linjc16/ctgov huggingface dataset:
Quantitative Ultrasound for Diagnosing Hepatic Steatosis in Nonalcoholic Fatty Liver Multicenter Study

Study Overview
=================
Brief Summary
-----------------
To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard

Official Title
-----------------
Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease: Multicenter Prospective Study

Conditions
-----------------
Diagnoses Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Quantitative ultrasound (QUS) technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD) Patients who are scheduled hepatic parenchymal biopsy for suspected liver disease or hepatectomy for living donor liver donation aged ≥ 18 years who are willing and able to complete all procedures Exclusion Criteria: excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women) clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders use of steatogenic or hepatotoxic medication evidence of decompensated liver disease history of liver surgery any other condition believed by investigator to affect a patients' compliance, or completion of the study

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 |
| --- |
|Diagnostic Test: Quantitative ultrasound (QUS) technique|Measurement of quantitative ultrasound parameter using clinical US machine (RS85)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1) | Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3) | Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S2 and S3)(reference standard: pathologic result) | 1 month | 
| Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH) | Evaluation of area under the ROC curve (AUC) for the detection of nonalcoholic steatohepatitis (reference standard: pathologic result) | 1 month |
Comparison Colon Capsule Endoscopy vs Optical Colonoscopy for Colorectal Cancer Screening in Familiar-Risk Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the adherence to screening in first grade relatives of patients with CCR is higher than optical colonoscopy.

Detailed Description
-----------------
The purpose of this study is to compare the adherence and effectiveness of colon capsule endoscopy (CCE-2) versus conventional colonoscopy to screen first-degree relatives of patients with colorectal cancer.

Official Title
-----------------
Effectiveness of Colon Capsule Endoscopy as Colorectal Cancer Method of Screening in The Familiar-Risk Population

Conditions
-----------------
Colorectal Cancer, Genetics of

Intervention / Treatment
-----------------
* Procedure: COLON CAPSULE ENDOSCOPY ADHERENCE
* Procedure: OPTICAL COLONOSCOPY ADHERENCE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic first-degree relatives (parents, siblings or children) of CRC patients aged less than 60 years or with two or more first-degree relatives of any age. Signing of informed consent. Exclusion Criteria: Personal history of adenoma or CRC. History of hereditary CRC. Chronic inflammatory disease. Presence of digestive symptoms. Patients with swallowing problems (dysphagia). Personal history of gastrointestinal surgery. Enteritis radioactive. Renal failure. Congestive heart failure Allergy or other contraindication to Bysacodyl to PEG or phosphates. Pregnancy. Suspected bowel obstruction or intestinal strictures or fistulas known. Colectomy. Paralysis with impaired intestinal motility. Any other process that the investigator's discretion to make inadequate participation.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COLON CAPSULE ENDOSCOPY<br> | Procedure: COLON CAPSULE ENDOSCOPY ADHERENCE<br>* An exploration with a COLON CAPSULE ENDOSCOPY eaten which capsule has a video-camera in both end to see the colon.<br>|
| Other: OPTICAL COLONOSCOPY<br> | Procedure: OPTICAL COLONOSCOPY ADHERENCE<br>* An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer | Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer | 6 month follow up |
Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Device Compared With Laboratory Assay

Study Overview
=================
Brief Summary
-----------------
Central Neuraxial Blockade (CNB) is commonly used in anaesthetics. It has several advantages over a general anaesthetic however contraindications include coagulopathy. Guidelines suggest a CNB should not be undertaken with an International Normalised Ratio (INR) of 1.5 or greater. A common cause of an elevated INR is warfarin therapy and regular monitoring of its effects is required. The Hemochron Signature Elite is a portable micro coagulation system that can be used as a point of care (POC) anticoagulation monitoring device. Marketing is focussed on its accuracy, convenience and efficiency in delivering a coagulation result. This study will assess the accuracy of this device in calculating the International Normalised Ratio (INR) result. This will be compared to another INR result obtained on the same sample via the current gold standard testing equipment in the Royal Infirmary Edinburgh (RIE) laboratories. The study will include patients presenting for surgery who have had their warfarin therapy stopped within the previous 7 days. Patients on warfarin therapy requiring surgery are currently identified in preoperative assessment clinics, on average 12 weeks prior to their date of surgery. Anecdotally there appears to be a difference between the 'expected' and actual INR when a POC device is used. Concern exists that patients may be inappropriately denied the potential benefits of central neural blockade (CNB) if a POC device provides a falsely high result, or conversely the investigators may be proceeding with CNB in patients with an unacceptably high INR if POC provides a falsely low result. There is also the possibility of improving hospital efficiency using this device as it provides a result much faster than the laboratory.

Official Title
-----------------
Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Micro Coagulation Instrument Compared With Laboratory Assay

Conditions
-----------------
Blood Coagulation Tests

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients presenting for elective surgery who have stopped their warfarin therapy within the last 7 days. Exclusion Criteria: Adults with incapacity
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical Patient<br>These are the results from the blood samples taken from the study participants. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The International Normalised Ratio (INR) will be measured by the laboratory assay and the Hemochron Signature Elite device. |  | 18 months |
Stocrin Re-examination Study (0831-028)

Study Overview
=================
Brief Summary
-----------------
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of STOCRIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Official Title
-----------------
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN in Usual Practice

Conditions
-----------------
HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 Infected Patient Patient Who Is Treated With Stocrin 600 Mg Tablet Within Local Label During The Enrollment Period (A Patient Who Changes The Therapy From Stocrin 200 Mg Capsule To Stocrin 600 Mg Tablet Can Be Eligible.) Exclusion Criteria: Patient Who Has A Contraindication To Stocrin According To The Local Label

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- |
| 1<br>Patients with HIV-1 infection taking Stocrin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with any adverse experience |  | Up to 14 days following cessation of treatment | 
| Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment |  | At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment | 
| Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed) |  | At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Infection
Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

Detailed Description
-----------------
Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

Official Title
-----------------
Predictive Ability of PEEP Induced CVP Changes to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery

Conditions
-----------------
Surgery, Critical Illness, Cardiac Output, Low

Intervention / Treatment
-----------------
* Procedure: PEEP increase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated and sedated patients admitted to the ICU after major abdominal surgery Exclusion Criteria: Heart failure NYHA III or more Severe obstructive or restrictive lung disease Hypotension with MAP < 60 mmHg Tachycardia > 140 beats / min

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanically ventilated patients after surgery<br>After ICU admission the patient's hemodynamics (MAP, HR, CO, PPV) will be measured in supine position. It will be remeasured after PEEP has been increased from +5 to +15 cmH20. Then the baseline measurement will be repeated. Then passive leg raise will be performed and all the parameters will be remeasured. | Procedure: PEEP increase<br>* PEEP increase +5 to +15 cmH2O. PLR at 30 degrees.<br>* Other names: Passive leg raise;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke volume increase after passive leg raise | Patients who have a stroke volume (measured in ml) increase of 7% or more after passive leg raise will be considered volume responsive. After the patients have been stratified into volume responders and volume non-responders, sensitivity and specificity of PEEP induced increase in CVP and pulse pressure variation will be assessed and further statistical analysis will be performed. | Within 30 seconds after PLR |
A Multicenter Prospective Study of High Risk Molecular Typing in Patients With Adult T Lymphoblastic Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the indicative value of high risk molecular typing in patients with adult T lymphoblastic lymphoma

Official Title
-----------------
A Multicenter Prospective Study of High Risk Molecular Typing in Patients With Adult T Lymphoblastic Lymphoma

Conditions
-----------------
T-Lymphoblastic Lymphoma/Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proved T lymphoblastic lymphoma newly diagnosed patients Exclusion Criteria: patients with biopsy samples unavailable

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 |
| --- | --- |
| tested group<br> | |
| controlled group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 3-years |
Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

Study Overview
=================
Brief Summary
-----------------
The objective of this survey was to understand the safety and efficacy of PAXIL tablets (PAXIL, hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.

Official Title
-----------------
Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with depression or in a depressed state Patients who start taking paroxetine at 20mg a day Exclusion Criteria: Patients who have been treated with paroxetine prior to this investigation Patients with hypersensitivity to paroxetine Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs Concomitant use in patients taking pimozide
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed PAXIL<br>Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period | Drug: Paroxetine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice | 12 weeks | 
| Efficacy evaluation based on overall improvement | The investigator compared the general condition over 1 week before each clinical visit with that over 1 week before the start of treatment with PAXIL. | 12 weeks | 
| Efficacy evaluation based on severity by symptoms | At every clinical visit, the investigator rated each of the specified symptoms including depressed mood, loss of interests/concerns, anxiety, lack of motivation, physical symptoms, and sleep disorders. | 12 weeks | 
| Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II) | The investigator asked each subject to fill out the self-administered form of BDI-II at every clinical visit (recommended clinical visit schedule: 1, 2, 4, 8, and 12 weeks after the start of treatment). | 12 weeks |
CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to learn if there are any changes in how blood gets to your heart muscle and if your heart size changed after your heart attack.

Official Title
-----------------
AIR-MI: Assessment of Ischemia and Remodeling Following Acute Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Technetium Tc99m Sestamibi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing primary or rescue PCI for acute MI with ECG evidence of a large territory at risk. Exclusion Criteria: History of prior MI or CABG surgery, persistent LBBB, Atrial Fibrillation, End stage renal disease, Weight > 350 lbs.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Technetium Tc99m Sestamibi|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To better understand the interactions between the abnormalities in blood supply from the small vessels of the heart to the heart muscle after a heart attack and the changes in heart size 6 months after the heart attack. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the frequency of residual ischemia as assessed by stress myocardial perfusion imaging (MPI) in patients undergoing primary PCI for AMI. |  |  | 
| To estimate the 6-month cardiac event rates (composite of death, another heart attack, hospitalization for heart failure, and irregular heart beats requiring treatment). |  |  | 
| To determine the relationship between changes (from baseline) in LV systolic volume index and LVEF, as measured by gated SPECT imaging 6 months following reperfusion, and the presence and severity of residual ischemia. |  |  | 
| To measure the performance of angiographic parameters of success of reperfusion therapy (TIMI frame count and TIMI myocardial perfusion grade) in predicting the presence of residual ischemia. |  |  |
Relationship Between Anterior Tibial Subluxation and the Prognosis of Anterior Cruciate Ligament Reconstruction.

Study Overview
=================
Brief Summary
-----------------
To identify the improvement of anterior tibial subluxation (ATS) and the relationship between ATS and patient reported outcome on pre- and postoperative anterior cruciate ligament-injured MRI images.

Detailed Description
-----------------
The value of preoperative anterior tibial subluxation (ATS) was used for the division of anterior cruciate ligament-injured patients in 2 groups. ATS was measured on pre- and postoperative MRI images. Patients were followed up 2 years after anterior cruciate ligament reconstruction, and patient reported outcomes (i.e. Lysholm score, etc.) were collected for further analysis.

Official Title
-----------------
A Prospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Reconstruction With 2-year Follow-up

Conditions
-----------------
Anterior Cruciate Ligament Injuries

Intervention / Treatment
-----------------
* Other: Different ATS values.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Diagnosed anterior cruciate ligament injuries; (2) available preoperative MRI scans at our hospital. - Exclusion Criteria: Patients were excluded in the case of under 18 years of age, bilateral anterior cruciate ligament injuries, concomitant posterior cruciate ligament injuries, concomitant collateral ligament injuries, and no access to the preoperative MRI scan at our hospital. -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Anterior cruciate ligament-injured patients with excessive ATS | Other: Different ATS values.<br>* Observational, different ATS values were measured on MRI images and were regarded as interventions for different cohorts.<br>|
| Cohort 2<br>Anterior cruciate ligament-injured patients with minimal ATS | Other: Different ATS values.<br>* Observational, different ATS values were measured on MRI images and were regarded as interventions for different cohorts.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients reported outcomes | (i.e. Lysholm score, etc.) | at least 1-year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI images | Anterior tibial subluxation were measured on postoperative MRI images | at least 1-year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior tibial subluxation