linjc16/ctgov huggingface dataset:
Preconditioning of One-lung Ventilation

Study Overview
=================
Brief Summary
-----------------
To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative oxygenation during thoracic surgery.

Detailed Description
-----------------
For lung isolation and better surgical view, one-lung ventilation(OLV) is essential for thoracic surgery. However, OLV may cause serious pulmonary complications due to intraoperative hypoxia. Animal studies showed a positive effect of OLV preconditioning (Intermittent OLV before surgical intervention) on perioperative pulmonary oxygenation. Thus, we designed a study to observe the effect of OLV preconditioning on perioperative oxygenation during thoracic surgery

Official Title
-----------------
Preconditioning of One-lung Ventilation for Lung Protection

Conditions
-----------------
One Lung Ventilation

Intervention / Treatment
-----------------
* Other: One-lung ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position Exclusion Criteria: Patients with severe cardiopulmonary disease, COPD, previous surgical history of pulmonary disease Thoracic surgery for pneumonectomy

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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-lung ventilation<br>Before surgical incision, 2-min of OLV followed by 2-min of TLV (1 cycle) is performed for 5 cycles. | Other: One-lung ventilation<br>* The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil. In the intervention group, 5 cycles of one-lung ventilation preconditioning (2-min of one-lung ventilation and 2-min of two-lung ventilation for 1 cycle) is performed before surgical incision. One-lung ventilation is done at dependent lung with FiO2 100% and tidal volume 6 ml kg-1. Two-lung ventilation is done with FiO2 50%, tidal volume 8 ml kg-1.<br>* Other names: Preconditioning;|
| No Intervention: Two-lung ventilation<br>Maintain two-lung ventilation until surgical incision | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoxemia | SpO2 < 95% | during one-lung ventilation, up to 5 hours | 
| P/F ratio | PaO2/FIO2 ratio | 30min after surgical incision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary complications | Acute lung injury, acute respiratory distress syndrome, atelectasis, pneumonia | 6, 24, 48 hours after surgery, during hospital stay. |
Video-based Counseling & Rapid HIV Testing for Teens

Study Overview
=================
Brief Summary
-----------------
This study evaluated the educational effectiveness of a youth-friendly pre-test video (derived from a previous qualitative study) and compared it with in-person HIV pre-test counseling. A convenience sample of 200 medically stable individuals between the ages of 15 and 21 presenting to an urban ED were recruited to participate in this study and randomized into 2 groups. Individuals were eligible if they were English-speaking, sexually active and able to consent. All participants completed a sexual risk factor and demographic survey. Group 1 completed a validated pre-test knowledge measure, viewed the HIV education video then completed a post-test knowledge measure. Group 2 completed the same knowledge measures, but received pre-test HIV counseling from a trained public health advocate. HIV testing was optional

Official Title
-----------------
An RCT to Evaluate the Effectiveness of an Emergency Department Based Multimedia HIV Testing Model in Adolescents

Conditions
-----------------
HIV, HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Video
* Behavioral: in-person HIV pre-test counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15-21 year old sexually active English-Speaking Exclusion Criteria: medically unstable

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 21 Years

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

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

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: Control<br>The participants spoke with a live counselor prior to answering the knowledge measure | Behavioral: in-person HIV pre-test counseling<br> <br> |
| Experimental: Video<br> | Behavioral: Video<br>* The participants saw a 6 minute video<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of HIV |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consent to HIV testing |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, HIV knowledge measure, Teen HIV testing, HIV Seronegativity
A Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Sugammadex Versus Neostigmine in Improving Surgical Condition in Subjects Undergoing Laryngeal Microsurgery

Study Overview
=================
Brief Summary
-----------------
Investigators hypothesized that the surgical condition will be improved with the use of sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery.

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients of age over 20 years scheduled for laryngeal microsurgery under general anesthesia Exclusion Criteria: anticipated difficult intubation, cervical spine disease, neuromuscular disease, acute or chronic renal failure, liver cirrhosis or liver failure history of allergy to nondepolarizing muscle relaxant history of malignant hyperthermia pregnant woman body mass index over 35 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: Neostigmine arm<br>Neostigmine arm | Drug: Neostigmine<br>* In neostigmine group, neostigmine 50 ㎍/kg will be administered intravenously with glycopyrrolate 10 ㎍/kg when the T2 response appears on TOF stimuli.<br>|
| Active Comparator: Sugammadex arm<br>Sugammadex arm | Drug: Sugammadex<br>* In sugammadex group, sugammadex (Bridion, Merck Shart and Dohme (MSD), Oss, the Netherlands) will be administered intravenously in different doses according to the degree of muscle relaxation. Sugammadex 8 mg/kg will be administered if there is no response on post-tetanic count (PTC) stimulus. Sugammadex 4 mg/kg will be administered if PTC is more than 1 or 2. Sugammadex 2 mg/kg will be administered if T2 response appears on train-of-four (TOF) stimulus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical condition | Primary outcome is the proportion of patients who have clinically acceptable surgical condition. The surgeon will evaluate the surgical condition as a surgical rating scale during surgery (extremely poor condition, poor condition, acceptable condition, good condition, optimal condition). | up to 1 hour after the end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sugammadex, Neostigmine, Surgery
Thrombophilia Assessment Under DOAC: Effectiveness of Activated Charcoal

Study Overview
=================
Brief Summary
-----------------
Direct oral anticoagulants (DOAC) are anticoagulant molecules that act either directly on factor Xa (Apixaban, Rivaroxaban) or on factor IIa (Dabigatran). AODs interfere with most coagulation tests, especially those performed by chronometric technique. For this reason, part of the thrombophilia workup (protein S, search for lupus anticoagulants, antithrombin for patients on dabigatran) cannot be performed on DOACs at the HUS. Recent studies have highlighted the effectiveness of activated charcoal to adsorb DOACs in order to perform certain hemostasis tests.

Official Title
-----------------
Thrombophilia Assessment Under Direct Oral Anticoagulants (DOAC): Efficacy of Activated Charcoal

Conditions
-----------------
Thrombophilia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult subject (≥ 18 years of age) Blood sample already analyzed in a usual way in the laboratory as part of the care Subject not objecting to the reuse of his or her medical data for scientific research purposes. Exclusion criteria: - Insufficient sample

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interference or not of activated charcoal in the measurement of protein S, antithrombin, and in the search for lupus anticoagulants. | This study compares the results of two diagnostic techniques (Thrombophilia work-up under direct oral anticoagulants (DOACs)), one using activated charcoal versus another not using it | Through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombophilia, direct oral anticoagulants, DOAC, Apixaban, Rivaroxaban, Dabigatran, Hemostasis tests
Ultrasound Guided Lateral Sphincterotomy: Long Term Results

Study Overview
=================
Brief Summary
-----------------
Ultrasound guided placement of the knife intersphincteric increases accuracy and safety during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter is divided.

Official Title
-----------------
Ultrasound Guided Lateral Sphincterotomy: Long Term Results

Conditions
-----------------
Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure

Intervention / Treatment
-----------------
* Procedure: lateral sphincterotomy
* Procedure: ultrasound guided lateral sphincterotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing lateral sphincterotomy for chronic anal fissure Exclusion Criteria: Previous diltiazem treatment og botox injections were not performed

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 |
| --- | --- |
| Patients with chronic anal fissure<br>Patients are included who had previous treatment with diltiazem or glycerol-nitrate and botox injections | Procedure: lateral sphincterotomy<br> <br> Procedure: ultrasound guided lateral sphincterotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal incontinence |  | 5 years or more | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of fissure |  | 5 years or more |
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, COPD

Intervention / Treatment
-----------------
* Drug: Roflumilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: FEV1/FVC ratio (post-bronchodilator) ≤70% FEV1 (post-bronchodilator) ≤50% of predicted Current smoker or ex-smoker Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline Main Exclusion Criteria: COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline Lower respiratory tract infection not resolved 4 weeks prior to baseline Diagnosis of asthma and/or other relevant lung disease Known alpha-1-antitrypsin deficiency Need for long-term oxygen therapy defined as ≥16 hours/day

Ages Eligible for Study
-----------------
Minimum Age: 40 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in FEV1 from baseline during the treatment period; number of COPD exacerbations. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function variables |  |  | 
| number of COPD exacerbations of different type and various subgroups |  |  | 
| quality of life variables |  |  | 
| patient diary variables |  |  | 
| time to study withdrawal |  |  | 
| safety. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roflumilast, Chronic obstructive pulmonary disease, COPD
Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of LVEDP

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0.

Official Title
-----------------
Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of Left Ventricular End Diastolic Pressure (LVEDP)

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age Patient undergoing elective cardiac catheterization during which LVED and aortic pressures are recorded Willing and able to sign informed consent prior to study initiation Exclusion Criteria: Subject has a baseline heart rate of < 60 or >100 beats/min Subject has moderate to severe valvular disease Subject suffers from atrial fibrillation or other tachyarrhythmias Subject suffers from hemodynamic instability Subject is candidate for primary PCI

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 |
| --- | --- |
| Elective Cardiac Catheterization<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the accuracy of the non-invasive device, C.A 2.0, to estimate LVEDP comparing it to the invasive hemodynamic measurement via left heart catheterization |  | During elective cardiac catheterization |
Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.

Detailed Description
-----------------
Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant. Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis

Official Title
-----------------
Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: 0.59 mg Fluocinolone Acetonide implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-infectious intermediate, posterior or panuveitis Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug Exclusion Criteria: Infectious uveitis
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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.59 mg Fluocinolone Acetonide implant<br>0.59 mg Fluocinolone Acetonide implant | Drug: 0.59 mg Fluocinolone Acetonide implant<br>* 0.59 mg Fluocinolone Acetonide implant<br>* Other names: Retisert;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Inflammation Recurrence | Number of eyes with inflammation recurrence | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Improvement in Visual Acuity | Visual acuity was improved by two or more lines from baseline. | baseline to 52 weeks | 
| Number of Participant's Eye Requiring Adjunctive Therapy | Adjunctive Therapy needed to control inflammation in the implanted eye | 5 years | 
| Number of Eyes With Increased Intraocular Pressure |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uveitis, Cystoid Macular Edema (CME), fluocinolone acetonide, non-infectious uveitis affecting the posterior segment
Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks

Study Overview
=================
Brief Summary
-----------------
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).

Detailed Description
-----------------
Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections.

Official Title
-----------------
Comparing the Use of Sulfamylon 5%, Dakins 0.025%, Cerium, Silver Nitrate 5% and/or Other Topical Antimicrobial Products for the Treatment of Excised and/or Grafted Burn Wounds

Conditions
-----------------
Burn

Intervention / Treatment
-----------------
* Drug: Sulfamylon 5% and Silver Nitrate Soaks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn Injury requiring excisional therapy Hospitalization required until wounds are closed Exclusion Criteria: Known hypersensitivity to products Outpatient treatment for burn injury

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sulfamylon 5% and Silver Nitrate Soaks<br>Application of Sulfamylon 5% Solution and Silver Nitrate soaked dressings to two different burned area. Sites were then monitored for infections during hospitalization. | Drug: Sulfamylon 5% and Silver Nitrate Soaks<br>* Application of Sulfamylon and Silver Nitrate Solution to burn wound daily<br>* Other names: Silver Nitrate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Rate | Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks. | Acute hospitalization following burn injury: admission to discharge (1-20 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients | At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data for this outcome. Although peer-reviewed articles have been located that reference NCT00675922 it is not clear and verifiable (without access to the actual study-related data) what the results for this outcome. | Admission to burn unit to discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, Wounds, Wound infection, Topical antimicrobials, Cerium, Dakins, Sulfamylon Soaks, Silver Nitrate