linjc16/ctgov huggingface dataset:
Eliquis Regulatory Post Marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to examine the safety profile of Eliquis in Korean nonvalvular atrial fibrillation patients.

Official Title
-----------------
Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation

Conditions
-----------------
NonValvular Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Apixaban


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Patients ≥19 years of age Adult patients who are diagnosed with nonvalvular atrial fibrillation and are initiating Eliquis anticoagulation therapy for risk reduction of stroke and systemic embolism Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study Exclusion Criteria: Receiving Eliquis treatment for an indication that is not approved in Korea Contraindicated for the use of Eliquis as described in the Korean label

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nonvalvular Atrial Fibrillation patients with risk of Stroke<br>Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release | Drug: Apixaban<br> <br> * Other names: Eliquis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AE) occurrence based on Incidence of serious adverse events, unexpected adverse drug reactions, Identification of AE profile in usual practice Nonserious adverse events, major bleeding |  | within 30 days after end of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final identification of major events and no event based on Incidence of stroke, systemic embolism, death, Effectiveness or death at 24 months after discontinuation of therapy or at the end of the observation period (whatever is later) | Final identification of major events based on Incidence of stroke, systemic embolism, death, Effectiveness: No evidence of stroke, systemic embolism, or death at 24 months after discontinuation of therapy or at the end of the observation period (whatever is later) | At 3, 6, 12, and 24 months after enrollment | 
| Final evaluation of clinical significance of Eliquis is provided by the physician's subjective decision (Excellent, Good, Moderate, Insufficient) |  | At 3, 6, 12, and 24 months after enrollment |
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

Study Overview
=================
Brief Summary
-----------------
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

Detailed Description
-----------------
The investigators conduct this clinical trial to evaluate the treatment outcome of RFA in HCC patients with tumor smaller than 7cm and tumor number less than five ,in comparison with TACE treatment.The primary outcome is overall survival.The secondary outcome is objective response rate.

Official Title
-----------------
Liver Cancer Institiute ,Fudan University

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Device: radiotherapy ablation
* Device: transarterial chemoembolization(TACE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age 18 to 75 years ; HCC confirmed by pathological or clinical diagnosis according to the American Association for the Study of Liver Diseases criteria ; solitary HCC less than 7cm in diameter or multiple HCC lesions less 5 the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases; lesions visible on ultrasound with a safe path between the lesion and skin; an Eastern Cooperative Oncology Group performance status of 0-1; Child-Pugh class A or B cirrhosis. The exclusion criteria : received any other previous treatment for HCC; severe coagulation disorders; evidence of hepatic decompensation including hepatic encephalopathy, ascites as well as esophageal or gastric variceal bleeding; presence of serious medical comorbidities, including serious dysfunction of the heart or kidney ; currently had other malignancies in addition to HCC.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group 1 RFA alone group 2 TACE alone
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA group<br>Patients in RFA group will accept RFA treatment | Device: radiotherapy ablation<br>* We using Cool Tip system or RITA system to perform RFA<br>|
| Active Comparator: TACE group<br>Patients in TACE group will accept TACE treatment | Device: transarterial chemoembolization(TACE)<br>* TACE treatment is a first line treatment for BCLC stage B HCC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | up to 60 months |
The Effect of a Probiotic on Hepatic Steatosis

Study Overview
=================
Brief Summary
-----------------
Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. Probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. Because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.

Official Title
-----------------
The Effect of a Probiotic on Hepatic Steatosis

Conditions
-----------------
Fatty Liver

Intervention / Treatment
-----------------
* Drug: VSL#3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult-onset diabetes Liver biopsy in the previous 2 months with diagnosis of fatty liver and fibrosis stage F2-F3 Exclusion Criteria: There are multiple exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VSL#3|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI |  |  | 
| Liver biopsy |  |  | 
| Blood work |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic steatosis, adult-onset diabetes, Non-alcoholic fatty liver disease
An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance

Study Overview
=================
Brief Summary
-----------------
In experimental and clinical settings it has been shown that transplant tolerance is possible. It has been suggested that regulatory T cells play a beneficial role in the establishment of tolerance. Calcineurin inhibitors may inhibit development of regulatory T cells. However, the influence of calcineurin inhibitors on markers of transplant tolerance has not been studied in patients undergoing liver transplantation. Currently the investigators conduct a study to evaluate the safety and efficacy of a calcineurin inhibitor free immunosuppression in patients undergoing liver transplantation. In this study measurements of immune function and CD4+CD25high-Foxp3+-Il2/CD8+ status will also be performed. In parallel these measurements should be compared to a group of patients undergoing standard immunosuppression including calcineurin inhibitors.

Official Title
-----------------
An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance

Conditions
-----------------
Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary liver transplantation Patients of age 18 years and older Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation Exclusion Criteria: Multiple organ graft recipients Patients receiving ABO incompatible grafts Patients with positive cross match Pregnancy Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule Patients under guardianship (e.g. individuals who are not able to freely give their informed consent)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard immunosuppression<br>Patients receiving standard immunosuppression after liver transplantation including calcineurininhibitors | |
| Immunosuppression without calcineurininhibitors<br>Patients receiving immunosuppression after liver transplantation not based on calcineurininhibitors | |

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
-----------------
liver transplantation, Patients undergoing liver transplantation
A Phase IIA Study of MK0457 in Patients With Cancer of the Lung (0457-006)

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate the effectiveness of an investigational drug in patients with cancer of the lung.

Official Title
-----------------
A Phase IIA Study Evaluating the Efficacy of MK0457 as a 5-Day Continuous Infusion in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: MK0457


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are at least 18 years of age with cancer of the lung and who have had either no previous treatment or 1 previous treatment for advanced cancer of the lung. Certain other treatments may also be allowed (prior cytotoxic chemotherapy in the adjuvant setting) Exclusion Criteria: Patients who have had treatment with any investigational therapy within the past 30 days are not eligible. Patients who have had a disease or medical condition that is not controlled will not be eligible. Patients who are pregnant or breastfeeding are not eligible.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>MK-0457 | Drug: MK0457<br>* IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of MK0457 as a 5 day infusion as measured by radiological exams at baseline and after every other cycle of treatment. After 3 post-treatment radiological assessments, response will be measured after every third cycle. |  | 5 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by duration, intensity (grade) and time of onset of toxicity. |  | 5 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Non-Small Cell Lung Cancer, NSCLC
ADenoVirus Initiative Study in Epidemiology in Spain

Study Overview
=================
Brief Summary
-----------------
The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Detailed Description
-----------------
Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in Spain. The planned duration of the study is one year from the first patient visit to the last patient visit.

Official Title
-----------------
Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis

Conditions
-----------------
Viral Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms. Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data. No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components). Exclusion Criteria: Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result. Previous enrolment in the present study. Any direct involvement with the study conduct at site or any family link with study site staff.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Frequency of patients with adenovirus conjunctivitis | The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis. | During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.

Official Title
-----------------
Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Carbetocin
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin Exclusion Criteria: Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>A single 100 microgram IV dose of carbetocin after operation | Drug: Oxytocin<br>* Oxytocin with 30 international units (IU) IV infusion was used in this investigation<br>* Other names: Pitocin;|
| Experimental: Carbetocin<br>A standard 30 international units (IU) IV infusion of oxytocin during two hours | Drug: Carbetocin<br>* Carbetocin with single 100 microg IV dosage was used in this investigation<br>* Other names: Lonactene;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screening of Cessation of bleeding |  | screening until 24 hours after placenta disconnection | 
| time duration to stop bleeding in the case of post-cesarean section |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention, cesarean section
Application of MR-PET in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This study will explore the potential value in proper therapeutic decision and clinical outcome prediction by using integrated MR-PET system and advanced MR techniques in patients with colorectal cancer.

Detailed Description
-----------------
This research expect that the image techniques and experience in this cancer group may be valuable and helpful for others. With advantage of MR-PET in better soft tissue delineation/functional information and less radiation dose than PET-CT, the ultimate goal in both research and clinical application is to establish new diagnostic standard and management guideline by MR-PET, which can further improve clinical outcome and disease prognosis in patients colorectal cancer.

Official Title
-----------------
Application of MR-PET in Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Device: The imaging biomarkers determined by MR-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1: Patients with newly diagnosed colorectal cancers Group 2: Patients with suspicious recurrent colorectal cancers Exclusion Criteria: Age <20 or >90 years old Contraindication for MRI: claustrophobia or MR non-compatible devices Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre > 2.0) History of other malignancy Prior arthroplasty of hip (may cause artifacts on MRI) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: The imaging biomarkers determined by MR-PET|This study will explore the potential value in proper therapeutic decision and clinical outcome prediction by using integrated MR-PET system and advanced MR techniques in patients with colorectal cancer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence rate at 1 year after surgery |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall survival at 1 year after surgery |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Application of MR-PET