linjc16/ctgov huggingface dataset:
Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the cost effectiveness, quality of life and outcomes of the endovascular stent graft repair with the open surgical repair of abdominal aortic aneurysms.

Detailed Description
-----------------
Abdominal Aortic Aneurysms have been traditionally repaired using the standard open surgical technique. The use of Endovascular stent grafts(EVAR) to treat aortic aneurysms has been ongoing for approximately 8-10 years. Use of EVAR to treat aortic aneurysms in high risk has been reported to be beneficial. However, the costs of this therapy are quite significant and therefore in order to best understand the cost effectiveness of this type of aneurysm treatment, an extensive prospective comparative evaluation is required. This study will compare outcomes and cost-effectiveness for patients receiving EVAR, with high surgical risk, and OSR, with low surgical risk, and OSR, where there is high surgical risk and not suitable for EVAR based on anatomical complexity. Demographic, medical, health care resource utilization, cost, and quality of life information is collected from participating patients over a period of a year following repair.

Official Title
-----------------
Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Procedure: Endovascular vs Open Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infrarenal abdominal aortic aneurysm, > 5.5 cm diameter scheduled for elective surgical repair Exclusion Criteria: previous repair of AAA

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endovascular vs Open Repair|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetics and Safety Study of LBAL in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Group Clinical Study to Compare Pharmacokinetics, Safety and Tolerability of LBAL 40 mg With Humira® 40 mg After a Single Subcutaneous Administration in Healthy Male Volunteers

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Biological: LBAL
* Biological: Humira


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-45 years old healthy males Body mass index 19.0   28.0 kg/m2 Exclusion Criteria: Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation (i.e. HIV Ab, HBsAg, HBcAb, HCV Ab) Fever greater than 38.3℃ within a week prior to administration of study drug Previous or current drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBAL<br>Developed by LG Life Sciences | Biological: LBAL<br>* Anti-inflammatory agents<br>* Other names: Adalimumab;|
| Active Comparator: Humira®<br>Abbvie | Biological: Humira<br>* Anti-inflammatory agents<br>* Other names: Adalimumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity |  | 0 to 65 days | 
| Maximum measured concentration of the analyte in serum |  | 0 to 65 days |
An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)

Study Overview
=================
Brief Summary
-----------------
This open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.

Official Title
-----------------
A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate) Adult patients greater than (>) 18 years of age Histologically confirmed breast cancer Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging) Life expectancy >6 months No previous bisphosphonate therapy Patients signed written informed consent form before study start Exclusion Criteria: All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate) Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate) Hypersensitivity to bisphosphonates

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 |
| --- | --- |
| Ibandronate<br>Patients receiving ibandronate will be evaluated for bone turnover markers for 12 months. Ibandronate is not an investigational medicinal product (IMP) in this study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta C-terminal telopeptide (B-CTx) level |  | 12 months | 
| Treatment response rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who died due to progression of breast cancer |  | 12 months | 
| Safety: Incidence of adverse events |  | 12 months |
Surgical Management of Post-Traumatic Kyphosis

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to examine the safety and efficacy of posterior sugary only in addressing post traumatic kyphosis. The main question[s]it aims to answer are: Is it a safe procedure? Is it a sufficient approach to address deformity? Participants will be managed by posterior only surgery to address their deformity and will be assessed for the radiological and functional outcomes.

Official Title
-----------------
Posterior Surgical Management of Post-Traumatic Kyphosis

Conditions
-----------------
Post-Traumatic Kyphosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients with age range from 18-65 years old with PTK underwent corrective surgery and have been followed for at least 2 years with complete documentation. Exclusion Criteria: Traumatic cervical spine deformities Pathologic fracture spine Congenital or developmental cases Degenerative cases

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in degree of kyphosis | we will measure the kyphosis in pre operative radiogragh and post operative radiograph to detect the change in the degree and the correction achieved after posterior only operative correction | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-Traumatic Kyphosis, Posterior only surgery
Open-Label Extension of LOCKCYST Trial

Study Overview
=================
Brief Summary
-----------------
Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available. Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.

Detailed Description
-----------------
van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut 2008 September;57(9):1338-9.

Official Title
-----------------
Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers

Conditions
-----------------
Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant

Intervention / Treatment
-----------------
* Drug: lanreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in the LOCKCYST trial 18 yrs-of age Multiple cysts > 20 Cooperating patient Is willing and able to comply with the study drug regimen and all other study requirements. Willingness to give written informed consent Exclusion Criteria: Use of oral anticonceptives or estrogen suppletion Females who are pregnant or breast-feeding History or other evidence of chronic pulmonary disease associated with functional limitation History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled. History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study Symptomatic gallstones (lanreotide decreases gall bladder volume) Renal failure requiring hemodialysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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 |
| --- | --- |
| Other: 1<br>lanreotide | Drug: lanreotide<br>* lanreotide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver volume reduction |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney volume Cyst volume |  | 24 weeks |
Stress Urinary Incontinence of Sporting Teenager

Study Overview
=================
Brief Summary
-----------------
Physical activity and sport are beneficial to the cardiovascular system, the musculoskeletal system and many chronic pathologies. The High Authority of Health (HAS) recommends a regular practice. However, depending on the discipline and level of practice, it may be responsible for traumatic injuries, degenerative musculoskeletal injuries, overtraining, eating disorders or cardiovascular events. It also promotes urinary stress incontinence, by increasing intra-abdominal pressure in some situations. The prevalence of urinary leakage in the athlete depends of the practiced physical activity. A classification of the sports activities can be carried out according to the risk of increased pressures on the pelvic floor: high-risk sports: trampoline (10.17), acrobatic gymnastics, aerobics, athletics (jumping hedges, heights, triple jump), horse riding, basketball, volleyball, handball, martial arts; moderate-risk sports: tennis, skiing ... low risk sports: walking, swimming, cycling, rollerblading, golf ... In sports, urinary incontinence also depends of the practiced movements (jumps, abdominal exercises ...), and the occurence of sports activity. This disorder has even become one of the concerns of federal sports authority (INSEP). However, there is no data regarding stress incontinence of sports teenagers found n the literature on

Official Title
-----------------
Stress Urinary Incontinence in Teenage Girls Practicing Sports

Conditions
-----------------
Urinary Incontinence, Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 10 and 18 years Consultation in medical sporting center Exclusion Criteria: urge incontinence

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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 |
| --- | --- | --- |
| prevalence of stress urinary incontinence in adolescent girls engaged in extra-scholar sports | answer by YES or NO to the question | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay of urinary incontinence according to the first menstruations | answer to question about the delay of first menstruations on day: less than 6 months- between 6 and 12 months- more than 12 months. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescent sports
Potentially Avoidable Hospitalisation in France

Study Overview
=================
Brief Summary
-----------------
Potentially Avoidable Hospitalizations (Pah) Are Studied As An Indirect Measure Of Access To Primary Care And Of The Interface Between Primary And Secondary Care. A Previous Work Unveils Considerable Geographic Variation In The Rate Of Pah In France And Suggest That Primary Care Organization Might Play A Role In This Variation. However, A Limitation Of This Work Lies In The Lack Of Data On Actual Primary Care Utilization. The Aim Of This Study Is To Analyze The Role Of Primary Care In The Variation Of Potentially Avoidable Hospitalizations At the Zip Code Level, In The French Region Languedoc-Roussillon-Midi-Pyrénées. The investigator will implement An Ecological Approach In Which The Geographic Variation In The Rate Of Pah Is Analyzed In The French Region Lrmp, Year 2014. Age- And Sex-Adjusted Rate Of Pah By Zip Codes (N=612) Is Modeled Using A Spatial Regression Model.

Official Title
-----------------
Are Potentially Avoidable Hospitalizations a Good Measure of Access To Primary Care in France?

Conditions
-----------------
Heart Failure, COPD, Diabetes

Intervention / Treatment
-----------------
* Other: measure of access to primary care and of the Interface Between Primary ans Secondary Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: year 2014 LRMP region Hospital admission in any public or private hospital Exclusion criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: measure of access to primary care and of the Interface Between Primary ans Secondary Care|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of potentially avoidable admissions |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Rate of potentially avoidable admissions |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Avoidable hospitalizations, primary care, geographicvariation
A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: LEEP intervention
* Procedure: Standard Phaco Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent. Subjects with a visually significant cataract scheduled to undergo cataract surgery Subjects > 18 years of age BCVA at baseline not better than 20/40 Grade 1+ cataracts Exclusion Criteria: Subjects not able to complete the informed consent form Subjects < 18 years of age Polar cataracts Zonular instability

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LEEP Intervention C1<br>Cataract surgery with micro-interventional LEEP technology lens fragmentation (non-randomized cohort 1) | Procedure: LEEP intervention<br>* Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation<br>|
| Active Comparator: LEEP Intervention C2<br>Cataract surgery with micro-interventional LEEP technology lens fragmentation (randomized cohort 2) | Procedure: LEEP intervention<br>* Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation<br>|
| Placebo Comparator: Control Phaco C2<br>Cataract surgery with conventional phaco-assisted lens fragmentation (randomized cohort 2) | Procedure: Standard Phaco Control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Dispersed Phaco energy | Total phaco power and energy used as recorded by the phaco machine | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell loss | Change from baseline endothelial cell density as measured by specular microscopy | 1 month |
Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks and duration of administration for 1 year in patients with high-risk essential thrombocythemia.

Official Title
-----------------
A Multicenter, Open-label, Clinical Study for Efficacy and Safety Evaluation of Anagrelide in Patients With Treatment-naïve, High-risk Essential Thrombocythemia as a Primary Treatment

Conditions
-----------------
Essential Thrombocythemia

Intervention / Treatment
-----------------
* Drug: Anagre Cap.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with essential thrombocythemia according to WHO 2008 Any of the following as high-risk patient Over 60 years old >100 X 10^4/ul of platelet count increased more than 300K of platelet count in 3 months Hypertension, diabetes, past history of thromboembolic bleeding Exclusion Criteria: Patients with an adverse drug reaction or intolerability to anagrelide Any of the following cardiac abnormalities; Complete left bundle branch block on ECG Patients using a pacemaker Patients with a family history of congenital QT prolongation syndrome or known QT prolongation syndrome Currently, there is no clinically uncontrolled ventricular or atrial tachycardia Clinically significant bradycardia (<less than 50 per minute) History of clinically proven myocardial infarction and unstable angina within 3 months Pregnant women, nursing mothers

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anagre Cap.<br>twice a day | Drug: Anagre Cap.<br>* from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate for less than 60 X 10^4/ul in platelet count |  | at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate for less than 60 X 10^4/ul in platelet count |  | at week 52 | 
| changes from baseline in 50% reduction rate in platelet count |  | up to 52 weeks | 
| response rate for less than 40 X 10^4/ul in platelet count |  | up to 52 weeks | 
| cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events) |  | at 52 week | 
| incidence of adverse events |  | up to 52 weeks |