linjc16/ctgov huggingface dataset:
Cardiac Elastography Measurement : an Intraoperative Cardiac Surgery Study

Study Overview
=================
Brief Summary
-----------------
Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist. We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography. This study will include 30 patients with cardiac disease whose rigidity varies with underlying disease. The purpose of this study is to evaluate the stiffness during open heart surgery.

Official Title
-----------------
Measurement of Cardiac Elastography: an Intraoperative Cardiac Surgery Study. Cardiac Elastography in Vivo

Conditions
-----------------
Diastolic Dysfunction and Cardiac Stiffness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent Patients older than 18 years Every patient scheduled for cardiac surgery Cardiac catheterization within 6 months before surgery, Women of childbearing age in effective contraception (a urine pregnancy test will be performed) Patient affiliated or covered by a plan of health insurance. Francophone Exclusion Criteria: Pregnant or lactating woman, Functional walking disability, Patient placed under judicial protection: guardianship, Patient participating in another trial and / or participated in another trial within two months, Patient under guardianship or trusteeship, Women who are not effective contraception, Patient with no liberty by administrative or judicial decision

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Young's Modulus measurement according to the equation E = Young 3ρCs ² | Ultrasound acquisition will be completed in epicardial vue using a linear probe SuperLinear 15-4 ™ connected to an ultrasound (AixplorerTM ® from Supersonic Imagine). The acquisitions will be completed in mode B + Elastrography Shear Wave ™ (SWE). A sterile gel is deposited in the bottom of the pouch of sterile protection of the probe. Many measurements will be done on accessible left and right ventricle areas. Measurement of Young's modulus: automated by the onboard model according to the equation E = Young 3ρCs ², where E is the Young's elastic modulus software, ρ is the tissue density and Cs the velocity of shear wave | During herat surgery (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diastolic function parameters | Correlation between young's modulus and diastolic function parameters is assess after surgery by post processing | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elastography
The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Clopidogrel is a antiplatelet agent and is effective at reducing intimal hyperplasia in animal models of thrombosis.Several large clinical trials have demonstrated that clopidogrel with aspirin can reduce ischemic events and mortality in patients with atherosclerotic disease,therefore the combination of two antiplatelets might be useful to prevent patients received coronary artery bypass graft surgery from Saphenous vein graft disease. the aim of this study is to estimate the safety and efficacy of clopidogrel and aspirin therapy versus aspirin alone in patients after CABG.

Conditions
-----------------
Atherosclerosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass. Exclusion Criteria: Emergency surgery Valve surgery Redo CABG Left ventricle ejection fraction < 30% Preoperative use of clopidogrel (with the exception of the current admission) Preoperative use of warfarin Allergy to aspirin or clopidogrel History of cerebrovascular accident History of severe liver disease Morbid obesity Current malignancy

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: clopidogrel and aspirin<br>* clopidogrel 75mg daily and aspirin 100mg daily<br>|
| Active Comparator: 2<br> | Drug: aspirin<br>* aspirin 100mg daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vein graft patency examined by CT scan |  | three months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse coronary events Incidence of major bleeding events |  | two years following surgery |
Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving treatments can deliver equivalent life prognosis in the management of small and medium sized uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most common eye-preserving treatment in the current management of uveal melanoma, but is complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy/maculopathy need to be developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits the activity of vascular endothelial growth factor A, a mediator in the development of choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as age related macular degeneration. This study will investigate the possible benefit of Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following plaque radiation for uveal melanoma.

Official Title
-----------------
A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma

Conditions
-----------------
Uveal Melanoma, Radiation Retinopathy, Radiation Maculopathy

Intervention / Treatment
-----------------
* Drug: Ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years new diagnosis of choroidal melanoma scheduled for plaque radiotherapy at Wills Eye Health System Exclusion Criteria: Pre-existing retinal disorders (i.e. age-related macular degeneration, diabetic maculopathy, retinal vascular occlusion, macular hole, surface wrinkling retinopathy) prior retinal detachment media opacities precluding accurate OCT imaging history of glaucoma pregnancy age <18 years.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ranibizumab|Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of optical coherence (OCT) evidence of macular edema. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up. |  | 4 months |
Comparison of 22Mhz and 18Mhz High-frequency Probes for the Ultrasound Study of Temporal Arteries in Patients Suspected of Having Giant Cell Arteritis

Study Overview
=================
Brief Summary
-----------------
Evaluation of the structural features of temporal arteritis using two frequencies probes: 18 and 22Mhz.

Detailed Description
-----------------
Comparison of the results obtained by using 2 different frequencies probes in the diagnosis of giant cell arteritis

Official Title
-----------------
Comparison of 2 Probes Frequencies in the Diagnosis of Giant Cell Arteritis

Conditions
-----------------
Giant Cell Arteritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sedimentation rate> 50 mm/h or recent unusual headache or unusual fever, recent visual trouble or jaw claudication, or induration temporal arteritis Exclusion Criteria: previous diagnosis of giant cell arteritis and relapse of the giant cell arteritis and opposition to participate

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| halo sign of temporal arteritis | hypoechogenicity of the wall artery | inclusion | 
| compression sign of of temporal arteritis | persistent of increased inflammatory arteries wall | inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| halo sign of carotid arteritis | hypoechogenicity of the wall artery | inclusion | 
| halo sign of subclavian arteritis | hypoechogenicity of the wall artery | inclusion | 
| halo sign of axillary arteritis | hypoechogenicity of the wall artery | inclusion | 
| other structural abnormalities in unilateral B mode | stenosis, occlusion | inclusion | 
| other structural abnormalities in bilateral B mode | stenosis, occlusion | inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound,, giant cell arteritis
Participation of Manual Wheelchair Users in the Community

Study Overview
=================
Brief Summary
-----------------
To explore the relationship between ability to do different wheelchair skills and the participation and quality of life of wheelchair users in and around their home and community. The investigators study hypothesis: Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is strongly related to self-reported participation. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is related to the average daily distance traveled in their wheelchair.

Official Title
-----------------
Participation of Manual Wheelchair Users in the Community: The Relationship to Wheelchair Skills Capacity

Conditions
-----------------
Wheelchairs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a manual wheelchair for home and community use; use a manual wheelchair at least once a week; have a minimum of 3 months experience using a manual wheelchair outside the hospital setting; be over the age of 18; be able to read and understand English and follow verbal and visual instructions; be competent to give informed consent; be willing to take part in the study, including signing the consent after carefully reading it; not have been under significant bed rest for the past month.

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 |
| --- | --- |
| Wheelchair users<br>People who have a wheelchair for home and community use. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheelchair Skills Test Questionnaire Capacity Version | Participants will be asked if they can perform 32 skills from the WST 4.1 (capacity)using a structured interview approach. A skill will be considered a pass if done describing a safe manner. | baseline | 
| Impact on Participation and Autonomy Questionnaire | This measure addresses autonomy with respect to activities and participation, and is a self-report measure. | baseline | 
| Average Distance Travelled | The average distance treavelled per day over a week in the participant's wheelchair will be measured. | Up to a week time period, one time measure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiological Studies Depression Scale short form | Self-reported depression. | baseline |
A Study to Evaluate the Mass Balance Absorption and AME of VBR

Study Overview
=================
Brief Summary
-----------------
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects

Official Title
-----------------
An Open Label Phase 1 Study in Healthy Adult Male Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] Vebicorvir Following Single Oral Dose Administration

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Vebicorvir (VBR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Consent Male between 18 and 55 years of age (inclusive) at the time of Screening Body mass index (BMI) between ≥18.0 kg/m2 and ≤32.0 kg/m2 at Screening; body weight between ≥55.0 kg and ≤100.0 kg at Screening Considered to be in good health by the Investigator Exclusion Criteria: History or presence of any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass) Clinically significant abnormal medical history History of cancer that has not been in full remission for >5 years Acute illness within 14 days prior to study drug administration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Group 1<br>VBR 300 mg solution containing 2 µCi [14C]VBR | Drug: Vebicorvir (VBR)<br>* 300mg Vebicovir containing 2 µCi [14C]VBR.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C) |  | Before dosing and at prespecified time intervals up to 168 hours after dosing | 
| Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Feces up to the Last Sampling Interval (Ae-feces, 14C) |  | Before dosing and at prespecified time intervals up to 168 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Adverse Events |  | Up to 168 hours | 
| Number of Participants Discontinued from the Study Due to an Adverse Event |  | Up to 168 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHB, HBV, hepatitis B
Soluble CD23 Expression in Asthma Patients Treated With OMA

Study Overview
=================
Brief Summary
-----------------
This study involves a FDA approved drug, Omalizumab, used in the treatment of moderate to severe allergic asthma that cannot be controlled by standard treatment. It works on IgE to control the allergic reaction. We are looking at the effects on non-allergic asthma. We hope to prove that Omalizumab will have the same effect on non-allergic asthmatics as it does allergic asthmatics.

Detailed Description
-----------------
This is a 1 year placebo controlled study looking at moderate to severe asthmatics (allergic or non-allergic) who are controlled by medication. Skin testing will be done to determine the allergic status, as well as a base line IgE done. The Omalizumab is administered by injection based on weight and IgE level, (once or twice a month). At several times during the year pulmonary function test will be done, as well blood drawn for immunological assays (CD23 and FcER1 expression, TH1/TH2 cytokines, CD23 production). A battery of questionnaires will also determine quality of life(with asthma), psychological stress measures and parameters of clinical response.

Official Title
-----------------
Soluble CD23 Expression as a Marker of Immunomodulation and CLinical Response in Asthma Patients Treated With Omalizumab

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

Intervention / Treatment
-----------------
* Drug: Omalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe asthmatic (based on 1997 NHLBI guidelines), controlled by medication for at least 6 months, initial IgE level between 30 and 700 IU, weigh between 30 an 150 kg, otherwise healthy. Exclusion Criteria: Smoker, uncontrolled asthma, immunotherapy in past six weeks, other diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of sCD23 in plasma |  |  | 
| CD23 expression on T cell correlated with spirometry, AQLQ and RQLQ. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic, Non allergic
Food Reward in Native American Women

Study Overview
=================
Brief Summary
-----------------
This study aims to characterize the neurobiology of obesity in American Indians (AI) using functional MRIs to examine the correlation between brain response to food stimuli in AI women. A functional MRI (fMRI) is used to visualize brain activity when obese and lean AI women look at images of fattening food, non-fattening food and non-food objects. Additionally examined is the effect of the drug naltrexone to suppress brain response to visual food cues and calorie intake in the women.

Detailed Description
-----------------
The study looks at both obese and lean women. Each woman comes in for two visits. Each woman takes both the Naltrexone or placebo (one during each visit). Research staff and participants are blinded. Drugs are not used as treatment, but rather to provide information for possible future treatments. Hypotheses are: Compared with their lean counterparts, obese women will demonstrate more fMRI activation in the brain in response to visual food cues. Naltrexone will reduce the activation in reward-relevant brain sites in response to viewing photographs of fattening food as compared in placebo in both groups. Naltrexone will suppress spontaneous intake of food in obese and lean AI women.

Official Title
-----------------
Neural Correlates of Food Reward in Native American Women

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Combination Product: Placebo and fMRI
* Combination Product: Naltrexone and fMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Self-identified AI BMI over 30 OR between 20 and 24.9 Must see clearly with or without glasses Capable of giving informed consent Exclusion Criteria: Smokes more than one cigarette a day Drinks more than two alcoholic drinks a day Uses recreational drugs Is pregnant Has had weight loss surgery Other major medical problems (e.g. diabetes) Taking medications that alter appetite or body weight Significant food allergies

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo/Naltrexone and fMRI<br>A placebo or Naltrexone will be given before fMRI. All participants will undergo both procedures. Naltrexone/placebo are not used as an intervention. | Combination Product: Placebo and fMRI<br>* Pill form, participant dosed one time an hour before fMRI.<br>Combination Product: Naltrexone and fMRI<br>* 50 mg pill given one time, one hour before fMRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI activation in the brain in response to visual food cue | fMRI activation in the brain in response to visual food cue | With In 30days |