linjc16/ctgov huggingface dataset:
Proportional Ventilation and Ventilatory Synchronism

Study Overview
=================
Brief Summary
-----------------
Synchronism of gas flow delivered by the ventilator and muscular effort of the patient will be studied during two kinds of ventilation. The first one is the proportional assisted ventilation during which the gas flow is theoretically adapted to the patient's muscular effort within the breath. The second is the pressure support ventilation during which the gas flow is delivered to maintain the inspiratory pressure stable. The hypothesis is that the first mode allows a better synchronism.

Official Title
-----------------
Proportional Ventilation and Ventilatory Synchronism

Conditions
-----------------
Mechanical Ventilation

Intervention / Treatment
-----------------
* Procedure: Mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing partial ventilatory support Exclusion Criteria: Patients failing the weaning process

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: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Mechanical ventilation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time lag between the onset of diaphragmatic electromyogram (EMG) signal and the zero crossing of the inspiratory flow, over five minutes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number per minute of failing breaths: breath with muscular effort without any inspiratory flow |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proportional assisted ventilation, Pressure support ventilation, Synchronism during mechanical ventilation, Patients undergoing partial mechanical ventilation
Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Study Overview
=================
Brief Summary
-----------------
The objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care. Main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.

Official Title
-----------------
Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Conditions
-----------------
Newborn, Pain Measurement

Intervention / Treatment
-----------------
* Drug: sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born between the 28th and 41th weeks of gestation admitted in intensive care unit Patient requiring a mechanical ventilation or CPAP Patient requiring a KTEC Given consent Exclusion Criteria: Contraindication to sévoflurane Patient already sedated with morphin and/or hypnotics Patient presenting neurologic troubles Patient enrolled in other study* Infant without legacy representant
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sevoflurane|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lasted realization of the gesture defined by delay between the first draining and the end of the bandage |  | 24 months |
QUALITATIVE SURVEY ABOUT NURSES FIRST WORK EXPERIENCE DURING COVID-19 PANDEMIC

Study Overview
=================
Brief Summary
-----------------
During covid-19 pandemic an huge reorganization of all PiacenzaHospital was done to manage the increasing requests for hosptitalization. New nurses had to face first work experience in full pandemic Emergency. Altough even before the pandemic, being a newly graduated nurses was described as a stressful and isolating experience , we can't find studies in the literatureconcerning newly graduated and newly hired nurses during the pandemic pediod. The study purpose is to describe and analyze, trough a phenomenological research, the experience of these nurses.

Official Title
-----------------
PHENOMENOLOGICAL QUALITATIVE SURVEY ABOUT NURSES FIRST WORK EXPERIENCE DURING COVID-19 PANDEMIC AT PIACENZA HOSPITAL, ITALY

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Other: in-depth individual interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults first work experience nurses after gratuation not opposed to partecipate to this study Exclusion Criteria: refusing to partecipate

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 |
| --- | --- |
| first work experience nurses<br> | Other: in-depth individual interviews<br>* in-depth individual interviews to explore their perspectives on their first work experience during covid-19 pandemic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nurses satisfaction | to detect emotional impact | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid 19, first work experience, nurse
A Sub-study of PREDICT Neurodevelopment Protocol

Study Overview
=================
Brief Summary
-----------------
To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use this group to compare the neurodevelopmental changes over time to the HIV-infected children with and without HAART (main study).

Detailed Description
-----------------
Normative data are mostly, if not exclusively, obtained from children in the Western world. Comparing data from Asian children to these norms may lead to the wrong interpretation of the results, as it does not account for cultural differences, translation issues and a possibly different education system. Therefore it is essential to include a matched control group to evaluate the participants of the study to the fullest extent in terms of cognition, memory, behavior and fine motor skills, in all age groups over the full course of the study.

Official Title
-----------------
The Neurodevelopment in Normal Children in Cambodia and Thailand

Conditions
-----------------
Neurocognitive Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for HIV negative exposed children Child from a HIV-positive mother Documented negative test for HIV-1 infection Between the age from 1-15 years Caregiver of the subject is willing and able to sign informed consent, prior to the study Thai or Cambodian origin HIV negative and not HIV exposed: Inclusion Child from a HIV-negative mother (by history) Documented negative test for HIV-1 infection Between the age from 1-15 years Caregiver of the subject is willing and able to sign informed consent, prior to the study Thai or Cambodian origin Exclusion Criteria: for HIV negative exposed children The inability of the caregivers to understand the nature and extend of the trial and the procedure required Patients with psychiatric disorder Patients with a syndrome that affects cognitive performance for HIV negative and not HIV exposed The inability of the caregivers to understand the nature and extent of the trial and the procedure required Patients with psychiatric disorder Patients with a syndrome that affects cognitive performance

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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 |
| --- | --- |
| HIV negative unexposed<br>HIV negative controls | |
| HIV negative exposed<br>HIV-negative children born to HIV-infected mothers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurodevelopment changes (composite of cognitive, fine motor and behavioral) | measured by cognitive test, fine motor test and behavioral assessment test | up to 96 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
normal controls
Pemetrexed as First Line Chemotherapy for Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine the safety of pemetrexed and any side effects that might be associated with it, whether pemetrexed can help patients with breast cancer and how much pemetrexed should be given to patients.

Official Title
-----------------
Study of Two Doses of ALIMTA (Pemetrexed) as First Line Chemotherapy for Advanced Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of old. Have been diagnosed with breast cancer At least one year disease-free interval after initial treatment. Have pre-study laboratory tests that are within the requirements of this study. Be able to visit the doctor's office weekly during the treatment period. Exclusion Criteria: To be pregnant or breastfeeding. To be currently taking aspirin or aspirin- like medicine and unable to stop for a few days during each cycle of therapy. To have received prior chemotherapy for the treatment of metastatic cancer. Patients may have received prior hormonal treatment. To have another illness that your doctor thinks would make you unable to participate. To be unable or not willing to take folic acid and vitamin B12.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pemetrexed|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess tumor response. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the toxicity profile of two doses of pemetrexed in breast cancer patients. |  |  | 
| To assess the following time-to-event efficacy variables: time to response, duration of response, duration of stable disease, time to documented progressive disease, time to treatment failure, progression-free survival, and overall survival. |  |  | 
| To identify the relationships, if any, that may exist between various molecular markers and pemetrexed efficacy and toxicity. |  |  |
Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Hypothesis:In patients with ulcerative colitis and Crohn's disease diagnosed with mild or moderate anaemia: iron supplementation will increase disease activity and oxidative stress the addition of antioxidant vitamin will reduce this detrimental effect

Detailed Description
-----------------
To maintain site/extent of disease and medication consistent among groups, the design is a double blind crossover placebo-controlled trial. If mild anaemia, patients are randomized to 300 mg of ferrous fumarate or placebo for 4 weeks followed by 2 weeks of washout period after which patients will crossover the opposite treatments for another 4 weeks. If moderate anaemia, patients will receive 600 mg of ferrous fumarate for 10 weeks. They are randomized to either vitamin E (800 IU) or placebo for 4 weeks followed by 2 weeks of washout period after which patients will crossover the opposite treatments for another 4 weeks

Official Title
-----------------
Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)

Conditions
-----------------
Crohn's Disease, Ulcerative Colitis, Mild or Moderate Anaemia

Intervention / Treatment
-----------------
* Drug: Iron supplement 300-600 mg/day
* Drug: Vitamin E 800IU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old diagnosed with inflammatory Bowel Disease (ulcerative colitis and Crohn's disease) with mild or moderate anaemia Exclusion Criteria: not diagnosed with bowel obstruction not diagnosed with short bowel syndrome not taking iron supplement or antioxidant vitamins and minerals

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iron supplement 300-600 mg/day|nan|
|Drug: Vitamin E 800IU|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calprotectin in stools at baseline, week 4, week 6, week 10 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease activity index |  |  | 
| oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase) |  |  | 
| blood measurement of CBD |  |  | 
| iron status |  |  |
Impact Evaluation of the Wise Guys Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of the Wise Guys program on the delaying sexual initiation on adolescent males in Eastern Iowa.

Detailed Description
-----------------
This study uses a randomized controlled design to compare the impacts of the Wise Guys Program to the business-as-usual school curriculum. The Wise Guys multi-session curriculum is delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections. Study participants are 7th grade boys attending a participating school in either the Davenport Iowa or North Scott Community school districts. This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.

Official Title
-----------------
Impact Evaluation of the Wise Guys Program

Conditions
-----------------
Sexual Behavior, Sexually Transmitted Infections

Intervention / Treatment
-----------------
* Behavioral: Wise Guys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 7th grade student in participating schools Male
Sexes Eligible for Study
-----------------
Male

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wise Guys<br>A sexual health and male responsibility program for adolescent males | Behavioral: Wise Guys<br>* Multi-session curriculum delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections.<br>|
| No Intervention: Control<br>Business as usual sexual education in schools | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual initiation |  | 24 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual initiation |  | 6 months post-intervention |
Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index

Study Overview
=================
Brief Summary
-----------------
Continuous Doppler ankle brachial index (ABI) is the gold standard for screening and monitoring of peripheral arterial disease (PAD) but is no longer carried out in clinical practice. The recommended measurement was gradually replaced by colour or pulsed Doppler without validation of these techniques. The objective of our study is to compare these two techniques (color Doppler and pulsed Doppler in echodoppler) with respect to the gold standard (continuous Doppler) for ABI measurement.

Official Title
-----------------
Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index

Conditions
-----------------
Peripheral Arterial Disease, Atherosclerosis Obliterans, Atherosclerosis Right Leg, Atherosclerosis Left Leg

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient referred to the Vascular Medicine Department of Caen University Hospital for a vascular examination with ABI measurement having been informed and not objecting to participation in the study and benefiting from a social protection system. Exclusion Criteria: Patient with arrhythmia Patient with trans-tibial or more proximal amputation Patient with extensive trophic disorder not allowing measurement Patient with subgonal bypass Known bilateral sub-clavian stenoses Patient deprived of liberty or under a measure of legal protection Interned patient for the treatment of a psychiatric or physical illness Patients who are legally incompetent, under the protection of justice, under guardianship or trusteeship.

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 |
| --- | --- | --- |
| Concordance on the IPS value measured with pulsed Doppler compared to gold standard |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankle brachial index, color duplex ultrasound, pulsed doppler
Chronic Lymphoid Leukaemia Observatory in Finistere Area, France

Study Overview
=================
Brief Summary
-----------------
Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns. Detailed Description: OFICE is a single center, prospective, observational registry of CLL patients designed to provide a general description of the CLL patients' population from the Finistere area, France. The registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. These data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.

Conditions
-----------------
Chronic Lymphoid Leukaemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of at least 18 years Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008) Willing and able to provide informed consent Willing and able to provide blood sample at time of enrollment Exclusion Criteria: Diagnosis of other B-cell malignancies

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 |
| --- | --- | --- |
| Prevalence | Clinical data | Year 0 (Y) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence | Clinical and biological data | Year 0 | 
| Description of baseline clinical-biological | Clinical data, complete blood count, Matutes score and parameters, cytogenetic, IgVH mutations, CD38 (%), medical treatment will be collected | Year 0, Year 1, Year 2, Year 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic lymphocytic leukemia, Observational study