfit Practice

Study Overview
=================
Brief Summary
-----------------
This study aims to precisely describe epidemiology of injuries than occur during practice of crossfit. Each participant will complete questionnaires in order to identify injuries. The first questionnaire will be completed at the moment of the inclusion and the second questionnaire will be completed if participant has injuries every 3 months until month 12.

Official Title
-----------------
Epidemiology of Injuries During Crossfit Practice : a Prospective Cohort Study at Reunion Island

Conditions
-----------------
Sport Injury

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: person affiliated to a crossfit structure at Reunion Island at the beginning of the study personne who agrees to participate in the study Exclusion Criteria: person under tutorship or curatorship, person whose the initial questionnaire initial is complete, person who can neither read nor write french. person planning to leave Reunion Island within 12 months after enrolment in the study

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 |
| --- | --- |
| Questionnaire<br>Participant must complete a questionnaire about injury during crossfit practice | Other: Questionnaire<br>* Participant must complete a questionnaire about injury during crossfit practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of injury by questionnaire | the location of the injury on the body must be specified | at month 3 | 
| laterality of injury by questionnaire | Laterality of injury must be precised if to be at right or left | at month 3 | 
| mechanism of injury by questionnaire | it will be identified as a traumatic injury or an overuse. Traumatic injury is due to an acute identified event. An overuse is due to repetitive train injury. | at month 3 | 
| circumstance of injury occurence by questionnaire | circumstance is defined as when occurs injury : suddenly or gradually | at month 3 | 
| injury relapse or not | injury relapse is classified as early relapse if occurs within 2 months after the healing, as late relapse if occurs from 2 months to 12 months after the healing or as very late relapse if occurs after more 12 months. | at month 3 | 
| diagnosis of injury | diagnosis will be classified according to the OSICS 10 classification | at month 3 | 
| record of exposure to injury | Training volume will be recorded by level of practice (leisure practice, club practice and competition practice) | at month 3 |
Nutrition Education Module for Preschooler Children

Study Overview
=================
Brief Summary
-----------------
This study evaluates the knowledge of preschooler children before and after intervention of nutrition education using nutrition education module for preschooler children. The teachers will be given training regarding the module and deliver it in the class during the intervention.

Detailed Description
-----------------
A nutrition education module for preschooler children had been developed in the previous study. The module consists of 3 topics of nutrition (my meal plate, fruits and vegetables, healthy snacks). Each topic consists of 4 activities engaging children and teachers. A total of 12 activities will be delivered on 4 consecutive school day every week. The teacher will deliver the nutrition education which trained prior to the study.

Official Title
-----------------
the Effectiveness of Nutrition Education Module to Knowledge of Preschooler Children in Public Kindergarten at 3 Districts of Riau Province

Conditions
-----------------
Children Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and Teacher

Intervention / Treatment
-----------------
* Behavioral: nutrition education module


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children registered in selected public kindergarten grade/class B kindergarten willing to follow the study Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a quasi-experimental research design with pre-and post-test control group design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nutrition education module<br>12 activities of the nutrition education module pre and post test | Behavioral: nutrition education module<br>* 12 activities of nutrition education module will deliver by the teacher. The activities consists of coloring my meal plate, playing pictures, story telling: Zizi and Ziko, pictures station, fruits and vegetables card, cooking class, planting bean sprouts, field visit to fruits and vegetables garden, making collages, dot to dot, watching video, making healthy snacks<br>|
| No Intervention: control group<br>no intervention pre and post test | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on nutrition related knowledge before and after intevention | a self administered structured questionnaire regarding nutrition related knowledge (my meal plate, fruits and vegetables, healthy snacks) using pictures yielding a total score between 0-100 | 3 weeks |
Retrospective Study in Patients With Metastatic Renal Cancer Treated With TKI Sequence (Tyrosine Kinase Inhibitors of VEGFR) - mTOR- Axitinib Inhibitors or Anti-VEGF Antibody -Inhibiteurs mTOR - Axitinib

Study Overview
=================
Brief Summary
-----------------
Describe in patients with metastatic kidney cancer treatment modalities with the type sequences: TKI - mTORi - Axitinib or VEGF mAb - mTORi - Axitinib.

Conditions
-----------------
Kidney Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient with metastatic kidney cancer (all histological types) Male or female aged (e) of 18 or more Patient has been treated or under treatment with axitinib (Inlyta®) in the third line after the first line of targeted TKI therapy and after mTORi in 2nd line, or Patient receiving the treatment sequence VEGFmAb - mTORi - axitinib For living patients: patient informed and having given oral consent Exclusion criteria: Patient who received more than one line of antiangiogenic therapy in the metastatic phase before initiation of treatment with axitinib (except patients in the study Pisces) Patient received a second line treatment with TKI Patient refused to participate in the study

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 |
| --- | --- | --- |
| Evolution of Kidney cancer |  | after surgery, up to 1 year] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Neoplasms, Kidney, Neoplasms, TKI, Axitinib, VEGF, mTORi