linjc16/ctgov huggingface dataset:
Effect of Mechanical Ventilation on the Incidence of Pneumothorax After Subclavian Vein Catheterization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether mechanical ventilation influences the incidence of pneumothorax after subclavian venous catheterization.

Conditions
-----------------
Subclavian Vein Catheterization

Intervention / Treatment
-----------------
* Other: Lungs were not mechanically ventilated during subclavian vein catheterization
* Other: Lungs were mechanically ventilated during subclavian vein catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients undergoing neurosurgery that requires the placement of subclavian venous catheterization Exclusion Criteria: infection over the puncture site history of prior clavicular fracture anatomical anomaly of subclavian vein Pneumothorax

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventilated group<br>Lungs were mechanically ventilated during subclavian vein catheterization. | Other: Lungs were mechanically ventilated during subclavian vein catheterization<br>* Ventilated group<br>|
| Active Comparator: Control group<br>Lungs were not mechanically ventilated during subclavian vein catheterization. | Other: Lungs were not mechanically ventilated during subclavian vein catheterization<br>* Control group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pneumothorax | Postoperative chest X-ray will be taken to check for the occurence of pneumothorax. | an expected average of one day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catheterization success rate |  | an expected average of one day after surgery |
Improving Informed Consent Process for Trauma Patients in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing trauma patients in emergency department (ED) about risks, benefits, and alternatives to receiving surgery.

Official Title
-----------------
Improving Informed Consent Process for Trauma Patients in the Emergency Department

Conditions
-----------------
Trauma, Surgery

Intervention / Treatment
-----------------
* Other: video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older scheduled to receive the surgery Exclusion Criteria: clinically unstable refuse to participate unable to understand the consent process for 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: video<br>Participants in the intervention group watched an educational video illustrating informed consent information | Other: video<br>* The videos will be developed and contain information on the procedure, risks, benefits, and alternatives of the surgery. The knowledge measure instrument will also be developed.<br>|
| No Intervention: control<br>Participants in the control group read an informed consent document. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge score | The primary outcome, patient understanding of the procedure, risks, benefits, and alternatives, will be determined by quantitative scores on the written examination | immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction | Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale. | immediately after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma, surgery, informed consent
Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial

Study Overview
=================
Brief Summary
-----------------
This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.

Official Title
-----------------
Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial

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

Intervention / Treatment
-----------------
* Procedure: Surgical revascularization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stable angina, unstable angina or NSTEMI candidate to CABG Significant LAD and/or LM lesion - proved by FFR or Angiography AND At least one more, angiographycally intermediate lesion Exclusion Criteria: Significant valvular disease with indication to surgical replacement Severe left ventricular dysfunction (EF<35%) Acute STEMI Atrial fibrillation, if Maze procedure is planned

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angio-guided arm<br>In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy. | Procedure: Surgical revascularization<br>* The final intervention (surgical revascularization) will be the same for both arms.<br>|
| Experimental: FFR-guided arm<br>In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy. | Procedure: Surgical revascularization<br>* The final intervention (surgical revascularization) will be the same for both arms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of occluded bypass grafts |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a) Lenght of hospital stay; b) Changes in surgical strategy: i.e. open-chest surgery vs. mini-thoracotomy; extensive surgery versus minimal invasive approaches. |  | participants will be followed for the duration of hospital stay, an expected average of 3-4 weeks |
Efficacy and Safety of Lumen Apposing Metal Stents

Study Overview
=================
Brief Summary
-----------------
Endoscopic ultrasonography (EUS) has revolutioned the management of gastroenterological patients and is acquiring an increasingly important role. The development of specifically designed stents has significantly increased the technical and clinical success rate of the EUS-guided procedures, considerably reducing the rate of adverse events. Currently EUS has a prominent role in drainage of peripancreatic fluid collections and it represents an important therapeutic option for patients with distal malignant biliary obstruction, in which the ERCP fails, allowing the positioning of a transgastric or transbulbar lumen apposing metal stent (LAMS) to drain the biliary duct. Moreover, the EUS-guided gallbladder drainage of patients with high surgical risk and acute cholecystitis, which cannot be operated, is another important therapeutic indication. Our aim is to perform a multicentre retrospective analysis of all types of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of LAMS in order to evaluate the rate of technical and clinical success and to assess the safety profile of these procedures.

Official Title
-----------------
Efficacy and Safety of Lumen Apposing Metal Stents: a Retrospective Multicentre Study

Conditions
-----------------
Biliary Obstruction

Intervention / Treatment
-----------------
* Device: Lumen apposing metal stent (LAMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Patients with distal malignant common bile duct obstruction with failed ERCP Patients with symptomatic peripancreatic fluid collections Patients with acute cholecystitis who are unfit for surgery Agree to receive follow up phone calls Able to provide written informed consent Exclusion Criteria: Coagulation and/or platelets hereditary disorders. Pregnant women Inability to sign the informed consent

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: Lumen apposing metal stent (LAMS)|Stent positioning|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the rate of technical and clinical success of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of lumen apposing metal stents |  | 6 years |
Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment

Study Overview
=================
Brief Summary
-----------------
The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting). However, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. Furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment. There is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.

Official Title
-----------------
Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment

Conditions
-----------------
Chronic Limb Ischemia

Intervention / Treatment
-----------------
* Procedure: Explantation of the femoro-popliteal arterial segment from the amputed limb


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age > 18 years old Men and women Patient with chronic limb ischemia that is scheduled for transfemoral amputation in the University Hospital of Strasbourg Patient giving his -non-opposition to the explantation and use of the femoro-popliteal arterial segment Exclusion criteria: Refusal to give his consent Impossibility to give clear information to the patient Pregnant and breastfeeding women Patient under administrative protection

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: Explantation of the femoro-popliteal arterial segment from the amputed limb|Explantation of the femoro-popliteal arterial segment from the amputed limb|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analysis of the arterial structure in micro-CT. | study precisely the pathological structure of the femoro-popliteal arterial segment in AOMI, both in imaging and histologically. | 3 years |
Anxiety Depression and Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Anxiety and depression are highly prevalent in people with rheumatoid arthritis (RA).This study is to investigate the effect of anxiety and depression on treatment response in people with RA using observational longitudinal study design.

Official Title
-----------------
The Effect of Anxiety and Depression on Treatment Response in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: Anxiety or depression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People diagnosed with rheumatoid arthritis according to the American College Rheumatology (ACR) criteria 2010 Exclusion Criteria: none

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 |
| --- | --- |
| Anxiety or depression<br> | Other: Anxiety or depression<br>* The presence of anxiety or depression measured by the Hospital Anxiety and Depression Scale (HAD)<br>|
| Non-anxiety or depression<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission | Clinical remission defined by the Disease Activity Score 28 (DAS28) with a score less than 2.6 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, Depression, Anxiety
Remote Brain Microhaemorrhages May Predict Haematoma in Glioma Patients Treated With Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
the study aim to evaluate the prevalence of cerebral remote microhaemorrhages (RMH) and remote haematomas (RH) using magnetic resonance susceptibility-weighted imaging (SWI) among patients treated for gliomas during follow-up.

Official Title
-----------------
Remote Brain Microhaemorrhages May Predict Haematoma in Glioma Patients Treated With Radiation Therapy

Conditions
-----------------
Glioma

Intervention / Treatment
-----------------
* Diagnostic Test: Cere


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glioma Exclusion Criteria: -

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 |
| --- |
|Diagnostic Test: Cere|Magnetic Rseonance imaging for brain tumour follow-up|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of microhaemorrhages (RMH) on magnetic resonance imaging |  | one year | 
| number of remote haematomas (RH) on magnetic resonance imaging |  | one year |
Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive pulmonary disease (COPD) and lung transplant recipients is described and will be correlated with clinical findings in order to described small airway remodelling in these patients.

Detailed Description
-----------------
In early phases of COPD, changes in small airway characteristics may develop. Elastin decay and matrix remodelling could be responsible for these changes. Using CLME changes of in the bronchiolar wall and alveolar ducts can be visualized, described and measured. In lung transplant recipients, CMLE will be performed to distinguish characteristics of distal airways in stabile patient in contrast to patients with bronchiolitis obliterans syndrome. In both groups data will be correlated with CT findings, pulmonary function tests and anatomopathological results.

Official Title
-----------------
Confocal Laser Micro-endoscopy: New Insights in COPD and Lung Transplant Recipients

Conditions
-----------------
Lung Transplantation, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referral for bronchoscopic investigation/sampling informed consent signed recent spirometric data Exclusion Criteria: sedated and/or ventilated patients patients on ICU patients under oral anticoagulation co-existing lung disease acute infectious pulmonary disease

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD<br>COPD Gold class 1-4 | |
| Transplant<br>Lung transplant recipients | |
| Control<br>Patients with normal spirometric data | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphometry | morpohometrical analysis at different time point after lung transplantation | 90 - 180 - 360 - 540 - 720 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | bleeding, pneumothorax, pleuritic chest pain during procedure | 90 - 180 - 360- 540- 720 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Confocal Laser Scanning Microendoscopy, Small airways, COPD, Lung transplantation
Exercise Study Including Patients With Hypertrophic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with HCM, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with HCM.

Official Title
-----------------
A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy

Conditions
-----------------
Cardiomyopathy, Hypertrophic

Intervention / Treatment
-----------------
* Behavioral: stop exercising


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 - 80 years old. Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) > 13 mm in any wall segment. Exercise £ 30 minutes, 1 day per week for the previous 3 months. Agreement to be a participant in the study protocol and willing/able to return for follow-up. Exclusion Criteria: History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia). Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy. Less than 3 months post septal reduction therapy (surgery or catheter based intervention). Hypotensive response to exercise (> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure). Pregnancy. ICD placement in last 3 months or scheduled. Life expectancy less than 12 months. Inability to exercise due to orthopedic or other non-cardiovascular limitations.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: stop exercising|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in ability to perform activities and tasks. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in heart size and function and quality of life (QOL). |  | 4 months |