linjc16/ctgov huggingface dataset:
CArdioMetabolism and Atherosclerotic PlaqUe progreSsion

Study Overview
=================
Brief Summary
-----------------
Systematic metabolic diseases are closely related to prevalence and progression of atherosclerosis. This prospective cohort consecutively enrolls patients with coronary artery disease compliacted with metabolic abnormalities such as diabtetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.

Detailed Description
-----------------
CArdioMetabolism and Atherosclerotic PlaqUe progreSsion (CAMPUS) study is a single center, prospective cohort study to investigate the impact of cardiometabolic factors on coronary diseases. This study consecutively enrolls patients with coronary artery diseases complicatied with metabolic abnormalities, including diabetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.

Official Title
-----------------
The Impact of Cardiometabolic Factors on Coronary Artery and Cardiovascular Diseases: a Prospective Cohort Study

Conditions
-----------------
Coronary Artery Disease, Diabetes Mellitus, Type 2, Dyslipidemias, Obesity, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years Type 2 diabetes diagnosed by one of the following criteria: HbA1c >/= 6.5% Fasting plasma glucose >/= 7.0 mmol/l (confirmed) 2h plasma glucose value during OGTT >/= 11.1 mmol/l Already receiving glucose-lowering agents Prediabetes Obesity Chronic kidney disease Hyperuricemia Receiving coronary angiography for clinically suspected coronary artery disease Exclusion Criteria: Severe liver failure (Child-Pugh grade B to C) Severe anemia (hemoglobin < 60g/L) Familial hypercholesterolemia Active malignant tumor Active autoimmune diseases on corticosteroids Acute or chronic infection Life expectancy < 1 year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary plaque progression | Assessed by coronary angiography and QCA | 12 months | 
| Coronary lesion severity | Assessed by coronary angiography and QCA | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary plaque characteristics | Assessed by intravascular imaging (IVUS or OCT) | 12 months | 
| Cardiovascular events | The incidence of MACCE (major adverse cardio and cerebral vascular events), lesion associated events (target lesion myocardial infarction, target lesion faliure, target vessel revascularization, etc.) | up to 5 years |
Massive Transfusion Protocol With Coagulation Algorithm

Study Overview
=================
Brief Summary
-----------------
In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM. Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution.

Detailed Description
-----------------
In 2008 at the USZ a massive transfusion protocol was introduced. Based on laboratory diagnostics and POC (point of care) devices including ROTEM. Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution over three years (2008-2010)

Official Title
-----------------
Introduction of a Massive Transfusion Protocol - Evaluation Over Three Years

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Device: Rotational thromboelastometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Massive transfusion Exclusion Criteria: non

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 |
| --- |
|Device: Rotational thromboelastometry|In bleeding patients point of care measurements are performed, in this case Rotational Thromboelastometry (ROTEM) to guide the use of blood products and coagulation factors.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coagulation in ROTEM | Point of care devices are used in bleeding patients. In the university hospital of Zurich an algorithm in the case of massive bleeding was introduced in 2008. The primary outcome measure is to investigate the changes of ROTEM parameters in the sense of amelioration reflected by better coagulation by using goal directed transfusions. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion needs | To evaluate the blood products and coagulation factors needed and to evaluate if there is a reduction between the time before the introduction of the algorithm compared to afterwards. | 3 years |
Examination the Ability to Early Diagnose HCC by Combining Three Biomarkers Technology Developed by WAKO, And Their Relevance to Cirrhotic of Patients With Various Backgrounds and the Israeli Population.

Study Overview
=================
Brief Summary
-----------------
Examination the ability to early diagnose HCC by combining three biomarkers technology developed by WAKO, And their relevance to cirrhotic of patients with various backgrounds and the Israeli population. This blood test will serve as an additional diagnostic tool tools currently in use (Ultrasound and AFP levels) to cirrhotic patients with high risk to develop hepatocellular carcinoma. Another group that will be examined for all three biomarkers will be patients which already diagnosed with hepatocellular carcinoma, and have normal AFP level in order to examine the correlation between the presence of tumor, the number of them and the tumor size and the three biomarkers concentration in their blood

Official Title
-----------------
Examination the Ability to Early Diagnose HCC

Conditions
-----------------
Fibrosis

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic liver disease or cirrhotic or with diagnoses HCC with HCV, HBV, NAFLD, Alcohol background Exclusion Criteria: patients with chronic liver disease or cirrhotic or with diagnoses HCC with autoimmune background or other background than HCV, HBV, NAFLD and Alcohol.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cirrhotic patients<br>if positive for 3 bio-markers- will be followed by MRI for HCC diagnosis | Device: MRI<br> <br> |
| No Intervention: non cirrhotic patients<br>control group - 3 bio-markers will be measured only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of HCC in cirrhotic patients with positive values of the bio-markers by MRI |  | within 3 years from the bio-markers examination |
Avicena LVDP Validation Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.

Official Title
-----------------
Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Diagnostic Test: Non-Invasive Estimation of Left Ventricular Diastolic Pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects >21 years of age. No known significant health problems. Willing and able to participate in all study evaluations. Ability to understand and sign informed consent. Exclusion Criteria: Open skin lesions at the site of Vivio application / examination. Inability to obtain brachial artery blood pressure.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Non-Invasive Estimation of Left Ventricular Diastolic Pressure|Modified blood pressure cuff used to detect arterial waveforms used for the estimation of LVDP|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left ventricular diastolic pressure
Genetic and Immunologic Basis of COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy

Official Title
-----------------
Genetic Factors Influencing the Response to Infection With SARS-COV-2

Conditions
-----------------
Genetic Basis of COVID-19 Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Whole Exome Sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe COVID-19 infection Exclusion Criteria: Comorbidity ((DM, hypertension, Chronic liver or Kidney diseases, HIV, morbid obesity, Malignancy, Immunosuppressive therapy)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 50 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Whole Exome Sequencing|Genetic study of patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutations leading to increase susceptibility to SARS-COV-2 infection | Genetic susceptibility to COVID-19 | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-COV-2, Genetics
Specific Language Impairment (SLI) in Children May Caused by Epileptic Brain Activity

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to find if there is a possible association and the impact of epilepsy and epileptiform activity in children with SLI.

Detailed Description
-----------------
This study concentrates on the impact of epileptiform activity for childhood epilepsy on the speech and language disturbances in addition to the associated social, cognitive and intellectual dysfunctions.

Official Title
-----------------
Specific Language Impairment (SLI) in Children May Caused by Epileptic Brain Activity

Conditions
-----------------
Specific Language Impairment

Intervention / Treatment
-----------------
* Diagnostic Test: EEG was recorded by EEG Machines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 80 children were suffering from specific language impairment 80 healthy children with age and sex match control group. Exclusion Criteria: Previous history of perinatal hypoxic-ischemic damage meningitis or encephalitis motor weakness hearing disorders IQ below seventy CP, social deprivation autism and psychiatric disorders .

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 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 |
| --- | --- |
| Group 1<br>80 Patient | Diagnostic Test: EEG was recorded by EEG Machines<br>* EEG was recorded by EEG Machines<br>|
| Group 2<br>80 Control subject | Diagnostic Test: EEG was recorded by EEG Machines<br>* EEG was recorded by EEG Machines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEGs finding | EEGs finding were defined according to the followings Normal: within the range of frequency and amplitude distribution. Epileptiform: Describes transient background activity with a characteristic spikes, sharp waves, spike-slow wave or sharp-slow wave complexes of focal or generalized distribution. Abnormal non-epileptiform: deviations from normal in terms of background frequency patterns, usually in the form of excessive slow activity. | 24-48 hours |
Tissue Penetration of Antibiotics in Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate cefoxitin pharmacokinetics in obese surgical patients.

Official Title
-----------------
Tissue Penetration of Antibiotics in Obesity

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI <25 and >40 Scheduled for elective abdominal or pelvic surgery Surgical plan for intraoperative cefoxitin prophylaxis Able to provide informed consent Exclusion Criteria: Allergy to Cefoxitin Renal or Hepatic insufficiency

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 |
| --- | --- |
| Obese patients<br>Obese patients | |
| Normal weight patients and volunteers<br>Normal weight patients and volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cefoxitin Plasma Concentrations | Cefoxitin plasma concentrations | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cefoxitin Tissue Concentrations | Cefoxitin tissue concentrations | 8 hours |
Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Pancreatic cancer is the 5th leading cause of cancer death in Australia. Surgery remains the most effective treatment for early pancreatic cancer and currently the only potential for cure. Unfortunately, many patients present with advanced disease and are not suitable for surgery. Therefore, it is vital to detect these cancers early. In the absence of significant data from prospective studies, all of the guidelines are based on a critical review of available data and consensus of experts. The primary aim is to delineate the progression of IPMN to pancreatic malignancy as confirmed by surgical pathology, radiology and biochemical diagnosis. The secondary aims are (i) To outline the management of IPMNs for those who have progressed straight to surgery or surveillance by endoscopic ultrasound (EUS) (ii)To validate the International consensus guidelines for management of IPMN - Fukuoka consensus guidelines and tertiary aim to identify potential risk factors, if any that increase risk of malignancy within the IPMNs.

Official Title
-----------------
Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer

Conditions
-----------------
IPMN, Pancreatic, IPMN

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients between the age of 18 and 90 years old who have been identified with a cystic mass consistent with IPMN on imaging Exclusion Criteria: Patients who formally decline enrolment into the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who have progressed to further investigations including endoscopic ultrasound (EUS) and/or surgical intervention. |  | From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years | 
| Risk stratification for patients with IPMN into those that require more intensive screening and possibly intervention versus those that are unlikely to progress to malignancy. |  | From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cyst
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection

Study Overview
=================
Brief Summary
-----------------
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.

Official Title
-----------------
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection

Conditions
-----------------
Pressure Ulcer, Pressure Injury, Falls Injury

Intervention / Treatment
-----------------
* Device: Masimo Centroid System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age ICU patient Primarily bedbound subjects Able to be monitored for a minimum of approximately 8 hours Exclusion Criteria: Pregnancy Prisoner status Pressure injury stage 2, 3, or ungroupable Has a pacemaker or internal defibrillator Has a history of complications with a similar study Has any medical condition which in the judgment of the Investigator, renders them inappropriate for participation in this 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masimo Centroid System<br>Single-arm study. All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered. | Device: Masimo Centroid System<br>* Noninvasive positional monitoring device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability Validation of Masimo Centroid System | The number of participants enrolled to assess the usability of the Masimo Centroid System. | At least 8 hours |
Health Practice of Hemophilia Patiente Care During Pregnancy, Delivery and Newborn Children

Study Overview
=================
Brief Summary
-----------------
Prenancy and specialy delivery for hemophilia mother and her children possibly hemophilia is risked. Diagnostical of hemophilia pregnan is the first difficulty but patients with hemorrhagic menstruation without etiology known, hemorrhagic complication during a chirurgical procedure or during previously pregnancy currently are examine in Haemostasis consultation. None French recommendation specifie for health practice of these hemophilia patients exists. However, Anglo-Saxon recommendations are published in 2011. The objective of this study is to realize a French investigation of health practice about hemophilia care of these patients and to compare them with the English reference table.

Conditions
-----------------
Hemophilia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Hemophilia A or B Pregnancy between 2014 and 2016 Exclusion Criteria: - Opposition

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

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

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 |
| --- | --- | --- |
| antenatal care in pregnant women carriers of hemophilia | Frequency of Diagnosis | during pregnancy | 
| labour and delivery procedures | childbirth procedure type | day of delivery | 
| post-partum care | treatment type | day of delivery until 3 month | 
| children care | complication type | day of delivery until 3 month | 
| antenatal care in pregnant women carriers of hemophilia | description of complications | 9 month (during pregnancy) | 
| antenatal care in pregnant women carriers of hemophilia | patient follow up | 9 month (during pregnancy) | 
| labour and delivery procedures | therapeutic protocol type | day of delivery | 
| labour and delivery procedures | analgesic type | day of delivery | 
| labour and delivery procedures | blood loss measurement | day of delivery | 
| post-partum care | feeding | day of delivery until 3 month | 
| post-partum care | contraception type | day of delivery until 3 month | 
| post-partum care | time of menses returns | day of delivery until 3 month | 
| children care | hemophilia diagnostic | day of delivery until 3 month | 
| children care | treatment type | day of delivery until 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia pregnant, Hemophilia delivery, Hemophilia children