linjc16/ctgov huggingface dataset:
Evaluation of the Interference of Antithrombotic Agents With Laboratory Monitoring of Heparin Therapy

Study Overview
=================
Brief Summary
-----------------
Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive cardiac procedures . Additional parenteral anticoagulation is necessary for these procedures (FA ablation and invasive coronary explorations). The unfractionated heparin doses are adapted on a monitoring test heparin, activated clotting time (ACT) with the aim of obtaining and maintaining an ACT > 300-400 sec. This goal is the same whether the patient is on oral anticoagulant treatment or not, and regardless of the initial level of anticoagulation. The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well documented, but few data have been published on the effects of heparin monitoring tests, particularly on the ACT. The aim of this stuy is to redefine the target values of ACT and unfractionated heparin doses to administer to optimize the efficacy / safety of invasive procedures in cardiology.

Conditions
-----------------
Blood Coagulation Tests

Intervention / Treatment
-----------------
* Procedure: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient treated with oral anticoagulant at curative dose and requiring a requiring a venous blood sample for his management Exclusion Criteria: opposition to the patient to participate 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated with oral anticoagulants<br>Ex vivo study using blood samples from patients treated with oral anticoagulant (direct oral anticoagulants or AVK) at curative dose, taken in the usual cardiac monitoring. | Procedure: Blood sample<br>* This blood sample does not require specific puncture because it is made on the occasion of a sample justified by the patient monitoring.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the plasmatic concentration in direct oral anticoagulants (DOAC) or International Normalized Ratio for AVK and the value of the Activated clotting time (ACT) |  | 1 hour |
Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.

Study Overview
=================
Brief Summary
-----------------
Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.

Official Title
-----------------
Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.

Conditions
-----------------
Aortic Arch, Aortic Arch Aneurysm, Dissection of Aortic Arch, Triple Branch

Intervention / Treatment
-----------------
* Device: Triple inner branched arch stentgraft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Presence of Aortic arch pathology Treatment planned with triple inner branch from Terumo Aortic Availability of the patients during the follow up period Informing patients about the study and providing written informed consent Exclusion Criteria: Women of childbearing age Patients under 18 years
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Triple inner branched arch stentgraft|New findings regarding treatment planning and management of patients with aortic arch pathologies.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 days after intervention | 
| feasibility in terms of cannulation and stentgrafting of the three branches |  | During intervention | 
| Stroke |  | 30 days after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Access issue, paraplegia, kidney failure | during the follow up period of 3 year | 
| Endoleaks Type I and III |  | during intervention and the follow up period of 3 year | 
| Longterm mortality |  | during the follow up period of 3 year | 
| Patency rate of branches | primary and secondary | during the follow up period of 3 year | 
| Stroke |  | during the follow up period of 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic arch pathologies, Aortic arch aneruysm, Aortic arch dissection, triple branch, stentgraft, Double branch, Inner branch
Effectiveness of Point of Care Complete Blood Cell Count Analyzer in Reducing Time to Results

Study Overview
=================
Brief Summary
-----------------
The current process for getting complete blood cell counts (CBC) results in the operating room during surgery relies on sending blood samples from the operating room to the hospital's central lab. This workflow is complex and often results in handing off the blood sample to 4 or more different staff members before arriving in the lab for analysis. This often causes delayed CBC results, which may lead to inappropriate or delayed clinical decision making. By providing prompt access to CBC results with the use of a point of care CBC analyzer, the clinical workflow efficiency can be significantly improved. This should resulting in better clinical decision making, reductions in costs, increase in patient satisfaction and facilitation of hospital processes.

Official Title
-----------------
Effectiveness of Point of Care Complete Blood Cell Count Analyzer in Reducing Time to Results

Conditions
-----------------
Laboratory Problem

Intervention / Treatment
-----------------
* Device: Central Lab based CBC
* Device: Point of Care CBC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All English speaking patients, 18 years or older, having surgery in the Lake Forest Hospital operating rooms, with a pre-existing indication for CBC analysis. Exclusion Criteria: All patients not meeting inclusion criteria or protected patient populations, specifically, pregnant women, prisoners, cognitively impaired patients, patients unable to consent, students, employees, and children)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 85 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 |
| --- | --- |
| Patient<br>Each patient will undergo simultaneous testing with two different CBC analyzers. | Device: Central Lab based CBC<br>* lab samples will be sent to the central lab for CBC analysis<br>Device: Point of Care CBC<br>* lab samples will be analyzed at point of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to result | Time between blood draw and CBC result displayed in Electronic medical record | Through study completion, an average of 1 year |
A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.

Official Title
-----------------
A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)

Conditions
-----------------
Kidney Disease, Kidney Failure, End Stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants previously enrolled in the CTOT-01 study. Participants who are at least 5 years post-transplant (+/- 6 months), no later than March 31, 2014. Exclusion Criteria: Withdrawal of consent to continue in the CTOT-01 study.
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 |
| --- | --- | --- |
| Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation | Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant |  | Day 1 | 
| Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant |  | Day 1 | 
| Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant |  | Day 1 | 
| Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, Transplant, Rejection
Analgesic Effect of Levobupivacaine in Breast Augmentation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether levobupivacaine is effective in the acute postoperative pain treatment in periprosthetic breast augmentation

Detailed Description
-----------------
One of the most common plastic surgery is breast augmentation using prosthesis ( mammoplasty Surgery with cohesive silicone gel prosthesis insubpectoral plane). Remains challenging management of acute postoperative pain that allows for early discharge of patients. To this end the following objectives are proposed: evaluate the analgesic efficacy of L-Bupivacaine 0.25% vs. Placebo (saline) administered irrigation into the surgical pocket bilaterally intraoperatively.

Official Title
-----------------
Analgesic Efficacy of Levobupivacaine Administration in Periprosthetic Breast Augmentation With Implants

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women> 18 and <= 65 years Mammoplasty Surgery with cohesive silicone gel prosthesis in subpectoral plane ASA I and II Informed consent signed Exclusion Criteria: Rejection of the patient ASA III or higher Other conditions that warrant their inclusion as medically indicated (eg psychiatric illness). Allergy to NSAIDs, local anesthetics and / or morphine Patients treated for chronic pain Placement of drains for surgical needs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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: levobupivaciane group<br>Levobupivacaine group (L- bupivacaine 0,25% -2,5 mg/ml-) 60 ml. Total dosis in topical use 150 mg (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively). | Drug: Levobupivacaine<br> <br> |
| Placebo Comparator: Placebo Comparator (saline solution)<br>Placebo group (saline solution) 60 ml (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively). | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS) at rest and movement (cough). |  | at 6 hours the early postoperative period (after the end of anesthesia) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative, Patient-reported
Diurnal Variation in Hypertensive Stroke Patients

Study Overview
=================
Brief Summary
-----------------
This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory BP (ABP).

Official Title
-----------------
Comparison of the Effects of Amlodipine and Losartan on Blood Pressure and Diurnal Variation in Hypertensive Stroke Patients

Conditions
-----------------
Hypertension, Stroke

Intervention / Treatment
-----------------
* Drug: Amlodipine, Losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 35 to 85 years hypertensive patients who had an ischemic stroke Exclusion Criteria: patients aged below 35 years or above 86 years; patients who had a hemorrhagic stroke; patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit; patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics; (7) patients with a severe stroke (NIH stroke scale > 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (AST or ALT ≥ 100); (10) patients with severely impaired renal function (serum creatinine ≥ 2.0 mg/dL); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amlodipine camsylate<br>amlodipine camsylate 5mg | Drug: Amlodipine, Losartan<br> <br> |
| Active Comparator: losartan potassium<br>losartan potassium 50mg | Drug: Amlodipine, Losartan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour ambulatory mean SBP |  | baseline and 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24H mean DBP, 24H mean SBP/DBP Variability,clinic SBP/DBP, awake, sleep, morning, evening, and prewake BPs, the morning surge, and the nocturnal dipping |  | baseline and 8weeks |
Prevalence of COVID-19 in High Altitude : Insights From the Highest City of the World

Study Overview
=================
Brief Summary
-----------------
Since the beginning of 2020, SARS-CoV-2 outbreak spread over the world, conducting in a pandemic state declared by the world health organization in March 2020. Conflicting data have been yet published regarding to the incidence rate of COVID-19 infection in altitude. Mainly based on analysis from national Peru database, some authors argued that COVID-19 disease, as well as case fatality rate was less frequent in altitude. However, epidemiological data are lacking regarding to the prevalence of COVID-19 in altitude, and more specially in high altitude. Aim of this cross-sectional study is to assess the prevalence of seroconversion for the SARS-CoV-2 in the population of La Rinconada, a mining town at 5,100 m, the highest city in the world.

Official Title
-----------------
Prevalence of COVID-19 and Risk Factors Associated With Seroconversion in La Rinconada, the Highest City of the World - 5,100 m

Conditions
-----------------
Covid19, High Altitude

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age > 18 years. Exclusion Criteria: Age < 18 years. Inability to give informed consent.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France)|Presence of specific SARS-CoV-2 antibodies (IgM or IgG).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Prevalence of seroconversion for SARS-CoV-2. |  | Through study completion, an average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Occupational and environmental exposures associated with SARS-CoV-2 seroconversion. |  | Through study completion, an average of 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevalence, Covid-19, SARS-CoV-2, Hight altitude
Deep Brain Stimulation in Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of deep brain stimulation surgery on movement-related cortical potentials in patients with Parkinson's disease.

Detailed Description
-----------------
Patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona will have electroencephalographic (EEG) measurements with the stimulator on followed by EEG measurements with the stimulator off. Patients who are scheduled to have deep brain stimulation surgery for Parkinson's disease will have EEG measurements before and after surgery.

Official Title
-----------------
The Effect of Deep Brain Stimulation on Movement-Related Cortical Potentials in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Procedure: Deep brain stimulation surgery.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona, or who are scheduled to have deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona. Exclusion Criteria: Patients unable to do repetitive dorsiflexion of the wrist due to orthopedic problems. Pregnant women. Prisoners or institutionalized individuals.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 82 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Ten patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona. | Procedure: Deep brain stimulation surgery.<br>* Deep brain stimulation surgery.<br>|
| Experimental: B<br>Ten patients who are scheduled to have deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona. | Procedure: Deep brain stimulation surgery.<br>* Deep brain stimulation surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary measures are six EEG bereitschaftspotential areas and amplitudes. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's disease rating scale score. |  | At time of EEG measurement. |