linjc16/ctgov huggingface dataset:
Effects of Pioglitazone in Congenital Adrenal Hyperplasia

Study Overview
=================
Brief Summary
-----------------
Congenital adrenal hyperplasia, an autosomal recessive condition, is mainly caused by mutations in the gene 21-hydroxylase and is treated with glucocorticoids in a slightly supraphysiological dose. Adult patients seem to be characterized by insulin resistance, which may be caused by the glucocorticoids and/or the accompanying obesity. The hypothesis of this study is that pioglitazone can improve insulin sensitivity and correlated cardiovascular risk factors in this specific group of patients. This will be tested in a randomized, placebo-controlled, cross-over trial; insulin sensitivity will be quantified by euglycemic hyperinsulinemic clamp studies.

Official Title
-----------------
Effects of Pioglitazone in Glucocorticoid-Induced Insulin Resistance. Studies in Congenital Adrenal Hyperplasia.

Conditions
-----------------
Congenital Adrenal Hyperplasia

Intervention / Treatment
-----------------
* Drug: Pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biochemical and genetically proven congenital adrenal hyperplasia stable corticosteroid replacement for 3 months Exclusion Criteria: age < 18 years inability to give informed consent significant cardiovascular disease, defined as myocardial infarction or stroke, six months preceding the study significant renal disease, GFR < 30 ml/min significant liver disease, defined as more than 3 times upper limit of normal values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) pregnancy mental disease

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis

Conditions
-----------------
Bacterial Conjunctivitis

Intervention / Treatment
-----------------
* Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
* Drug: AL-15469A 0.5%
* Drug: AL-6515 0.3%
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients of any race 5 years of age and older at the time of the Day 1 visit with a primary clinical diagnosis of bacterial conjunctivitis. Exclusion Criteria: Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days Presence of punctal plug or punctal occlusion Visual Acuity worse than 20/80 Upper respiratory infection

Ages Eligible for Study
-----------------
Minimum Age: 5 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: AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension<br> | Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension<br>* Topical ocular dosed 3 times per day for 3 days<br>|
| Experimental: AL-15469A 0.5%<br> | Drug: AL-15469A 0.5%<br>* Topical ocular dosed 3 times per day for 3 days<br>|
| Experimental: AL-6515 0.3%<br> | Drug: AL-6515 0.3%<br>* Topical ocular dosed 3 times per day for 3 days<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* Topical ocular dosed 3 times per day for 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Clinical Cure rate |  | Day 3 | 
| End of therapy Clinical Cure rate |  | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained bulbar conjunctival injection |  | Day 3 | 
| Microbiological Success |  | Day 4 |
Covered Stents in Treatment of Coronary Artery Perforation

Study Overview
=================
Brief Summary
-----------------
Covered stents have been mainly used for treatment of potentially life-threatening coronary artery perforation and coronary artery aneurysm. Prior studies suggest that the use of covered stents improves event-free survival, enabling a life-threatening situation to be managed without emergency surgery and with significantly reduced rates of mortality, cardiac tamponade, and major adverse cardiac events. Although the devices are used for a long time, very limited study has described procedural-related outcomes with this specific technology. We therefore want to report procedural, in-hospital and long term outcomes among patients treated with the covered stents.

Official Title
-----------------
Procedural and 1-year Outcomes Following Large Vessel Coronary Artery Perforation Treated by Covered Stents Implantation: Multicentre CRACK Registry

Conditions
-----------------
Coronary Artery Perforation

Intervention / Treatment
-----------------
* Device: Percutaneus Coronary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Iatrogenic, peri-PCI CAP treated with covered stent implantation Exclusion Criteria: CAP caused due to other cause than PCI PCI of other vascular territories during the same procedure

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consecutive patients treated with covered stents post PCI CAP<br> | Device: Percutaneus Coronary Intervention<br>* Covered Stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) | MACE | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Thrombosis (ST) | ST | 1 year | 
| Cardiac Death | CV Death | 1 year | 
| Target Lesion Revascularization (TLR) | TLR | 1 year | 
| Myocardial Infarction (MI) | MI | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous coronary intervention, Coronary artery perforation, Covered stent
Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2

Study Overview
=================
Brief Summary
-----------------
Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal is an interesting option due to the simplicity and non-invasive nature of its calculation. The present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.

Detailed Description
-----------------
This is a prospective and observational study designed to test the accuracy and precision of the non-invasive capnodynamic cardiac output measurement in mechanically ventilated patients. We will study 30 patients undergoing cardiovascular by pass in which an invasive trans-thoracic thermodilution method (PICCOScience) is indicated - the reference method. A pair of thermodilutions and capnodynamic cardiac output measurement will be performed along the surgery. Analysis of precision will be done at the begining of the protocol and during stable hemodynamic conditions. Accuracy will then assessed using the Bland-Altmann plot and regression analysis.

Official Title
-----------------
Accuracy and Precision of Non-invasive Effective Pulmonary Perfusion Measurement Using Volumetric Capnography

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Programmed cardiac surgeries Surgeries with cardiopulmonary bypass Exclusion Criteria: Emergency surgeries. Acute pulmonary diseases Contraindication of femoral catheters. Need of counter-pulsation baloon

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing cardiovascular surgery<br>Patients ASA 3-4 undergoing cardiac surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy and precision of capnodynamic to measure cardiac output | Comparison between a reference method (thermodilution) with a new one (capnodynamics) | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carbon dioxide, cardiac output, ventilation, thermodilution
Cognition Following Computer Assisted Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
A significant number of patients experience postoperative cognitive changes following total joint arthroplasty. Among other causes, the mental status change may be the result of fat and bone marrow debris embolization. We hypothesized that the use of computer assisted total knee arthroplasty, which does not utilize intramedullary alignment rods, would produce less fat and bone marrow debris embolization and, hence, fewer mental status changes.

Detailed Description
-----------------
Inclusion criteria Primary, cemented knee arthroplasty Unilateral or bilateral TKA Exclusion criteria Patient is unable to speak English Unable to read and write Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.) Patients with history of IV drug abuse Previous history of dementia Patients on mental status changing medications

Official Title
-----------------
Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study

Conditions
-----------------
Cognition, Embolism, Fat

Intervention / Treatment
-----------------
* Device: Total Knee Arthroplasty Implant (Scorpio®)
* Device: Total Knee Arthroplasty Implant (Scorpio®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary, cemented knee arthroplasty Unilateral or bilateral TKA Exclusion Criteria: Patient is unable to speak English Unable to read and write Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.) Patients with history of IV drug abuse Previous history of dementia Patients on mental status changing medications
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Computer Assisted Total Knee Arthroplasty | Device: Total Knee Arthroplasty Implant (Scorpio®)<br>* Implantation of a Total Knee Arthroplasty using a Computer Assisted Software, without Intramedullary Instrumentation<br>* Other names: Scorpio Total Knee Arthroplasty;|
| 2<br>Conventional Instrumented Total Knee Arthroplasty | Device: Total Knee Arthroplasty Implant (Scorpio®)<br>* Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation<br>* Other names: Scorpio Total Knee Arthroplasty;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Folstein Mini Mental State Examination (MMSE) |  | 6 Months Post-Operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mental Cognition Change, Fat Embolism, Bone Marrow Debris Emboli, Computer Assisted Total Knee Arthroplasty, Conventional Instrumented Total Knee Arthroplasty
VATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized study comparing VATS( Video-Assisted Thoracoscopy ) to reinsertion of a Thoracostomy Tube in patients with retained haemothorax. The hypothesis is that early VATS as opposed to reinsertion of a thoracostomy tube , will lead to less complications and shorter hospital stay.

Official Title
-----------------
VATS( Video-Assisted Thoracoscopy ) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax A Single Center Prospective Randomized Study

Conditions
-----------------
Haemothorax, Empyema

Intervention / Treatment
-----------------
* Procedure: VATS ( Video-Assisted Thoracoscopy )
* Procedure: Thoracostomy Tube reinsertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and radiological diagnosis of retained haemothorax Thoracostomy tube blockage or failure to drain Exclusion Criteria: more than one attempt at thoracostomy tube drainage unable to consent to trial coexisting pathology requiring other interventions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thoracostomy Tube<br>patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube for traumatic haemothorax | Procedure: Thoracostomy Tube reinsertion<br>* the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax<br>|
| Active Comparator: VATS<br>patients selected for VATS after failure of first thoracostomy tube drainage of traumatic haemothorax will undergo a Video-Assisted Thoracoscopic clearance of the persistent/retained haemothorax | Procedure: VATS ( Video-Assisted Thoracoscopy )<br>* the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of hospitalization | number of days spent in hospital | patients will be followed during their hospital stay, average 5-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients that develop empyema | each arm of the study will be monitored for septic complications , specifically empyema of the pleural cavity | 2 months form initial injury | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VATS( Video-Assisted Thoracoscopy ), Thoracostomy Tube, Empyema, Thoracotomy
A Study To Explore The Effect On Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.

Study Overview
=================
Brief Summary
-----------------
After a nasal allergen challenge it should be possible to measure markers of inflammation that may be useful to assess the properties of future drugs. If these markers are reproducible and impacted by the study drugs they could be useful for future drug development.

Official Title
-----------------
A Double Blind (3rd Party Open), 3-Way Crossover Study To Explore The Reproducibility Of Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis (Out Of Season) And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Ibuprofen
* Drug: Fluticasone propionate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects with seasonal allergic rhinitis (out of season). Sensitive to ragweed skin prick test and screening nasal allergen challenge. Exclusion Criteria: Subjects with significant concomitant diseases. Subjects with symptoms of allergic rhinitis in 2 weeks prior to screening. Female subjects that are pregnant or nursing. Subjects with hypersensitivity to study drugs or allergen challenge.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br> | Drug: Ibuprofen<br>* 800 mg oral<br>|
| Experimental: Fluticasone propionate<br> | Drug: Fluticasone propionate<br>* 200 mcg intra-nasal<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal inflammatory markers |  | 8h 45 min post dose | 
| Acoustic rhinometry |  | 8h 45 min post dose | 
| Nasal symptom scores |  | 8h 45 min post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry |  | 8h 45 min post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinitis Nasal Allergen Challenge Inflammatory Markers
Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT)

Detailed Description
-----------------
This is a multi-center, double-blind, randomized, active-controlled study.

Official Title
-----------------
Efficacy of Tegoprazan Based Bismuth Quadruple Therapy Compared With Bismuth Quadruple Therapy for Helicobacter Pylori Infection: Randomized, Double-blind, Active-Controlled Study

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: Tegoprazan
* Drug: Lansoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection Exclusion Criteria: patients who have H.pylori eradication history patients with history of gastric cancer surgery patients who have taken antibiotics within 4 weeks prior to trial a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine pregnant or breastfeeding women

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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: tegoprazan based bismuth quadruple therapy group<br>tegoprazan based bismuth quadruple therapy group | Drug: Tegoprazan<br>* oral administration of tegoprazan-based bismuth quadruple therapy(tegoprazan 50 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 days<br>|
| Active Comparator: PPI based bismuth quadruple therapy group<br>PPI based bismuth quadruple therapy group | Drug: Lansoprazole<br>* oral administration of PPI-based bismuth quadruple therapy(lansoprazole 30 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori eradication rate of each group | H. pylori eradication rate of each group | UBT test 4 weeks after completion of eradication treatment |
New Urine and Blood Markers for Acute Kidney Injury in Liver Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find new blood and urine tests that detect acute kidney injury earlier than our current blood tests in patients receiving a liver transplant.

Detailed Description
-----------------
Patients with end stage liver disease that receive a liver transplant will be studied to determine if novel serum and urine biomarkers (serum cystatin C, urine interleukin-18 [IL-18] and urine neutrophil gelatinase associated lipocalin [NGAL]) can predict the outcome measures listed above.

Official Title
-----------------
Early Biomarkers of Acute Kidney Injury in Liver Transplant Patients

Conditions
-----------------
Renal Insufficiency, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time liver transplant recipient Cadaveric or living donor livers Exclusion Criteria: Unconscious patients or patients who cannot give consent Pregnant women Prisoners Patients receiving dialysis before or during liver transplant operation Patients receiving simultaneous liver-kidney transplants

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver transplant recipients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of acute kidney injury as defined by a 50% increase in serum creatinine |  | Within 2 to 5 days of liver transplant that is sustained for at least 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of severe acute kidney injury, as defined as a doubling of serum creatinine |  | Within 2-5 days of transplant that is sustained for at least 24 hours | 
| The need for renal replacement therapy |  | After liver transplant operation to discharge | 
| All cause mortality |  | After liver transplant operation to discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biological Markers, Renal Replacement Therapy, Mortality