linjc16/ctgov huggingface dataset:
Surgical Correction of Moderate Ischemic Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to try and determine whether repair of moderate ischemic mitral regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on survival.We will compare patients undergoing CABG + mitral repair or CABG only groups. Primary endpoints include late survival. Secondary endpoints include event free survival, symptoms, and echocardiographic outcomes.

Conditions
-----------------
Moderate Ischemic Mitral Regurgitation

Intervention / Treatment
-----------------
* Procedure: mitral valve annuloplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing coronary bypass surgery who have moderate degree of ischemic MR Exclusion Criteria: etiology of mitral regurgitation other than ischemic, degree of regurgitation other than moderate.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: mitral valve annuloplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival at 1,5 and 10 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event free survival |  |  | 
| symptoms |  |  | 
| echocardiographic parameters |  |  |
Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether or not the addition of Herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel.

Official Title
-----------------
A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Herceptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older; patients with histologically proven diagnosis of ovarian cancer. Patients with metastatic disease and an overexpression of HER2 (as determined by immunochemistry) Patients who have progressed while receiving treatment, or within 6 months after completion of treatment. Patients must have received carboplatin and paclitaxel. Patients who have received at minimum one line of chemotherapy 3 weeks minimum since last treatment with chemotherapy must have elapsed Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) or an assessable cancer antigen (CA) 125 > 1.25 x upper limit of normal (ULN) Patients must have ECOG of 2 or less Left ventricular ejection fraction (LVEF) of 50% or better Patients have given their signed and verbal consent Exclusion Criteria: Previous treatment with Herceptin or similar products affected growth factors (eg: Iressa) Another experimental treatment in the previous 30 days No overexpression of HER2 receptors Patients having received high-dose chemotherapy or stem-cell interventions Other cancers within the last 5 years Patients with dyspnea at rest or requiring oxygen therapy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Herceptin|nan|

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
-----------------
HERCEPTIN, Carboplatin, Paclitaxel, Relapse
Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

Study Overview
=================
Brief Summary
-----------------
This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects

Official Title
-----------------
Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: gemcitabine
* Drug: capecitabine
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced and/or metastatic breast cancer. Measurable disease Previously treated with anthracycline Exclusion Criteria: Patients with inflammatory breast disease

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine|nan|
|Drug: capecitabine|nan|
|Drug: docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival. The final analysis will occur when 250 patients have progressed or died. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall toxicity |  |  | 
| Quality of Life |  |  | 
| Overall Survival |  |  | 
| Overall Response Rate |  |  | 
| Time to Treatment Failure |  |  |
A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.

Official Title
-----------------
A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: ipilimumab (MDX-010, BMS-734016)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with previously treated Stage III (unresectable)or Stage IV melanoma

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ipilimumab (MDX-010, BMS-734016)<br> | Drug: ipilimumab (MDX-010, BMS-734016)<br>* IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate disease control rate |  |  | 
| estimate progression free survival rate at Week 12 |  |  | 
| estimate PFS |  |  | 
| estimate overall survival |  |  | 
| estimate survival rate at one year |  |  | 
| estimate duration of BOR |  |  | 
| evaluate proportion of patients whose duration of response is >=24 weeks |  |  | 
| estimate time to BOR |  |  | 
| evaluate safety profile of ipilimumab during the induction and maintenance phases |  |  | 
| evaluate health-related quality of life |  |  | 
| obtain PK sample for population PK analysis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Previously treated melanoma, Unresectable Stage III, Stage IV
Nutritional Status Study of Inpatients in Hospitals

Study Overview
=================
Brief Summary
-----------------
evaluating the nutritional status of inpatients with 7 catogories of diseases ( including digestive system, respiratory system, cardiovascular and endocrine system, tumor, nervous system, urinary system) within 24 48 hours after admission. Among them, the Second Affiliated Hospital of Zhejiang University School of Medicine has undertaken 200 cases, and a total of 25 hospitals in zhejiang participated（5000 cases in total）.

Official Title
-----------------
Nutritional Status Study of Inpatients in Hospitals

Conditions
-----------------
Nutritional Status

Intervention / Treatment
-----------------
* Other: Cross-sectional obeservational survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients with 7 categories of diseases (including digestive system, respiratory system, cardiovascular and endocrine system, tumor, nervous system, and urinary system) Age ≥ 18 24～48h after admission Exclusion Criteria: Age<18 Critically ill patient With mental illness and cannot think or behavior normally Any other serious or uncontrolled illness which the investigator think is undesirable for the patient to enter the trial

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 |
| --- | --- |
| adult inpatients<br>adult inpatients with 7 categories of diseases (including digestive system, respiratory system, cardiovascular and endocrine system, tumor, nervous system, and urinary system) | Other: Cross-sectional obeservational survey<br>* Cross-sectional obeservational survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional risk screening scored with NRS 2002 questionnaire | Detect the presence of undernutrition and the risk of developing undernutrition by Risk Screening 2002 questionnaire(NRS-2002) . The overall score range is from 0 to 7, when score≥3, the patient is nutritionally at-risk | 24 48 hours after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat mass | Body Fat Mass is assessed by bioelectrical impedance analysis (BIA) | 24 48 hours after admission | 
| Body muscle mass | Body muscle mass is assessed by bioelectrical impedance analysis (BIA) | 24 48 hours after admission |
Endocan Blood Level in Pulmonary Circulation

Study Overview
=================
Brief Summary
-----------------
Endocan is a proteoglycan produced by the vascular endothelium. Animal studies suggested that the synthesis mainly happen in the pulmonary circulation, but this hypothesis has never been confirmed in humans.

Detailed Description
-----------------
The investigators will measure endocan levels in both pulmonary and systemic venous blood in patients undergoing on pump cardiac surgery. The main objective is to quantify the difference of endocan blood level between the pulmonary and the systemic circulation.

Official Title
-----------------
Venous Pulmonary Compared to Venous Systemic Blood Level of Endocan During On-pump Cardiac Surgery

Conditions
-----------------
Cardiac Surgery, Cardiopulmonary Bypass, Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned on pump coronary artery bypass surgery Non opposition Exclusion Criteria: Age < 18 years old Emergent surgery Valvular replacement surgery Combined cardiac surgery Patients with inflammatory, infectious or evolutive neoplastic pulmonary disease Patients with valvular problems, in particular aortic insufficiency Patients who refuse to participate Legal inability or disability Patients who will probably not cooperate for the study Pregnancy and/or breast feeding Patients not in the Social security system Patients in the exclusion period of another study

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the difference of Endocan blood levels between pulmonary and systemic circulation at the end of cardiopulmonary bypass | Blood samples will be collected at the same time in both pulmonary and systemic circulation at the end of cardiopulmonary bypass to measure Endocan blood level. The primary outcome will be the absolute difference between the Endocan blod level in the pulmonary circulation and in the systemic circulation. | At the end of cardiopulmonary bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetic of Endocan blood level in the systemic circulation during on pump cardiac surgery | Blood samples will be collected in the systemic circulation prior to the start of cardiopulmonary bypass, at the beginning of the cardiopulmonary bypass and at the end of cardiopulmonary bypass, and at the end of the surgery | Prior to the start of cardiopulmonary bypass, at the beginning and at the end of cardiopulmonary bypass, and at the end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endocan
Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC

Study Overview
=================
Brief Summary
-----------------
Prostate cancer is a leading cause of mortality and morbidity. The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC, T-cells and circulated tumor DNA in prostate cancer patients.

Official Title
-----------------
Clinical Trials on Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells

Conditions
-----------------
Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Metastatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent: The patient must sign the appropriate approved informed consent documents in the presence of the designated staff Exclusion Criteria: Pregnant women Minors (subjects less than 18 years of age) Prisoners Patients having other than one cancer Subjects unable to consent for themselves Symptomatic of acute prostatitis

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

Sexes Eligible for Study
-----------------
Male

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br> | |
| Prostate Cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of prostate cancer | We will develop the linear model and a threshold value differentiating breast cancer from control based on the 100 patient training set. The model will be provided to the researchers: Methylation score=CG1*b1+CG2*b2+ CG3*b3 + e CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept. We will develop the regression coefficient and intercept as well as the DNA methylation values for each patient for each CG. We will first compute the polygenic methylation score for each patient. Then based on the computer threshold based on the training cohort will call the samples as prostate cancer or not. | 6 months to 1 year |
CONECCT (Colorectal Neoplasia Endoscopic Classification To Chose the Endoscopic Treatment)

Study Overview
=================
Brief Summary
-----------------
Prospective study so as to evaluate CONECCT score to determine both histological tissue and therapeutic choice

Official Title
-----------------
CONECCT Score so as to Improve the Diagnosis and the Treatment of Colorectal Neoplasia

Conditions
-----------------
Digestive System Disease

Intervention / Treatment
-----------------
* Procedure: Endoscopic exams


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: N/A Exclusion Criteria: N/A

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic exams|Coloscopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the CONECCT endoscopic score so as to improve colon therapeutic treatment polyps | There are recognized diagnostic criteria so as to predict the histology of colorectal lesions and thus to choose the right therapy. For the moment, these criteria are scattered in at least 5 different classifications and the CONECCT tool will allow gastroenterology interns to more easily predict the histology of the lesion and so to improve the management of them. | one year |
Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A

Detailed Description
-----------------
Phase 1 to evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A. Which is designed as ramdomized, oral, single dose, two-way crossover.

Official Title
-----------------
Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: YYC506-T and YYC506-A (phase 1)
* Drug: YYC506 (phase 1)
* Drug: YYC506-T and YYC506-A (phase 2)
* Drug: YYC506 (phase 2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 19 ages healthy men Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2 Men who don't have congenital disease and other cronic disease need to be cared. etc. Exclusion Criteria: Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN) Men who have drunken or eatten something including caffeine within 24 hours before. etc.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Interventional Model Description: ramdomized, open-label, single-dose, two-way crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A Group<br>Two-way Crossover | Drug: YYC506-T and YYC506-A (phase 1)<br>* Comparator<br>* Other names: Comparator;Drug: YYC506 (phase 2)<br>* Test<br>* Other names: Test;|
| Other: B Group<br>Two-way Crossover | Drug: YYC506 (phase 1)<br>* Test<br>* Other names: Test;Drug: YYC506-T and YYC506-A (phase 2)<br>* Comparator<br>* Other names: Comparator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: Cmax | Cmax | Until 48 hours | 
| Pharmacokinetic parameters: AUC | YYC506-T, YYC506-A, YYC506 AUC | Until 48 hours |
MADIT-CRT LONG-TERM INTERNATIONAL FOLLOW-UP REGISTRY - EUROPE

Study Overview
=================
Brief Summary
-----------------
The registry is designed to determine the long-term mortality and morbidity benefit as a result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The registry will collect data on patients that previously participated at MADIT-CRT sites within Europe through five years of participation from their orginal enrollment in the MADIT-CRT IDE study.

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

Intervention / Treatment
-----------------
* Device: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study
* Device: MADIT-CRT ICD ONLY ARM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active patients who were enrolled in the MADIT-CRT IDE within Europe Exclusion Criteria: Patients who are unable or unwilling to comply with the protocol requirements

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| MADIT-CRT CRT-D<br>Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study | Device: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study<br> <br> * Other names: Boston Scientific market approved cardiac resynchronization therapy defibrillators;|
| MADIT-CRT ICD<br>Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study | Device: MADIT-CRT ICD ONLY ARM<br> <br> * Other names: Market approved Boston Scientific implantable cardioverter defibrillators;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 36 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure event or death | The combined end point of heart-failure or death, whichever came first. | 36 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRT, HEART FAILURE