linjc16/ctgov huggingface dataset:
The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The study will assess the serum expression of MMP-9 in normal people, type 2 diabetic patients and type 2 diabetic patients with atherosclerosis.

Official Title
-----------------
The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis in Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: diagnosed as type 2 diabetes without atherosclerosis
* Diagnostic Test: diagnosed as type 2 diabetes with atherosclerosis
* Diagnostic Test: people without type 2 diabetes or atherosclerosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteer to participate and be able to sign informed consent prior to the trial. patients with type 2 diabetes, aged 18-60 years old, meeting WHO1999 diagnostic criteria, have not used any drugs. The patients have completed carotid ultrasound during hospitalization. Exclusion Criteria: patients with any antidiabetic drugs. impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal. drug abuse and alcohol dependence in the past 5 years. systemic hormone therapy was used in the last three months. patients with infection and stress within 4 weeks. any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Normal people<br>No diabetes and atherosclerosis | Diagnostic Test: people without type 2 diabetes or atherosclerosis<br>* normal people without type 2 diabetes or atherosclerosis<br>|
| type 2 diabetes mellitus without atherosclerosis<br>Newly diagnosed type 2 diabetes without atherosclerosis | Diagnostic Test: diagnosed as type 2 diabetes without atherosclerosis<br>* patients diagnosed as type 2 diabetes without atherosclerosis<br>|
| type 2 diabetes mellitus with atherosclerosis<br>Newly diagnosed type 2 diabetes with atherosclerosis | Diagnostic Test: diagnosed as type 2 diabetes with atherosclerosis<br>* patients diagnosed as type 2 diabetes with atherosclerosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total MMP-9 levels | the different group of total MMP-9 levels | 6 months |
Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Study to investigate the efficacy and safety of Vardenafil

Official Title
-----------------
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, History of unresponsiveness to sildenafil Stable sexual relationship for > 6 month. Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy Other exclusion criteria apply according to the US Product Information

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 20mg to be taken 1 h prior to sexual intercourse<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Encounter Profile Question 2 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Encounter Profile Question 3 |  | 12 weeks | 
| Internation Index of Erectile Function-Erectile Function domain |  | 12 weeks | 
| Safety and tolerability |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile dysfunction, Vardenafil
Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure.

Detailed Description
-----------------
Patients admitted for acute decompensated heart failure are included in the study. After gaining informed consent, concentrations of high-sensitivity troponin on admission and on discharge are assessed. 6 months after discharged, the incidence of clinical endpoint (mortality of all cause and of cardiovascular cause, hospitalization) is assessed by telephone contact to the patient and/or the physician. The aim of the study is to investigate the prognostic value of high-sensitivity troponin concentration for predicting death and re-hospitalization.

Official Title
-----------------
Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital admission for acute cardiac decompensation Systolic and / or diastolic heart failure Exclusion Criteria: Myocardial infarction in the last 4 weeks Serum creatinine >2.5 mg/dl Pulmonary embolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Time to cardiovascular death or hospitalization |  | 6 Months Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to all cause death or hospitalization |  | 6 Months Follow-Up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Troponin concentration in heart failure
Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The technique of sentinel lymph node mapping in patients with colon cancer varies among reports, and the optimal method remain to be established. The purpose of this study was to determine the optimal injection technique for sentinel lymph node mapping for colon cancer.

Official Title
-----------------
Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer

Conditions
-----------------
Sentinel Lymph Node Biopsy, Colon Cancer

Intervention / Treatment
-----------------
* Procedure: Intraoperative injection (in vivo)
* Procedure: Postoperative injection (ex vivo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage I - III colon cancer patients Exclusion Criteria: cancer located at the low rectum which were located within 10 cm of the dentate, recurrent or metastatic colon carcinoma, adjacent organ invasion tumor, prior chemotherapy or radiation, cancer with intestinal obstruction, past intestinal surgery

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>In vivo injection group | Procedure: Intraoperative injection (in vivo)<br>* Intraoperative injection<br>|
| Other: 2<br>Ex vivo injection group | Procedure: Postoperative injection (ex vivo)<br>* postoperative injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy & sensitivity of sentinel lymph node mapping |  | After confirmed pathological report | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sentinel lymph node-colon cancer
Prevalence of Osteoporosis in Korean Prostate Cancer Patients Who is Receiving LHRH Agonist and/or Anti-androgen Agent

Study Overview
=================
Brief Summary
-----------------
Prevalence rate of osteoporosis and it's actual management condition in Prostate cancer patients who takes LHRH antagonist and anti androgen

Official Title
-----------------
Prevalence of Osteoporosis in Korean Prostate Cancer Patients Who is Receiving LHRH Agonist and/or Anti-androgen Agent

Conditions
-----------------
Prostate Cancer, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologic confirmation of prostate cancer patients who are taking LHRH antagonist or anti- androgen or both of them within 6 months since starting. Exclusion Criteria: patients who are hard to be analysed by limitation of chart record according to investigators'discretion patients who already have been registered in this study
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| To define prevalence rate of osteoporosis in Prostate cancer patients who take LHRH antagonist or anti androgen (include MAB) at the stage of before treatment or it's initial stage. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess whether proper osteoporosis prevention and treatment was given or not according to osteoporosis treatment guideline in prostate cancer patients who are enrolled in this study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Prostate cancer, LHRH agonist and/or anti-androgen agent, Korean prostate cancer
CABG Without the Use of CPB

Study Overview
=================
Brief Summary
-----------------
Comparison of clinical outcomes in patients undergoing coronary bypass surgery using the heart/lung machine as opposed to using off-pump techniques.

Official Title
-----------------
A Prospective Randomised Study od Coronary Artery Bypass Surgery Without the Use of Cardiopulmonary Bypass

Conditions
-----------------
Coronary Artery Bypass

Intervention / Treatment
-----------------
* Procedure: Coronary artery bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for coronary surgery - Exclusion Criteria: Less than 18 years Emergency and salvage operations -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Coronary artery bypass|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of clinical outcomes for coronary artery bypass graft surgery when performed using cardiopulmonary bypass versus beating heart surgery without cardiopulmonary bypass |  | 2 years |
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

Detailed Description
-----------------
To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

Official Title
-----------------
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Drug: Amifostine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0). tumor distance from anus less than 12 cm. KPS score not less than 70 can be tolerated chemotherapy and radiotherapy. pelvic who had no history of radiation therapy. Non-allergic history of fluorouracil or platinum-based chemotherapy drugs. blood pressure can be controlled by drugs in the normal range (90 ≤ systolic blood pressure ≤ 140,60 ≤ diastolic blood pressure ≤ 90). a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. Exclusion Criteria: other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous). pregnant or lactating patients. fertility but did not use contraceptive measures. existing active infection. merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension. concurrent treatment with other anticancer drugs. can not complete treatment or follow-up.

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

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amifostine<br>intrarectal Amifostine assign to the Amifostine arm | Drug: Amifostine<br>* intrarectal Amifostine administration 1500mg QD x 5 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute radiation-induced toxicity: daily diarrhea frequency |  | about 3 months from chemo-raditherapy to operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, amifostine, pre-operative chemo-radiation
Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard.

Official Title
-----------------
Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Diagnostic Test: FFR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years; Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel; Able to provide informed consent. Exclusion Criteria: Subjects judged unsuitable for diagnostic intervention or FFR; Myocardial infarction within 6 days; LVEF ≤50%; eGFR <60ml/min（1.73m²） Severe coagulation dysfunction or bleeding disorders; Allergic to iodine contrast agent or adenosine, or ineligible for adenosine; Participated in other clinical trials within 1 months; Other situations that were not suitable for inclusion, as judged by investigators.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: FFR|FFR measured by pressure wire, AccuFFRangio computed by coronary angiographic images|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard | Hemodynamically significant coronary artery stenosis: FFR≤0.8 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard | Hemodynamically significant coronary artery stenosis: FFR≤0.8 | 7 days | 
| AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis | Hemodynamically significant coronary artery stenosis: FFR≤0.8 | 7 days |
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

Study Overview
=================
Brief Summary
-----------------
To examine the efficacy and safety of radiofrequency therapy on vaginal laxity, The investigators enrolled 30 women with vaginal laxity. Radiofrequency therapy was consisted of 2 sessions with 3 week interval. A session included 20 minutes radiofrequency therapy on vaginal mucosa. Vaginal laxity score, female sexual function index (FSFI), female sexual distress scale (FSDS), vaginal pressure, adverse events were examined. Follow up period is 3 months.

Official Title
-----------------
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

Conditions
-----------------
Vaginal Laxity

Intervention / Treatment
-----------------
* Device: vaginal radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vaginal laxity score >= 3 negative pregnancy test within 2 months Exclusion Criteria: genital anomaly pelvic prolapse stage >= stage 3 active genital infection vulvar pain or deformity disease related to sexual behavior current, chronic NSAIDs intake fever any acute illness cognitive disorder pacemaker insertion metal implants

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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: Experimental<br>women who undergo radiofrequency therapy | Device: vaginal radiofrequency<br>* 2 sessions of vaginal radiofrequency therapy with 3 week interval. A session last 20 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of vaginal laxity score from baseline | subjective vaginal laxity | baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of FSFI score from baseline | female sexual function index, higher is better | baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session | 
| change of FSDS score from baseline | female sexual distress scale, lower is better | baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session | 
| change of vaginal pressure from baseline | vaginal pressure measured with manometer | baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session |