linjc16/ctgov huggingface dataset:
Hematoma Block for Reduction of Distal Radius Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Prove that injection of 15 to 20 mL of lidocaine 1% into the fracture site (Hematoma block) is more effective in terms of pain relieving then injection of 10 mL of lidocaine 2%, and equally safe in terms of complications, for closed reduction of distal radius fractures.

Official Title
-----------------
Phase 4 Study of Hematoma Block for Reduction of Distal Radius Fractures

Conditions
-----------------
Fractures of the Distal Radius

Intervention / Treatment
-----------------
* Drug: Lidocaine HCl 2% .
* Drug: Lidocaine HCl 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Fractures of the distal radius, with or without ulna fracture Exclusion Criteria: Children, pregnant women, patients with infection or suspected infection on the site for injection. Patients whose condition requires general anesthesia (patients with more fractures other than the distal radius and ulna, patients with many damage...)

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Active Comparator: Lidocaine HCl 2%<br>Lidocaine HCl 2% (200mg/10ml) 10 ml. | Drug: Lidocaine HCl 2% .<br>* comparison of different dosages of drug<br>* Other names: ESRACAIN;|
| Experimental: Lidocaine HCl 1%<br>Lidocaine HCl 1% (100mg/10ml) 15-20 ml. | Drug: Lidocaine HCl 1%<br>* comparison of different dosages of drug<br>* Other names: ESRACAIN;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study will be measured effective in terms of pain relieving with Visual Analog Scale. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study will be measured safe in terms of complications to injection. | Number of Participants with Adverse Events as a Measure of Safety and Tolerability. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fractures of the distal radius, Hematoma block, Lidocaine
Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

Study Overview
=================
Brief Summary
-----------------
To evaluate the diagnosis value of MRI and positon emission tomography (PET) scan for studying macrophagic infiltration and other brain modification in multiple sclerosis (MS) patients treated with Natalizumab (Tysabri).

Official Title
-----------------
MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: pet-scan FDG-F18


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with MS Treatment with Tysabri planned Exclusion Criteria: Allergy to Tysabri or MRI contrast products Pregnancy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pet-scan FDG-F18|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain). |  | At baseline and after 3 months of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with relapses. |  | During the 3 months of treatment and the 3 following months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, PET scan
Natural Killer Cells and Polycythemia Vera (Vaquez's Disease)

Study Overview
=================
Brief Summary
-----------------
Natural Killer cells (NK) are pivotal cells of innate immunity, that sense defective expression of HLA class I molecules and are complementary to specific cytotoxic T lymphocytes. A defect in NK cell cytotoxicity has been described in some hematopoietic malignancies such as acute myeloid leukemia, multiple myeloma, myelodysplastic syndroms. This defect is at least partially linked to a decreased or absent expression of some activating NK cell molecules, more particularly the so-called Natural Cytotoxicity Receptors (NCRs) NKp30, NKp44 and NKp46. Some old publications have demonstrated defective NK cytotoxicity in myeloproliferative syndroms (chronic myeloid leukemia, primary thrombocytosis, polycythemia vera). The investigators more particularly focused their attention on polycythemia vera (Vaquez's disease), a myeloproliferative disease characterized by the recently describet mutation V617F of the JAK2 tyrosine kinase. The investigators will precise the mechanisms leading to this cytotoxicity defect, the investigators also will evaluate the implication of V617F mutation on NK physiology, and will study the interactions between NK cells and hematopoietic progenitors.

Conditions
-----------------
Polycythemia Vera

Intervention / Treatment
-----------------
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polycythemia vera Treatment by therapeutic bleedings No cytotoxic treatment during the previous six months Exclusion Criteria: No Polycythemia vera No treatment by therapeutic bleedings Cytotoxic treatment during the previous six months

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 |
| --- |
|Biological: blood sample|blood sample coming from therapeutic bleeding in hospital|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe immunologic anomalies in polycythemia vera |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment by bleedings
Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.

Official Title
-----------------
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Effects of Vasopressin V2 Receptor Antagonist on Clinical Improvement in Patients With Severe Chronic Heart Failure

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: Vasopressin V2 Receptor Antagonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Men or women with chronic heart failure (NYHA Class IIIB and IV). Women must be post-menopausal or surgically sterilized; they cannot be pregnant or nursing. Age 21 to 80 years. Chronic heart failure of at least 3 months duration. For 2 months prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 50% of the time. For 2 weeks prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 90% of the time. Patients must be receiving a diuretic and an ACE inhibitor (or an angiotensin II receptor antagonist) for the treatment of heart failure. Patients may be receiving digoxin, a beta-blocker or spironolactone

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: Vasopressin V2 Receptor Antagonist|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status at day 120. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Heart Failure, Heart Disease
Twinrix Alternative Schedule Study

Study Overview
=================
Brief Summary
-----------------
To compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months. To compare the seroconversion (>= 1 IU/l) and seroprotection (>= 10 IU/l) rate at month 6,7,12 and 13. To compare the distribution of anti-HBs at these different moments.

Official Title
-----------------
A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)

Conditions
-----------------
Antibody Response After Vaccination

Intervention / Treatment
-----------------
* Biological: Combined vaccine against hepatitis A and B (Twinrix)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older; a good physical condition as confirmed by history and physical examination at entry of the study; for female participants who could become pregnant in the course of the study a contraceptive programme is foreseen; all participants have provided written informed consent. Exclusion Criteria: Employees occupationally exposed to hepatitis B virus Other exclusion criteria listed for the vaccine (licensed vaccine): Each acute disease at the inclusion in the study; A history of hypersensibility to one of the components of the vaccine; Simultaneous participation in another clinical trial

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Combined vaccine against hepatitis A and B (Twinrix)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibodies concentration 1 month after 3th vaccine dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
combined hepatitis A and B vaccine, hepatitis B virus, immunity
Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU

Study Overview
=================
Brief Summary
-----------------
Prospective, observational clinical multicentric study in ICU; during the period surrounding the orotracheal intubation.

Detailed Description
-----------------
Main objective: to describe the characteristics of reventilation collapse: collapse rate, duration and treatment implemented Secondary objectives: identify risk factors of reventilation collapse compare mortality, hemodynamic, respiratory, infectious and biological data between collapse group and no reventilation collapse group.

Official Title
-----------------
Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU

Conditions
-----------------
Arterial Line, Consent of Patients, Adult Patients, Tracheal Intubation in ICU

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arterial line Consent of patients Adult patients Tracheal intubation in ICU Exclusion Criteria: tracheal intubation for cardiac arrest pregnant woman major protected

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| reventilation collapse<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reventilation collapse |  | at day 1 (at least thirty minutes despite 500 or 1000ml of fluid resuscitation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reventilation collapse |  | in the last 72 hours | 
| Duration of mechanical ventilation |  | at day 1 | 
| mortality |  | at day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reventilation collapse, Rate of reventilation collapse, Risk factor of reventilation collapse, Hemodynamic profile of reventilation collapse, Biologic approach of reventilation collapse
China PEACE Million Persons Project

Study Overview
=================
Brief Summary
-----------------
China PEACE Millions Persons Project is a national screening project for cardiovascular disease in China. This Project was approved by National Health and Family Planning Commission (NHFPC), China and founded by Ministry of Finance, China in 2014. The specific objectives of the project are to: identify subjects at high-risk of CVD and provide counseling for medication and lifestyle improvements evaluate the feasibility of such screening methods for subjects at high risk of CVD, and to assess the effect of health counseling on CVD incidence rates and risk factors control inform future intervention and long-term follow up efforts for primary and secondary CVD prevention in China.

Official Title
-----------------
China PEACE Million Persons Project

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35 - 75 years old registered in the Hukou of the selected region sign the consent form Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Incidence of Cardiovascular diseases | Number of new cardiovascular diseases in high-risk subjects | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, counseling, follow-up, cardiovascular disease, population-based project, China
Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized, comparative study is to determine whether Hyalomatrix is as effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive concurrent treatments with both products on their first and/or second degree burns located on both hands.

Conditions
-----------------
Bandages

Intervention / Treatment
-----------------
* Device: Hyalomatrix
* Device: Integra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent must be obtained First and/or second degree burns on both hands Subject must be enrolled within 48 hours of the injury occurrence. Exclusion Criteria: Subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation. Subject has a prognosis that indicates unlikely survival past the study period. Subject's diagnosis indicates third degree burns. Subject suffers from burns sustained as a result of an electrical/chemical injury or by frostbite. Subject suffers from any inhalation-related burn trauma. Subject suffers from ongoing bone fractures. Subject has a known sensitivity to materials containing silicone, hyaluronan, bovine collagen, or chondroitin and/or derivatives of these products. Subject has received any treatment prior to study enrollment that may, in the opinion of the Investigator, affect the outcome of the study. Subject suffers from a medical condition that may impede wound healing, above any beyond that which would typically be expected.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyalomatrix<br>Sterile, single use, flexible, and conformable wound dressing comprised of a derivative of hyaluronic acid which acts as a three dimensional regenerative matrix. | Device: Hyalomatrix<br> <br> |
| Active Comparator: Integra<br>Sterile, single use, wound care dressing comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan | Device: Integra<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Infection Rate |  | Up to 21 days | 
| Number of days required for wound healing |  | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion Scores | Analysis of Range of Motion Scores | Up to 21 days | 
| Physician Scores on Products Ease of Use | Analysis of physician scores | Up to 21 days |
Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTMd

Study Overview
=================
Brief Summary
-----------------
Establish a data repository of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedure supplemented by the Implanet Jazz System.

Detailed Description
-----------------
The purpose of this study is to create a data repository of patients who have undergone spinal arthrodesis procedures supplemented with the Implanet Jazz System. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid bony fusion. Patients who are candidates for hybrid thoracolumbar fixation with the Implanet Jazz System during arthrodesis surgery will be asked to participate in this protocol. Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36 48, and 60 months post surgery in the database. Data collected will include demographic and surgical information, physiological data, neurological assessments and patient reported outcomes. This comprehensive database will allow for gathering of relevant information for potential future research use.

Official Title
-----------------
Prospective Multi-Center Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTM

Conditions
-----------------
Spondylolisthesis, Spinal Stenosis, Proximal Joint Kyphosis (PJK)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are candidates for spinal arthrodesis surgery (thoracic and/or lumbar) supplemented by the Implanet Jazz System are eligible to participate in this study. Exclusion Criteria: Patients under the age of 18 are excluded because the investigators do not routinely perform spinal arthrodesis surgery on these patients.

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 |
| --- | --- | --- |
| Number of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System. |  | 60 months |