linjc16/ctgov huggingface dataset:
Evaluation of the IKORUS Technology in Patients Undergoing Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this observational substudy is to evaluate the feasibility, performance and behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new tissue perfusion device using urethral photoplethysmography in patients undergoing major abdominal surgery and in whom an advanced hemodynamic monitoring is placed.

Detailed Description
-----------------
Continuous monitoring of tissue perfusion in patients undergoing major surgery remains challenging because of the lack of tools available. Through using urethral photoplethysmography, the urethral perfusion index (uPI) could allow tissue perfusion monitoring through a modified urinary catheter. The goal of this observational study is to evaluate the feasibility , performance and behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new device in the field. We aimed to assess its performance (duration and signal quality), the uPI variations during hemodynamic events (fluid challenge) in patients undergoing major abdominal surgery and equipped with an advanced hemodynamic monitoring.

Official Title
-----------------
Evaluation of the Urethral Photoplethysmography-derived Perfusion Device (IKORUS) in Patients Undergoing Major Abdominal Surgery

Conditions
-----------------
Technology

Intervention / Treatment
-----------------
* Device: IKORUS technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients undergoing major abdominal surgeries and equipped with an advanced hemodynamic monitoring for goal directed therapy Exclusion Criteria: Atrial fibrillation Ejection fraction < 30%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: IKORUS technology|Ikorus technology is a new micro perfusion device measuring via urethral photoplethysmography, the urethral perfusion index (uPI) in patients equipped with an urinary catheter.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of uPi evolution during surgery and comparison with Stroke volume | Percentage of case time with positive correlation between both variables (positive or negative) during a fluid challenge and during the whole case | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of decreased perfusion during surgery | Occurrence of decreased perfusion during surgery | during surgery |
Retrospective Experience Of CIED Implantation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to retrospectively gather information on patients who underwent a CIED procedure with either a CanGaroo Envelope, TYRX Envelope, or no envelope.

Detailed Description
-----------------
A single center will retrospectively review up to 700 subjects who underwent implantation of a CIED with a CanGaroo Envelope, TYRX Envelope, or no envelope. All sets of subjects enrolled will also be examined for any follow-up visits and/or adverse events that occurred up to 12 months post-surgery.

Official Title
-----------------
Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology

Conditions
-----------------
Cardiac Disease, Heart Failure, Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: CanGaroo Envelope
* Device: TYRX Envelope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient that had a CIED implanted with either a CanGaroo Envelope, a TYRX Envelope, or no envelope on or after March 27, 2017 Exclusion Criteria: Any patient that had a CIED implanted with any other type of envelope Any patient that had a CIED implanted prior to March 27, 2017
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CanGaroo Envelope<br>Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation. | Device: CanGaroo Envelope<br>* CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation<br>|
| TYRX Envelope<br>Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation. | Device: TYRX Envelope<br>* TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation<br>|
| No Envelope<br>Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Infection Post Procedure | Major CIED infections are defined as a CIED infection resulting in one or more of the following: CIED system removal Any invasive procedure (e.g., pocket opened) without system removal Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage Death | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Pocket Related Issues Prompting an Office Visit | Any pocket related issues that prompted an office visit | 12 months post procedure |
Active Video Games to Promote Physical Activity in Children With Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy and feasibility of active video gaming with regard to the promotion of physical activity and motor learning in children with cancer. Experienced fatigue, body mass index and the development of metabolic risk factors during treatment are also examined.

Official Title
-----------------
Active Video Games to Promote Physical Activity, Motor Performance and Quality of Life in Children With Cancer: an Intervention Study With 2-year Follow-up

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Exercise based on active video gaming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer diagnose treated with Vincristine in Turku University Hospital or Tampere University Hospital Exclusion Criteria: other diseases limiting functional ability not able to communicate

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active video games<br>Exercise based on active video gaming | Behavioral: Exercise based on active video gaming<br> <br> |
| No Intervention: Routine care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer, average counts of dynamic acceleration (physical activity) | Change in the children's physical activity levels with accelerometer | 1 week at baseline and at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement assessment battery for children (M-ABC-2) scores (motor performance) | Change in M-ABC scores | At baseline, 2, 6, 12 and 24 months | 
| PedsQL Multidimensional Fatigue Scale scores (fatigue) | Change in experienced fatigue | At baseline, 2, 6, 12 and 24 months | 
| Blood sugar | Change in blood sugar | At baseline, 2, 6, 12 and 24 months | 
| Blood insulin | Change in blood insulin | At baseline, 2, 6, 12 and 24 months |
Pediatric and Ambulatory Research in Infectious Diseases

Study Overview
=================
Brief Summary
-----------------
Many ambulatory networks are mainly based on diagnoses made by first-line physicians not specifically trained to join the network. Here we aim to set up a surveillance network on pediatric infectious diseases with an investment in teaching with specific trainings of participating pediatricians, increasing in use of point of care tests, and automated data extraction from the computers of the pediatricians.

Detailed Description
-----------------
107 pediatricians among the 1400 members of the French ambulatory pediatric association, AFPA (Association Française de Pédiatrie Ambulatoire) were involved in this survey.To belong to the PARI network, pediatricians have to use the same software, Axi5-Infansoft (developed by CompuGroup Medical, Nanterre, France) for electronic medical record of children. The pediatricians were trained to the use of point of care tests and to the infectious diagnoses (otitis, pharyngitis, varicella, bronchiolitis, influenza, pneumonia, etc..). The study population consisted of all children under 16 years of age from the patient population for which an infectious disease was diagnosed.

Official Title
-----------------
Real Time Surveillance of Pediatric Infectious Diseases in French Ambulatory Care: PARI Study

Conditions
-----------------
Otitis, Bronchiolitis, Influenza, Pharyngitis, Varicella, Pneumonia, Gastroenteritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children under 16 years of age with at least one infectious disease among: pharyngitis otitis pneumonia influenza bronchiolitisz varicella gastroenteritis enterovirus disease bordetella pertussis disease using the same same software, Axi5-Infansoft (developed by CompuGroup Medical, Nanterre, France) Exclusion Criteria: parental refusal

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 16 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 |
| --- | --- | --- |
| Evaluation of the number of infectious diseases |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the use of point of care tests | Proportion of use of point of care tests and positivity rate according to the infectious diseases | 5 years | 
| Evaluation of the antibiotic treatments | Proportion of each antibiotic treatments according to the infectious diseases | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccination, Antibiotic treatment, Point of care test, automated data extraction, network
Influence of Organic Anion Transporting Polypeptide1B1(OATP1B1) Genotype on Rosuvastatin PK, PD and Lipid Profiles

Study Overview
=================
Brief Summary
-----------------
This study aimed to explore the influence of organic anion transporting polypeptide1B1 (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after rosuvastatin administration.

Detailed Description
-----------------
Open, one arm, single sequence study for healthy volunteers are investigated. Thirty four subjects may be enrolled. Rosuvastatin are administered once a day for 21 days. Before and after rosuvastatin administration, PK, PD and lipid profiles are investigated.

Official Title
-----------------
Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration

Conditions
-----------------
Organic Anion Transporting Polypeptide1B1 (OATP1B1), Rosuvastatin

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent) Weight: Over 55 kg, within ±20% of ideal body weight Must be reliable and willing to make themselves available during the study period Must be willing to give blood sample for genotyping Exclusion Criteria: History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease History of a significant surgical resection of gastrointestinal tract except appendectomy History or evidence of drug abuse Use any medication during the last 14 days period before first dosing Hypersensitivity to HMG-CoA reductase inhibitor Judged to be inappropriate for the study by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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: Rosuvastatin<br>rosuvastatin treatment | Drug: Rosuvastatin<br>* 20 mg once daily for 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin |  | Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid panel(LDL,HDL,TG,Total cholesterol) |  | Day 1 0h, Day 22 0h | 
| lipid metabolites |  | Day -1 0h, Day21 0h, 4h, 8h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OATP1B1, rosuvastatin
Stimulating Catheter for Lumbar Plexus

Study Overview
=================
Brief Summary
-----------------
Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. Furthermore no volume-response study has compared the success rates of the two techniques for continuous lumbar plexus block. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters decrease the minimal effective volume (MEAV) of 1.5% mepivacaine required for successful lumbar plexus block (LPB) in 50% of patients compared with conventional non-stimulating catheters.

Official Title
-----------------
Are Stimulating Catheters More Efficacy for Lumbar Plexus Block Compared With Traditional Non-stimulating Ones? A Randomized, Prospective, Blinded, up and Down Study.

Conditions
-----------------
Knee Arthritis Disease

Intervention / Treatment
-----------------
* Device: stimulong 100, pajunk, germany
* Device: plexolong 100, pajunk, germany


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing total knee arthroplasty Exclusion Criteria: diabetes coagulation disorders allergy to local anesthetic

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stimulating catheters group<br>Lumbar plexus block performed through stimulating catheter | Device: stimulong 100, pajunk, germany<br>* simulating catheter<br>|
| Active Comparator: nonstimulating catheters<br>lumbar plexus block through nonstimulating catheters | Device: plexolong 100, pajunk, germany<br>* nonstimulating catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minimum effective anesthetic volume in 50% of patients |  | thirty minutes after local anesthetic injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine requirement |  | intraoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumbar plexus block, total knee arthroplasty, stimulating catheters, peripheral nerve blocks
Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
The propose of this study to determine efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis

Detailed Description
-----------------
Chronic rhinosinusitis (CRS) is characterized by symptoms > 12 weeks Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure reduction or loss of smell) Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no studies in gentamicin irrigation in chronic rhinosinusitis. The aims of this study are to evaluate: Efficacy of gentamicin nasal irrigation in chronic rhinosinusitis (outcomes: frequency of sinusitis, frequency of antibiotic usage) Complication of gentamicin nasal irrigation usage

Official Title
-----------------
Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

Conditions
-----------------
Chronic Sinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic rhinosinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between January 1, 2005, and February 28, 2011 Gentamicin nasal irrigation usage for longer than 3 months Exclusion Criteria: Patients who used azithromycin prophylaxis within 1 year before and 6 months after started gentamicin nasal irrigation Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
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 |
| --- | --- | --- |
| Frequency of sinusitis |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of gentamicin nasal irrigation usage |  | 1 year | 
| Frequency of antibiotic usage |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic sinusitis, gentamicin nasal irrigation
Investigation of Stem Cells in Human Lipoaspirate

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this study is to enhance identification and isolation of ADSCs and adipocytes, to find the optimum culturing conditions to increase growth and volume of grafts, and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections are used in aesthetic surgery but tend to disassemble over time. If the investigators can enhance growth and volume of fat in culture, the investigators could use fat grafts in reconstruction of cancer and traumatic injury defects with the patients own cultured fat cells and grafts.

Official Title
-----------------
Investigation of Adipose-Derived Stem Cells in Human Lipoaspirate

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults (18-70 yrs) who have scheduled surgical lipectomy of the hips, abdomen, or thighs are prospective subjects for this study. Exclusion Criteria: Pregnant women will be excluded to protect the unborn child.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 18-30 yrs, 31-50 yrs, 51-70 yrs<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Viable ADSCs | Percent of viable ADSCs will be measured on fresh samples and samples refrigerated for different times. | Day of Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Apoptotic ADSCs | Percent of apoptotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days refrigerated storage. | Day of Surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adipose-derived stem cells, viable ADSCs, apoptosis, necrosis, cryopreservation