linjc16/ctgov huggingface dataset:
Study of the Aerosol Deposition With Vented and Unvented Jet Nebulizer in Healthy Subjets

Study Overview
=================
Brief Summary
-----------------
Open-vent jet nebulizers are frequently used to promote drug lung deposition but their clinical efficacy and indications are not clear. Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a 110 ml corrugated piece of tubing.

Conditions
-----------------
Aerosol Drug Therapy

Intervention / Treatment
-----------------
* Device: Vented and Unvented Jet Nebulizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers between 18 and 60 years old Exclusion Criteria: Smokers Pathological spirometry History of treatment with aminoglygosides 1 month prior the study Known allergy to aminoglycosydes Any lung pathology or history of lung surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vented and Unvented Jet Nebulizer|Nebulizers used with 500mg aminoglycosides in 4ml until One minute after the sputerring point.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amikacin Urinatory excretion |  | Each miction during 24 hours |
Impact of Media Images, Alcohol and Tobacco to Youth

Study Overview
=================
Brief Summary
-----------------
The main objective is to assess the relationships between French teenagers' attitudes and beliefs towards alcohol and tobacco products and the degree to which they watch and relate to television series and music videos.

Detailed Description
-----------------
The research extends existing research conducted by Cristel A. Russell to assess the relationships between French teenagers' attitudes and beliefs towards alcohol and tobacco products and the degree to which they watch and relate to television series and music videos. We test whether the consumption of media (TV series and music video) are related to French youth's perceptions of the consequences related to the use of alcohol and/or tobacco and ultimately their intentions and behaviors. To do so, an online questionnaire will be passed. Teenagers will be recruited through a private research firm, Cint. Because the study focuses on teenagers (14-17 y.o), parental consent to participate to the study will be obtained prior to the teenager's one.

Official Title
-----------------
Impact of Media Images, Alcohol and Tobacco to youthImpact Study and Development of a Prevention Program

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

Intervention / Treatment
-----------------
* Other: Investigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between14 to 17 years inclusive; Have access to television Exclusion Criteria: Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 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 |
| --- | --- |
| 14 to 17 years old French teenager<br>14 to 17 years old French teenager representative of French population from whom parental consent to particpare to the study has been given | Other: Investigation<br>* Investigation of relationships between French teenagers' attitudes and beliefs towards alcohol and tobacco products and the degree to which they watch and relate to television series and music videos<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Connectedness scale to media and intention of drinking and/or smoking | Connectedness scale to media and intention of drinking and/or smoking | 15 minutes |
Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum

Study Overview
=================
Brief Summary
-----------------
The current study is a case control study involving comparisons of tissue interstitial fluid from breast cancer and adjacent non-cancerous tissue as well as that from benign breast lesion and its adjacent non-diseased tissue for a distinguishable breast cancer profile. The purpose of this research is to collect fresh breast nodule/cancer and surrounding non-cancerous tissue for proteomic studies of the interstitial fluid to identify a profile distinguishing breast cancer which will also permit future research on stored interstitial fluid, blood or tissue samples. Specific markers identified from interstitial fluid study will be investigated in blood samples to develop serum markers for breast cancer diagnosis and prognosis. Additionally, we will perform both prospective and retrospective research on breast cancer involving clinical, demographic, epidemiologic information, treatment, follow-up and outcomes on breast nodule/cancer cases collected.

Official Title
-----------------
Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects ≥ 18 years of age undergoing surgery for indeterminate breast nodules, breast tissue reduction, prophylactic mastectomy, and all subjects with newly diagnosed invasive breast cancer will be eligible to participate. If invasive breast cancer or suspicion of invasive breast cancer, target lesion must measure ≥ 1.0 cm on breast imaging before core biopsy. Exclusion Criteria: Anyone < 18 years of age. Multiple synchronous primary malignancies from different organ systems.

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
-----------------
Proteomics, Breast Cancer Markers, Tissue Interstitial Fluid
Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The study will not entail change in treatment of the disease.

Official Title
-----------------
Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Conditions
-----------------
Retinal Vein Occlusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected central retinal vein occlusion. Informed consent for participation. No treatment before the first oximetry measurement. Exclusion Criteria: History of other retinal disease. Glaucoma and diabetes without retinopathy are not exclusion criteria but should be registered. History of cardiovascular or respiratory diseases that can be expected to influence systemic or retinal oxygen saturation. Examples: Known COPD or carotid stenosis. Subjects with high blood pressure will not be excluded but blood pressure should be registered. Poor quality images will be excluded based on the images themselves. Therefore, grading of cataract or other media opacities is not strictly necessary for the purpose of the study.

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 |
| --- | --- | --- |
| Retinal vessel oxygen saturation |  | 12 months | 
| Visual acuity |  | 12 months | 
| Central retinal thickness |  | 12 months | 
| Presence or absence of ocular neovascularisation | As determined by gonioscopic examination | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal vessel oxygen saturation |  | Baseline | 
| Visual acuity |  | Baseline | 
| Central retinal thickness |  | Baseline | 
| Presence or absence of ocular neovascularisation | As determined by gonioscopic examination | Baseline | 
| Retinal vessel oxygen saturation |  | 3 months | 
| Visual acuity |  | 3 months | 
| Central retinal thickness |  | 3 months | 
| Presence or absence of ocular neovascularisation | As determined by gonioscopic examination | 3 months | 
| Retinal vessel oxygen saturation |  | 6 months | 
| Visual acuity |  | 6 months | 
| Central retinal thickness |  | 6 months | 
| Presence or absence of ocular neovascularisation | As determined by gonioscopic examination | 6 months |
Females With Severe or Moderate Hemophilia A or B: A Multi-Center Study

Study Overview
=================
Brief Summary
-----------------
To collect and analyze data on females with hemophilia so as to better define the difference between the study population and the male population with hemophilia.

Detailed Description
-----------------
This study is designed as an epidemiological study with retrospective clinical and genetic data collection and prospective quality of life (QOL) data collections and genotyping of subjects without current molecular diagnosis. Data on the genetic/chromosomal etiology of the condition will be collected through chart review. For those subjects who have not had molecular or cytogenetic analysis, molecular and cytogenetic testing will be offered after genetic counseling. Those subjects who agree to have genetic testing will have 5-10 ml of blood drawn and sent to the cytogenetic laboratory at Weill Cornell Medical College for testing to determine the chromosomal complement, and 5 ml of blood sent to Dr. Arupa Ganguly at the University of Pennsylvania for the identification of a factor VIII or factor IX mutation, and X-chromosome inactivation studies.

Official Title
-----------------
Females With Severe or Moderate Hemophilia A or B: A Multi-Center Study

Conditions
-----------------
Hemophilia A, Hemophilia B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females with severe (FVIII<0.01u/dl) or moderate (FVIII-0.01<0.06 u/dl) hemophilia A Females with severe (FIX<0.01u/dl) or moderate (FIX-0.01<0.06u/dl) hemophilia B Willingness to participate in the study. Exclusion Criteria: Subjects who do not meet the inclusion criteria with respect to gender or hemophilia severity.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Females with Hemophilia<br>Females with severe or moderate Hemophilia A or B. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of females with severe or moderate hemophilia A or B in the United States. |  | Study Duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect existing data on the genetic and/or chromosomal causes for severe and moderate hemophilia A and B in females in the United States. |  | Study Duration | 
| To determine the natural history of hemophilia in females by collecting and analyzing data on the symptoms, treatment patterns, and complications of hemophilia in this cohort. |  | Study Duration | 
| Collect and analyze data on the health-related quality of life and psychosocial adaptation to disease of females in the United States. |  | Study Duration |
Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

Official Title
-----------------
A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents

Conditions
-----------------
Primary Open Angle Glaucoma (POAG)

Intervention / Treatment
-----------------
* Device: iStent
* Device: iStent
* Device: iStent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open-angle glaucoma (POAG) Subject on two topical hypotensive medications Exclusion Criteria: Traumatic, uveitic, neovascular, or angle closure glaucoma Fellow eye already enrolled

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: iStent 1, 2, or 3 stents
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Arm: One iStent, medication<br>Device: One iStent, medication | Device: iStent<br>* Implantation of One iStent through a small temporal clear corneal incision.<br>|
| Experimental: Second Arm: Two iStents, medication<br>Device: Two iStent devices, medication | Device: iStent<br>* Implantation of Two iStents through a small temporal clear corneal incision<br>|
| Experimental: Third Arm: Three iStents, medication<br>Device: Three iStent devices, medication | Device: iStent<br>* Implantation of Three iStents through a small temperal clear corneal incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diurnal IOP <18 mmHg at month 12 |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle, Glaucoma, surgery, Glaucoma, Open-Angle, Ocular Hypertension, Eye Diseases
Surgery or Clincial Follow up, in Patients With Bell' s Palsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if an early surgical intervention on patienst with Bell´s Palsy has a better impact on their facial muscular function and their quality of life as compared to conventional therapy.

Official Title
-----------------
Surgery or Clinical Follow-up in Patients With Bell's Palsy. A Prospective, Parallell, Single Center, Randomized , Open Surgery Clinical Study.

Conditions
-----------------
Bell Palsy

Intervention / Treatment
-----------------
* Procedure: Baby-sitter surgery N. fascialis
* Other: Conventional treatment and follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Bell´s Palsy Men and women aged 18-55 y Score < 70 according to Sunny Brook scale (SB) Signed informed consent Exclusion Criteria: High bloodpressure Diabetes Pregnancy Currently on immunodepressive treatment Smoker Psychiatric disorder Cor incomp, according to NYHA grade: IV, kidney or liver disorder, that greatly influence patienst ability to receive surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Early surgery<br>Patienst with Bell´s Palsy with an early surgical intervention (< 3month), according to 'baby-sitter' method | Procedure: Baby-sitter surgery N. fascialis<br> <br> |
| Active Comparator: Conventional treatment and follow-up<br>Patienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model. | Other: Conventional treatment and follow-up<br>* Patient´s with Bells´palasy are treated with conventional treatment and follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sunny Brook (SB) score > 70 | Patients with Bell´s Palsy that has been randomized to conventional treatment or early surgical intervention are scored according to SB after 12 month of study participation. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial Disability Index | Change in Facial Disability Index | 15 month | 
| FaCe | Change in FaCe quality score | 15 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cranial Nerve fascial paresis
The Diastolic Pressure Gradient for Patients With Acute Coronary Syndrome: Evaluation of Non Culprit Lesions

Study Overview
=================
Brief Summary
-----------------
The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration is currently required for functional evaluation of stenosis severity using the fractional flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the instantaneous wave-free ratio (iFR), was recently introduced. Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow reserve (FFR) in ACS patients.

Conditions
-----------------
Functional Evaluation of Non Culprit Lesions in ACS Patients

Intervention / Treatment
-----------------
* Other: Measurement of intracoronary pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 40 to 80 years recent Acute Coronary Syndrome indication for coronary angiography presence of at least one non-culprit lesion requiring functional evaluation with fractional flow reserve (FFR): Exclusion Criteria: Haemodynamically significant valvular disease controindication for Adenosin administration previous CABG on the index vessel

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Acute Coronary Syndrome<br>Patients with Acute Coronary Syndrome and multivessel coronary artery disease undergoing functional evaluation of non-culprit lesions. | Other: Measurement of intracoronary pressure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia

Study Overview
=================
Brief Summary
-----------------
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.

Official Title
-----------------
A Multiple-dose, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCQ908 in Patients With Severe Hypertriglyceridemia and Chylomicronemia (Phenotypes I and V)

Conditions
-----------------
Hyperlipoproteinemia

Intervention / Treatment
-----------------
* Drug: LCQ908
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed). Non breast feeding women. Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing. Exclusion Criteria: Patients with: uncontrolled type 1 or type 2 diabetes mellitus, active pancreatitis (the month prior to study start), history of drug or alcohol abuse within the 12 months prior to dosing, or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCQ908<br> | Drug: LCQ908<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting and postprandial plasma triglycerides |  | baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration to characterize LCQ908 kinetics |  | serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose | 
| Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids) |  | after 3 weeks of treatment with each dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Familial hyperchylomicronemia, Lipoprotein lipase deficiency, Hyperlipoproteinemia, Triglycerides, Hypertriglyceridemia, LCQ908, Hyperlipoproteinemia associated with lipoprotein lipase deficiency