linjc16/ctgov huggingface dataset:
Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer.

Detailed Description
-----------------
The addition of dimethyldiguanide might increase the efficacy of AI in patients with metastatic breast cancer after the failure of the first line endocrine therapy.

Official Title
-----------------
Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.

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

Intervention / Treatment
-----------------
* Drug: AI plus Dimethyldiguanide
* Drug: Aromatase Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal HR positive breast cancer patients; inoperable locally advanced or metastatic breast cancer patients; candidate for endocrine therapy; ECOG equal to or less than 1; adequate bone marrow function(Hb>=90g/L, WBC >=3.5×10^9/L,ANC>=1.5×10^9/L, PLT>=80×10^9/L; adequate renal function(Ccr<=ULN);adequate liver function(ALT,AST,AKP<=2.5*ULN,or <=5*ULN if liver metastases) life expectancy >=12weeks; no severe history disease of liver,heart,lung or kidney; written informed consent form; Exclusion Criteria: Her-2 overexpression; patients who has visceral endocrisis；

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI plus Dimethyldiguanide<br>AI 1 tablet qd plus Dimethyldiguanide 0.5 bid | Drug: AI plus Dimethyldiguanide<br>* AI 1 tablet per day Dimethyldiguanide 0.5 bid<br>* Other names: Dimethyldiguanide;|
| Active Comparator: Aromatase Inhibitor<br>AI monotherapy | Drug: Aromatase Inhibitor<br>* 1 tablet per day<br>* Other names: letrozole or exemestane;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 9 months |
Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy

Study Overview
=================
Brief Summary
-----------------
In this study the investigators want to determine if the detection of lymph node is applicable in prostatectomy by laparoscopy.

Official Title
-----------------
Evaluation of the Sentinel Lymph Node Technic of the Prostate by Laparoscopy

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Procedure: lymph nod detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years Diagnosis of invasive cancer of the prostate (T1 or T2 or T3) PSA ≥ 4, Gleason ≥ 6 No treatment prior to surgery Indication of lymphadenectomy by coeliscopique ECOG or Karnofsky index 2 Patient information and signed informed consent Exclusion Criteria: neoadjuvant hormone therapy Interventions prior pelvic Patients who received anterior resection of part of prostate Patient or denied having an altered mental status Any contre indication to laparoscopy

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

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

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

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

Design Details

Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lymph nod detection<br> | Procedure: lymph nod detection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate and false-negative rate for the sentinel lymph node detection |  | The day of at laparoscopy (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with infiltrant prostatic carcinoma
The Angiography Characteristic of Free Wall Ruptrue in STEMI

Study Overview
=================
Brief Summary
-----------------
To analyze whether the location of myocardial infarction and infarct related artery are related to FWR.

Detailed Description
-----------------
To know the characteristic of FWR that different location of STEMI and coronary distribution

Official Title
-----------------
The Coronary Angiography Characteristic of Free Wall Ruptrue in ST-Elevation Myocardial Infarction Patients

Conditions
-----------------
ST-Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Diagnostic Test: Coronary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had to be ≥18 years of age, be admitted for STEMI Accord with STEMI diagnostic criteria STEMI patients anticipated to undergo angiography Exclusion Criteria: Pregnant Acute stroke Aortic dissection

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 |
| --- | --- |
| Anterior infarction<br>Patients with anterior ST-elevation myocardial infarction | Diagnostic Test: Coronary intervention<br>* Patients with STEMI undergo coronary intervention<br>|
| Inferior infarction<br>Patients with inferior ST-elevation myocardial infarction | Diagnostic Test: Coronary intervention<br>* Patients with STEMI undergo coronary intervention<br>|
| Lateral infarction<br>Patients with lateral ST-elevation myocardial infarction | Diagnostic Test: Coronary intervention<br>* Patients with STEMI undergo coronary intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cardiac death | In-hospital cardiac death during 30 days | 30 days | 
| Number of free-wall rupture | The FWR after STEMI patients | 30 days | 
| Number of reperfusion arrhythmia | Reperfusion arrhythmia during coronary intervention | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FMC time | First Medical Contact time | 30 days | 
| Symptom onset to angiology time | The time from symptom onset to beginning of angiography | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, Ruptrue, Angiography
The Effect of High Frequency Jet Ventilation (HFJV)During Laparoscopic Operations

Study Overview
=================
Brief Summary
-----------------
Investigators conducted a randomised perspective study to determine whether the use of HFJV instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects of pneumoperitoneum during laparoscopic surgery.

Official Title
-----------------
The Effect of High Frequency Jet Ventilation (HFJV)on Pneumoperitoneum Induced Cardiovascular Changes, During Laparoscopic Surgery.

Conditions
-----------------
Cholecystolithiasis

Intervention / Treatment
-----------------
* Procedure: High Frequency Jet Ventilation
* Procedure: HFJV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy patients, undergoing laparoscopic surgery for Symptomatic cholecystolithiasis. Exclusion Criteria: ASA 3 and 4

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFJV<br> | Procedure: High Frequency Jet Ventilation<br> <br> Procedure: HFJV<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac functionality (Cardiac output,VOLUME) | Cardiac functionality (Cardiac output,VOLUME) |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumoperitoneum, laparoscopy, HFJV, cardiovascular, Symptomatic
Phase 2 Study of TLK286 Administered Weekly in Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of TLK286 in the treatment of advanced non-small cell lung cancer.

Conditions
-----------------
Carcinoma, Non-small-cell Lung

Intervention / Treatment
-----------------
* Drug: TLK286


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic or cytologic diagnosis of non-small cell lung carcinoma Progressed while on or after treatment on platinum-based regimen Patients may not have had more than one prior cytotoxic chemotherapy regimen Stage IV or IIIB Age at least 18 years Adequate liver and kidney function Adequate bone marrow function Exclusion Criteria: Pregnancy or lactation Unstable medical conditions Chemotherapy, hormonal therapy, radiotherapy, radiopharmaceuticals or immunotherapy within 3 weeks of TLK286 CNS metastasis unless controlled by treatment

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TLK286|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Perception of Facial Expression in Subjects With and Without Crow's Feet Lines

Study Overview
=================
Brief Summary
-----------------
This study will examine the perception of facial expressions among individuals with and without crow's feet lines.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: Photographic Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English fluency Exclusion Criteria: None

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Photographic Review<br>Photographic review of subjects who received treatment with onabotulinumtoxinA for crow's feet lines. | Other: Photographic Review<br>* Photographic review of subjects who received treatment with onabotulinumtoxinA for crow's feet lines.<br>* Other names: BOTOX® Cosmetic;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independant Observers' Perception of Expressed Emotions on a 7-Point Scale |  | Day 1 |
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital

Study Overview
=================
Brief Summary
-----------------
This study evaluates the different response of Ursodeoxycholic Acid in primary biliary cholangitis only and primary biliary cholangitis with high immune globulin G or aminotransferase at West China Hospital from 2008-2017.

Official Title
-----------------
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital

Conditions
-----------------
Primary Biliary Cholangitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with primary biliary cholangitis Treated with Ursodeoxycholic Acid in West China Hospital for at least 1 year Exclusion Criteria: Autoimmune hepatitis Primary sclerosing cholangitis

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Description of demographics, clinical index after treatment | age，sex，ALT（IU/L），AST（IU/L），ALP（IU/L），GGT（IU/L）,IgG（g/L） | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation whether the PBC patients have response after treatment | Use Paris II criterion to estimate | within 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ursodeoxycholic Acid, Response
Correlation Between Various Adipokines and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG) (18FDG-PET)

Study Overview
=================
Brief Summary
-----------------
The inflammatory state and composition of atherosclerotic plaques are considered the main contributing factors responsible for acute cardiovascular events, rather than the degree of stenosis. Recently, positron emission tomography (PET) with 18F-fluoro-deoxyglucose (FDG) has been suggested as a promising novel imaging technique to identify the inflammatory state of atherosclerotic plaque. Recently, a few clinical studies showed that circulating A-FABP level had a close relation with the development of atherosclerosis in human. Therefore, in the present study, the investigators examined the relationship between circulating A-FABP and vascular inflammation of carotid arteries measured using FDG-PET in healthy male subjects.

Official Title
-----------------
Correlation Between Various Adipokines and Vascular Inflammation Measured by 18FDG-PET In Healthy Male Subjects

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Other: Cross sectional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers for visiting routine medical check in our clinic Exclusion Criteria: History of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization) Diabetes Hypertension Malignancy Severe renal or hepatic disease Subjects taking medications that might affect inflammation such as NSIAD and statin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy male participants<br> | Other: Cross sectional study<br>* This is not intervention study. The purpose of the study is to examine the relationship between various adipokine levels and PET imaging at the cross section setting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular inflammation in carotid arterial wall, represented as the target-to-background ratio (TBR), using FDG-PET |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating serum A-FABP levels |  | 12 weeks | 
| Circulating serum leptin levels |  | 12weeks | 
| Circulating serum adiponectin levels |  | 12 weeks | 
| Carotid intima-media thickness levels measured using ultrasonography |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerosis, vascular inflammation, adipocyte fatty acid binding protein, adiponectin, leptin, 18FDG-PET
Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®

Official Title
-----------------
Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Candesartan (test)
* Drug: Felodipine (test)
* Drug: Candesartan Cilexetil
* Drug: Felodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005) Exclusion Criteria: Not healthy Chronic drug intake

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-arm<br>3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan) | Drug: Candesartan (test)<br>* 16 mg oral tablet, single dose<br>Drug: Felodipine (test)<br>* 5 mg oral extended release tablet, single dose<br>Drug: Candesartan Cilexetil<br>* 16 mg oral tablet, single dose<br>* Other names: Atacand®;Drug: Felodipine<br>* 5 mg oral extended release tablet, single dose<br>* Other names: Splendil®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®. |  | 76 blood samples per subject | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, candesartan, felodipine, test formulations, Atacand®, Splendil®, healthy volunteers, blood samples, after meal intake interaction, Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.
The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Pioglitazone and rosiglitazone are used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose levels and lipid profiles. The effect of these two different thiazolidinediones on atherosclerotic and inflammatory markers has not been compared in prospective manner. The purpose of this prospective, randomized, open-label, crossover trial is to compare the effect of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients with metabolic syndrome.

Official Title
-----------------
The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome: A Prospective, Randomized, Open-label, Crossover Trial

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Pioglitazone, Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with at least 3 metabolic syndrome criteria of Asian-Pacific ATP III guideline: fasting blood glucose ≥ 110 mg/dl, systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, triglyceride ≥ 150 mg/dl, HDL-cholesterol < 40 mg/dl for men and < 50 mg/dl for women. Age: 18 years and above Exclusion Criteria: Hypertensive patients with the use of ACE inhibitor or ARB Hyperlipidemic patients with the use of statin or fenofibrate Patients with any contraindications to the treatment of thiazolidinediones Pregnant or lactating patients Chronic alcohol or drug abuse Hepatic dysfunction Renal dysfunction Heart failure (EF < 50%) Expected life expectancy of < 1 year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pioglitazone, Rosiglitazone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rosiglitazone, Pioglitazone, FMD, PWV, atherosclerosis