linjc16/ctgov huggingface dataset:
Coronary Thromboaspiration and Infarct Size

Study Overview
=================
Brief Summary
-----------------
Distal embolization can occur during coronary angioplasty performed in the acute phase of myocardial infarction and is associated with poor long-term outcome. We hypothesize that the use of a system allowing thrombus aspiration before angioplasty and stent implantation will limit infarct size and its severity.

Detailed Description
-----------------
Patients scheduled for emergency angioplasty in the acute phase of a first ST-elevation myocardial infarction will be treated either by thromboaspiration followed by angioplasty or by angioplasty alone. The infarct size and severity will be assessed by ce-MRI and rest Tc99m-mibi gated SPECT performed during initial hospital stay (5th-8th day). A control MRI will be performed at 6-month follow-up to analyse the evolution of left ventricular volumes.

Official Title
-----------------
Assessment of Efficacity of Coronary Thromboaspiration (Export System) Performed Before Angioplasty on Infarct Size in Patients Treated by Coronary Percutaneous Interventions During Acute Phase.

Conditions
-----------------
Ischemic Heart Disease, Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: Export Aspiration System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute phase of myocardial infarction (>48 hours from the onset of chest pain) stable hemodynamic conditions completely occluded infarct related artery Exclusion Criteria: heart failure signs in the acute phase contra indication for MRI or SPECT IMAGING

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Export Aspiration System|Patients scheduled for emergency angioplasty|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT |  | by ce-MRI and rest Tc99m-mibi gated SPECT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of evolution toward left ventricular remodelling (defined as an increase of end-diastolic volume of>20% between the acute phase and 6-montcontrol) |  | of end-diastolic volumeof>20% between the acute phase and 6-montcontrol) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myocardial infarction, Thromboaspiration, Infarct size, Left ventricular remodelling
Insulin Glargine in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in daily practice and to improve the physicians' knowledge and experience concerning Insulin glargine

Official Title
-----------------
Open Trial of the Safety and Efficacy of Lantus for Insulin Naive Type 2 Diabetes Mellitus Patients or Patients Who Use Insulin Combined With 1 or More Oral Antidiabetic Drugs and Don't Have Good Glycemic Control.

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

Intervention / Treatment
-----------------
* Drug: Insulin Glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus patients, Diabetic patients receiving insulin or patients who are insulin-naive and whose glycemic control cannot be sufficiently maintained with single or combined oral antidiabetic agents, Patients with HbA1C>8 Patients able to self-measure its blood glucose levels. Exclusion Criteria: According to package insert information (Summary of Product Characteristics)

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: Insulin Glargine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For efficacy: FBG (Fasting Blood Glucose), HbA1c |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For safety: ICA (Insulin Cell Antibody) |  |  |
Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.

Official Title
-----------------
A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

Conditions
-----------------
Melanoma, Metastases

Intervention / Treatment
-----------------
* Drug: ABI-007


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed Metastatic Melanoma At least 18 years old No other active malignancy Hemoglobin at least 9 Platelet Count at least 100,000 cells/mm3 ANC at least 1500 cells/mm3 AST & ALT less than 2.5X upper limit of normal Total bilirubin less than 1.5mg/dL Creatine less than 1.5 mg/dL Alkaline phosphatase less than 2.5X upper limit of normal Life expectancy of at least 12 weeks ECOG performance status of 0-1 Patient must provide informed consent Patient must provide authorization to disclose Exclusion Criteria: Evidence of active brain metastases The only evidence of metastasis is lytic or blastic bone metastases Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2 Received radiotherapy in last 4wks, except if to a non-target lesion only Clinically significant concurrent illness Investigator's opinion that patient unlikely to complete study Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks History of allergy/hypersensitivity to study drug Serious Medical Risk Factors determine by the investigator

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

| Intervention/Treatment |
| --- |
|Drug: ABI-007|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate number of cycles required before patients achieve maximum response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Melanoma
Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.

Official Title
-----------------
A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin (100 mg qd) In Patients With Type 2 Diabetes (Extension Study of Study CLAF237A1303)

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

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis as Type 2 Diabetes Patients who have completed study CLAF237A1303 Outpatients Exclusion Criteria: Patients who prematurely discontinued Study CLAF237A1303 Other protocol-defined inclusion/exclusioncriterial may apply

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

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

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: Vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events profile after 52 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint on HbA1c at 52 weeks |  |  | 
| Change from baseline to endpoint on fasting plasma glucose at 52 weeks |  |  | 
| Change from baseline to endpoint in HOMA B at 52 weeks |  |  | 
| Change from baseline to endpoint in HOMA IR at 52 weeks |  |  | 
| Change from baseline to endpoint in body weight at 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Vildagliptin, HbA1c
A Retrospective Analysis of Laboratory Testing on Chronic Wound Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to pursue statistical analysis on a series of molecular laboratory results obtained from chronic wounds. It elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds.

Detailed Description
-----------------
The information was processed from culture results that were processed to compile an antibiogram for a laboratory.

Official Title
-----------------
A Retrospective Analysis of Laboratory Testing on Chronic Wound Patients

Conditions
-----------------
Wound Chronic Draining

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with chronic wounds. Exclusion Criteria: -Patients without chronic wounds.
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 |
| --- | --- | --- |
| Improve selection of systemic antibiotics based on results using molecular diagnostics. | The study elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds. It evaluated samples from different regions, different types of wounds, different outcomes, and longitudinal data if multiple samples were sent over time from a single individual. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Data Collection: The molecular wound cultures have been performed on thousands of patients from around the country. The information from the culture results that were processed were used to compile an antibiogram for a laboratory. | There are many geographic regions which have a number of samples which could be analyzed and compared to other geographic regions yielding valuable insight into the microbiology of chronic wounds. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound chronic
Iclusig PMS in CML or Ph+ALL Patients

Study Overview
=================
Brief Summary
-----------------
This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP). This PMS is to assess safety and effectiveness data after administrating Ponatinib (of Iclusig® Tablets) per approved indication, usage and dosage.

Official Title
-----------------
Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the Risk Management Plan

Conditions
-----------------
Chronic Myeloid Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: Ponatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment Exclusion Criteria: Patients with known or suspected hypersensitivity to ponatinib or to any ingredient of the drug Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ponatinib|Iclusig 45mg, 15mg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR |  | until 14 days after last administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects who satisfy CHR |  | at 3 months and 6 months from administration | 
| The percentage of subjects who satisfy CHR |  | at 3 months and 6 months from administration | 
| The number of subjects who satisfy MCyR |  | at 3 months and 6 months from administration | 
| The percentage of subjects who satisfy MCyR |  | at 3 months and 6 months from administration | 
| The number of subjects who satisfy MMR |  | at 3 months and 6 months from administration | 
| The percentage of subjects who satisfy MMR |  | at 3 months and 6 months from administration |
Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to healthy subjects.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers

Conditions
-----------------
Pharmacokinetics, Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: BTA-C585 oral capsules
* Drug: BTA-C585 matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women aged 18-60 years; Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32; Female subjects must be of non-childbearing potential; Male subjects must agree to use a double barrier method of birth control; Able to provide informed consent Exclusion Criteria: Current or recent (within 14 days of Day 0) bacterial or viral infection; Positive results for hepatitis B, hepatitis C, or HIV; Clinically significant abnormalities noted on ECG; Safety laboratory abnormalities; Regular use of medications, prescription or non-prescription; Poor vein access or fear of venipuncture; Major surgery, significant recent injury or trauma within 30 days; Received an investigational drug or vaccine within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BTA-C585 oral capsules<br>25 or 100 mg oral capsules; Single ascending doses (SAD) from 50 mg to 800 mg | Drug: BTA-C585 oral capsules<br>* BTA-C585; Single ascending doses from 50 mg to 800 mg<br>* Other names: BTA585;|
| Placebo Comparator: BTA-C585 matching placebo<br>BTA-C585 Matching placebo capsules; single doses | Drug: BTA-C585 matching placebo<br>* Single ascending doses to match 50 to 800 mg BTA-C585 capsules<br>* Other names: BTA585;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Day 0 to Day 11 | 
| Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours |  | 0-24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Viral Diseases, Antiviral, Paramyxoviridae Infections, RSV, Respiratory Syncytial Virus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Though refusal of radical surgery was often happened in rectal cancer patient after neoadjuvant chemoradiotherapy, little is currently known about the actual oncologic outcome of it. Thus the investigators designed this study to compare the oncologic outcome of unintended rectal preservation with intended rectal preservation by surgeon.

Detailed Description
-----------------
The investigators identified patients whose organ were preserved by non-operative management or local excision after neoadjuvant chemoradiotherapy for mid to low rectal cancer. Then, the patients were categorized into two groups according to the agreement on omitting radical surgery (rectal preservation). When treatment decision was agreed by their surgeon, the patients were categorized as intended rectal preservation. When there was disagreement by surgeon on rectal preservation, then the patients categorized as unintended rectal preservation. Oncologic outcome was compared between two groups.

Official Title
-----------------
Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer: a Multicenter Comparative Study With Rectal Preservation as Supported by Surgeon

Conditions
-----------------
Rectal Cancer, Chemoradiation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proven rectal cancer (anal verge ≤ 10cm) neoadjuvant radiotherapy or chemoradiotherapy no radical surgery after neoadjuvant therapy Exclusion Criteria: other malignant disease other fatel disease incompletion of half of radiotherapy course metastasis on initial presentation

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intended rectal preservation<br>When rectal preservation (non-operative management or local excision) was agreed by their surgeon. | |
| Unintended rectal preservation<br>When rectal preservation (non-operative management or local excision) was disagreed by their surgeon. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival | Overall survival rate at 3-year after completion of chemoradiotherapy | from date of completion of chemoradiotherapy until the date of death from any cause, whichever came first, assessed at 31th December 2017 by checking expire date of a resident registration number | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Organ preservation, Oncologic outcome
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Detailed Description
-----------------
To evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Radiation: Radiotherapy alone
* Radiation: Concurrent chemoradiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma Exclusion Criteria: A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions,supposed to live less than 6 months.

Ages Eligible for Study
-----------------
Minimum 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
Interventional Model Description: Concurrent cisplatin based chemoradiotherapy versus radiotherapy alone
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensity-modulated Radiotherapy<br>Radiotherapy alone was given. | Radiation: Radiotherapy alone<br> <br> |
| Active Comparator: Concurrent chemoradiotherapy<br>Concurrent cisplatin-based radiotherapy was given. | Radiation: Concurrent chemoradiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic success | A combined primary end point, named therapeutic success(TS), was used; it took into account activity, toxicity, and compliance.A TS was defined as a patient completing radiotherapy at the planned dose and schedule (no re-treatment delays beyond 2 weeks), and having an objective response (either complete or partial based on RECIST criteria) without (1) grade 3-4 nonhematological toxicity, (2) complications associated with hematologic toxicity such as febrile neutropenia, infection, bleeding, or transfusion, or (3) any toxicity leading to hospitalization or death. | From date of treatment until the date of completing treatment 1 month later |