linjc16/ctgov huggingface dataset:
Prediction of Hypotension During Beach Chair Position Using Pleth Variability Index

Study Overview
=================
Brief Summary
-----------------
The beach chair position for shoulder operation induces hypotension during general anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia. Masimo is a pulse oximetry which shows pleth variability index noninvasively. The pleth variability may predict the hypotension during beach chair position.

Detailed Description
-----------------
The beach chair position for shoulder operation induces hypotension during general anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia. Masimo is a pulse oximetry which shows pleth variability index noninvasively. The investigators put the masimo probe before general anesthesia and recorded the values before and after beach chair position, The values include arterial pressure, heart rate, blood pressure, perfusion index, pleth variability index. The primary end point was the predictive value and threshold or pleth variability index for hypotension induced by the beach chair position. The occurrence of hypotension was counted by using vasopressor. The use of vasopressor was performed when mean blood pressure less than 65 mmHg or 20% of baseline. The investigators planned to recruit 57 patients.

Official Title
-----------------
Pleth Variability Index Predicts Hypotension in Beach Chair Position in Mechanically Ventilated Adults During General Anesthesia

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Device: Pleth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective shoulder surgery under general anesthesia Exclusion Criteria: right heart failure morbid obesity (BMI > 30) arrhythmia on preoperative electrocardiography pulmonary hypertension peripheral vascular disease or pulmonary disease pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Pleth<br>The masimo probe is attached on the index fingertip and cover with black cover in all patients. Record the pleth variability index and blood pressure | Device: Pleth<br>* apply the masimo probe on index fingertip and record the pleth variability and blood pressure during beach chair position<br>* Other names: Masimo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of hypotension defined as mean blood pressure less than 65 mmHg or 20% of baseline | hypotension occurs or not after beach chair position and hypotension was defined as mean blood pressure less than 65 mmHg or 20% of baseline | 10 minutes after beach chair position |
Venous Site for Central Catheterization

Study Overview
=================
Brief Summary
-----------------
Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites. The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.

Official Title
-----------------
Comparison of Subclavian, Femoral and Internal Jugular Venous Catheterization in Term of Complications in the Intensive Care Unit: a Randomized Controlled Trial

Conditions
-----------------
ICU, Critical Care, Catheterization

Intervention / Treatment
-----------------
* Procedure: Randomization of the site for catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted in the Intensive Care Unit Requiring Central Venous Catheterization Exclusion Criteria: Patients with only one site available

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subclavian catheterization<br> | Procedure: Randomization of the site for catheterization<br>* Ultra-sound guided insertion strongly recommended<br>|
| Active Comparator: Internal Jugular catheterization<br> | Procedure: Randomization of the site for catheterization<br>* Ultra-sound guided insertion strongly recommended<br>|
| Active Comparator: Femoral Catheterization<br> | Procedure: Randomization of the site for catheterization<br>* Ultra-sound guided insertion strongly recommended<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complications including catheter-related bloodstream infection | Catheter-related bloodstream infection: (positive catheter-tip quantitative culture plus positive peripheral blood culture(s)) | From central catheter insertion to 48-h after removal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Central venous catheterization, Major complications, Internal Jugular, Femoral, Subclavian
Mortality Post-TAVI and Correlation With Haemodynamic Parameters.

Study Overview
=================
Brief Summary
-----------------
Until a few years ago the only interventional option available for severe aortic stenosis was surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was applied for the first time in humans, the transcatheter aortic valve implantation (TAVI). Initially this procedure was reserved for those patients deemed too high risk for surgical intervention. As technology progressed in this domain, the indication for TAVI expanded to a broader population of patient with severe aortic stenosis. To-date there are no long-term data for mortality and this is the central question this study will explore in correlation with haemodynamic parameters. Essentially, this study will explore the effect of TAVI in the long term. All patients that had a TAVI within the RBH&HH NHS Foundation Trust between January 2008 and December 2017 will be included in the study. This is a retrospective study.

Detailed Description
-----------------
Aortic valve stenosis is the most prevalent valvulopathy in the developed world countries. Until a few years ago the only interventional option available for severe aortic stenosis was surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was applied for the first time in humans, the transcatheter aortic valve implantation (TAVI) as a keyhole procedure. Initially this procedure was reserved for those patients deemed too high risk for surgical intervention. As technology progressed in this domain, the indication for TAVI expanded to a broader population of patient with severe aortic stenosis. As the experience broadens there are no long-term data for mortality and this is the central question this study will explore in correlation with haemodynamic parameters. Essentially, this study will explore the effect of TAVI in the long term. All patients that had a TAVI within the RBH&HH NHS Foundation Trust between January 2008 and December 2017 will be included in the study. This is a retrospective study and will not change anything in the patients' standard of care.

Official Title
-----------------
Mortality Post-TAVI and Correlation With Haemodynamic Parameters.

Conditions
-----------------
Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with TAVI within the Royal Brompton & Harefield NHS Foundation Trust Exclusion Criteria: None
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 |
| --- | --- | --- |
| Death post-TAVI | Death during or after TAVI | Within 3 years from TAVI procedure |
Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to analyze results of treatment of proximal humerus fractures with mini-invasive technique and plate fixation. In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray results will be statistically analyzed to evidence any connection between clinical outcomes and osteoporosis.

Official Title
-----------------
Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures

Conditions
-----------------
Osteoporosis, Humerus Fracture

Intervention / Treatment
-----------------
* Procedure: proximal humerus fracture fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proximal humerus fracture Exclusion Criteria: High risk to surgery (ASA 4 - 5)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| proximal humerus fracture<br>Patients with proximal humerus fracture treated with mini-invasive plate. | Procedure: proximal humerus fracture fixation<br>* Mini-invasive proximal humerus fixation with plate, patient in beach chair position, general anesthesia, a small incision lateral to shoulder is made to insert the plate under scope control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlate osteoporosis (Cortical index) with clinical (Constant score) and radiological (X-ray) results of the procedure | Osteoporosis will be analyzed with the cortical Index, already described in previous articles about this topic. Clinical evaluation will consider the Constant score, the most used functional score for shoulder. X-ray evaluation will analyze the healing of the fracture, studied by a radiologist, and mobilization of the plate or screws. Data will be combined to analyze correlation between clinical results, plate and screws stability and osteoporosis. | 30 months average |
Cannabinoid Modulation of Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models.

Official Title
-----------------
Cannabinoid Modulation of Pain

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Thermal
* Other: Electrical
* Other: Capsaicin
* Drug: THC
* Drug: THC
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one lifetime exposure to cannabis Acceptable Birth Control methods for females Exclusion Criteria: Cannabis naive Medical or psychiatric contraindications Analgesic medication Previous sensitivity to THC or cannabis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: THC 0.01 mg/kg<br> | Other: Thermal<br>* Thermal sensation/pain testing<br>Other: Electrical<br>* Electrical sensation/pain testing<br>Other: Capsaicin<br>* Intradermal Capsaicin<br>Drug: THC<br>* Active THC (0.01 mg/kg) administered over 10 minutes<br>* Other names: Delta-9-tetrahydrocannabinol;|
| Placebo Comparator: Placebo<br> | Other: Thermal<br>* Thermal sensation/pain testing<br>Other: Electrical<br>* Electrical sensation/pain testing<br>Other: Capsaicin<br>* Intradermal Capsaicin<br>Drug: Placebo<br>* Control: small amount of alcohol with no THC, administered over 10 minutes<br>|
| Active Comparator: THC 0.03 mg/kg<br> | Other: Thermal<br>* Thermal sensation/pain testing<br>Other: Electrical<br>* Electrical sensation/pain testing<br>Other: Capsaicin<br>* Intradermal Capsaicin<br>Drug: THC<br>* Active THC (0.03 mg/kg) administered over 10 minutes<br>* Other names: Delta-9-tetrahydrocannabinol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capsaicin-induced hyperalgesia |  | On each test day at baseline (-30), peak (+20) and post (+120) drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Measures |  | On each test day at baseline (-30), peak (+20) and post (+120) drug administration | 
| Non-pain subjective responses |  | On each test day at baseline (-30), peak (+20) and post (+120) drug administration | 
| Cognitive subjective responses |  | On each test day at baseline (-30), peak (+20) and post (+120) drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cannabis, THC, Pain
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Adolescents With Impulsivity and Aggressive Behavior in Conduct Disorder This Study is Not Being Conducted in the United States.

Study Overview
=================
Brief Summary
-----------------
Conduct disorder is a group of psychiatric symptoms that can include clinical characteristics of impulsivity and aggressive behavior. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of adolescents with conduct disorder.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Cross-over, Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o. (300-1200 mg/Day) as Adjuvant Therapy for Impulsivity and Aggressive Behavior in Conduct Disorders in Adolescents

Conditions
-----------------
Conduct Disorder

Intervention / Treatment
-----------------
* Drug: Oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified Score >8 on the Impulsivity Rating Scale Exclusion Criteria: Other serious medical or psychiatric conditions excluding conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified Treatment with antiepileptic medications Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 6 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxcarbazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction on Impulsivity Rating Scale (IRS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in the Modified Overt Aggression Scale (MOAS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxcarbazepine, conduct disorder, adolescents
SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK

Study Overview
=================
Brief Summary
-----------------
International, observational registry to investigate the outcome in patients with cardiogenic shock. The primary aim of this study is to investigate the clinical outcome of patients in cardiogenic shock.

Detailed Description
-----------------
There is a focus on interventional therapies, mechanical circulatory support and new cardiovascular therapeutics in patients with cardiogenic shock (CS). The investigators will describe current practice in study sites including concomitant patients with CS. Therefore, the investigators will monitor drug therapies initiated, devices being utilized as well as outcome and side effect of possible interventions

Official Title
-----------------
SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK - an International, Observational Registry

Conditions
-----------------
Cardiogenic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cardiogenic shock treated at a tertiary care hospital. Exclusion Criteria: Age ≤17 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| All-cause mortality | by registration office | Within 30 days after admission. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic events, bleeding events, heart failure, sepsis, dialysis. | by survey, number of ischemic events, number of bleeding events, number of patients developing heart failure as well as heart failure severity (NYHA), patients developing terminal kidney failure requiring dialysis. | Within 30 days after admission. | 
| All-cause mortality | by registration office | Within 12 months after admission. | 
| Ischemic events, bleeding events, heart failure, sepsis, dialysis. | by survey, number of ischemic events, number of bleeding events, number of patients developing heart failure as well as heart failure severity (NYHA), patients developing terminal kidney failure requiring dialysis. | Within 12 months after admission. |
Personalised Program for Women Treated for Hodgkin Disease

Study Overview
=================
Brief Summary
-----------------
After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by treatment, are the first cause of death. The investigators will estimate the risk to develop breast cancer in this population of women treated for hodgkin disease, and will propose women at high rish to participate in an intensive screening program based on an annual detection based on mammography, echography, and RMI.

Official Title
-----------------
Personalised Program for Women Treated for Hodgkin Disease : Risk Evaluation of Breast Cancer and Intensive Screening Program for Women at High Risk of Breast Cancer. PROPER/IPC 2010-001

Conditions
-----------------
Hodgkin Disease, Breast Cancer

Intervention / Treatment
-----------------
* Procedure: intensive screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women > 18 years treated for Hodgkin disease signed informed consent high risk of breast cancer Exclusion Criteria: patients unable to have a regular follow-up

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intensive screening<br>annual breast cancer detection based on mammography, echography and RMI. | Procedure: intensive screening<br>* Each year, women will have breast cancer detection based on mammography, echography and RMI. Questionaries will also be completed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of the screening | The efficacy of the screening will be evaluated by the rate of early stage breast cancer detected. The rate of in situ, < 10 mm(T1b), and N0 will be estimated. | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interest | The rate of interest is the % of women at high risk who will accept the intensive screening | 1 month | 
| adhesion | The adhesion rate is the % of women who will effectively undergo the first screnning among the women who had accepted their participation in this intensive screening | 1 month | 
| compliance | The compliance will be evaluated yearly. The number of exam realised compared to the theoric number and the time between 2 exams will be estimated. | 15 years | 
| psychologic impact | The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction. | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin disease, Breast cancer