linjc16/ctgov huggingface dataset:
Peripheral Artery Tonometry in Children With Type 1 Diabetes and Obese Children

Study Overview
=================
Brief Summary
-----------------
Background: The reactive hyperemia-peripheral artery tonometry (RH-PAT) is a newly developed method for noninvasive endothelial function assessment. Objective: The goal of this study is to determine whether a significant difference in RH-PAT score is present between adolescents with type 1 diabetes (T1D) in comparison with controls. We will also compare RH-PAT scores in obese adolescents versus controls.

Official Title
-----------------
Peripheral Artery Tonometry in Children With Type 1 Diabetes and Obese Children.

Conditions
-----------------
Peripheral Artery Tonometry, Diabetes, Children, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-19 years of age Exclusion Criteria: type 2 diabetes; obesity in group of type 1 diabetes

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 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 |
| --- | --- |
| control<br> | |
| type 1 diabetes<br> | |
| obesity<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RHPAT |  | 2 years |
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal women.

Official Title
-----------------
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

Conditions
-----------------
Hypoactive Sexual Desire Disorder

Intervention / Treatment
-----------------
* Drug: testosterone gel
* Drug: placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be between the ages of 30 to 65 years Must have undergone hysterectomy and bilateral salpingo-oophorectomy Exclusion Criteria: A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation Any systemic skin diseases or local skin abnormalities in the area of application Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder). A medical condition that could affect or interfere with sexual function Using a systemic transdermal gel or cream estrogen therapy.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: testosterone gel<br>1% testosterone transdermal gel | Drug: testosterone gel<br>* once daily transdermal gel, 300 mcg<br>* Other names: LibiGel;|
| Placebo Comparator: Placebo gel<br>placebo transdermal gel | Drug: placebo gel<br>* once daily transdermal placebo gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score. |  | Time Frame: Baseline and 21-24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline over time for multiple efficacy measurements |  | change over timepoints from baseline period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
testosterone, hypoactive sexual desire disorder, menopause
Telephone Support Program for Lung Cancer Patients and Their Family Caregivers

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to examine the physical and psychological health benefits of a novel, telephone-delivered symptom management intervention for advanced lung cancer patients and their family caregivers.

Official Title
-----------------
Telephone Symptom Management for Advanced Lung Cancer Patients and Caregivers

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: Telephone counseling
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of lung cancer Must be able to speak and read English Exclusion Criteria: No working phone service Does not have a family caregiver

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone counseling<br>Telephone counseling to enhance symptom management and reduce distress | Behavioral: Telephone counseling<br> <br> |
| Active Comparator: Education<br>Overview of resources for psychosocial support and health information | Behavioral: Education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire-8 |  | baseline, 2 and 6 weeks post-intervention | 
| Change in Generalized Anxiety Disorder 7-item scale |  | baseline, 2 and 6 weeks post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, family caregiving, behavioral intervention, counseling, symptom management
Growth Hormone Treatment in Children With Hypophosphatemic Rickets

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect on height of a two year treatment with growth hormone in 19 children with X linked hypophosphatemic rickets.

Official Title
-----------------
Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial

Conditions
-----------------
X Linked Hypophosphatemic Rickets

Intervention / Treatment
-----------------
* Drug: norditropine simplex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical, biochemical and genetic diagnosis of XLH height SDS < 2 at least two years of treatment with oral phosphate and calcitriol Exclusion Criteria: uncontrolled rickets (ALP>600 IU) growth hormone deficiency hyperparathyroidism, nephrocalcinosis, renal insufficiency associated disease previous treatment with growth hormone

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 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: norditropine simplex<br> | Drug: norditropine simplex<br> <br> * Other names: growth hormone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in height SDS (standard deviation score) |  | at year one and year two from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth hormone
Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock

Study Overview
=================
Brief Summary
-----------------
The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)

Conditions
-----------------
Septic Shock, Arterial Pressure, Hemodynamics, Mortality, Clinical Trial

Intervention / Treatment
-----------------
* Drug: maintain mean arterial pressure between 80-85 mm Hg
* Other: maintain mean arterial pressure between 65-70 mm Hg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with septic shock according criteria of Bone minimal dose of norepinephrine Written informed consent obtained from the patient or surrogate Exclusion Criteria: Age < 18 years Pregnancy Participation in other trials with the same endpoints moribund absence of registration in french health care system patient protected by law

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high pressure<br> | Drug: maintain mean arterial pressure between 80-85 mm Hg<br>* protocolized hemodynamic care aiming to maintain mean arterial pressure between 80-85 mm Hg<br>|
| Placebo Comparator: normal pressure<br> | Other: maintain mean arterial pressure between 65-70 mm Hg<br>* protocolized hemodynamic care aiming to maintain mean arterial pressure between 65-70 mm Hg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in mortality at day 90 |  | day 90 | 
| decrease in sequential organ failure assessment |  | day 1 to day 28 | 
| extra renal replacement free days |  | day 28 | 
| renal function |  | day 1 to day 28 | 
| amount of fluids |  | day 1 to end of shock | 
| catecholamines free days |  | day 1 to day 28 |
Cystatin C and Uncontrolled Hypertension

Study Overview
=================
Brief Summary
-----------------
Hypertension is an underdiagnosed and undertreated disease in real-life. Blood pressure and kidney functions are known to be closely related. Increased serum level of Cystatin C, a sensitive biomarker for renal function, seems to predict adverse cardiovascular events. The investigators aimed to evaluate the predictive value of serum Cystatin C for control of hypertension in a community-based study.

Official Title
-----------------
Cystatin C and Uncontrolled Hypertension

Conditions
-----------------
Uncontrolled Hypertension

Intervention / Treatment
-----------------
* Other: other


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who accept to participate to the survey > 18 years Exclusion Criteria: Individuals who are not able to complete the questionnaire Individuals who didn't give informed consent

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

| Intervention/Treatment |
| --- |
|Other: other|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of uncontrolled hypertension | The outcome measures will be obtained at the time of enrollment | At subject enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The value of cystatin C to determine uncontrolled hypertension | The outcome measures will be obtained at the time of enrollment | At subject enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, blood pressure, cystatin C, real-life, kidney
Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will examine the effects of add-on sildenafil to bosentan monotherapy in patients with Pulmonary Arterial Hypertension. Patients on bosentan monotherapy will be followed every 6 months to assess if they have met the pre-defined treatment goals. If a patient fails to achieve these treatment goals or fails to maintain them, sildenafil will be added to their existing bosentan monotherapy. Patients will be assessed 6 months after start of combination therapy for changes in 6MWT, Borg dyspnea scale, WHO functional class, quality of life.

Official Title
-----------------
Addition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion & Exclusion Criteria

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sildenafil<br> | Drug: Sildenafil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Validation of the Utility of Myopia Intelligent Diagnostic System

Study Overview
=================
Brief Summary
-----------------
The screening of myopia via artificial intelligence represents an challenge in computational medicine. Here, the investigators use deep learning to create an automatic diagnostic system for myopia screening using ocular appearance images. The investigator also use this system and conduct clinical trial to validate its performance.

Official Title
-----------------
Validation of the Utility of Myopia Intelligent Diagnostic System: A Clinical Trial

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Myopia Intelligent Diagnostic System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Student aged 6-18 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eligible patients for AI test<br> | Device: Myopia Intelligent Diagnostic System<br>* An artificial intelligence to make diagnosis of myopia using ocular appearance images<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The AUC of the Myopia Intelligent Diagnostic System |  | up to 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of the Myopia Intelligent Diagnostic System |  | up to 3 month | 
| The specificity of the Myopia Intelligent Diagnostic System |  | up to 3 month |
Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes

Study Overview
=================
Brief Summary
-----------------
This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.

Official Title
-----------------
Open, Multicenter, Randomised, Controlled Phase IIIb Study Evaluating the Immunogenicity and Safety of Subcutaneous Versus Alternative Administration Route of Combined MeMuRu-OKA Vaccine to Healthy Children Aged 11 to 21 Months.

Conditions
-----------------
Measles, Mumps, Rubella, Varicella

Intervention / Treatment
-----------------
* Biological: MeMuRu-OKA (study vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children must be healthy and have a birth weight > 2000 g to participate Exclusion Criteria: confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors. Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study. Children must have received one dose (but not more) of MMR and of varicella at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days. Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol within 30 days before vaccination. Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start. New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child

Ages Eligible for Study
-----------------
Minimum Age: 11 Months
Maximum Age: 22 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MeMuRu-OKA (study vaccine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rates after vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study) |  |  |
Systematic Assessment of Competitive Flow in Coronary Artery Bypass Grafts by Wave Intensity Analysis

Study Overview
=================
Brief Summary
-----------------
Narrowing of the arteries that supply blood to the heart can lead to heart attacks and death. One way of treating this is to use artery and vein grafts from other parts of the body to bypass the narrowing. However, the blood flow from these grafts competes with flow through the natural coronary artery. This may contribute to grafts narrowing with time. This protocol aims to determine the pressure changes responsible for this effect. This could improve our understanding of why some grafts last longer than others.

Official Title
-----------------
Systematic Assessment of Competitive Flow in Coronary Artery Bypass Grafts by Wave Intensity Analysis

Conditions
-----------------
Coronary Artery Bypass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with previous coronary artery bypass grafts undergoing coronary angiography and graft restudy Exclusion Criteria: Patient's with cardiac pacemakers, valvular heart disease, and chronic renal failure Unable to consent Contraindications to adenosine Contraindications to cardiac MRI

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
-----------------
Competitive Flow, Coronary artery bypass, Wave Intensity Analysis