linjc16/ctgov huggingface dataset:
Continuous Regional Analgesia After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This prospective, comparative and double blind study is aimed to determine if normal saline or dextrose 5% in water will modify the stimulation during the insertion of the stimulating catheter used for continuous femoral and sciatic blocks in total knee replacement.

Detailed Description
-----------------
The operator is blinded to the medium fluid to expand the perineural femoral and sciatic nerves before threading in the stimulating catheter. He records all the electric data of electrolocation of nerve, which will be compared to determine whether or not a difference in intensity is found between normal saline or dextrose 5% in water.

Official Title
-----------------
Continuous Regional Analgesia After Total Knee Arthroplasty. Normal Saline or Dextrose 5% in Water as Fluid Medium for Pre-Placement Expansion in Order to Facilitate the Catheter Passing

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Other: Glucose 5%
* Other: NaCl 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) I and II Male or non-pregnant female 18 - 80 years of age Not allergic to iodine or local anesthetics Absence of abnormality of coagulation Scheduled for total knee replacement

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

| Intervention/Treatment |
| --- |
|Other: Glucose 5%|nan|
|Other: NaCl 0.9%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of electrolocation of nerve during insertion of the exploring needle and of the stimulating catheter |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of post-operative analgesia |  | during 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal saline, Dextrose 5% in water, neurostimulation, Continuous regional analgesia after total knee arthroplasty
Glenohumeral Cortisone Injection

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.

Detailed Description
-----------------
THis is a randomized control trial to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.

Official Title
-----------------
A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures

Conditions
-----------------
Humeral Fractures

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.18-90 2. Proximal Humerus Fracture 3. Decreased range of motion at 6 wk follow-up 4. Likely to be available for follow up for 26 wks Exclusion Criteria: Known drug allergy to kenalog or lidocaine Unable to complete functional outcome Pregnant Women

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 |
| --- | --- |
| Placebo Comparator: Controls<br>Patients receiving lidocaine | Drug: Lidocaine<br>* Lidocaine injection into shoulder<br>|
| Active Comparator: Cases<br>Patients receiving Kenalog | Drug: kenalog<br>* Cortisone injection into shoulder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder Elbow Society Score | Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | pain scale - high is bad - low is good 0-100 | 24 weeks |
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.

Detailed Description
-----------------
Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability. The effects of rhRlx on hemodynamics will be assessed.

Official Title
-----------------
A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: Relaxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients over the age of 18 New York Heart Association (NYHA) Class II-III CHF Left Ventricular Ejection Fraction (LVEF) of < 35% Exclusion Criteria: Acute coronary syndrome Acute decompensated CHF Hypotension Recent significant arrhythmia Recent stroke Significant renal or hepatic impairment Pregnancy or child-bearing potential

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac hemodynamics including PCWP, CO/CI, SVR |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 
| Tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive heart failure, Relaxin, Cardiac hemodynamics
Virtual Visitation in Intensive Care Unit Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the efficacy of virtual visitation in Intensive Care Unit on patients and their caregivers during COVID-19 Pandemic.

Detailed Description
-----------------
After being informed about the study, all patients who meet the eligibility requirements will be randomized in a 1:1 ratio to intervention group (Virtual visitation once a day) or Control group (Phone interviews once a day).

Official Title
-----------------
Efficacy of Virtual Visitation in Intensive Care Unit During COVID-19 Pandemic: Randomized Controlled Trial

Conditions
-----------------
Critically Ill Patients

Intervention / Treatment
-----------------
* Behavioral: Virtual meeting between patients/physicians and caregiver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are expected to stay in the intensive care unit for more than 48 hours Patients with a RASS score of -2 or higher Exclusion Criteria: Patients who discharge or die within 48 hours of admission to ICU

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional group Control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual visitation group<br>Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day | Behavioral: Virtual meeting between patients/physicians and caregiver<br>* Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day<br>|
| No Intervention: Control group<br>Phone interview between physicians-caregivers once a day | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FS-ICU score from caregivers at discharge or 7 days after initiation of study enrolled | The FS-ICU survey score reflected the satisfaction degree of caregivers. The overall satisfaction score is derived from questions 1 through 24. | 7 days |
Left Ventricular Dyssynchrony in Multipole Pacing

Study Overview
=================
Brief Summary
-----------------
Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator.

Detailed Description
-----------------
Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator using a quadripolar left ventricular lead.

Official Title
-----------------
The Impact of Multipole Pacing (MPP) on Left Ventricular Dyssynchrony in Patients With Cardiac Resynchronization Therapy (CRT) - a Real-Time Three Dimensional Echocardiography Approach

Conditions
-----------------
Heart Failure，Congestive

Intervention / Treatment
-----------------
* Device: Different programming of a CRT defibrillator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for the implantation of a defibrillator with cardiac resynchronisation therapy Exclusion Criteria: Cardiac surgery, acute coronary syndrome / myocardial infarction, percutaneous coronary intervention within the past 4 weeks Indication for coronary artery revascularisation Atrial fibrillation with insufficient rate control ASA (American Society of Anesthesiologists) class V or cardiogenic shock age <18 years, pregnancy, tutelage inability to understand the patient consent for or study refusal anticipated insufficient echocardiographic image quality

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Different programming of a CRT defibrillator|Different programming of a CRT defibrillator using pacing modalities of a quadripolar left ventricular lead|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular dyssynchrony | Left ventricular dyssynchrony | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fraction | left ventricular ejection fraction | 15 minutes |
Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)

Study Overview
=================
Brief Summary
-----------------
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.

Official Title
-----------------
A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma

Conditions
-----------------
Intraocular Pressure

Intervention / Treatment
-----------------
* Drug: Travoprost 0.004% + Brinzolamide 1.0%
* Drug: Travoprost 0.004% + Tears Natural


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years; CACG (Chronic Angle Closure Glaucoma) ≥ 1eye have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes clinical stability of VA (Visual Acuity) and optic nerve throughout the study Exclusion Criteria: Abnormality restricts exam of the fundus or anderior chamber conjunctivitis, keratitis or uveitis unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks ocular surgery prior to the 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost 0.004% + Brinzolamide 1.0%<br>Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) | Drug: Travoprost 0.004% + Brinzolamide 1.0%<br>* Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)<br>|
| Active Comparator: Travoprost 0.004% + Tears Natural<br>Travoprost 0.004% (once daily) + Tears Naturale (twice daily) | Drug: Travoprost 0.004% + Tears Natural<br>* Travoprost 0.004% (once daily) + Tears Naturale (twice daily)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP (Intraocular Pressure) |  | Screening: Week 12; (At 9 am and 4 pm time points) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IOP lowering efficacy and safety of Azopt plus Travatan
Preoperative Level of Hemoglobin A1c and Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery

Study Overview
=================
Brief Summary
-----------------
Background: The development of acute kidney injury (AKI) is an important indicator of clinical outcomes after cardiac surgery. Elevated preoperative hemoglobin A1c level may be associated with acute kidney injury in patients undergoing coronary artery bypass grafting. This study will investigate the association of preoperative HbA1c levels with AKI after isolated coronary artery bypass grafting (CABG).

Official Title
-----------------
Association Between Preoperative Level of Hemoglobin A1c and the Incidence of Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery: a Cohort Study

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Diagnostic Test: increase in serum creatinine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status II-III scheduled to undergo isolated coronary artery bypass grafting Exclusion Criteria: Patients with history of renal failure Patients with history of hepatic failure Patients with history of heart failure previous cardiac surgery cerebrovascular event in the last 30 days percutaneous coronary intervention in the last 30 days prior to operation peripheral arterial disease malignancy infectious diseases patients who required surgical revision patients who required postoperative intra-aortic balloon pump patients with CBP time > 120 min or aortic cross clamp time > 90 min

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Pre-diabetic group<br>Patients with preoperative HbA1c 5.7-6.4% (group A) (prediabetics) | Diagnostic Test: increase in serum creatinine<br>* any of the following: increase in serum creatinine by ≥ 0.3 mg/dl within 48 h of surgery or increase in serum creatinin<br>|
| Diabetic group<br>Patients with preoperative HbA1c > or = 6.5% till 7% or > 7% in case of emergency surgery or rapidly progressive cases with no time for long-term glycemic control (group B) (diabetics) | Diagnostic Test: increase in serum creatinine<br>* any of the following: increase in serum creatinine by ≥ 0.3 mg/dl within 48 h of surgery or increase in serum creatinin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine level | increase in serum creatinine by ≥ 0.3 mg/dl within 48 h of surgery or increase in serum creatinine to ≥ 1.5 times baseline within 3 days of cardiac surgery | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients in need of RRT | The number of patients requiring postoperative renal replacement therapy | 7 days |
A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients During Acute Exacerbation

Study Overview
=================
Brief Summary
-----------------
One of the main goals of the respiratory physical therapy is to help people who are suffering from accumulating of secretions in their airways and lungs. Chronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute Exacerbation of their medical condition. Those patients usually get only the standard medical care during the acute phase and don't get respiratory physical therapy treatment. The study's main aim is to investigate if respiratory physical therapy treatment in addition to standard medical care during the acute phase, can improve the respiratory and medical condition and reduce hospitalization stay. In order to do so we will compare three groups of COPD patients during acute exacerbation; two groups will get one out of two respiratory physical therapy techniques; manually or Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the third group will get standard medical care alone.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Chronic Bronchitis

Intervention / Treatment
-----------------
* Procedure: respiratory physical therapy manual technique- Autogenic Drainage
* Device: respiratory physical therapy technique- IPV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of Acute Exacerbation of COPD or Acute Exacerbation of Chronic Bronchitis Respiratory Rate>25 PaCO2> 45 mmHg 7.35 < PH < 7.38 Exclusion Criteria: intubation apnea glasgow coma scale < 8 pneumothorax FEV1 < 50% predicted Ischemic Hearth Disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: respiratory physical therapy manual technique<br>respiratory physical therapy manual technique- Autogenic Drainage | Procedure: respiratory physical therapy manual technique- Autogenic Drainage<br> <br> |
| Experimental: respiratory physical therapy technique- IPV<br>respiratory physical therapy technique- Intrapulmonary Percussive Ventilation | Device: respiratory physical therapy technique- IPV<br> <br> |
| No Intervention: standart medical care<br>standard medical care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in the hospital |  | up to three months |
A Study is to Understand the Treatment Patterns for Immunotherapy Agents and BRAF/MEK Inhibitors Used in the Treatment of Advanced Melanoma

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to understand the treatment patterns for immunotherapy agents and BRAF/MEK inhibitors used in the treatment of advanced melanoma

Official Title
-----------------
Understanding the Treatment Patterns, Healthcare Resource Utilization, Costs of Care, and Clinical Outcomes Among Patients Treated for Advanced Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have ≥1 medical or pharmacy claim for nivolumab, ipilimumab, pembrolizumab, nivolumab+ipilimumab (on the same day), dabrafenib, vemurafenib, cobimetinib, trametinib, dabrafenib+trametinib (on the same day) and vemurafenib+cobimetinib (on the same day) Patients must have ≥6 months of continuous health plan enrollment prior to index date Patients must have ≥2 medical claims at least 30 days apart with a diagnosis for melanoma during the study period AND ≥1 diagnosis for melanoma during the baseline period prior to or on the index date Exclusion Criteria: Patients with ≥1 claim for the agents of interest including immunotherapy agents and BRAF/MEK inhibitors between the first diagnosis of metastatic disease and the day prior to the index date will be excluded Patients with a claim for acquired immunodeficiency virus (AIDS) anytime during the study period Patients under the age of 18 as of index date Other protocol defined inclusion/exclusion criteria could apply

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 treated with immunotherapy and BRAF/MEK inhibitors<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment free interval (TFI) |  | Approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | Approximately 6 months |