linjc16/ctgov huggingface dataset:
Pleural Effusion Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features

Study Overview
=================
Brief Summary
-----------------
Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effusions, defined as those requiring therapeutic pleural drainage.

Detailed Description
-----------------
This was a retrospective cohort study of prevalence and characteristics of patients who had a pleural effusion after coronary artery bypass graft, valve replacement or both procedures. Information was collected on all consecutive patients who underwent CABG surgery and/or valve replacement between January 1, 2004 and December 31, 2005. Demographic information, anthropometric parameters, cardiac and renal function assessments, and comorbid conditions were retrieved from medical files. We also collected data on the type of procedure, whether it was elective or urgent, the number and origin of the grafts, the duration of surgery and of cardiopulmonary bypass and the postoperative complications, including pleural effusions. Clinical presentation and evolution of the effusions as well as pleural fluid characteristics were also studied. Patients were considered to have a clinically significant pleural effusion when they met at least one of the following criteria: need for thoracentesis, a pleural drainage tube or a hospital readmission due to a pleural effusion that occurred within one year of surgery.

Official Title
-----------------
Pleural Effusions Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features.

Conditions
-----------------
Pleural Effusion, Coronary Artery Bypass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery bypass grafting (CABG) Valve replacement Combined CABG and valve replacement between January 1st, 2004 and December 31st, 2005 Exclusion Criteria: Previous CABG Pulmonary and/or aortic artery surgery Heart or lung transplant Pleural effusion present at the time of surgery
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 |
| --- | --- | --- |
| Pleural effusion requiring therapeutic drainage |  | within the first 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pleural effusion, coronary artery bypass, heart valve replacement
Use of Lidocaine in Rapid Sequence Induction

Study Overview
=================
Brief Summary
-----------------
Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased in patients that receive rapid sequence induction and intubation, where opioids are spared and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that lidocaine when administered intravenously in patients who undergo rapid sequence induction may not only blunt the hemodynamic response to intubation, but may also increase the anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension, arrhythmias and also awareness.

Official Title
-----------------
Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction

Conditions
-----------------
Hemodynamic Response

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: reason for rapid sequence induction (emergency, reflux), ASA I-II, no antihypertensive drugs, no antiarrhythmic drugs Exclusion Criteria :

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine<br> | Drug: Lidocaine<br>* lidocaine 1.5 mg/kg intravenously<br>|
| Placebo Comparator: normal saline<br> | Drug: Placebo<br>* normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS changes after lidocaine administration in rapid sequence induction |  | change from baseline in BIS values during 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in blood pressure |  | change from baseline in blood pressure during 10 minutes | 
| change in Heart rate |  | change from baseline in heart rate durng 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lidocaine, anesthetic depth, hemodynamics, rapid sequence induction, BIS
Cryo Global Registry

Study Overview
=================
Brief Summary
-----------------
Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry

Detailed Description
-----------------
The Cryo Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to evaluate and describe clinical performance and safety data in a broad patient population treated with a commercially available Arctic Front™ Family of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System). The cryoballoon ablation(CBA) procedure will be performed according to routine hospital practice. The study is expected to have a 24 month enrollment period. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Official Title
-----------------
Cryo Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥ 18 years of age or minimum age as required by local regulations Planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements Exclusion Criteria: Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager Subject with exclusion criteria required by local law

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 |
| --- | --- | --- |
| Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months | Estimate the 12 month freedom from AF recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System | 12 Months | 
| Freedom from Atrial Arrhythmia at 12 Months | Estimate the 12 month freedom from AF / Atrial Flutter (AFL)/ Atrial Tachycardia (AT) using the Arctic Front™ Cardiac Cryoablation Catheter System. | 12 Months | 
| Freedom from Device / Procedure Related Adverse Events | Estimate device and procedure-related adverse events for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12 months. | 12 Months |
Measurements Of Zinc Concentration On Specimens Taken During Trans-Perineal Prostate Biopsy

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to: i) confirm and improve the accuracy of the correlation between levels of Zinc in prostate tissue and the grade of prostate cancer in that tissue as determined through pathology; and ii) determine the levels of zinc in prostate tissue declared as non-cancerous by pathology and located in the vicinity of tissue declared as cancerous by pathology, and verify that the Zinc levels for the declared non-cancerous tissue are lower (statistically significantly) than the levels for benign tissue not in the vicinity of cancerous tissue.

Official Title
-----------------
Measurements Of Zinc Concentration On Specimens Taken During Trans-Perineal Prostate Biopsy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: prostate biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated PSA, >10ng/mL Subject underwent primary and at least one secondary (repeat) prostate biopsy with negative diagnosis Subject directed at saturated trans-perineal biopsy Exclusion Criteria: Subject was under Zn supplement nutrition treatment

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate cancer<br>Men. Subjects have undergone primary and at least one secondary prostate biopsy with negative diagnostics. Elevated PSA (Prostate Specific Antigen), typically above 10 ng/mL. | Other: prostate biopsy<br>* Measurements of Zinc concentration along fresh Specimens taken during Trans-Perineal saturated repeat Prostate Biopsy before Specimens are sent to Pathology.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify the existence of correlation between low levels of Zinc concentration in a biopsy specimen and the prostate cancer grade for that specimen determined by pathology. |  | Zinc measurements on biopsy specimens are performed during the biopsy session; pathology classification is typically performed within 2-4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify that the levels of zinc in non-cancerous specimens located in the vicinity of a specimen declared as cancerous by pathology are lower (statistically significantly) than the levels for benign specimens not in the vicinity of the cancerous specimen. |  | Time frame for pathology: within 2-4 weeks |
Difficult Intravenous Access Perception: Difficult IV Access - Assessment of Patient Understanding

Study Overview
=================
Brief Summary
-----------------
Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief video education vignette to determine understanding and preferences among general emergency department patients of rescue access techniques. A challenge of emergency care is providing patient education surrounding procedures in a standardized and patient-oriented manner. This data would provide insight on a patient's understanding of the risks and benefits of rescue access, assess patient preference, and potentially influence what rescue technique is employed in the future. This information may also give us insight onto why DIVA patients might refuse randomization.

Official Title
-----------------
Assessment of Patient Understanding and Preference of Rescue Venous Access When Shown a Narrated Video Vignette Versus Traditional Paper Information Sheet

Conditions
-----------------
Understanding Emergency Room Procedures

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than or equal to 18 years of age fluent in English hemodynamically stable emergency department patient Exclusion Criteria: history of or current status of difficult intravenous access

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 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 |
| --- | --- |
| Video<br>Patients in this group will be shown an informational video, narrated in English. | Other: Survey<br> <br> * Other names: Patients will complete a survey to assess their understanding and preferences.;|
| Text<br>Patients in this group will read a single-page printed information sheet in English. | Other: Survey<br> <br> * Other names: Patients will complete a survey to assess their understanding and preferences.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Understanding | Assess patients' understanding of and preferences regarding emergency department procedures: ultrasound-guided IV access and intra-osseous access. | Baseline |
Gastric Pacemaker Implantation for Gastroparesis

Study Overview
=================
Brief Summary
-----------------
Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.

Detailed Description
-----------------
Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.

Official Title
-----------------
Gastric Electric Stimulation-Enterra Therapy for the Treatment of Chronic Intractable (Drug Refractory) Nausea and Vomiting Secondary to Gastroparesis of Diabetic or Idiopathic Etiology

Conditions
-----------------
Gastroparesis

Intervention / Treatment
-----------------
* Device: Enterra Gastric Pacemaker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Used only if patients have tried and failed conventional treatment ( drug therapy and dietary modification)due to intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients who have severe symptoms and have been identified by the PI and Sub I to qualify for the treatment will be under one single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatement<br>All subjects that meet the requirement for gastric stimulator placement | Device: Enterra Gastric Pacemaker<br>* Gastric Pacemaker<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
-----------------
Gastroparesis, Gastric electrical stimulator
Traumatic Brain Injury Among Homeless Veterans

Study Overview
=================
Brief Summary
-----------------
Objectives include: 1) establishing a psychometrically sound traumatic brain injury (TBI) screening measure for use among homeless veterans; 2) identifying the prevalence of those that screen positive for TBI among homeless veterans seeking VA services; and 3) comparing psychiatric and psychosocial outcomes between those with and without a history of TBI.

Detailed Description
-----------------
Short-term Objectives include: Establishing the criterion-related validity of the Traumatic Brain Injury-4 (TBI-4) questionnaire in the Veteran homeless population using the Ohio State University TBI-Identification Method (OSU TBI-ID) (Corrigan et al., 2007) as the gold standard for establishing traumatic brain injury (TBI) diagnosis. Identifying the prevalence of those that screen positive for a lifetime history of TBI among homeless Veterans. Comparing psychiatric outcomes (psychiatric hospitalizations, suicide attempts and deaths, and clinical contacts) and psychosocial outcomes between those with and without a lifetime history of TBI.

Official Title
-----------------
Traumatic Brain Injury Among Homeless Veterans

Conditions
-----------------
Traumatic Brain Injury, Homelessness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age, seeking homeless services at one of the VA Homeless Services Programs. Exclusion Criteria: Failure to provide informed consent, not older than 89 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| OSU TBI-ID | History of TBI | One Time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic Brain Injury, Homelessness
To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast

Study Overview
=================
Brief Summary
-----------------
Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing. The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat. In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms. Expect clinical application of light therapy in the future is more accurate and effective.

Detailed Description
-----------------
Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing. Therapeutic methods to promote wound healing are hyperbaric oxygen therapy, vacuum assisted therapy and photostimulation. Although there are many treatments but no one has been widely accepted. The clinical effects of uncertainty, high cost and inconvenience of use is the main reason. Each year amputation of the population due to chronic ulcers has not decreased. In order to break the current medical difficulties, We refer to the new light therapy technology. Look forward to shorten the healing time and reduce medicine costs. The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat. In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms. Expect clinical application of light therapy in the future is more accurate and effective irradiative time points and dosage.

Official Title
-----------------
To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast

Conditions
-----------------
Non-pressure Chronic Ulcer of Skin, Not Elsewhere Classified

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic ulcer normal skin age 50 80 years, chronic skin ulcer patient skin-grafting patient Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic ulcer<br>1x1cm2 tissue from chronic ulcer wound | |
| normal skin<br>1x1x0.1 cm3 normal skin from graft | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Inhibitory Receptors in Eosinophils of Atopic Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the expression and activity of inhibitory molecules on eosinophils obtained from allergic subjects.

Official Title
-----------------
Characterization of the Expression and Activity of Inhibitory Receptors Such as CLM-1 in Eosinophils of Atopic Subjects

Conditions
-----------------
Atopy, Atopic Dermatitis, Asthma, Allergic Rhinitis, Food Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20-60 years a physician-diagnosed atopic disease Exclusion Criteria: atopic disease not active steroid treatment active non-atopic inflammatory disease, including infections pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| atopic subjects<br>Patients with one atopic disease or more (atopic dermatitis,rhinitis, asthma, food allergy) | |
| non-atopic subjects<br>Control group without atopic diseases. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of surface molecules on eosinophils as assessed by flow cytometry | Blood samples from donors will be stained and evaluated by flow cytomtery | December 2013 |