linjc16/ctgov huggingface dataset:
Vibration Response Imaging in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to test intersubject variability and establish the qualitative features of normal VRI images and the range of normality of the VRI quantitative lung data values that may be used to differentiate normal from abnormal breath sound distribution. Our hypothesis was that VRI breath sound images of healthy subjects are similar in a qualitative and quantitative manner.

Detailed Description
-----------------
Computerized analyses have shown that normal lung sounds have distinctive characteristic that can be differentiated from abnormal lung sounds.However, technical issues and complicated display modes have restricted the use of computerized lung sound analyses in the clinical environment. The VRI provides dynamic gray-scale images and quantitative lung data showing the breath sound distribution of healthy individuals. Typical features that are discerned by trained raters and quantitative lung data may serve as a reference for comparison to abnormal breath sound images.

Official Title
-----------------
Passive Acoustic Imaging With the Vibration Response Imaging Device in Healthy Subjects

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to read, understands, and provides written Informed Consent; Male or Female in the age range of 18-85 years; Subject is healthy and has not exhibited symptoms of acute respiratory tract disease for the past two months; Subject has normal chest X-ray and normal lung function during the past 6 months that were judged stable; BMI > 21. Exclusion Criteria: Subject has a history of a chronic condition that affects the lungs or heart (e.g.chronic obstructive pulmonary disease, asthma, congestive heart failure) or is suspected of having such a condition; Subject has a chest cage deformation; Subject has spine deformation (including severe scoliosis); Subject is Hirsute; Subject has a skin lesion (potentially contagious) on the back; Subject has a cardiac pacemaker or implantable defibrillator;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy, Lung sounds, Breath sounds
Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation

Study Overview
=================
Brief Summary
-----------------
Intestinal transplantation is associated with high numbers of ejection events. A close endoscopic controll of the intestinal graft is possible. Sasaki et al. presented 2002 an endoscopic score using zoom-endoscopes for early detection of rejection events.

Detailed Description
-----------------
Small bowel transplantation is a potentially life-saving procedure for patients with irreversible gut failure, especially for those with total parenteral nutrition complications, inability to adapt to quality-of-life limitations posed by intestinal failure, and high risk of death if the native gut is not removed. Endoscopy provides the quickest method for assessing the overall health of graft mucosa and is essential in obtaining specimens from large areas for histologic evaluation, which continues to remain the gold standard for a diagnosis of rejection. Recently, the use of zoom videoendoscopy has been reported as a better evaluation of intestinal mucosa than the use of a standard endoscope. Acute cellular rejection in short-term follow-up, appears with acute and dramatic clinical symptoms (fever, vomiting, nausea, increased stomal output/diarrhea, abdominal pain, and distension), so that it is rarely predictable with surveillance. Comparison of endoscopic and histo-pathologic findings should be performed.

Official Title
-----------------
Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation, Role of SASAKI Score

Conditions
-----------------
Intestinal Graft Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: zoom-endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intestinal transplant recipients Exclusion Criteria: younger age (< 16)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: zoom-endoscopy|Endoscopic monitoring of intestinal transplant recipients is done with zoom-endoscopes for exact diagnostic of intestinal mucosa.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of congruent findings of zoom-endoscopy and pathological examinations | Reliability of zoom-endoscopy and pathological examinations | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic monitoring, intestinal transplantation
Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to establish which anesthetic procedure used during flexible bronchoscopy has the lowest index of complications.

Detailed Description
-----------------
This prospective randomized study analyzed 80 patients that underwent flexible bronchoscopy. Patients were randomly assigned to four groups of 20 patients each according to the anesthetic combination used: 200 mg topical lidocaine (LID group); 200 mg topical lidocaine and 2 mg/kg propofol (PPF group); 200 mg topical lidocaine and 20 mcg/kg alfentanil (ALF group); or 200 mg topical lidocaine and 0.05 mg/kg midazolam (MID group). Scores were assigned to patients according to the different variables observed during the endoscopic procedure; the lower the score, the lower the complication index.

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: propofol
* Drug: midazolam
* Drug: alfentanil
* Drug: lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients included in this study were referred to FBC for the investigation of bronchial carcinoma (diagnostic procedure). Patients included in the study were classified as ASA I, II and II according to the anesthetic risk classification of the American Society of Anesthesiologists (ASA). Exclusion Criteria: ASA IV classification of anesthesiology risk procedure that lasted longer than 15 minutes indication of therapeutic bronchoscopy cardiac arrhythmia and / or hypoxemia detected at admission.

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: propofol|nan|
|Drug: midazolam|nan|
|Drug: alfentanil|nan|
|Drug: lidocaine|nan|

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
-----------------
alfentanil, anesthesia, bronchoscopy, lidocaine, midazolam, propofol.
A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).

Detailed Description
-----------------
The aim of the present study is to compare patients' satisfaction with pain medication during the first 7 first postoperative days following elective hallux valgus surgery in general anaesthesia between etoricoxib and diclofenac in a prospective randomised double-blind study design.

Official Title
-----------------
A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

Conditions
-----------------
Hallux Valgus, Postoperative Pain

Intervention / Treatment
-----------------
* Drug: etoricoxib
* Drug: Diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiology (ASA) physiological class 1-2 patients aged 18-65 years scheduled for elective hallux valgus surgery in general anesthesia Exclusion Criteria: NSAID allergy liver disease renal disease uncontrolled cardiovascular disease Lithium therapy chronic pain regular analgesia use

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: etoricoxib<br>active study drug, coxib | Drug: etoricoxib<br>* 120 mg once daily for the 1st 6 postoperative days<br>|
| Active Comparator: diclofenac<br>active traditional NSAID control | Drug: Diclofenac<br>* 50 mg oral 3 times daily the 1st 6 postoperative days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Global Evaluation of Study Medication | Patients self-assessment of global satisfaction with pain medication | postoperative day 1-6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Day case surgery, postoperative pain, NSAIDs, Coxibs
Effects of Projected Peripheral Defocus on Ocular Biometrics

Study Overview
=================
Brief Summary
-----------------
Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery will stimulate physiological changes similar to those in the literature.

Official Title
-----------------
Effects of Projected Peripheral Defocus on Ocular Biometrics

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field
* Device: Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spherical equivalent +2.00 to -4.00 diopters Refractive cylinder ≤ 0.75 diopters Visual acuity 20/20 -3 or better Exclusion Criteria: Pregnant or lactating Active ocular infection History of dry eye, strabismus, or amblyopia Previous or planned ocular surgery Use of medication known to affect vision or accommodation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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: Test Arm<br> | Device: Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field<br>* For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image<br>Device: Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field<br>* For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length (AL) | Change in AL from baseline in the test eye vs. control eye | 1 hour | 
| Choroidal thickness (CT) | Change in CT from baseline in the test eye vs. control eye | 1 hour |
An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU.

Detailed Description
-----------------
This was an open-label, multicenter extension study that was conducted to evaluate the safety and efficacy of etanercept in the treatment of adult subjects with AS who had completed study 0881A3-311-EU. The study consisted of an open-label treatment period of up to approximately 96 weeks.

Official Title
-----------------
An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Completed the entire 12 weeks of therapy in study 0881A3-311-EU, or completed at least 8 weeks of therapy and returned for the week 12 visit in study 0881A3-311-EU. Negative serum β-HCG pregnancy test at baseline (all women of childbearing potential). Sexually active women of childbearing potential had to use a medically acceptable form of contraception. Medically acceptable forms of contraception included oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms was suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy. Sexually active men had to agree to use a medically accepted form of contraception during the study. Able to reconstitute and self-inject test article or have a designee who can do so. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed. Able to store injectable test article at 2°C to 8°C.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Knee Joint Icing and Knee-extension Strength

Study Overview
=================
Brief Summary
-----------------
With this study the investigators wish to (1) investigate the acute effect of knee joint icing on knee-extension strength shortly after total knee arthroplasty (TKA); and (2) investigate the acute effect of knee joint icing on knee pain, knee joint circumference and functional performance shortly after TKA.

Detailed Description
-----------------
As knee joint icing had no acute effect on knee-extension strength in the present study, prolonged icing may have an effect on one or more of the parameters, and further studies are needed to determine the potential beneficial effects of cooling after TKA.

Official Title
-----------------
No Effect of Knee Joint Icing on Knee-extension Strength After Total Knee Arthroplasty. A Randomized Cross-over Study

Conditions
-----------------
Arthroplasty

Intervention / Treatment
-----------------
* Other: Thermotherapy
* Other: Thermotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary unilateral total knee arthroplasty Exclusion Criteria: inability to speak and understand Danish inability to perform the measurements due to other diseases

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control treatment<br>Elbow joint icing using two plastic bags with crushed ice | Other: Thermotherapy<br>* Elbow joint icing<br>* Other names: Cryotherapy;|
| Active Comparator: Active treatment<br>Knee joint icing using two plastic bags with crushed ice | Other: Thermotherapy<br>* Knee joint icing<br>* Other names: Cryotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee-extension strength | Maximal knee-extension strength is measured using a hand-held dynamometer | In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee pain | Knee pain was quantified by using The Visual Analog Scale (VAS) at rest and during active measurements. | In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee joint icing, knee-extension strength
Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo.

Official Title
-----------------
Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: DWJ1319
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 19 years of age Patient who undergoes gastrectomy (total, distal or proximal gastrectomy) D1+ or D2 lymph node dissection Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale Written informed consent Exclusion Criteria: Patients with cholangitis, cholecystitis, non-functional gall bladder, or biliary obstruction Presence of gallstones on ultrasonography and/or CT History of previous cholecystectomy Patients undergoing pylorus-preserving gastrectomy Pregnant or lactating women and fertile women who is not using proper contraceptive method Patients with history of drug or alcohol abuse within 5 years ago

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWJ1319 300 mg BID<br>DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months | Drug: DWJ1319<br> <br> |
| Experimental: DWJ1319 300 mg QD<br>DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months | Drug: DWJ1319<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>Placebo, orally, twice daily (BID) for up to 12 months | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patient developing gallstone at 12 month after gastrectomy |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy |  | 3, 6 and 9 months | 
| Time to gallstone formation |  | 12 months |