linjc16/ctgov huggingface dataset:
Learning Curves in Laparoscopic Distal Pancreatectomy: A Different Experience for Each Generation

Study Overview
=================
Brief Summary
-----------------
This study compared the learning curves and outcome of Laparoscopic Distal Pancreatectomy between 'pioneers' and early adopters in terms of feasibility and proficiency using short term outcomes.

Detailed Description
-----------------
Learning curves of laparoscopic distal pancreatectomy (LDP) are mostly based on 'pioneering' surgeons who acquired sufficient proficiency largely through self-teaching. No learning curves have been investigated for early adopting surgeons who performed surgery in later stages of the IDEAL framework and build on the experience of the 'pioneering' surgeons. This study compared the learning curves and outcome of LDP between 'pioneers' and early adopters in terms of feasibility and proficiency using short term outcomes over a period from 1997-2019.

Official Title
-----------------
Learning Curves in Laparoscopic Distal Pancreatectomy: A Different Experience for Each Generation

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Procedure: Laparoscopic distal pancreatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The collected data included the name of the surgeon so inclusion criteria for participating surgeons could be determined. Surgeons who were experienced with a minimum of 40 LDPs in total with at least 10 LDPs per year and who performed their LDPs in the same institution (i.e. no outside institutions) were included. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early adopting surgeons<br>Surgeons who started performing LDP during phase 3 of the IDEAL framework; the Assessment phase. They received training in the form of fellowships, proctoring, and courses | Procedure: Laparoscopic distal pancreatectomy<br>* Comparison of performed laparoscopic distal pancreas surgery in two different surgeon groups<br>|
| Pioneering surgeons<br>Surgeons who started performing LDP during phase 2 of the IDEAL framework; the Development and Exploration phase. They did not receive any specific form of training and were therefore considered self-taught. | Procedure: Laparoscopic distal pancreatectomy<br>* Comparison of performed laparoscopic distal pancreas surgery in two different surgeon groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility learning curve | Feasibility learning curves are based on operation time | 1997-2019 | 
| Proficiency learning curve | Proficiency learning curves are based on major complications | 1997-2019 |
Individualized Prevention Strategy for High Risk Patients in Cardiovascular Disease: Prospective Cohort Study (Cardiovascular and Metabolic Disease Etiology Research Center - HIgh Risk Cohort) CMERC-HI

Study Overview
=================
Brief Summary
-----------------
Set the prospective cohort (CMERC-HI) to study the known and novel etiologies and related factors for predicting clinical outcomes in Korean patients with high risk cardiovascular disease.

Conditions
-----------------
High Risk Cardiovascular Disease Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high risk hypertension patients a. eGFR > 60 with one of target organ damages b. eGFR <= 60 diabetes mellitus with microalbumin ration (AC ratio >= 30mg/g) anuric ESRD patients on dialysis the relatives of acute myocardial infarction patients under 55 years old (men)/ 65 years old (women) atherosclerotic cardiovascular disease (abdominal aorta diameter ≥3 cm or ankle-brachial index <0.9, or carotid plaque or carotid intima-media thickness ≥0.9 mm, or asymptomatic old cerebrovascular accident, or >30% stenosis in at least one major coronary artery) rheumatoid arthritis patients aged > 40 years on MTX and steroid therapy atrial fibrillation patients with CHADS-VASc Score ≥ 1 kidney transplant recipient at > 3 months after transplantation Exclusion Criteria: acute myocardial infarction, acute coronary syndrome patients, symptomatic coronary artery disease or history of these diseases symptomatic peripheral artery disease, heart failure and history of these diseases desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis) women with pregnancy or on nursing history of contrast allergy and related side effects within the first three months after transplantation acute renal allograft rejection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| cardiovascular disease<br>high risk cardiovascular disease patients and their relatives | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis of high risk cardiovascular disease | all-cause mortality, cardiovascular mortality, non-cardiovascular mortality new onset of acute myocardial infarction, acute coronary syndrome, heart failure, stroke, peripheral artery disease, hospitalization for revascularization and these disease | 10 year after recruting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular disease, metabolic disease, high risk, prospective cohort
Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether pegaptanib sodium (Macugen) is safe and effective in slowing the leakage of fluid within the retina and thereby stabilizing or improving vision when compared to placebo injections. A total of 176 patients will be enrolled

Official Title
-----------------
A Phase II Randomized, Controlled, Double-Masked, Dose-Finding, Multi-Center, Comparative Trial, in Parallel Groups, to Establish the Safety and Preliminary Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer), Given Every 6 Weeks for 12 to 30 Weeks to Patients With Clinically Significant Diabetic Macular Edema (CSME) Involving the Center of the Macula

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: pegaptanib sodium (Macugen)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically significant DME, VA 20/50-20/320 in the study eye and 20/100 in the fellow eye

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pegaptanib sodium (Macugen)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pulse Spectrum Analysis in Adult Asthmatics: Correlation With Lung Function, Asthma Control Exhaled Nitric Oxide and Metabolites in Exhaled Breath Condensate

Study Overview
=================
Brief Summary
-----------------
Our hypothesis is that radial arterial pulse may reflect the severity and airway function in asthmatics. The aims of this study are to investigate the pulse spectrim of the radial artery in adult asthmatics, and evaluate its correlation with airy inflammation an lung funtion in asthmatics.

Detailed Description
-----------------
The microcirculation is directly involved in the cellular matabolism and homeostasis. Our hypothesis is that radial arterial pulse spectrum may reflect the airway condition in asthmatics. The aims of this study are to investigate the pulse spectrim of the radial artery in adult asthmatics, and evaluate its correlation with lung function, asthma control status,exhaled nitric oxide, and metabolites in the exhaed breath condensates.

Official Title
-----------------
Pulse Spectrum Analysis in Adult Asthmatics: Correlation With Lung Function, Asthma Control Exhaled Nitric Oxide and Metabolites in Exhaled Breath

Conditions
-----------------
Pulse Spectrum Analysis, Pulmonary Function, FeNO, Metabolites

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the diagnostic criteria of GINA guideline asthma patients Exclusion Criteria: Cancer or immune impaired patients; pack-year smoking> 5; long-term ventilator-dependent patients Control group: 30 age matched healthy controls

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Pulse spectral analysis |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Pulse spectrum analysis, lung function, exhaled nitric oxide, metabolites, exhaled breath condensate
Pneumatic Compression Stockings During Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the effect of pneumatic compression devices (PCDs) on central blood volume in hemodialysis patients. We hypothesize that PCDs will help maintain central blood volume, and therefore prevent sudden decreases in blood pressure during hemodialysis.

Official Title
-----------------
The Effect of Pneumatic Compression Stockings on Hemodynamic Parameters in Hemodialysis Patients: A Randomized Crossover Trial

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Device: Pneumatic Compression Stockings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: on hemodialysis at least 3 months on hemodialysis at least 3 times per week Exclusion Criteria: dialyzing with a central venous catheter vascular access dysfunction peripheral vascular disease active medical issue unable to provide informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumatic compression stockings<br> | Device: Pneumatic Compression Stockings<br>* Thigh-high pneumatic compression stockings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central blood volume |  | pre and post hemodialysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac output |  | pre and post hemodialysis | 
| cardiac index |  | pre and post hemodialysis | 
| systemic vascular resistance |  | pre and post hemodialysis | 
| intracellular fluid volume |  | pre and post hemodialysis | 
| extracellular fluid volume |  | pre and post hemodialysis | 
| total body water |  | pre and post hemodialysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Intradialytic hypotension
Evaluation of the Benefits of a Prehabilitation Program : Pilot Study

Study Overview
=================
Brief Summary
-----------------
The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed prehabilitation. In the present pilot trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be evaluated.

Official Title
-----------------
Evaluation of the Benefits of a Program of Prehabilitation: Pilot Study

Conditions
-----------------
Surgery, Cancer

Intervention / Treatment
-----------------
* Other: Prehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years old Affiliated with a social security system Having indicated their non-opposition Must undergo a surgical intervention within a period of at least one month after the completion of the initial inclusion assessment and / or chemotherapy and / or radiotherapy Non-inclusion criteria: Refusal of participation Pregnant or breastfeeding woman Inability to walk or initial physical assessment Patient under guardianship or curatorship Inability to complete questionnaires Exclusion criteria: Cognitive disorders detected by the geriatric consultation Lost Death before surgery or chemotherapy or radiotherapy Shortened preoperative preparation time (<18 days)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation program<br>Multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being | Other: Prehabilitation program<br>* multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walk test |  | 7 months |
NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized Trial of the Relationship of Intragastric Acid Control and Healing Status of Moderate and Severe Erosive Esophagitis After Treatment With Esomeprazole Magnesium (NEXIUM®) 10 mg and 40 mg Once Daily

Conditions
-----------------
Erosive Esophagitis, Reflux Esophagitis, Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: esomeprazole magnesium (oral medication)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years Patients must have moderate to severe erosive esophagitis Exclusion Criteria: Significant gastrointestinal bleeding Severe heart, lung, liver or kidney disease Esophagitis not related to acid reflux

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: esomeprazole magnesium (oral medication)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the relationship between 24-hour intragastric pH at Day 5 and healing status of moderate to severe erosive esophagitis, after 4 weeks of treatment with 2 doses of esomeprazole magnesium. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes and the relationship to pH will also be assessed. |  |  |
Second Line Breast Cancer Trial

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.

Official Title
-----------------
A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer.

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

Intervention / Treatment
-----------------
* Drug: Fulvestrant
* Drug: Anastrozole
* Drug: Fulvestrant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal women with confirmation of breast cancer objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer Exclusion Criteria: presence of life-threatening metastatic visceral disease previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer more than 1 prior endocrine medical treatment for advanced breast cancer .

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

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

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: 1<br>Faslodex 125mg and Arimidex 1 mg | Drug: Fulvestrant<br>* 125mg<br>* Other names: Faslodex;Drug: Anastrozole<br>* ARIMIDEX<br>|
| Experimental: 2<br>Faslodex 250mg and Arimidex 1mg | Drug: Anastrozole<br>* ARIMIDEX<br>Drug: Fulvestrant<br>* 250mg<br>* Other names: Faslodex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to tumor progression |  | Every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective tumor response |  | Every 3 months | 
| time to treatment failure |  | Every 3 months | 
| time to death |  | Every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced breast cancer, FASLODEX, ARIMIDEX, Fulvestrant, Anastrozole, postmenopausal
Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?

Study Overview
=================
Brief Summary
-----------------
Post thyroidectomy laryngeal nerve injuries are frequently encountered specially in total and near total thyroidectomy some unilateral injuries are not clinically evident and asymptomatic. The aim of this study is to compare mandatory versus selective post-thyroidectomy endoscopic examination of larynx to detect laryngeal nerve injuries.

Detailed Description
-----------------
100 patients were randomly divided into two groups, group I for whom mandatory post thyroidectomy endoscopic laryngoscopic examination and the other group of only symptomatic patients selected for direct laryngoscopic examination.

Official Title
-----------------
Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?

Conditions
-----------------
Thyroid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all post thyroidectomy patients Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 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 |
| --- | --- |
| videoscopic laryngeal examination<br>50 patients post thyroidectomy will do mandatory post thyroidectomy videoscopic examination of the larynx | |
| No vedioscopic larygeoscopic examination<br>50 patients post thyroidectomy will be followed up and will not do vedeoscopic videoscopic laryngeal examination routinely they will do it if indicated | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endoscopic laryngeal examination post thyroidectomy | usefulness of endoscopic laryngeal examination post thyroidectomy | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post thyroidectomy, laryngeoscopic examination