linjc16/ctgov huggingface dataset:
Identification of Celiac Ganglia

Study Overview
=================
Brief Summary
-----------------
Computer-aided image recognition will improve the technique of endoscopic ultrasound-celiac plexus block/celiac plexus neurolysis (EUS-CPB/CPN) and improved pain relief.

Detailed Description
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All subjects who are undergoing EUS will be eligible. Consecutive patients undergoing EUS will be invited to participate in this study. Subjects must be 18 years old or above at the time of the procedure.

Official Title
-----------------
Identification of Celiac Ganglia for Endoscopic Ultrasound

Conditions
-----------------
Celiac Ganglia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all EUS patients Exclusion Criteria: under 18 yrs

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?
-----------------
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
-----------------
celiac ganglia
Phenotyping of Primary Hyperoxaluria

Study Overview
=================
Brief Summary
-----------------
985 / 5000 Résultats de traduction Primary hyperoxaluria is a rare autosomal recessive disease with an estimated prevalence of around 1 to 3 cases per million population. The most frequent attacks are urolithiasis disease and nephrocalcinosis, ultimately leading to end-stage chronic renal failure. The phenotype of this pathology is very heterogeneous, making the diagnosis difficult. There is currently a significant diagnostic delay. This is potentially due to atypical forms, or to insufficient clinicians' awareness of its research. However, the early diagnosis of this pathology is essential, since end-stage chronic renal failure can be avoided or at least delayed with early and appropriate management. The objective of the study is to describe the phenotype of currently diagnosed primary hyperoxaluria, in order to identify the classic presentations but also the characteristics of atypical presentations

Official Title
-----------------
Phenotyping of Primary Hyperoxaluria in Children and Adults

Conditions
-----------------
Primary Hyperoxaluria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major or minor subject having undergone genetic research for primary hyperoxaluria between 01/01/2015 and 31/12/2019 Major subject not having expressed, after information, the reuse of his data for the purposes of this research Child and holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research Exclusion criteria: Subject (or his parental authority if he is a minor) who has expressed his opposition to participating in the study Subject not residing in France Subject of foreign nationality Subject under tutorship or curatorship Subject under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retropsective study of classic presentations of atypical presentations of primitive hyperoxaluria and its characteristics of atypical presentations |  | Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary hyperoxaluria, Autosomal recessive, Urolithiasis., Nephrocalcinosis, Renal failure
DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)

Study Overview
=================
Brief Summary
-----------------
This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect & describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.

Official Title
-----------------
A Non-Interventional, Post-Authorisation Study to Assess Adverse Events and Drug Utilisation Among Chronic Kidney Disease Patients Treated With DYNEPO

Conditions
-----------------
Anemia, Kidney Diseases, Renal Failure, Chronic, Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: DYNEPO (epoetin delta)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients must have established Chronic Kidney Disease (CKD) and be willing and able to provide written informed consent. Patients must already be receiving DYNEPO treatment at time of study entry. Patients who are likely to receive DYNEPO for at least 1 year. Exclusion Criteria: Known intolerance to EPO of any of its excipients Known of suspected Pure Red Cell Aplasia (PRCA)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DYNEPO (epoetin delta)|dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits, as this is an observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo | This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal. | up to 3 years |
The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System

Study Overview
=================
Brief Summary
-----------------
Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of HCV infection, leading to fatty infiltration of the liver and cirrhosis.

Detailed Description
-----------------
Samples will be collected from 4 groups of patients with HIV/HCV infection, identified by the virologic control of either HIV, HCV, or both. Sera will be used in an in-vitro hepatocyte model of hepatitis C infection to better understand the pathogenesis of HIV/HCV co-infection, and to gain insight into intracellular mechanisms.

Official Title
-----------------
The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System.

Conditions
-----------------
Human Immunodeficiency Virus (HIV), Hepatitis C, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets one of the following criteria: detectable HIV RNA and detectable HCV RNA undetectable HIV RNA (treated) and detectable HCV RNA undetectable HIV RNA (treated) and undetectable HCV RNA undetectable HCV RNA (mono-infected) detectable HCV RNA (mono-infected) detectable HIV RNA (mono-infected) Participants will be men and women, ages 18 and older, and who are patients being seen in the clinics of the Medical Faculty Associates, and meet the above criteria. Exclusion Criteria: None

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 |
| --- | --- |
| Detectable HIV RNA and HCV RNA<br>HIV and HCV co-infected with detectable HIV RNA and HCV RNA | |
| Undetectable HIV and Detectable HCV<br>HIV and HCV infected, HIV RNA Undetectable(treated) and Detectable HCV RNA. | |
| Undetectable HIV and HCV<br>HIV and HCV infected, Undetectable HIV RNA and HCV RNA | |
| Undetectable HCV<br>HCV(mono-infected,) HCV RNA undetectable | |
| Detectable HCV RNA<br>Monoinfected HCV, detectable RNA | |
| Detectable HIV RNA<br>Monoinfected HIV, Detectable RNA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory analysis of Tat Protein | The validation that HIV Tat protein is a potent inducer of HCV in dual infected patients will likely lead to anti-tat therapy to manage HCV patients for whom treatment options are rather limited. | Single sample analysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV/HCV Coinfection, Tat Protein, HCV
Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism. (ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)

Official Title
-----------------
Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

Conditions
-----------------
Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism Exclusion Criteria: Not applicable
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 |
| --- | --- | --- |
| The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb |  | 3 months | 
| Occurrence of adverse events of bleeding |  | 3 months | 
| Presence or absence of venous thromboembolism after treatment of fondaparinux |  | 3 months |
Clinical Application of Cholangiojejunostomy in the Surgical Treatment of Cholelithiasis With Moderate Dilatation of Common Bile Duct

Study Overview
=================
Brief Summary
-----------------
This study evaluates the clinical application of cholangiojejunostomy in the surgical treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the other half will receive hepatectomy and T-tube Drainage.

Conditions
-----------------
Cholelithiasis, Cholangiojejunostomy

Intervention / Treatment
-----------------
* Procedure: cholangiojejunostomy
* Procedure: hepatectomy
* Device: T-tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatic bile duct stone disease, need surgery No residual stones in the operation Extrahepatic bile duct dilatation, 15-30 mm in diam. No relaxation or stenosis of the sphincter of Oddi Exclusion Criteria: Patient involuntary Surgical treatment can not be performed because of various reasons. Intrahepatic and extrahepatic bile duct stones can not be taken away with other biliary tract diseases, such as bile duct cancer Oddi sphincter relaxation or stenosis loss to follow-up

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participants receive cholangiojejunostomy<br>participants will receive hepatectomy、cholangiojejunostomy and T-tube Drainage | Procedure: cholangiojejunostomy<br>* Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage,while the other half will receive hepatectomy and T-tube Drainage<br>Procedure: hepatectomy<br> <br> Device: T-tube<br>* T-tube Drainage<br>|
| Active Comparator: participants receive no cholangiojejunostomy<br>participants will receive hepatectomy and T-tube Drainage | Procedure: hepatectomy<br> <br> Device: T-tube<br>* T-tube Drainage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of bile duct stones |  | 2-3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderate dilatation of common bile duct
Total Knee Arthroplasty (TKA) Cemented Versus Cementless

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement. One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur. Patients will be reviewed at 2, 6 and 12 months.

Official Title
-----------------
Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: cement Palacos R40 and LV40


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis) Indication of surgical treatment by total knee arthroplasty Age between 50 and 90 years Acceptance and signature to participate Exclusion Criteria: Rheumatoid or other inflammatory arthritis Association with other surgical procedure (osteotomy) Range of motion inferior to 90° Previous knee surgery (except arthroscopy)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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

| Intervention/Treatment |
| --- |
|Device: cement Palacos R40 and LV40|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKS (International Knee Society) score at 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee arthroplasty, Femoral loosening, Total Knee Arthroplasty
Continuity of Care and Outcomes After Discharge From Hospital

Study Overview
=================
Brief Summary
-----------------
1. INTRODUCTION: Continuity of care (COC) occurs when separate elements of patient care are connected. COC is made up primarily of Continuity of Provider (COP) and Continuity of Information (COI). Many authorities believe that COC is essential to high-quality care. Previous studies have shown poor COC in varied populations. Many studies have shown that increased COC has been associated with improved intermediate outcomes. However, no study has definitively determined whether COC or either of its components is associated with important outcomes. The Ontario-Outcomes After the Hospitalization (Ontario-OAtH) study will enroll 5900 adults who are discharged to the community from medical and surgical services from 13 teaching and community hospitals in 5 regions across Ontario. Patients will be followed for 6 months to record details about all interactions with the health care system. This information will give us a detailed measure of both provider and information continuity for all patients over time. The Ontario-OAtH study will have the power to precisely determine whether COC is associated with time to urgent readmission or death after hospital discharge. Since COC is potentially modifiable, the Ontario-OAtH study will give us essential information required for designing interventions to improve outcomes for patients after they are discharged from hospital.

Detailed Description
-----------------
See above

Official Title
-----------------
The Association of Provider Continuity and Information Continuity With Patient Outcomes After Discharge From Hospital

Conditions
-----------------
Patient Safety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: discharged to the community from medical and surgical services Exclusion Criteria: -
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 |
| --- | --- | --- |
Octylseal Surgical Adhesive in General Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how surgical adhesive is used.

Detailed Description
-----------------
In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures.

Official Title
-----------------
Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Device: Cyanoacrylate (Octylseal )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for use of a topical surgical skin adhesive Exclusion Criteria: Subjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde) Subjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history Subjects who present with a contraindications for product usage as per labeling A wound with evidence of active infection or gangrene or wounds of decubitus etiology Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to bodily fluids or with dense natural hair Subjects with known hypersensitivity to cyanoacrylate or formaldehyde

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Surgical Adhesive<br>The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures. | Device: Cyanoacrylate (Octylseal )<br>* surgical adhesive<br>* Other names: cyanoacrylate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Length Closure | Primary incision wound length treatment in adult and pediatric general surgery | During Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Score of 0 (No Hurt) on the Pain Rating Scale | Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst | At Surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wounds
Risk of Acute Kidney Injury Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence of hospitalization for acute kidney injury among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of other oral antidiabetic drugs in classes other than Dipeptidyl peptidase IV (DPP4) inhibitors.

Detailed Description
-----------------
Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice. This will be a prospectively-designed database cohort study comparing hospitalizations for acute kidney injury among new initiators of Saxagliptin compared to those who are new initiators of OADs in classes other than DPP4 inhibitors. The study time frame will be from 2009 through 2014.

Official Title
-----------------
Comparison of Risk of Hospitalization for Acute Kidney Injury Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments

Conditions
-----------------
Diabetes Mellitus, Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Newly prescribed Saxagliptin or an OAD in a class other than DPP4 inhibitors Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD Exclusion Criteria: Patients identified with a diagnostic code for acute kidney injury within the 180-day baseline period Patients with DPP4 inhibitor exposure during the baseline period Patients currently using Exenatide or Insulin

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 |
| --- | --- |
| Patients exposed to Saxagliptin<br> | |
| Patients exposed to OAD in classes other than DPP4 inhibitors<br>OAD - Oral Antidiabetic Drug | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital admission for acute kidney injury |  | 52 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deaths due to acute kidney injury |  | 18 months | 
| Deaths due to acute kidney injury |  | 36 months | 
| Deaths due to acute kidney injury |  | 54 months | 
| Hospitalizations for acute kidney injury and/or death due to acute kidney injury |  | 18 months | 
| Hospitalizations for acute kidney injury and/or death due to acute kidney injury |  | 36 months | 
| Hospitalizations for acute kidney injury and/or death due to acute kidney injury |  | 54 months |