linjc16/ctgov huggingface dataset:
Investigation About Advance Directives

Study Overview
=================
Brief Summary
-----------------
Advance directives are again in the heart of debate since the Leonetti-Claeys's law . These pieces of legislation allow everyone to decide by advance their wishes of the end of life.However, it does not seem that to legislate on a subject is enough to apply the text of law. High authority of health suggest that medical and paramedical staff have to participate to the elaboration of the questionnaire and the redaction of advance directives. So the aim is that ,before asking patient about their knowledge on these advance directive, to evaluate if the staff knows about the law .

Official Title
-----------------
Investigation About Advance Directives

Conditions
-----------------
Advance Directive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nurse doctors paramedical staff Exclusion Criteria: refusing participation

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring the degree of knowledge of the staffs and doctors of the GHPSJ | every staff and doctors have to answer to a questionnaire | 1 day |
Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation

Detailed Description
-----------------
The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Official Title
-----------------
Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

Conditions
-----------------
Eye Infections, Bacterial

Intervention / Treatment
-----------------
* Drug: Azithromycin (T1225)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged from 18 to 45 years old; Written informed consent; Healthy volunteers (without any ocular symptom); Normal ocular examination in both eyes (corrected visual acuity (VA) >= 6/10 - Slit lamp examination without clinical relevant abnormalities - Tear break-up time (BUT) ≥10 seconds - Lachrymal secretion in the Schirmer test >= 10 mm in 5 minutes - Lissamine green test total score < 4 +). Exclusion Criteria: Ocular trauma, infection or inflammation within the last 3 months; Blepharitis; Conjunctival hyperaemia (score >= 2 +); Watering (score >= 2); Contact lenses; Ocular surgery, including LASIK and PRK, within the last 12 months; Topical ocular treatment within the last month; Systemic antibiotics within the last 7 days; Any medication during the study (except: Paracetamol and contraceptives).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin (T1225)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular subjective symptoms |  |  | 
| Ocular objective symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular pharmacokinetic. |  |  | 
| Ocular and systemic adverse events. |  |  |
Adiponectin and Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease (NAFLD)

Study Overview
=================
Brief Summary
-----------------
In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus.

Detailed Description
-----------------
In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus. In addition, these forms also are related to insulin resistance and inflammation in adipose tissue. Today, there is no study that investigate the role of adiponectin an anti-inflammatory adipokine, on macrophage polarization in non-alcoholic fatty liver disease.

Official Title
-----------------
The Relationship of Adiponectin With Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease

Conditions
-----------------
Non-alcoholic Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistently (at least 6 months) elevated aminotransferases Ultrasonographic presence of bright liver without any other liver or biliary tract disease Liver histology compatible with a diagnosis of NASH or SS Exclusion Criteria: A history of alcohol consumption >40 g/wk, as assessed by a detailed interview extended to family members Morbid obesity [body mass index (BMI) ≥40 kg/m2], hypertension Positive blood markers of viral, autoimmune, or celiac disease Abnormal copper metabolism or thyroid function tests A diagnosis of T2DM and systemic arterial hypertension Total cholesterol (TC) ≥250 mg/dL, triglycerides (TG) ≥400 mg/dL, exposure to occupational hepatotoxins or drugs known to affect glucose and lipid metabolism

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| P and C<br>P: NAFLD patients C: Healthy controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For laboratory analyses, the collection of all blood samples from the study participants. |  | Collection of blood samples in one year and analyses of data in 3 months. |
Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females

Study Overview
=================
Brief Summary
-----------------
Interval exercise involves short bouts of high intensity exercise interspersed with periods of lower intensity exercise. The benefit is that a shorter total duration of exercise may be required to achieve cardiovascular benefits similar to or even superior to traditional longer bouts of steady state endurance exercise. However how this type of exercise affects appetite and energy intake, particularly in overweight and obese females is not well known. This study involves two trials of exercise, one at high intensity and one at low intensity, followed by a buffet lunch, in overweight and obese females.

Official Title
-----------------
Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Adult apparently healthy overweight or class I obese eumenorrheic Exclusion Criteria: Diabetes pregnancy cardiovascular disease greater than 1 hour of structured physical activity per week thyroid disease polycystic ovary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-intensity<br> | Other: Exercise<br>* high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max<br>|
| Experimental: low-intensity<br> | Other: Exercise<br>* high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in energy expenditure | caloric expenditure measured via indirect calorimetry | immediately pre-breakfast, immediately pre-exercise, during exercise, and immediately post-exercise. | 
| Change in energy intake | measured via standardized lunch | immediately post exercise | 
| Change in appetite | measured via circulating hormones leptin and acylated ghrelin | immediately pre-breakfast, immediately post-breakfast, immediately post-exercise and immediately pre-lunch | 
| Change in subjective hunger | via visual analogue scale 100 mm, higher scores indicate greater hunger | baseline, immediately pre-exercise, immediately post-exercise, immediately pre-lunch, and immediately post-lunch |
AZD2624 Multiple Ascending Dose Study in Japan

Study Overview
=================
Brief Summary
-----------------
This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624

Official Title
-----------------
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2624 When Given in Multiple Ascending Oral Doses in Young Healthy Male Japanese Subjects

Conditions
-----------------
Healthy, Safety

Intervention / Treatment
-----------------
* Drug: AZD2624
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young male Japanese volunteers Exclusion Criteria: Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1 Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1 Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1 Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator at screening or pre first dose

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD2624<br>* oral suspension, 3 doses<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs |  | All assessments are made at each visit, at least daily, during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma |  | Blood samples will be taken before and after study drug administration. | 
| Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624 |  | A single blood sample will be obtained | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Safety, Tolerability
Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effectiveness of a community health worker intervention to expand access to hearing health care among older adults facing health disparities.

Official Title
-----------------
Oyendo Bien: Reducing Disparities in Access to Hearing Health Care on the U.S.-Mexico Border

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Behavioral: community health worker-audiologist communication education and support group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age: 50 years Audiometrically-confirmed hearing loss Availability of a communication partner to attend the program with the participant Be Spanish speaking and able to sign written informed consent Exclusion Criteria: Cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate communication education and support group<br> | Behavioral: community health worker-audiologist communication education and support group<br>* A 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist.<br>|
| No Intervention: Waitlist<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean frequency of communication strategy use as measured at eight weeks post baseline for each of a series of study-specific strategies taught in the intervention | Participants rate the frequency of use of each communication strategy on a five-point Likert scale. Communication strategies include such things as discussing hearing loss, talking face-to-face, and speaking slowly and clearly. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline | Questionnaire includes 7 possible actions for managing hearing health or accessing hearing health care services (discussed with family, discussed with doctor, discussed with specialist, had a hearing test, used an assistive device, used a hearing aid, used hearing protection). | 8 weeks |
A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)

Study Overview
=================
Brief Summary
-----------------
A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: MK0476; montelukast sodium
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females between the ages of 2 and 14 who have infrequent episodic asthma.

Ages Eligible for Study
-----------------
Minimum Age: 2 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0476; montelukast sodium|nan|
|Drug: Comparator: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent/caregiver QOL endpoints. |  |  | 
| The safety and tolerability of montelukast when use as an episode modifier. |  |  | 
| The duration and severity of the episode assessed by the parent/caregiver symptom score and the use of b-agonist and oral corticosteroid. |  |  |
Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as medullary expression of WT1 gene), performed at Baseline and during treatment according to clinical practice. MRD results will be relate to treatment outcome and survival analysis variables (Overall Survival, Disease Free Survival, Cumulative Incidence of Relapse)

Official Title
-----------------
Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta

Conditions
-----------------
Acute Myeloid Leukemia, Minimal Residual Disease, Wilms Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Acute Myeloid Leukemia Age > 18 years Intensive chemotherapy as first line curative treatment Observation period: March 2004 - September 2014 Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry performed at baseline Written informed consent Exclusion Criteria: Diagnosis of Acute Promyelocytic Leukemia Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry NOT performed at baseline Patient ineligible to intensive chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Response | Complete remission after chemotherapy | +28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival | Date of relapse or date of remission status | +28 days after End of induction chemotherapy -Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy - +30 days after Allogeneic Transplant - Date of Relapse for at least 1 year (up to 10 years) | 
| Overall Survival | Time to last follow-up or death | Date of last follow-up for at least 1 year (up to 10 years) or Death | 
| Cumulative Incidence of Relapse | CIR was calculated from the date of allo-HCT to the date of relapse or the date of the last follow-up, with death without relapse as a competing event. | Date of Allogeneic Transplant, Date of Relapse for at least 1 year (up to 10 years - assessed every 3 months), Date of last follow-up for at least 1 year (up to 10 years) or Death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myeloid Leukemia, Minimal Residual Disease, Wilms Tumor
Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

Study Overview
=================
Brief Summary
-----------------
To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone removal without use of fluoroscopy. Success for this study will be defined as the successful removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will only be used at the end of a presumed successful procedure to confirm that all stones are removed.

Official Title
-----------------
Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

Conditions
-----------------
Common Bile Duct Gall Stones

Intervention / Treatment
-----------------
* Procedure: Common bile duct stone removal without fluoroscopy.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients able to give informed consent Patients referred to IES for the endoscopic evaluation and treatment of suspected bile duct stones Exclusion Criteria: Patients with >3 bile duct stones or with any stone >12mm on EUS Patients with no bile duct stones on EUS Patients with altered biliary anatomy (periampullary diverticulum, anomalous pancreatibiliary junction, altered surgical anatomy) Patients who are pregnant or breast-feeding

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: Patients with common bile duct stones.<br>Common bile duct stone removal without fluoroscopy | Procedure: Common bile duct stone removal without fluoroscopy.<br>* ERCP stone extraction technique without fluoroscopy involves: (1) catheter or catheter with wire access into the bile duct, (2) confirmation of biliary access with catheter aspiration of bile, (3) performance of endoscopic biliary sphincterotomy or balloon dilation to widen the bile duct opening to permit stone removal, (4) stone removal - number of stones seen on EUS should match the number removed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful removal of all stones from the bile duct without the use of fluoroscopy. |  | Up to 24 hours. |