linjc16/ctgov huggingface dataset:
Relationship of Essential Hypertension and Its Treatments on the Postoperative Pain Management: a Prospective, Observational, Cross-sectional Study

Study Overview
=================
Brief Summary
-----------------
Numbers of postoperative PCA related side effects among three groups will be determined by comparing and analyzing frequency distributions. To determine whether the patients with hypertension require less post operative opiate analgesics than others, multivariate analysis with repeated measures will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. The major aim of the study is to test the hypothesis that the morphine comsumpted by the hypertension group is less than those of the normotension group. The minor aims for the study are the difference related to pain intensity, or the incidence of side effects among groups.

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 300 eligible subjects No contraindication for inhalation anesthesia Elective surgery Age between 20-75 y/o No contraindication for postoperative morphine pain control Female or male Essential hypertension stage I and II (140<=SBP<=180; 90<=DBP<=110) Exclusion Criteria: Liver disease Renal disease Those who is presumed to go to ICU after surgery The patients with dementia or conscious disturbance Pregnancy or breast feeding Secondary hypertension events in recent 6 months myocardial infarction cardiac bypass surgery unstable angina cerebrovascular events congestive heart failure significant arrhythmia thoracic surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| normotension group<br>Until 11,March, 2015, 31 cases are collected. | |
| hypertension group without treatment<br>Until 11,March, 2015, 60 cases are collected. | |
| hypertension group with antihypertensive treatment<br>(ACEI, beta-blocker, Ca blocker, Diuretics) prior to the surgery. Until 11,March, 2015, 59 cases are collected. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | Post-operation Day1 to Day4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption |  | Post-operation Day1 to Day4 |
Analysis of Orthopedic Patients Response to New Pain Modulating Substances and Drugs

Study Overview
=================
Brief Summary
-----------------
Data of patient reported outcomes (PRO) are collected during treatment with various pain alleviation methods (drugs or substances)

Detailed Description
-----------------
The study aims at collecting BPI (brief pain inventory) and other PRO of patients in need of pain relief due to chronic orthopedic pain conditions

Official Title
-----------------
Effect of New Pain Modulating Substances in Orthopedics

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: standard medications crossed over to cannabis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic pain of orthopedic origin treated for at least one year unsuccessfully Exclusion Criteria: contra-indication for cannabis treatment

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: standard medications crossed over to cannabis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief pain inventory score (BPI) | score of PRO | 2 years |
Pharmacokinetic Study of Two Oral Bemiparin Formulations

Study Overview
=================
Brief Summary
-----------------
The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity

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

Intervention / Treatment
-----------------
* Drug: Oral bemiparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers: male or female subjects aged between 18 and 45 years Body weight: 65-80 Kg Not meaningful abnormalities in physical examination and in clinical history Without evidence of significant organic or psychiatric illness Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months Not give blood in the last 4 weeks. Healthy male volunteers who have not received heparin in the past Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent contraceptive methods double barrel or sterile surgery Exclusion Criteria: Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption Important consumption of exciting drinks: alcohol consumption > 30 g/day; coffee, tea, cola > 5 /day Allergy, idiosyncrasy or hypersensitivity to medicines Healthy volunteers who are receiving another medication in the past 15 days Positive serology of hepatitis B, C or HIV Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events Mayor Surgery in the last 6 months Smoking > 10 cigarettes / day Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine Healthy volunteers with a familiar history evident hemorrhagic episodes positive fecatest and comburtest positive pregnant test Bemiparin contraindication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral bemiparin|Bemiparin tablets and bemiparin tablets into hard gelatine capsules|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity |  | pre-medication, +1 h , +2 h, +3h, +4 h , +5h, +6 h, +8 h, +10h, +12h, +18 h, +24 h,+25h, +26h, +27h, +28h, +29h, +30h, +32h, +34h, +36h, +42h, +48 h, +60 h and +72 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers
Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane

Study Overview
=================
Brief Summary
-----------------
Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting membrane is frequently performed procedure and we suspected that these procedures may affect integrity of foveal avascular zone. The purpose of the present study is to evaluate the change of foveal avascular zone after removal of epiretinal membrane and internal limiting membrane

Conditions
-----------------
Epiretinal Membrane

Intervention / Treatment
-----------------
* Procedure: epiretinal membrane and internal limiting membrane removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epiretinal membrane Exclusion Criteria: history of vitrectomy, intraocular surgery any macular disease other than epiretinal membrane media opacity obscuring the image of fluorescein angiography

Ages Eligible for Study
-----------------
Minimum Age: 20 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: epiretinal membrane<br> | Procedure: epiretinal membrane and internal limiting membrane removal<br>* fluorescein angiography is performed before, 1 week, 3months and 6months after the epiretinal membrane and internal limiting membrane removal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area of foveal avascular zone | the change in area of foveal avascular zone at postoperative 6 months | postoperative 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in visual acuity |  | postoperative 6 months | 
| change in macular thickness |  | at 6 months | 
| change in metamorphopsia |  | postoperative 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epiretinal membrane, foveal avascular zone, internal limiting membrane
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer

Official Title
-----------------
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer

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

Intervention / Treatment
-----------------
* Drug: Cetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Measurable disease Tumor available for biopsies. Life expectancy of at least 3 months. Exclusion Criteria: Known or documented brain metastases prior to Cetuximab therapy.

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: A<br> | Drug: Cetuximab<br>* IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.<br>* Other names: Erbitux;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of response to Erbitux in subjects with metastatic colorectal cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Response |  |  |
Reliability of Fluorescent Camera in Diagnosis of Occlusal Carious Lesion

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to compare the diagnostic predictive values of a light induced fluorescence camera and Caries detection dye versus visual assessment method in identification of occlusal carious lesion.

Detailed Description
-----------------
A total of 43 volunteer patients will be assigned in this study. Each patient must have at least two occlusal carious lesions. Each lesion will be evaluated by three diagnostic methods (D), where D1 represents light induced fluorescence camera, D2 represents Caries detection dye. And D3 represents visual assessment method (ICDAS criteria)

Official Title
-----------------
Reliability of Fluorescent Camera and Caries Detection Dye Versus Visual- Assessment in Diagnosis of Occlusal Carious Lesion in Adult Patients: Invivo Diagnostic Study

Conditions
-----------------
Caries

Intervention / Treatment
-----------------
* Device: fluorescence camera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be over 18 Years old Patient should have good oral hygiene and general health patients With at least 2 non-cavitated first and/or second molar teeth in each quadrant of maxilla or mandible Exclusion Criteria: Known allergy to any component of the dyes used. Patients having caries at proximal, buccal, lingual surface. Previously placed sealants or restorations. Bruxism or malocclusion

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diagnostic tool<br>Light induced fluorescence camera Caries detection dye. visual assessment method (ICDAS criteria) | Device: fluorescence camera<br>* drug - diagnostic test<br>* Other names: visual assessment method (ICDAS criteria);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability and level of agreement between operators for all diagnostic methods. | It will be assessed using reliability & reproducibility by kappa strength measuring unit | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pit and fissure caries
Non-invasive Left Ventricle Contractility dp/dt as Prognostic Marker in Chest Unit Patients

Study Overview
=================
Brief Summary
-----------------
Ischemic heart disease is a major public health problem with high mortality rate despite the progress in management and the resources mobilized. The idea is that myocardial ischemia is generally associated with left ventricular dysfunction and, consequently, a possible alteration of the dp/dt index. As dp/dt could be assessed non-invasively by plethysmographic method, it is interesting to investigate its prognostic performance in patients with indifferentiate chest pain.

Detailed Description
-----------------
Ischemic heart disease remains a major public health problem. Despite all the advances in the prognostic approach to ischemic heart disease, the risk of occurrence of major cardiovascular events is not negligible. Several scores have been proposed for chest pain stratification risk, the most widely used are the TIMI and the GRACE scores. The dP/dt max is therefore an excellent index of contractility, corresponding to the maximum level of tension developed by an isolated cardiac muscle during the isovolumic contraction phase. the investigator theorized that a less value of dp/dt would be associated with more major cardiovascular events (MACE), because ischemia reduces myocardial contractility. The current study describes non-invasive plethysmographic dp/dt changes, which could be used as a prognostic marker in patients presenting at the emergency department with acute chest pain.

Official Title
-----------------
Non Invasive Left Ventricle Contractility dp/dt Could be Used as a Prognostic Marker in Patients Admitted to the Emergency Department for Chest Pain

Conditions
-----------------
Chest Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age over 18 years old, acute chest pain Exclusion criteria: traumatic chest pain, hemodynamic instability; arrhythmias; holders of a pacemaker; STEMI

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 |
| --- | --- | --- |
| MACE | the occurrence of a major cardiovascular event (MACE) | one month | 
| MACE | : the occurrence of a major cardiovascular event (MACE) | SIX MONTHS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chest pain,, myocardial ischemia,, acute myocardial dysfunction,, plethysmography,, non invasive dp/dt.
Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.

Detailed Description
-----------------
Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.

Official Title
-----------------
Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Conditions
-----------------
Osteoarthritis of Hip

Intervention / Treatment
-----------------
* Device: Stemless femoral component
* Device: IPS, Depuy cementless femoral stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of hip joint requiring total hip arthroplasty Exclusion Criteria: Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
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 |
| --- | --- |
| Active Comparator: Stemless femoral component<br>Stemless PROXIMA femoral component | Device: Stemless femoral component<br>* Total hip femoral component anatomically designed for a proximal fit without a stem<br>* Other names: PROXIMA, DePuy stem,;|
| Active Comparator: Stemmed femoral component<br>IPS, proximal anatomical fit stemmed femoral component | Device: IPS, Depuy cementless femoral stem<br>* Anatomical proximal fitted cementless stemmed femoral component<br>* Other names: IPS, Depuy anatomical proximal fit stemmed femoral component;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density of surrounding proximal femur according to Gruen zones |  | At least 2years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris hip score |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress shielding, Bone mineral density, stemless femoral component
AVERT Plus Post-Market Registry

Study Overview
=================
Brief Summary
-----------------
The devices used in this observational registry are the Osprey Medical Contrast Monitoring System (CMS) and the Osprey Medical AVERT Reflux Reduction System. Both products have CE Mark designations. The purpose of this registry is to evaluate the usability characteristics of the combined Osprey Medical AVERT System and the Contrast Monitoring System during normal clinical use.

Detailed Description
-----------------
This is a prospective, single-center, non-randomized, single arm, observational registry of the AVERT System used in combination with the Contrast Monitoring System. Patients undergoing manual manifold injection coronary artery imaging for diagnostic or PCI procedures that utilize the AVERT System and the CMS will be included in this registry. Device use characteristics including, measurement of contrast media volume used, contrast media volume saved by the use of the AVERT System, evaluation of angiographic image quality, and physician feedback on device features and function will be obtained. All data will be collected on the day of the procedure and there will be no long-term follow-up.

Official Title
-----------------
AVERT Plus Post-Market Registry

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: AVERT Plus System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for a coronary diagnostic or PCI procedure using manual manifold injection with the AVERT System and CMS according to the labeled indications for these devices. Patient consent to participate Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AVERT Plus System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast media volume usage | Compare cumulative contrast media volume usage as displayed by the CMS to volume estimation commonly performed in the catheterization laboratory | Day of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast media volume savings | Use the displayed volume savings function of the Contrast Monitoring System to determine the percent reduction in contrast media delivered to the patient due to the use of the AVERT System. | Day of procedure | 
| Angiographic image quality |  | Day of procedure | 
| Physician feedback on device features |  | Day of procedure |