linjc16/ctgov huggingface dataset:
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)

Official Title
-----------------
Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

Conditions
-----------------
Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases

Intervention / Treatment
-----------------
* Device: Micronized Small Intestinal Submucosa (SIS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB Patient is unable to be treated by endovascular or surgical means Exclusion Criteria: Patient is pregnant or breastfeeding Patient has had a previous surgery within 30 days of the study procedure Patient has a planned surgical or interventional procedure within 30 days after the study procedure Patient has a life expectancy of less than 1 year Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue. Additional restrictions as specified in the protocol

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

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

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

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: Treatment<br> | Device: Micronized Small Intestinal Submucosa (SIS)<br>* Micronized Small Intestinal Submucosa (SIS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and types of adverse events |  | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Limb Ischemia, Amputation
Evaluation of Radiation Exposure and Risk Factors During Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the radiation exposure in patients undergoing coronary angiography, and to identify reference values for the main radiation doses parameters.

Detailed Description
-----------------
Exposure of patients to X-rays during interventional coronary procedures may have deleterious effects, including an increased risk of developing cancer.Individual justification for the procedure and its optimization are the cornerstones of dose-reduction for patients.Radiation exposure is influenced by a variety of technical and clinical factors.Few multicenter data from large populations exist concerning the radiation doses to which patients are exposed during interventional coronary procedures.The aims of this prospective, multicenter survey is to: 1) evaluate the radiation exposure in 4000 patients undergoing coronary angiography by monitoring the parameters of Air kema,fluoroscopy Dose-area product and total Dose-area product; 2) analyze factors associated with variation in radiation dose in everyday clinical practice, such as number of frames, body surface area, sex, age, BMI, arterial approach, fluoroscopy time and so on.

Official Title
-----------------
A Prospective Multicenter Case Study to Evaluate Radiation Exposure and Risk Factors in Patients During Coronary Angiography

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

Intervention / Treatment
-----------------
* Radiation: Coronary Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who need to perform coronary angiography Exclusion Criteria: Contrast medium reactions Severe cardiopulmonary insufficiency Uncontrolled severe arrhythmia Uncorrected kaliopenic, digitalism and acid-base imbalance Severe liver and renal dysfunction Hemorrhagic disease Severe infection disease Others who were unwilling to participate the study

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 |
| --- |
|Radiation: Coronary Angiography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation exposure of the patients |  | during coronary angiography procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reference values for the main radiation doses parameters |  | during coronary angiography procedure |
Monocytosis and Culprit Vessel in STEMI Patients

Study Overview
=================
Brief Summary
-----------------
Increased white blood cell count at the onset of an acute ST elevation myocardial infarction has been shown to be associated of increased incidence of heart failure and mortality. Now monocytes which are a subset of white blood cells may have a prognostic value for patients presenting with acute ST segment elevation myocardial infarction. A monocyte count of greater than 800/mm3 following acute myocardial infarction has been shown to be associated with increased incidence of left ventricular dysfunction. The investigators study would retrospectively collect data on patients with ST elevation myocardial infarction, looking for an association between high monocyte count and the culprit vessel causing the myocardial infarction. The investigators would also investigate whether monocytosis would be a marker of poor prognosis.

Official Title
-----------------
Significance of Monocytosis and Culprit Vessel in Patients With Acute ST Elevation Myocardial Infarction

Conditions
-----------------
STEMI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: STEMI Exclusion Criteria: Patients on antibiotics and steroids
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 |
| --- | --- | --- |
| Association between monocyte count and culprit vessel |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcomes of troponin and monocyte in stemi patients |  | 0 - 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
monocytes, culprit vessels
A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation.

Detailed Description
-----------------
After one drop is instilled subjects will complete a comfort assessment at 1, 3, 5, and 10 minutes after drop instillation.

Official Title
-----------------
A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft in Patients With a History of Allergic Conjunctivitis

Conditions
-----------------
Allergic Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each patient must meet the following criteria to be enrolled in this study: Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis. Have allergic ocular symptoms within the last three days. Are willing/able to follow instructions from the study investigator and his/her staff. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study: Have known hypersensitivity to either BEPREVE™ or LASTACAFT® or to any component of the test article (including procedural medications such as anesthetic and/or fluorescein drops, dilating drops, etc.). Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. Are pregnant or nursing/lactating.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bepreve<br>Subjects with a history of allergic conjunctivitis. | |
| Lastacaft<br>Subjects with a history of allergic conjunctivitis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Perioperative Endothelial Dysfunction in Patients Undergoing Minor Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
This study on minor surgery serves to explore whether a dose-response relationship exists between surgical stress and endothelial dysfunction in the early postoperative period. The aim of this explorative and observational clinical study is to closely examine the endothelial function and its dynamics in the early postoperative period after minor surgery (lap. inguinal hernia repair). The endothelial function will be assessed indirectly by EndoPat and plasma biomarkers of nitric oxide bioavailability. The study will contribute to the understanding of perioperative myocardial injury, which is crucial for optimized treatment of patients at risk of cardiovascular complications.

Detailed Description
-----------------
The investigators will include 60 patients undergoing elective inguinal hernia repair. The endothelial function will be measured before surgery and 4 hours after surgery with the EndoPat system. The NO-bioavailibility will be measured by plasma l-arginine, plasma ADMA and plasma biopterins.

Official Title
-----------------
Perioperative Endothelial Dysfunction in Patients Undergoing Minor Abdominal Surgery. The POETRY Minor Study.

Conditions
-----------------
Myocardial Injury

Intervention / Treatment
-----------------
* Procedure: Elective Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for a laparoscopic inguinal hernia repair Patients ≥ 18 years old Exclusion Criteria: Not capable of giving informed consent after oral and written information Previously included in the trial ￼￼ - Surgery within 7 days of the trial

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 |
| --- |
|Procedure: Elective Surgery|Elective laparoscopic inguinal hernia repair|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endothelial function assessed by the EndoPat system |  | At baseline and 4 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomarkers of endothelial function: plasma arginine, plasma ADMA, plasma biopterins |  | At baseline and 4 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, endothelial dysfunction, cardiovascular complications, EndoPat, myocardial injury, myocardial infarction
OAGB-MGB Conversions for Post-operative Complications

Study Overview
=================
Brief Summary
-----------------
Laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB) is a relatively new bariatric procedure and is gaining ground over the surgical approach for morbid obesity as a safe and effective operation. Revision of MGB/OAGB was never studied before as multicenter data collection: we collected data from 21 italian centers who perform MGB/OAGB to evaluate patients' conditions which determinated the conversion from this procedure to another kind of bariatric technique.

Detailed Description
-----------------
MGB / OAGB has been shown to be an effective and safe bariatric technique. Despite that, the complications of this procedure have already been extensively described in the literature. Our goal is to collect data from 21 Italian centers that practice MGB / OAGB to evaluate the reasons and complications that led surgeons to revise this surgery with a subsequent bariatric procedure. For this reason we have analyzed the data provided by the centers on 8676 patients undergoing MGB / OAGB, focusing attention on phenomena such as GERD, anastomotic stenosis, bleeding and marginal ulcers which are the most frequent causes of re-intervention. We also evaluated the changes in BMI between the primary procedure and the revision procedure to ensure that the bariatric purpose of the surgical program was maintained.

Official Title
-----------------
OAGB-MGB Conversion for Failed Procedure: a Multicenter Italian Study

Conditions
-----------------
Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Procedure: OAGB-MGB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent to OAGB-MGB who needed conversion to other bariatric procedure Exclusion Criteria: Patients underwent to OAGB-MGB who needed conversion to other bariatric procedure in emergency within 48/72 hours after the first surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: OAGB-MGB|One Anastomosis Gastric Bypass - Mini Gastric Bypass as both restrictive and malabsorptive bariatric procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for Conversion from MGB/OAGB to other bariatric procedures | We evaluated the reasons for conversion from MGB/OAGB in terms of late post-operative complications. | From 2006 to 2020 | 
| Surgical type of conversion from MGB/OAGB | We evaluated the type of bariatric revisional procedure performed in each patient underwent to MGB/OAGB | From 2006 to 2020 |
Assessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study

Study Overview
=================
Brief Summary
-----------------
We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years after myocardial infarction (MI) in primary prevention. Left ventricular ejection fraction (LVEF) is proposed as the one tool predicting sudden cardiac death after MI. Several studies have shown that impairment of spontaneous baroreflex sensitivity (BRS) after MI was predictor of sudden death.

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

Intervention / Treatment
-----------------
* Other: Baroreflex assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients implanted with an implantable cardioverter defibrillator for primary prevention of of cardiac sudden death, ischaemic cardiomyopathy Implantable cardioverter defibrillators implantation for at least 3 years Age ≥ 18 years Exclusion Criteria: ventricular or atrial pacing ≥1%, atrial fibrillation history age under 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAROREFLEX<br> | Other: Baroreflex assessment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spontaneous baroreflex sensitivity by the sequence method (mean slope) |  | 10 days |
Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among NAFLD Patients

Study Overview
=================
Brief Summary
-----------------
This study was designed to assess the relation between serum ferritin and hepatic fibrosis in patients with NAFLD. It included 83 patients with NAFLD with or without hepatic fibrosis, in addition to 30 healthy subjects included as controls. Measurement of serum ferritin and its correlation with steatosis and fibrosis was done.

Detailed Description
-----------------
Background: many studies have found a relationship between hepatic iron, serum ferritin and NAFLD or its progress. Aim of the work: is to assess the value of serum ferritin as a non-invasive marker in prediction of hepatic fibrosis in NAFLD. Methods: This study included 113 subjects who were classified into 3 groups. Group I: included 30 healthy subjects as control with no evidence of NAFLD by liver biopsy. Group II: included 31 NAFLD patients without fibrosis proved by liver biopsy. Group III: included 52 patients with hepatic fibrosis on top of NAFLD proved by liver biopsy. Serum ferritin was determined using Ferritin ELISA kit. FIB4 was calculated and liver biopsy was done for all patients.

Official Title
-----------------
Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among Non-alcoholic Fatty Liver Disease Patients

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Diagnostic Test: serum ferritin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with NAFLD with or without hepatic fibrosis Exclusion Criteria: Significant alcohol consumption, other causes of liver disease such as viral hepatitis, schistosomiasis, autoimmune, hereditary, drug induced, or decompensated liver cirrhosis.
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 |
| --- | --- |
| control group<br> | Diagnostic Test: serum ferritin<br>* serum samples and ferritin ELISA test<br>|
| NAFLD patients without hepatic fibrosis<br> | Diagnostic Test: serum ferritin<br>* serum samples and ferritin ELISA test<br>|
| NAFLD patients with hepatic fibrosis<br> | Diagnostic Test: serum ferritin<br>* serum samples and ferritin ELISA test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ferritin in patients with hepatic fibrosis on top of NAFLD | measurement of serum ferritin in patients with hepatic fibrosis on top NAFLD in comparison with normal control and simple steatosis | 1 year |
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.

Official Title
-----------------
CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients

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

Intervention / Treatment
-----------------
* Device: CentriMag Ventricular Assist System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 5 years to 16 years, inclusive Inability to wean from cardiopulmonary bypass (CPB) Exclusion Criteria: Body weight < 20 kg Severe aortic insufficiency Unrestricted intra-cardiac communications (i.e. large VSD) Pulmonary vascular resistance index (PVRI) > 10 IU Presence of DIC On hemodialysis (excluding hemofiltration) Contraindications to systemic anticoagulation Active systemic infection unresponsive to antibiotics Unresolved malignancy On other investigational VAS

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 Years

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

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

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 |
| --- | --- |
| Other: All Patients<br>All patients meeting the patient selection criteria will be treated with the CentriMag device. | Device: CentriMag Ventricular Assist System<br>* All patients will be treated with the CentriMag device for up to 30 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | In patients who recover and do not go on to transplantation or a long-term device: • Survival 30 days after removal of the CentriMag VAS or to discharge, whichever is longer. In patients who do not recover: • Ability to be removed from the CentriMag VAS and survive to induction of anesthesia for implantation of a long-term device or heart transplantation. | 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of end-organ function | Improvements in measures of end-organ function | 30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoratec Corporation