linjc16/ctgov huggingface dataset:
Opioid-potentiated Volative Anaesthetic Vs. Remifentanil And Propofol During Abdominal Aortic Aneurysm Surgery

Study Overview
=================
Brief Summary
-----------------
Comparing 2 different anaesthetic methods during abdominal aortic aneurysm surgery. The patients will be followed up 30 days postoperative. Number of patients included will be 200. Perioperative details will be analyzed.

Official Title
-----------------
Opioid-potentiated Volative Anaesthetic(Sevoflurane)Compared to Remifentanil and Propofol During Abdominal Aortic Aneurysm Surgery

Conditions
-----------------
Aortic Diseases, Abdominal, Aneurysm, Surgery

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are planned for open, elective abdominal aortic aneurysm surgery. ASA group 1-4. Exclusion Criteria: Patients below 18 years. Patients who are included in other pharmaceutical studies. Opioids-, benzodiazepins-, antiepileptic drugs-, alcohol- and α2-agonists abuse. Pregnant and breastfeeding women. Patients with familiar history of malignant hyperthermia. Patients with known hypersensitivity for opioids, propofol or volative anaesthetics. Patients with considerable arrythmia (atrial fibrillation /atrial flutter is acceptable). Uncontrolled hypertension, serious psychiatric disease. Patients with unstable angina pectoris or myocardial infarction last month before inclusion. Acute abdominal aortic surgery. Acute dissection or rupture. Planned laparoscopic abdominal aortic aneurysm surgery.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Propofol<br>* Infusion intravenously (IV) 0-10 mg/kg/h<br>|
| Active Comparator: 2<br> | Drug: Sevoflurane<br>* 0,7-1,5 MAC<br>|

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
-----------------
propofol, Anaesthesia, Sevoflurane, Abdominal, Aortic, Aneurysm
Lutonix Global SFA Registry

Study Overview
=================
Brief Summary
-----------------
The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.

Official Title
-----------------
A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: Lutonix Drug Coated Balloon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant female ≥18 years of age; Rutherford Clinical Category ≤ 4; Patient is willing to provide 5-year informed consent and comply with the required follow up; Stenotic or obstructive vascular lesions of the femoropopliteal artery; Lesion(s) can be treated with available LUTONIX Drug Coated PTA Dilatation Catheter device size matrix per current IFU; At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter). Exclusion Criteria: Patient is currently participating in an investigational drug or device study; Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; Pregnant or planning on becoming pregnant or men intending to father a child; Rutherford Class > 4 Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion

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 |
| --- | --- |
| Lutonix Drug Coated Balloon<br>Paclitaxel coated ballooncatheter | Device: Lutonix Drug Coated Balloon<br>* Subject will receive treatment with the Lutonix Drug Coated Balloon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Target Lesion Revascularization (TLR) | Efficacy: Freedom from TLR at 12 months. | 12 months | 
| Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death | Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death | 30 days |
Can Frailty Inform the Management of Hypertension in Older People?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate in large scale routine primary care data whether frailty is a prognostic factor for relevant outcomes in the management of hypertension in older people and whether frailty causes effect modification of the association of blood pressure or blood pressure lowering treatment and outcomes in older people.

Detailed Description
-----------------
A retrospective cohort study used linked electronic health records from the Welsh Secure Anonymised Information Linkage (SAIL) databank. All patients had hypertension in the absence of established cardiovascular disease, and were over the age of 65 years in 2007. Systolic blood pressure and frailty, measured using the electronic frailty index were recorded. Patients were followed up for ten years. Time to event analysis measured first ever major adverse cardiovascular or cerebrovascular event (MACCE), all-cause mortality and injurious falls. Adjustment was made for established cardiovascular risk factors.

Official Title
-----------------
Is Frailty a Prognostic Factor for Relevant Outcomes in the Management of Hypertension in Older People, and is There Evidence That the Association of Blood Pressure and Outcomes is Different in the Context of Frailty?

Conditions
-----------------
Hypertension, Frailty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient registered with a general practitioner contributing to SAIL database for at least 1 year Patient with blood pressure measured and recorded at any time after 1st January 2007 and before 1st January 2008, was used as the individual's index start date. Patient aged 65 years or older at the time of study entry. Exclusion Criteria: Patient did not have a diagnosis of hypertension or did not have blood pressure meeting criteria for hypertension; Patient had an established history of cardiovascular disease (previous stroke, heart failure or myocardial infarction) prior to the start date.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Major adverse cardiovascular and cerebrovascular events | Myocardial infarction; stroke; new diagnosis of heart failure; cardiovascular death | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Death from any cause | 10 years | 
| Injurious falls | Fall leading to fracture of bone and hospital admission | 10 years |
Aerobic Fitness in Overweight and Obese Individuals

Study Overview
=================
Brief Summary
-----------------
Oxyjun is known for improving cardiovascular endurance. Overweight and obese individuals are at increased risk of cardiovascular complications. To lower the risk, these individuals need to remain physically active with acceptable aerobic fitness. Hence, the objective of the study is to investigate the effect of Oxyjun on aerobic fitness in physically active overweight and obese individuals. All subjects in the study will be tested for maximum aerobic capacity , body composition, and serum biomarker for fitness.

Official Title
-----------------
A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.

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

Intervention / Treatment
-----------------
* Dietary Supplement: Oxyjun
* Dietary Supplement: Pacebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index ≥ 25 - ≤ 34.9 kg/m2. Waist Circumference ≥ 80 cms. Non-smoker. BP ≤ 140/90 mm Hg FBS ≤ 125 mg/dl Hb ≥ 11 g/ dl Can abstain from strenuous exercise and alcohol for at least 48 hours. Can abstain from caffeine for at least 24 hours. Exclusion Criteria: Participants with history of regular (≥2 times a week) structured exercise (gym, walking, yoga, etc). Inter-arm blood pressure is ≥10 mm Hg. Known cases of type II Diabetes Mellitus. Known cases of hypertension with or without anti-hypertensive medication. Visual or balance problems, or who cannot walk on a treadmill without using the handrails.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxyjun<br>Oxyjun- 400 mg OD after breakfast | Dietary Supplement: Oxyjun<br>* Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.<br>|
| Placebo Comparator: Methyl Crystalline Cellulose<br>Methyl Crystalline Cellulose- 400 mg OD after breakfast | Dietary Supplement: Pacebo<br>* Methyl Crystalline Cellulose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals | Measured by change in VO2 max | From baseline to Day 56 |
Refractory IHCA and OHCA Treated With ECMO

Study Overview
=================
Brief Summary
-----------------
Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted the potential early application of this method in improving the prognosis of prolonged cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the cause of CA and waiting for the recovery of the injured myocardium. The investigators have created a flow-chart to decide which patients are eligible. The aims of this study are to evaluate if, with this flow-chart, the investigators are able to detect which patients have more probability of survival.

Official Title
-----------------
Refractory In and Out of Hospital Cardiac Arrest Treated With Extracorporeal Membrane Oxygenation. Observational, Single Centre, Prospective Study.

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Procedure: ECMO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18-75 years old In and out of hospital Witnessed Cardiac Arrest No-flow time < 5 min. or VF,VT,TP as rhythm of presentation Low-flow time < 45 min. End Tidal CO2 > 10 after 20 min.of CPR Exclusion Criteria: Comorbidities such: Terminal Malignancy Aortic Dissection Severe Cardiac Failure without transplant indication Severe Aortic Valve Failure Known Severe Peripheral arteriopathy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extracorporeal Membrane Oxygenation<br>All patients have to start ECMO under CPR, by insertion of peripheral VA cannulas. | Procedure: ECMO<br>* Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days survival |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic recovery | Neurologic recovery defined as minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2. | 28 days | 
| Cardiac recovery | Measured by echocardiography | 28 days | 
| Six months survival with minimal neurologic impairment | survival with minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2. | 180 days |
Mixed Venous Oxygen Saturation From Central Venous Line, Venous Side of Heart Lung Machine and the Pulmonary Artery

Study Overview
=================
Brief Summary
-----------------
This study was designed to examine if venous saturations from the central venous line and from the venous side of the heart lung machine are interchangeable or not with mixed venous saturation from the pulmonary artery in children undergoing open heart surgery for correction of various congenital heart defects.

Detailed Description
-----------------
Forty children aged from 1-15 years undergoing correction for different congenital heart procedures with cardiopulmonary bypass [CPB] were included in this study. Simultaneous samples were taken from the central venous line, pulmonary artery, and from venous side of the heart lung machine. Samples were taken after 10 minutes on full CPB and at the end of surgery before end of CPB. Bland and Altman plots were used to study the agreement between venous saturations.

Official Title
-----------------
Are Venous Saturations From the Central Venous Line, Venous Side of the Heart Lung Machine Interchangeable or Not With Mixed Venous Saturation From the Pulmonary Artery in Children Undergoing Open Heart Surgery?

Conditions
-----------------
Heart Defects, Congenital

Intervention / Treatment
-----------------
* Other: venous saturations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children in the age from 1-15 years undergoing correction for congenital heart defects with cardiopulmonary bypass Exclusion Criteria: Any chest renal or hepatic problems

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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 |
| --- | --- |
| venous saturations<br>venous saturations from the central venous line, venous side of the heart lung machine and from the pulmonary artery | Other: venous saturations<br>* Samples of venous saturations from the central venous line (CVP), from venous side of the heart lung machine and from the pulmonary artery were taken at 10 min after being on CPB and after correction of the cardiac defects.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bland and Altman Analysis was used to plot the difference in mixed oxygen saturation | The agreement between these samples from the central venous line, venous side of the heart lung machine and from the pulmonary artery were done using bland and Altman Analysis | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mixed venous saturation, open heart surgery, children
Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology

Study Overview
=================
Brief Summary
-----------------
Abnormal cervical cytology was the most common reason for women being referred to the colposcopy unit. We prospectively included the women with negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive High RiskHPV test other than HPV 16 or HPV 18. Comparing the immediate colposcopy findings among women with High Risk HPV other than HVPV16/18 and negative cytology and determine positive predictive values for CIN2+ of other high risk HPV genotypes

Official Title
-----------------
Immediate Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology

Conditions
-----------------
Human Papillomavirus Infection

Intervention / Treatment
-----------------
* Other: Colposcopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive HrHPV test other than HPV 16 or HPV 18 Exclusion Criteria: Previous diagnosis for cervical cancer Previous diagnosis for vaginal cancer Previous diagnosis for cervical dysplasia Previous diagnosis for ASCUS previous history of cervical conisation or hysterectomy previous history ofhysterectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective cohort study comparing the immediate colposcopy findings among women with HrHPV other than HVPV16/18 and negative cytology
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Other High Risk HPV Positivity<br>Colposcopy performed to women with High risk HPV positive ,negative for intraepithelial lesions or malignancy cytology | Other: Colposcopy<br> <br> |
| Active Comparator: HPV16/18<br>Colposcopy performed to women with HPV 16/18 positive ,negative for intraepithelial lesions or malignancy cytology | Other: Colposcopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysplasia | Pathologic diagnosis of cervical dysplasia | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Papilloma Virus, negative for intraepithelial lesions or malignancy, HPV16, HPV18
Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions. A total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the PMS more precisely. At the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.

Official Title
-----------------
A Multi-centre, Open Label, Observational, Non-interventional, Post Marketing Surveillance to Evaluate Safety and Effectiveness During Long-term Treatment With Tresiba® (Insulin Degludec) in Patients With Diabetes Mellitus Requiring Insulin Therapy Under Normal Clinical Practice Conditions

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin degludec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment Exclusion Criteria: Patients who are or have previously been on Tresiba® therapy Patients who have previously been participating in this PMS
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tresiba® users<br> | Drug: insulin degludec<br>* Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AEs (Adverse Events) by preferred term |  | During 3 years of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AEs (Adverse Events) by preferred term |  | During 6 months of treatment | 
| Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term |  | During 6 months of treatment | 
| Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term |  | During 3 years of treatment | 
| Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term |  | During 6 months of treatment | 
| Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term |  | During 3 years of treatment | 
| Incidence of severe hypoglycaemia |  | During 6 months of treatment | 
| Incidence of severe hypoglycaemia |  | During 3 years of treatment |