linjc16/ctgov huggingface dataset:
Zenith TX2® Post-market Approval Study

Study Overview
=================
Brief Summary
-----------------
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.

Official Title
-----------------
Zenith TX2® TAA Endovascular Graft Post-approval Study

Conditions
-----------------
Descending Thoracic Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Zenith TX2® TAA Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter Exclusion Criteria: Age less than 18 years Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years) Pregnant, breast-feeding, or planning on becoming pregnant within 24 months Unwilling or unable to comply with the follow-up schedule Inability or refusal to give informed consent Simultaneously participating in another investigative device or drug 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular repair<br>treatment | Device: Zenith TX2® TAA Endovascular Graft<br>* Endovascular treatment with the study device<br>* Other names: TEVAR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality | Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endovascular Aneurysm Repair, Aortic Aneurysm, Thoracic
Increasing PrEP Among African Americans in Louisville KY

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness of a multifaceted strategy to increase pre-exposure prophylaxis (PrEP; a medication regimen to reduce HIV risk) uptake among high risk African Americans in Louisville, KY. We will do this by 1) implementing a media campaign to raise awareness about PrEP, 2) providing PrEP education to medical personnel who can prescribe PrEP, and 3) partnering with AIDS service organizations to improve outreach and linkage to PrEP services.

Official Title
-----------------
Increasing Pre-exposure Prophylaxis Among High-Risk African Americans in Louisville KY

Conditions
-----------------
HIV/AIDS PREVENTION

Intervention / Treatment
-----------------
* Behavioral: Project Prevent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between ages 18-29 years old Self-identifies as African American or Black Resident of Louisville, KY Member of a priority group for PrEP HIV prevention (Men who have sex with men, people who inject drugs, trans women, high risk heterosexuals, people in serodiscordant relationships). Not diagnosed with HIV Exclusion Criteria: Older than 29 and younger than 18 years old Does not identify as African American or Black Does not reside in Louisville, KY Not a member of a priority group Diagnosed with HIV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>All study participants will be exposed to the intervention | Behavioral: Project Prevent<br>* The Project Prevent intervention entails 1) a media campaign to raise PrEP awareness, 2) geographically targeted education initiatives with medical personnel to increase access to consumers, and 3) programming with AIDS service organizations to improve service delivery around PrEP.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP uptake | Reported use of PrEP | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP intentions | Intention to use PrEP | 12 months | 
| PrEP prescription | Prescription of PrEP to eligible individuals by medical personnel | 12 months |
Postural Analysis of Patients Receiving Rehabilitation Program

Study Overview
=================
Brief Summary
-----------------
This is a study for evaluation of posture of patients with neurological disease in rehabilitation department.

Detailed Description
-----------------
In this study, we evaluate the static posture stability of the patient, such as during sitting, standing and dynamic posture stability of the patient, such as during walking, time-up-and-go test.

Official Title
-----------------
Kaohsiung Medical University Chung-Ho Memorial Hospital

Conditions
-----------------
Stability

Intervention / Treatment
-----------------
* Device: Ankle foot orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with physical disability followed-up in rehabilitation department Exclusion Criteria: Patients with congitive impairment that can't complete the evalaution well Patients with uncontrolled comorbidity diseases Attended other study in recent 3 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental group-with rehabilitation intervention<br>We evaluate the static or dynamic posture stability of patients with rehabilitation intervention | Device: Ankle foot orthosis<br>* We evaluate the difference of with or without ankle foot orthosis<br>|
| Control group-without rehabilitation intervention<br>We evaluate the static or dynamic posture stability of patients without rehabilitation intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Displacement of center of gravity during standing | Data collected by motion analysis system | 1 day | 
| Displacement of center of gravity during walking | Data collected by motion analysis system | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk movement | Data collected by motion analysis system | 1 day | 
| Hip movement | Data collected by motion analysis system | 1 day | 
| Knee movement | Data collected by motion analysis system | 1 day | 
| Ankle movement | Data collected by motion analysis system | 1 day | 
| Foot pressure | Data collected by Pedar (foot pressure system) | 1 day | 
| Foot reaction force | Data collected by Pedar (foot pressure system) and force plate | 1 day |
Impact of Non Invasive Ventilation on Quality of Sleep

Study Overview
=================
Brief Summary
-----------------
Quality of sleep is profoundly affected in patients with hypercapnic respiratory failure and restrictive disorders, with a decrease in rapid eye movement (REM) and slow wave sleep, and an increase in sleep fragmentation. Assisted ventilation aims at improving blood gases, but may also have a favorable impact on sleep structure. The investigators reviewed polysomnographic and blood gas data obtained between 1987 and 2008 in 95 patients with restrictive pulmonary disorders, before and after implementing non-invasive ventilatory support.

Detailed Description
-----------------
Chart review of all patients with predominantly restrictive pulmonary disorders treated for respiratory failure by NIV at our institution between 1987 and 2008. Data systematically recorded included pulmonary function tests, diurnal arterial blood gases, and polysomnography before and after implementation of nocturnal NIV.

Official Title
-----------------
Impact of Non Invasive Ventilation on Quality of Sleep

Conditions
-----------------
Restrictive Pulmonary Disorders, Non Invasive Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with restrictive pulmonary disorders (neuro-muscular diseases, chest wall disorders, sequellae of tuberculosis) leading to hypercapnic respiratory failure requiring non invasive ventilation (NIV), investigated according to clinical standards in our institution by polysomnography before and after implementation of NIV Exclusion Criteria: Patients fulfilling inclusion criteria for whom diagnostic polysomnography and/or polysomnography under NIV were not performed

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Chronic respiratory failure<br>Patients with restrictive pulmonary disorders leading to progressive hypercapnic respiratory failure and requiring nocturnal non-invasive ventilation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime arterial blood gases and Polysomnography before and after non invasive ventilation |  | Average of 4 months |
A Study in People With High Cholesterol

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine: The safety of the study medication and any side effects that might be associated with it Whether the study medication can help patients with high levels of bad cholesterol (low-density lipoprotein-cholesterol [LDL-C]), alone or in combination with additional study medication

Official Title
-----------------
PPAR Alpha (LY518674): A Phase 2 Study of the Combinatorial Effect of LY518674 and Atorvastatin in Subjects With Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: PPAR alpha
* Drug: atorvastatin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between 18 and 80 years of age People with abnormal cholesterol levels Exclusion Criteria: People with diabetes People whose blood pressure >160/95 mm Hg, on or off blood pressure medicine People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure including stent placement, within the past 3 months

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PPAR alpha|nan|
|Drug: atorvastatin|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on bad cholesterol, LDL-C, after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety after 12 weeks |  |  | 
| Effects on other lipids and biomarkers associated with atherosclerosis after 12 weeks |  |  | 
| Evaluate interaction of the 2 different study medications |  |  |
Pain in Single Incision Laparoscopic Surgery Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. In this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.

Official Title
-----------------
Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy

Conditions
-----------------
Laparoscopic Cholecystectomy

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Cholecystectomy
* Procedure: SILS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index less than 30 Attacks of cholelithiasis Exclusion Criteria: Body Mass Index more than 30 Signs of acute cholecystitis

Ages Eligible for Study
-----------------
Minimum Age: 28 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 |
| --- | --- |
| Active Comparator: Laparoscopic Cholecystectomy<br>Four ports classic laparoscopic cholecystectomy | Procedure: Laparoscopic Cholecystectomy<br>* Four ports classic laparoscopic cholecystectomy<br>|
| Active Comparator: SILS<br>Single transumbilical incision laparoscopic cholecystectomy | Procedure: SILS<br>* Single transumbilical incision laparoscopic cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minimally invasive surgery, scarless cholecystectomy, new techniques in laparoscopy, invisible scar, single port access, abdominal pain, shoulder pain
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion

Study Overview
=================
Brief Summary
-----------------
VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.

Detailed Description
-----------------
Vital Therapies, Inc. (VTI) is conducting clinical trial VTI-206 in which subjects with acute on chronic hepatitis (AOCH) and acute alcoholic hepatitis (AAH) are treated with the ELAD system to assess the safety and efficacy of this therapy. The ELAD system incorporates cloned immortalized human liver cells (C3A cells). A hypothetical risk exists that, over an extended period of time, there may be an increased incidence of tumor in subjects treated with ELAD. The company is also collecting data related to whether a patient received a liver transplant and on survival.

Official Title
-----------------
Registry Protocol for Tracking the Incidence of Transplant, the Incidence and Type of Cancer, and Survival Rate of Subjects Participating in Protocol VTI-206 (NCT00973817)

Conditions
-----------------
Acute Liver Failure

Intervention / Treatment
-----------------
* Drug: ELAD (Extracorporeal Liver Assist System)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects participating in the VTI-206 clinical trial. Exclusion Criteria: Subjects not participating in the VTI-206 clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AOCH patients<br>Patients with acute on chronic hepatitis | Drug: ELAD (Extracorporeal Liver Assist System)<br>* ELAD (Extracorporeal Liver Assist System)<br>|
| Experimental: AAH patients<br>Patients with acute alcoholic hepatitis | Drug: ELAD (Extracorporeal Liver Assist System)<br>* ELAD (Extracorporeal Liver Assist System)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gather data | See previous description | Five years post study participation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver, liver failure, acute liver failure, ELAD, alcoholic hepatitis, acute on chronic hepatitis
Right-front Direction in Parabolic Flight

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to objectively determine the perceived direction of the right-front by the subjects in weightlessness. The direction of the right-front has not been investigated to date with the measurements of the position of the eyes. The investigators will compare the intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent direction of the right-front indicated by the subjects when they look right front in the dark (LOOK) and that they indicate when they determine whether a visual target through the right-front apparent (PERCEPTION). Then, the investigators will compare these measurements between normal gravity and microgravity hypergravity during parabolic flight.

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

Intervention / Treatment
-----------------
* Other: Parabolic flight
* Other: Measurements of eye movements and perception


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers (men or women) Aged between 20-65 years Affiliates to a social security system Who are willing to take part in the study, Who gave written informed consent, Declared fit after a similar visit to a medical aeronautical medical fitness for the non-professional cabin crew in civil aviation. There will be no other aptitude tests for the selection of subjects. Exclusion Criteria: People who participated in a biomedical research protocol for which the exclusion period is complete, pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Measurements of eye movements and perception<br> | Other: Parabolic flight<br> <br> Other: Measurements of eye movements and perception<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eye movements | measurements between normal gravity and microgravity hypergravity during parabolic flight | Baseline | 
| acceleration of the head | measurements between normal gravity and microgravity hypergravity during parabolic flight | Baseline | 
| perception by the subjects of the right-front. | measurements between normal gravity and microgravity hypergravity during parabolic flight | Baseline | 
| acceleration of the arms | measurements between normal gravity and microgravity hypergravity during parabolic flight | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers