linjc16/ctgov huggingface dataset:
VERRARI - Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the influence of the rate response function of implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in patients with an ICD.

Detailed Description
-----------------
Background: Studies have shown that bradycardia and irregular heart rates may increase the incidence of ventricular arrhythmias. Regularizing the heart rate and avoiding bradycardias by rate responsive pacing may be a way to reduce these arrhythmias. This is a prospective, open-label, randomized multicenter study. Inclusion criteria: Patients with an indication for an ICD according to the AHA/ACC-guidelines who get a rate response system and have more than 5 % rate adaptive pacing during a one month screening phase may be included if they have given written informed consent. Rate adaptive pacing must not be contraindicated, patients must be able to perform a 6 min walk test, must not be NYHA IV and should have a life expectancy of more than 18 months. Patients will be randomly assigned to 6 months of rate responsive pacing followed by 6 months of no rate responsive pacing, vice versa respectively. At 6 and 12 months follow ups, ICD stored data, arrhythmic episodes, medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry will be evaluated and compared.

Official Title
-----------------
VERRARI - Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?

Conditions
-----------------
Ventricular Fibrillation

Intervention / Treatment
-----------------
* Device: ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for an ICD according to ACC/AHA guidelines ICD with rate response function implanted at least 5% rate response ventricular pacing during the one month screening phase signed informed patient consent Exclusion Criteria: rate responsive pacing contraindicated patient not able to perform 6 min walktest heart failure NYHA IV life expectancy below 18 months

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ICD|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of ventricular arrhythmias at 6 and 12 months follow ups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups, |  |  |
Effects of Joint Effusion on Quadriceps Muscle

Study Overview
=================
Brief Summary
-----------------
The present study investigated whether the presence of fluid in the joint affected peak torque and the root mean square (RMS) values of surface electromyography (EMG) in patients symptomatic for osteoarthritis (OA).

Detailed Description
-----------------
Several studies have shown that knee effusion influenced quadriceps muscle activity and induced quadriceps arthrogenic muscle inhibition in normal volunteers. However, the effect of joint effusion on the quadriceps of patients with OA is controversial,and few patients with OA have been included in studies of joint effusion.

Official Title
-----------------
Effects of Joint Effusion on Quadriceps Muscle in Patients With Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: normal saline injection
* Other: sham injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 years old or older with knee osteoarthritis knee pain without joint effusion confirmed by ultrasonography Exclusion Criteria: the presence of knee joint effusion determined using US a history of knee injury or surgery a history of knee injection within 3 months a history of inflammatory arthritis taking anticoagulants balance or gait disturbance diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal saline injection<br>20 cc normal saline injection into the knee joint | Other: normal saline injection<br>* 20 cc normal saline injection into knee joint<br>* Other names: normal saline;|
| Sham Comparator: sham injection<br>knee injection without saline | Other: sham injection<br>* no saline injection<br>* Other names: no normal saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the peak torque of the knee extensors | to evaluate the effect of effusion on the peak torque of the knee extensors | within 5 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the root mean square values of the vastus medialis and vastus lateralis muscles | to evaluate the effect of effusion on the RMS of the vastus medialis (VM) and vastus lateralis (VL) muscles | within 5 minutes after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, Osteoarthritis, Effusion.
Relationship Between STOP BANG Score and Airway Management

Study Overview
=================
Brief Summary
-----------------
Nowadays, anesthetists may encounter many patients who are not diagnosed with obstructive sleep apnea syndrome (OSAS) to undergo elective surgery. Recognition of these patients by anesthesiologists and taking necessary precautions will significantly reduce perioperative complications and mortality. STOP-BANG is a questionnaire used to predict high risk of OSAS. The aim of our study is to evaluate the clinical use of the oxygen reserve index as an early warning of possible desaturation in patients with low and high risk of OSAS according to the Stop Bang score.

Official Title
-----------------
Evaluation of Relationship Between Oxygen Reserve Index and Difficult Airway With Stop Bang Score

Conditions
-----------------
Hypoxia, Airway Obstruction, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) I-III Between 18-65 years old Volunteered to participate in the study Exclusion Criteria: diagnosed with asthma, COPD, heart failure or coronary artery disease, OSAS morbidly obese (BMI>45 kg/m2), patients with a history of alcohol or drug addiction women in pregnancy or lactation allergic to the drugs used in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 D<br>STOP BANG Score <3 | Procedure: intubation<br>* Endotracheal tube placement<br>|
| Group Y<br>STOP BANG Score ≥ 3 | Procedure: intubation<br>* Endotracheal tube placement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Oxygenation | prediction of desaturation by oxygen reserve index in patients with low and high risk of OSAS | up to intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of difficult Airway | using mask-ventilation scale in patients with low and high risk of OSAS | up to intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxygen Reserve Index, STOP BANG Score, Difficult Airway
Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data

Study Overview
=================
Brief Summary
-----------------
In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to obtain 30 days of glucose measurements from 30 people with diabetes treated with insulin. The purpose of this study is to characterize glycemia (glucose) control in 30 people without diabetes and to compare these data to the 30 people with diabetes from a previous study. Through this approach it may be possible to develop a means of establishing a model of normal glucose patterns and a basis of comparison with glucose patterns in people with diabetes.

Official Title
-----------------
Observational Study of Interstitial Glucose Monitoring With the FreeStyle Navigator CGM System to Develop Novel Methods for Displaying, Reporting and Analyzing CGM Data for Clinical Decision-Making: Phase 2-Establishing Ambulatory Glucose Profiles for Individuals Without Diabetes

Conditions
-----------------
NonDiabetes, Glucose Variability, CGM

Intervention / Treatment
-----------------
* Device: CGM System for Type 1 and Type 2 Diabetes Mellitus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Within normal range for two hour OGTT glucose level (<140 mg/dl) Within normal range for fasting glucose level (<100 mg/dl) Within normal range for total insulin level as measured by radioimmunoassay BMI <30kg/m2 Age 21-75 years of age, inclusive (15 subjects in the 21-49 years of age group, 15 subjects in the 50-75 years of age group) Willing to give informed consent Capable of following the protocol and instructions of study staff Available for scheduled visits Access to telephone communications Exclusion Criteria: Under 21 years of age or over 75 years of age Abnormal OGTT Previous history of diabetes Outside of normal insulin range BMI > 30kg/m2 Unable to follow protocol Unable to read and write in English Skin abnormalities at insertion sites Allergy to adhesives Any concomitant medical condition that would likely affect the evaluation of device performance Taken prednisone or cortisone medications in the previous 30 days Blood transfusion within the past 90 days Blood donation within the past 30 days Metabolic syndrome (NCEP ATP III guidelines) Any medical condition that would affect glucose (per investigator decision)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CGM System for Type 1 and Type 2 Diabetes Mellitus|nan|

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
-----------------
CGM, NonDiabetes
Acute Haemodynamic Effects of Peritoneal Dialysis as Evaluated by Sphygmocor Technology

Study Overview
=================
Brief Summary
-----------------
Subjects with peritoneal dialysis are randomized to different groups. The different groups receive different intra-abdominal volumes and different glucose-concentrations. The effects on blood pressure and other cardiovascular parameters (e.g. central blood pressure, augmentation index, ...) will be evaluated.

Official Title
-----------------
Acute Haemodynamic Effects of Peritoneal Dialysis as Evaluated by Sphygmocor Technology

Conditions
-----------------
Peritoneal Dialysis

Intervention / Treatment
-----------------
* Procedure: Different abdominal volumes and different glucose-concentrations during peritoneal dialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with peritoneal dialysis Aged 18-80 years

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Different abdominal volumes and different glucose-concentrations during peritoneal dialysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  |  |
Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the incidence and impact of brain lesions in MRI after coiling and clipping of unruptured intracranial aneurysms on clinical and neurological outcome of patients.

Detailed Description
-----------------
Silent ischemic lesions after treatment of unruptured intracranial aneurysm (UIA) might alter patients' clinical and neurological outcome. Furthermore silent brain lesions are not well documented after endovascular and surgical treatment of unruptured intracranial aneurysms. Therefore, the investigators investigate the incidence and influence of treatment-related ischemic lesions in magnetic resonance / diffusion-weighted-imaging after endovascular and surgical treatment of UIA.

Official Title
-----------------
Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms: Incidence and Influence on Clinical Outcome in a Prospective Study.

Conditions
-----------------
Unruptured Intracranial Aneurysms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis and treatment of unruptured intracranial aneurysm age ≥ 18 yrs written informed consent by patients prior to study participation willingness to participate in follow-up Exclusion Criteria: ruptured intracranial aneurysm contraindication for MRI Participation in an intervention-/AMG-study

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of
Transseptal Italian Registry (TITLE)

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about the changing over the time of transseptal (TSP) catheterization for catheter ablation of arrhythmias in the left heart. This study aims to investigate if auxiliary tools for TSP catheterization improved the safety and efficacy.

Detailed Description
-----------------
Data regarding transseptal catheterization in the Centers involved will be retrospectively collected over the past 10 years. Will be collected: 1) patients characteristics type of procedure requiring transseptal catheterization success rate adverse events use of tools for transseptal catheterization: intracardiac echocardiography (ICE) guidance simplified transseptal puncture pig tail catheter safe sept guidewire powered radiofrequency transseptal needle

Official Title
-----------------
Transseptal Catheterization Registry. An Italian Overview

Conditions
-----------------
Arrhythmia, Cardiac Disease

Intervention / Treatment
-----------------
* Procedure: transseptal catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation) Exclusion Criteria: patients with learning disabilities

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 |
| --- | --- |
| transseptal catheterization performed without auxiliary tools<br>patients in whom transseptal catheterization have been performed without auxiliary tools | Procedure: transseptal catheterization<br>* puncture of interatrial septum at the level of fossa ovalis, using transseptal needle.<br>* Other names: transseptal puncture;|
| transseptal catheterization performed with auxiliary tools<br>patients in who transseptal catheterization have been performed with the use of auxiliary tools | Procedure: transseptal catheterization<br>* puncture of interatrial septum at the level of fossa ovalis, using transseptal needle.<br>* Other names: transseptal puncture;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events related to inadvertent puncture cardiac structures other than atrial septum | absence of adverse events related to transseptal catheterization | Procedure time | 
| Accomplishment of transseptal catheterization and electrophysiology procedure requiring transseptal catheterization | accomplishment fo transseptal catheterization | Procedure time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Catheter ablation, Transseptal catheterization
Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This study is a multi-center, prospective, self-controlled study, to evaluate the feasibility of targeted axillary lymph node resection (TAD) guided by tissue marker clip with methylene blue single tracer after neoadjuvant chemotherapy in T1-4N1M0 breast cancer patients. Evaluate the accuracy and false negative rate of TAD, comparing with sentinel lymph node biopsy, and explore a new axillary-preserving mode after neoadjuvant chemotherapy for breast cancer.

Official Title
-----------------
Targeted Resection of Axillary Metastatic Lymph Nodes Guided by Tissue Marker Clip After Neoadjuvant Chemotherapy for Breast Cancer: a Multicenter, Prospective and Self-controlled Study

Conditions
-----------------
Breast Cancer, Surgery, Lymph Node Metastases

Intervention / Treatment
-----------------
* Device: Tissue Marker Clip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer with axillary lymph node metastasis confirmed by puncture pathology (T1-3N1M0) accord with the indications of neoadjuvant chemotherapy for breast cancer informed consent has been signed Preoperative anesthesia assessment is low to medium risk (ASA score) Exclusion Criteria: There are absolute and relative contraindications of chemotherapy Refuse surgery or can't tolerate surgery Unable to cooperate or unwilling to place Marker Pregnant women Do not have full capacity for behavior, such as mental patients, drug dependence, anxiety and so on Diabetes patients who are difficult to control Excessive smokers high risk of anesthesia Any serious complications are not suitable for patients participating in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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: TAD ARM<br> | Device: Tissue Marker Clip<br>* Tissue Marker Clip Placed in Metastatic Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False negative rate (FNR) of targeted axillary lymph node resection | False negative rate (FNR) of targeted axillary lymph node resection of breast cancer with methylene blue single tracer after neoadjuvant chemotherapy for T1-3N1M0 breast cancer | Up to 60 months |