linjc16/ctgov huggingface dataset:
Dietary Supplementation of of DHA, Vitamin D3 and Uridine in Children

Study Overview
=================
Brief Summary
-----------------
The feasibility of combining a motor and cognitive exercise program with dietary supplementation (DDU: Vitamin D, DHA and Uridine or Placebo) is tested in a smaller group of prepubescent children.

Conditions
-----------------
Children

Intervention / Treatment
-----------------
* Dietary Supplement: DDU-supplement
* Dietary Supplement: Placebo supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - age 8 to 11 yrs. Exclusion Criteria: history of neurological or psychiatric disorders.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 11 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Dietary Supplement: DDU-supplement<br>* DDU: Vitamin D, DHA, Uridine<br>|
| Placebo Comparator: Group 2<br> | Dietary Supplement: Placebo supplement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to cognitive and motor training program (Move It To Improve It: MiTii) | Internet based program with evaluation of numbers of training sessions. At least 14 training sessions out of 18 should be completed. | 6 weeks | 
| Dietary compliance | Supplement was provided to the children and ingestion was registered by the parents. | 6 weeks |
A Follow-up Physician Survey to Evaluate Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe

Study Overview
=================
Brief Summary
-----------------
With this follow up physician survey researcher want to collect the same data from all participants of the study using a highly structured questionnaire. The questionnaire will gather information related to physician characteristics and experience with Aflibercept, as well as assess physicians' knowledge and understanding of storage and preparation, proper injection technique, and the risks associated with Aflibercept injection into the eye (intravitreal injection). Analysis will be done using descriptive statistics.

Official Title
-----------------
Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe: A Follow-up Physician Survey

Conditions
-----------------
Ophthalmology, Macular Degeneration

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has signed informed consent Is a licensed and practicing ophthalmologist Has prescribed and/or administered aflibercept to at least one patient in the past 6 months Exclusion Criteria: None
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 |
| --- | --- |
| Physicians with recent aflibercept experience<br>Ophthalmologists who have prescribed and/or administered aflibercept in the past 6 months | Other: Physician questionnaire<br>* This is a one-time cross-sectional survey of physicians, conducted electronically; there are no in person visits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of physicians responding correctly to each individual knowledge question |  | Up to 1 year |
Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis

Detailed Description
-----------------
Treatment medication will be administered topically, twice a day for 4 weeks.

Official Title
-----------------
An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Product 0405


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Atopic Dermatitis Good health with the exception of Atopic Dermatitis Percent body surface area minimum requirements Exclusion Criteria: Subjects who are pregnant, nursing, or planning a pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Product 0405<br>Topical Active Investigational Product 0405 | Drug: Product 0405<br>* Product 0405 will be administered topically, twice daily for 28 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment. |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis
Breath Analysis in Chronic Obstructive Lung Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
To answer the question whether a disease specific profile of breath in patients with COPD can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

Detailed Description
-----------------
This is an observational study comparing the volatile organic compounds (VOCs) in exhaled breath between COPD patients and matched control subjects (age, gender, smoking-state). 40 COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be examined by SESI-MS on the composition of exhaled breath for identification of COPD specific markers.

Official Title
-----------------
Exhaled Breath Analysis in Patients With COPD by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS)

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed COPD GOLD stage I-IV, based on a post-bronchodilator spirometry (FEV1/FVC < 0.7) performed within the last 6 months age between 18 and 80 years at study entry healthy controls: normal spirometry Exclusion Criteria: COPD exacerbation within the last 6 weeks any lung disease other than COPD acute inflammatory disease (e.g. common cold) within the last 6 weeks acute or chronic hepatic disease renal failure or renal replacement therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| COPD<br>40 COPD patients (20 non-frequent and 20 frequent-exacerbators). No intervention. | |
| Controls<br>Subjects with no apparent lung disease and normal lung function testing. Matched for age, gender and smoking history (pack years). No intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD-specific mass spectrometric exhaled breath pattern |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exhaled breath, volatile organic compounds (VOCs), SESI-MS
Physiological and Clinical Changes in NHF Therapy

Study Overview
=================
Brief Summary
-----------------
The study explores the changes in pressure, volume and in hypercapnia in patients with COPD and ILD. The investigators will use different application forms.

Official Title
-----------------
Physiological and Clinical Changes in NHF Therapy

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Hypercapnia, Interstitital Lung Disease

Intervention / Treatment
-----------------
* Device: Nasal Highflow (NHF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD, ILD Exclusion Criteria: Unstable 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ventilatory effects<br>measuring mean airway pressure, breathing volumes and decrease in hypercapnia | Device: Nasal Highflow (NHF)<br>* changes in breathing physiology in NHF<br>* Other names: TNI softflow50;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in mean airway pressure (mbar) |  | 1 month | 
| changes in tidal and minute volume (l) |  | 1 month | 
| changes in breathing frequency (beats/ minute) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in partial pressure of carbon dioxide (CO2) in arterial blood (pCO2) |  | 4 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasal high flow
Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles

Study Overview
=================
Brief Summary
-----------------
The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.

Detailed Description
-----------------
The TriPollar technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.

Official Title
-----------------
Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles and Rhytides

Conditions
-----------------
Facial Wrinkles

Intervention / Treatment
-----------------
* Device: TriPollar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject read, discussed and signed the Consent Form, Healthy female/male aged 35 65 years, Has facial wrinkles, Capable of reading, understanding and following instructions of the procedure to be applied, Able and willing to comply with the treatment and follow-up schedule. Exclusion Criteria: Listed in approved protocol, and ICF

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Device: TriPollar<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of TriPollar | Safety will be established by physician's assessment/observation of adverse events. | 6 months | 
| Efficacy of TriPollar | Efficacy will be established by level of wrinkle reduction at 3 m fu based on photos evaluation by independent physicians. | 6 months |
Handheld Echocardiography in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
Transthoracic echocardiography (TTE) represents an established and fundamental tool for the evaluation of patients with known or suspected cardiovascular disease. Recently, manufacturers have developed handheld echocardiograms small enough to fit in the pocket of a physician's lab coat. Studies assessing these handheld devices have several limitations. While they have generally evaluated the handheld devices favorably, previous studies has not consistently studied handheld devices under the best possible clinical conditions and have not necessarily highlighted the devices' limitations. In this proposal, we seek to analyze the applicability of handheld echocardiograms to standard clinical practice. The investigators plan to use trained sonographers to perform handheld examinations on patients referred for TTE without established cardiovascular disease. The handheld images will be interpreted by experienced, consultant-level echocardiographers. The investigators then plan to compare findings from the handheld echocardiogram to the patient's standard clinical TTE.

Official Title
-----------------
Handheld Echocardiography in Clinical Practice

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Adult patients referred for a resting transthoracic echocardiogram. Exclusion criteria Referral for quantitative assessment of valvular heart disease Referral for strain imaging Referral for measurement of left atrial mechanical function or cardiac resynchronization studies Known diagnosis of congenital heart disease, restrictive cardiomyopathy, constrictive pericardial disease, or pulmonary hypertension Patients who have received left ventricular assist devices or those who have undergone cardiac transplants

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
-----------------
Handheld echocardiography, V-scan, Handheld ultrasound, Portable ultrasound
MicroRNAs in Patients With Neurofibromatosis Type 1

Study Overview
=================
Brief Summary
-----------------
MicroRNAs are small molecules which have recently been discovered in cells. They are known to be responsible for the normal development of cells and when they are disrupted can contribute to the development of cancer. Many previous studies have been done evaluating the expression of microRNAs in normal tissues as well as in a wide variety of cancers. Recently, microRNAs from tumor cells have been detected circulating in the blood of patients with cancer. This presents a novel opportunity to assess the utility of microRNAs in the blood as an early predictor of cancer as well as a marker of response to therapy. No previous studies have been performed evaluating microRNAs in archived tumor tissue and blood of patients with Neurofibromatosis type 1 (NF-1). The investigators propose a feasibility study to evaluate the presence of microRNAs in archived tumor tissue and the blood of patients with NF-1. If the investigators are able to identify circulating microRNAs in this population of pediatric patients, they will build upon this data in proposing a future study.

Official Title
-----------------
MicroRNAs as Disease Markers for Central Nervous System Tumors in Patients With Neurofibromatosis Type 1

Conditions
-----------------
Glioma, Neurofibromatosis Type 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ages 2 years to 21 years. Patients with NF-1 being followed in the Neurofibromatosis Clinic. Patients have had MRI imaging in the 24 months prior to enrollment on the study. Patients may have known concurrent malignancies such as plexiform neurofibroma. Patients and/or parents/legal guardians must have signed an informed consent and assent when applicable. Exclusion Criteria: Patients who have had prior tumor-directed therapy (including chemotherapy and/or radiation) Patients with a prior or current diagnosis of a malignant peripheral nerve sheath tumor. Patients who are considered too ill to participate as determined by their treating physician Patients who are pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 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 |
| --- | --- |
| NF-1 without evidence of glioma<br> | |
| NF-1 with evidence of glioma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate miRNA expression patterns in tissue of low grade gliomas |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluated miRNA expression patterns between patients with and without imaging findings of gliomas |  | 2 years |
Representations and Prevention of Cancers in Schools

Study Overview
=================
Brief Summary
-----------------
The main objective is to develop an educational program and to measure the impact on social representations identified as acting in the prevention of cancer. Child should write, draw and speak about cancer signifiance to identify individual conceptions and representations of health and cancer in children aged 9 to 12 years in school.

Detailed Description
-----------------
The stages are : Selection of forms Technique of write and draw and interview by a school nurse Data analysis

Official Title
-----------------
Representations and Prevention of Cancers in Schools

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

Intervention / Treatment
-----------------
* Other: Write, draw and interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 9 and 12 Exclusion Criteria: Boy or Girl ages over 12 years and under 9 years Children refusal

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 12 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 |
| --- | --- |
| Student 9 to 12 years<br>Students aged 9 to 12 years and enrolled in classes CM1, CM2 and 6th | Other: Write, draw and interview<br>* Child should write, draw cancer signifiance and after, they were interview by a school nurse about cancer signifiance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cancer and health representations in children | Identification of individual cancer and health conceptions and representations in children aged 9 to 12 years in schools | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of association of cancer and health representations with the ecological deprivation index | Assess whether the prevalence of cancer and health representations is associated with socioeconomic level school zones | 60 minutes |
Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
RATIONALE: The use of bipolar energy sealing system or ultrasonic coagulation for hemostasis during thyroidectomy may reduce blood loss and hypocalcemia and may be more cost-effective.

Detailed Description
-----------------
PURPOSE: This clinical trial is studying how well bipolar energy sealing system and ultrasonic coagulation for hemostasis during thyroidectomy reduce blood loss and hypocalcemia, as well as which device is the most cost-effective approach for thyroidectomy.

Official Title
-----------------
Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Procedure: Bipolar Versus Ultrasonic Hemostasis Techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring thyroidectomy Exclusion Criteria: Patients unwilling or unable to provide informed consent Age less than 18 years old Reoperative case Patients who use pacemakers

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bipolar Versus Ultrasonic Hemostasis Techniques|OUTLINE: Patients undergoing thyroidectomy for thyroid cancer, thyroid nodules, hyperthyroidism and goiter will be randomized to either bipolar energy sealing system or ultrasonic coagulation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss and hypocalcemia |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of thyroidectomy |  | one week |