linjc16/ctgov huggingface dataset:
Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors

Study Overview
=================
Brief Summary
-----------------
PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological similarities were seen between PEComa and infantile hemangioma. Propranolol is highly efficient to treat infantile hemangioma and we believe that this drug can also be useful for the treatment of PEComa. Purpose : to understand the mechanism of action of propranolol in PEComas and related pediatric vascular lesions and to select possible novel targets of betablockers in vascular tumors related to PEComas by using YAP oncogene activation as a molecular marker

Official Title
-----------------
Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors

Conditions
-----------------
PEComa, Hemangioma

Intervention / Treatment
-----------------
* Other: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who will have biopsy or surgery for PEComa or vascular pediatric tumor (RICH, NICH, hemangioma or pyogenic granuloma) A free, informed and written consent will be established Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who will have biopsy or surgery for Perivascular epithelioid cell tumor (PEComa) or vascular pediatric tumor (Rapidly Involuting Congenital Hemangioma (RICH), Non Involuting Congenital Hemangioma (NICH), hemangioma or pyogenic granuloma) | Other: Biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YAP cellular expression by immunohistochemistry study on collected tissues |  | At inclusion (day 0)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta adrenergic receptors expression by immunohistochemistry study on collected tissues |  | At inclusion (day 0)] | 
| Study of Hippo/YAP pathway expression by western-blot, and correlation with propranolol efficacy |  | At inclusion (day 0)] | 
| Study of MAP/kinases pathway expression by western-blot, and correlation with propranolol efficacy |  | At inclusion (day 0)] | 
| Study of PKA/AMPc pathway expression by western-blot, and correlation with propranolol efficacy |  | At inclusion (day 0)] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propranolol, betablocker, angiogenesis
Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine

Study Overview
=================
Brief Summary
-----------------
observational prospective study, designed for patients with colorectal cancer receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations.

Detailed Description
-----------------
All patients enrolled will be evaluated for cardiovascular risk factors and, if resulted at cardiovascular risk, they will be submitted to cardiac examination and therapy optimization before starting chemotherapy. Patients will be evaluated with 12-lead ECG and blood sample for TnI and NT pro-BNP before start chemotherapy and on day 3 of chemotherapy during the first, second and third cycle. All patients developing cardiovascular events will be submitted to blood sample for TnI, NT-proBNP, hsTnI and cardiac examination.

Official Title
-----------------
CHEmotherapy-induced Cardiotoxicity and Study of risK Factor Correlation in Patients With Colorectal Cancer Receiving Oral or INfusional Fluoropyrimidine Treatment - CHECKPOINT

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Age ≥ 18 years Histologically confirmed adenocarcinoma of colon or rectum (any T, any N, any M) receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations Exclusion Criteria: Prior treatment with fluoropyrimidines Prior or concurrent chest radiotherapy Any prior or concurrent treatment with cardiotoxic drug Any serious or uncontrolled cardiovascular disease (defined by the specialist during cardiac examination, see section 6.3.2 for details )

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 |
| --- | --- | --- |
| Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiotoxicity, fluoropyrimidine, colorectal cancer
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device. To evaluate rare and unanticipated adverse events. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

Official Title
-----------------
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Conditions
-----------------
Carotid Artery Disease

Intervention / Treatment
-----------------
* Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and above Informed consent Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use Meet Instruction for Use (IFU)/ Centers for Medicare & Medicaid Services (CMS)defined anatomical or clinical high risk criteria Exclusion Criteria: Subjects with contraindications as outlined in the Instructions for Use

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: Device<br>Device | Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device<br>* Carotid artery stenting with distal embolic protection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. | Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation. | 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carotid Artery Disease, Embolic Protection
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.

Official Title
-----------------
A Phase 2 Clinical Trial Evaluating the Incidence of Upper Gastrointestinal Mucosal Damage Following Administration of Either PL3100 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated GI Damage

Conditions
-----------------
Erosion, Gastroduodenal Ulcerations

Intervention / Treatment
-----------------
* Drug: PL3100
* Drug: Naproxen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (Selected) Male and female healthy adult subjects Exclusion Criteria (Selected) Subject has protocol specified significant medical history. Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study. Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PL3100<br> | Drug: PL3100<br>* Oral administration<br>|
| Active Comparator: Naproxen<br> | Drug: Naproxen<br>* Oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of GI Injury at Day 15 | Degree of mucosal injury was assessed by endoscopy, with the following scoring system: Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: > 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: > 10 erosions and/or an ulcer | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSAID-induced gastroduodenal ulcerations or erosion
Online Social Networking for HIV Prevention

Study Overview
=================
Brief Summary
-----------------
In this randomized controlled trial, we will identify social networks on Facebook, an randomly assign each network to control or intervention status. We will then intervene at the level of the network with dynamic, interactive HIV prevention messages (intervention) or static messages about HIV prevention (control). We will develop the intervention content with input from our target audience (Facebook users) and will measure baseline, and 3 and 6 month assessments of condom use and abstinence among all participants

Official Title
-----------------
Online Social Networking for HIV Prevention

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: Online social networking HIV prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Facebook user with an existing Facebook page at least 16 no older than 24 English speaker Exclusion Criteria: older than 24 or younger than 16 non English speaker does not have a Facebook page

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 24 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facebook Arm<br>Participants in this arm will have exposure to innovative, dynamic and regularly updated HIV Prevention messages on Facebook | Behavioral: Online social networking HIV prevention<br>* messages about HIV posted in online social networking sites<br>|
| Active Comparator: Control arm<br>Participants in this arm will have exposure to static information on HIV prevention currently available online | Behavioral: Online social networking HIV prevention<br>* messages about HIV posted in online social networking sites<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Condom Usage | number of times condom used divided by number of times person had sex in past 60 days | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condom and Abstinence Norms, Attitudes, Self-efficacy and Intentions |  | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Prevention, Social Networking, Technology Based Intervention
Fetus Weight Estimation by Ultrasound Data Collection

Study Overview
=================
Brief Summary
-----------------
This research aims to allow deployment & optimization of SAMPL plain wave algorithm so as to make required advancement towards a light-weight portable US platform or wireless probe - thus elevating clinician's care level and patient treatment by allowing more scan availability and flexibility.

Official Title
-----------------
Fetus Weight Estimation by Ultrasound Data Collection

Conditions
-----------------
Fetal Weight

Intervention / Treatment
-----------------
* Device: SAMPL plain wave algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 24+0 weeks and 41+6 weeks gestation. Women with a singleton viable pregnancy. Exclusion Criteria: None

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: performing US scans for fetal weight assessment.<br> | Device: SAMPL plain wave algorithm<br>* SAMPL's plain-wave algorithm allowing portable US or Wireless Probe scanning - thus enabling clinicians with more flexible point-of-care locations when performing US scans for fetal weight assessment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| US scans for fetal weight assessment | 1) To evaluate SAMPL's plain-wave algorithm allowing portable US or Wireless Probe scanning - thus enabling clinicians with more flexible point-of-care locations when performing US scans for fetal weight assessment. | 1 year |
Clinical Trial to Compare the Pharmacokinetics of DP-R208

Study Overview
=================
Brief Summary
-----------------
A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in comparison to each component administered alone in healthy male volunteers

Official Title
-----------------
A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R208 (Candesartan Cilexetil and Rosuvastatin Calcium Fixed Dose Combinations) in Comparison to Each Component Administered Alone in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: DP-R208
* Drug: Candesartan cilexetil
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 17.5 30.5 signed the informed consent form prior to the study participation Exclusion Criteria: Clinically significant disease Previously donate whole blood within 60 days or component blood within 14 days Clinically significant allergic disease Taken IP in other trial within 90 days An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order | Drug: DP-R208<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Candesartan cilexetil<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Rosuvastatin<br>* Investigational product is prescribed to all of randomized subjects<br>|
| Experimental: Group B<br>DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order | Drug: DP-R208<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Candesartan cilexetil<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Rosuvastatin<br>* Investigational product is prescribed to all of randomized subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | up to 72 hours post dose | 
| Area under the plasma concentration versus time curve (AUC) |  | up to 72 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DP-R208
Immediate Effect Analysis of Vocal Techniques

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical and experimental study was to verify the immediate effect of vocal techniques: vibration, nasal sound and articulation in women without vocal complaints.

Detailed Description
-----------------
Vocal techniques have been used, but few studies had as their aim to effectively verify its use and effect produced in voice and the larynx. The objective of this clinical and experimental study was to verify the immediate effect of vocal techniques: vibration, nasal sound and articulation. Material and method: 32 female subjects with normal to mild dysphonia participated in the research, with ages from 20 to 45 years. All subjects were submitted to realization of vocal techniques of vibration of the lips, articulation and nasal sounds for twenty minutes. The subjects were submitted to record the voice and laryngostroboscopic exams for perceptual analysis and laryngostroboscopic exams before and after the use of vocal techniques.

Official Title
-----------------
Perceptual, Acoustic and Laryngological Analysis of Vocal Techniques Immediate Effect

Conditions
-----------------
Voice Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female subjects with normal voices or slightly altered voice without vocal complaints Exclusion Criteria: subject with altered voices of moderate and severe grades with lesions in the vocal folds; fusiform or double gap on the phonation subjects with neurological disorders subjects who had been treated earlier speech by voice changes and / or surgery in the larynx

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects were submitted to perceptual analysis and laryngostroboscopic exams before and after the use of vocal techniques. |  | twenty minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voice, Voice Quality, Voice Training, Evaluation
Femoral Remodeling Following Total Hip Arthroplasty With OMNI Apex Modular™ and OMNI Apex ARC™ Stem Compared to Competitive Designs

Study Overview
=================
Brief Summary
-----------------
This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.

Official Title
-----------------
A Dual Energy X-Ray Absorptiometry (DXA) Evaluation Of Bone Density Changes After Hip Replacement. Performance Of The OMNI Apex Modular™ Hip Stem And The OMNI Apex ARC™ Hip Stem In Primary Total Hip Arthroplasty, Five-Year Clinical And DXA Analysis

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Device: OMNI Apex Modular™ Hip Device
* Device: OMNI Apex ARC™ Hip Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age 20 years, maximum age 80 years Osteoarthritis of the hip Elective THA Signed Informed Consent Exclusion Criteria: Osteoporosis Revisions Clinically obese (>40 body mass index [BMI]) Femoral dysplasia Trochanteric osteotomy Inflammatory arthritis Breast-feeding, pregnancy, or women of childbearing potential without documentation of a negative pregnancy test and not utilizing contraception Patients with a history of having taken or currently taking bisphosphonates, PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect bone mineral density in a substantial way Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study Use of other investigational agent in the last 30 days Unable to sign Informed Consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| APEX Modular<br>APEX Modular Stem group | Device: OMNI Apex Modular™ Hip Device<br> <br> |
| ARC Stem<br>ARC Stem group | Device: OMNI Apex ARC™ Hip Device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral bone mineral density | Change in bone mineral density (BMD) as measured by DXA imaging. | Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (HHS) | Hip functional outcomes will be assessed using the Harris Hip Score. | Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DEXA, Total Hip Arthroplasty, Bone Loss, Femoral Remodeling, Bone mineral density, THA, DXA, Dual Energy X-Ray Absorptiometry