linjc16/ctgov huggingface dataset:
Age-Dependent Impact of the SYNTAX-score on Mortality

Study Overview
=================
Brief Summary
-----------------
The SYNTAX-score has been proposed as a tool for risk stratification and guiding revascularization therapy in patients with complex coronary artery disease. There are limited data on the prognostic value of the SYNTAX-score among elderly patients. Aim of this study was to investigate whether age modifies the impact of the SYNTAX-score on all-cause mortality at 2 years after percutaneous coronary intervention (PCI).

Detailed Description
-----------------
SYNTAX score has been used as a tool to quantify severity of coronary artery disease. Interventional or operative treatment of patients is associated with improvement in SYTAX score after PCI so called residual SYNTAX score. The higher the SYNTAX score value the higher is the mortality. Whereas this is true for both young and old patients is debatable. Therefore we aim to investigate in this registry age-dependent impact of baseline and residual SYNTAX score on 1- and 2-year mortality after PCI

Official Title
-----------------
Age-Dependent Impact of the SYNTAX-score on Mortality After Percutaneous Coronary Intervention in an All-Comer Population

Conditions
-----------------
Coronary Artery Disease, PCI

Intervention / Treatment
-----------------
* Procedure: PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing PCI at our center Exclusion Criteria: prior coronary artery bypass grafting no PCI

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 undergoing PCI<br>all-comer population undergoing PCI | Procedure: PCI<br>* treatment of coronary arteries and evaluation of SYNTAX score pre and post (to quantify severity of disease)<br>* Other names: percutaneous coronary intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medium- to long-term Mortality | Overall mortality | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SYNTAX score, PCI, elderly
Full Plate Diet Study

Study Overview
=================
Brief Summary
-----------------
Comparison between two groups, experimental and control. Experimental will undergo lectures on a diet to increase fiber consumption. Blood tests and anthropometric measures will be done before and after the 3-months long program. Comparisons will be made pre and post and with groups.

Detailed Description
-----------------
The Full Plate Diet Clinical Trial is a study that will verify if the three months course is sufficient to change diet behavior of the participants. Forty participants will be recruited and then randomly assigned to one of two groups (20 in each group): The Experimental group will attend one weekly session with instructions on how to increase fiber intake; Control group will not have the intervention. The goal of the study is to see if the Full Plate Diet program will improve blood measures of metabolic diseases and weight.

Official Title
-----------------
Full Plate Diet Clinical Trial

Conditions
-----------------
Diet Modification

Intervention / Treatment
-----------------
* Other: Full Plate Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any gender and age between 21-65 years Exclusion Criteria: BMI between 25 to 35, no debilitating disease, no previous participation in the FPD program, no allergies to beans

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FPD group<br>This group will undergo three months of weekly lectures to incorporate more fiber in their diet. | Other: Full Plate Diet<br>* 12 weekly sessions on how to incorporate more fiber in the diet.<br>|
| No Intervention: FPD Control group<br>This group will receive all the assessments before, during and after the three months program period but will not attend the weekly lectures. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | weight and height will be combined to report BMI in kg/m^2 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Fat | Body Fat % measured by InBody 520 BIA machine | 3 months | 
| Lipids | Measure of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides | 3 months | 
| HbA1C | Glycated Hemoglobin | 3 months |
Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight < 1250 g and have ureaplasma urealyticum colonization.

Conditions
-----------------
Chronic Lung Disease

Intervention / Treatment
-----------------
* Drug: Clarithromycin
* Drug: Dextrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The babies under 1250 gram The babies must be appropriate for gestational age Exclusion Criteria: Multiple congenital anomalies or known syndromes Intrauterine growth retardation with birthweight less than 10 percentile for gestational age

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 2 Days

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clarithromycine Group: Active Comparator<br>Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days) | Drug: Clarithromycin<br> <br> |
| Placebo Comparator: Placebo Group: Placebo Comparator<br>Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days. | Drug: Dextrose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges | Efficacy of clarithromycin in eradication of Ureaplasma and incidence of CLD were the major outcomes of the study. Nasopharyngeal swabs for Ureaplasma were taken in postnatal first 3 days and on the 12th day only in culture positive infants, transported to the laboratory and cultured for Uu immediately. | 12 days after treatment by clarithromycin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization. | Efficacy of clarithromycin in eradication of Ureaplasma urealyticum and incidence of chronic lung disease were the major outcomes of the study. Chronic lung disease of newborn was defined as a persistent oxygen requirement at 36 weeks post menstrual age or death. | From first day of inclusion of study to at postpartum 36th week of day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic lung disease, Clarithromycin, Ureaplasma urealyticum
Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

Study Overview
=================
Brief Summary
-----------------
During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) < 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.

Detailed Description
-----------------
Hypothesis : the area under the ROC curves (ROC AUCs) at 1, 2 and 5 minutes of LepMAP would be superior to AMAP

Official Title
-----------------
Micro-sleep During Maintenance Wakefulness Tests

Conditions
-----------------
Lobectomy, Hepatectomy, Pancreaticoduodenectomy

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from sleep pathologies (apneas, narcolepsy, etc.) hospitalized for polysomnography and MWT, in order to evaluate their sleepiness (usually before they resume driving) hospitalized in the Center for Sleep Medicine (Hôpital Lyon Croix Rousse) between September 2017 and January 2019 Exclusion Criteria: patient with active encephalopathy or epilepsy whose EEG was abnormal denial of study participation availability of all the recordings (n=4 tests) of the MWT

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 |
| --- | --- |
| Cohort 1<br>Cohort of 98 patients suffering from sleep disorders hospitalized between September 2017 and January 2019 in the Sleep Medicine Center of the Croix Rousse Hospital (Lyon) for objective sleepiness evaluation with polysomnography and MWT. | Other: No intervention<br>* patients have benefited from maintenance wakefulness tests as part of their clinical evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TThe primary endpoint was to determine if LepMAP was better than ΔMAP for the prediction of hypotensive event at 1, 2 and 5 minutes, defined as a mean arterial pressure of less than 65 mmHg | the number of patients with MS during MWT as well as the mean number of MS per patient will be measured | Only during perioperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maintenance Wakefulness Tests, micro-sleep, sleepiness, latency, EEG
Standard Versus Comprehensive Care for Post Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The investigators aim to compare between standard versus comprehensive care for post-acute kidney injury who are admitted with acute kidney injury at least stage 2 or receive renal replacement therapy.

Official Title
-----------------
Standard Versus Comprehensive Care for Post Acute Kidney Injury: A Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Other: Comprehensive care
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute kidney injury at least stage 2 OR Received renal replacement therapy Exclusion Criteria: Post kidney transplantation End-stage renal 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

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>Regular follow-up by internists every 3 month May consult nephrologists case-by-case | Other: Standard care<br>* Regular follow-up by internists every 3 month May consult nephrologists case-by-case<br>|
| Experimental: Comprehensive care<br>Regular follow-up by nephrologists every 1-3 month Multidisciplinary team consisting pharmacists, nurses, and dieticians | Other: Comprehensive care<br>* Regular follow-up by nephrologists every 1-3 month Multidisciplinary team consisting pharmacists, nurses, and dieticians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year major adverse kidney events |  | 1-year |
Nasal Humidified High Flow Oxygen During Weaning From Mechanical Ventilation : Ultrasonography Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.

Detailed Description
-----------------
Prospective randomized clinical multicentric study on ICU (Intensive Care University) comparing nasal humidified high flow therapy versus standard oxygen with Lung Ultrasound Score during weaning from mechanical ventilation

Conditions
-----------------
Adult Patients Ventilated More Than 48 h, Stable Respiratory and Hemodynamic Conditions for SBT, Consent of Patients, Arterial Line

Intervention / Treatment
-----------------
* Other: mechanical ventilation
* Other: mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions for SBT Consent of patients Arterial line Exclusion Criteria: COBP Laryngeal dyspnea Tracheostomy Arythmya No echogenicity Paraplegia >T8

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: optiflow<br> | Other: mechanical ventilation<br>* Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.<br>|
| Other: O2<br> | Other: mechanical ventilation<br>* Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variations of lung ultrasound score |  | 24 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung ultrasound score |  | at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation | 
| rates of patients with postextubation distress |  | during the 48th post-extubation | 
| Electrical Impedance tomography |  | at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation | 
| Epithelial and endothelial biomarkers |  | at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weaning from mechanical ventilation, Lung ultrasound, Oxygen inhalation therapy
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized controlled trial to investigate the effects of Real-time 3D transesophageal echocardiography (RT3D-TEE)-guided mitral valve repair on surgical failure and 1-year reoccurrence of mitral valve regurgitation in patients with degenerative mitral value disease.

Official Title
-----------------
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease

Conditions
-----------------
Degenerative Mitral Valve Disease

Intervention / Treatment
-----------------
* Procedure: RT3D-TEE-guided mitral valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram. Informed consent was obtained Exclusion Criteria: Re-operation of mitral regurgitation Concurrent surgical plan for congenital heart disease, coronary artery bypass grafting, aortic valve surgery, radiofrequency ablation of atrial fibrillation and other cardiac surgeries. Mitral valve replacement Unable to undergo TEE

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT3D-TEE-guided mitral valve repair<br>Two experienced surgeons and two experienced echocardiography technicians jointly formulated the plan for the TEE-guided mitral valve repair. | Procedure: RT3D-TEE-guided mitral valve repair<br>* RT3D-TEE forms a surgical plan before surgery and 3 to 4 senior doctors with more than 50 cases of mitral valve repair perform the procedure.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation | mitral valve repair failure, 1-year reoccurrence of mitral regurgitation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation |  | 1 year | 
| The incidence of secondary transfer, perioperative complications |  | 1 year | 
| Intraoperative conditions including extracorporeal circulation time, aortic occlusion time |  | 1 year | 
| The recurrence rate of residual mitral valve regurgitation |  | 1 year |
Electrolyte Imbalance Analysis at Intensive Care Unit Admission : Retrospective Study

Study Overview
=================
Brief Summary
-----------------
The type and severity of electrolyte imbalance in patients admitted to the intensive care unit were analyzed.It was evaluated whether these results had an effect on mortality, length of hospital stay, APACHE II scores and ventilator days

Official Title
-----------------
Electrolyte Imbalance Analysis at Icu Admission : Retrospective Study

Conditions
-----------------
Electrolyte Imbalance

Intervention / Treatment
-----------------
* Other: electrolyte imbalance analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all of the ıcu patients - Exclusion Criteria: -

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 |
| --- | --- |
| sodium (hypo-hyper-normonatremia)<br> | Other: electrolyte imbalance analysis<br>* ın this retrospective study we aimed to evaluate the relationship between the ıcu prognosis and the electrolyte imbalance<br>|
| potassium (hypo-hyper-normokalemia)<br> | Other: electrolyte imbalance analysis<br>* ın this retrospective study we aimed to evaluate the relationship between the ıcu prognosis and the electrolyte imbalance<br>|
| calcium (hyper-hypo-normocalcemia)<br> | Other: electrolyte imbalance analysis<br>* ın this retrospective study we aimed to evaluate the relationship between the ıcu prognosis and the electrolyte imbalance<br>|
| magnesium (hyper-hypo-normocalcemia)<br> | Other: electrolyte imbalance analysis<br>* ın this retrospective study we aimed to evaluate the relationship between the ıcu prognosis and the electrolyte imbalance<br>|
| phosphor (hypo-hyper-normophosphatemia)<br> | Other: electrolyte imbalance analysis<br>* ın this retrospective study we aimed to evaluate the relationship between the ıcu prognosis and the electrolyte imbalance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The analysis the electrolyte imbalance in ICU and the relationship between the icu prognosis. | Natremia (Hypo: <136 mmol/L, Normo: 136-145 mmol/L, Hyper: >145 mmol/L) Kalemia (Hypo: <3.5 mmol/L, Normo: 3.5-5.5 mmol/L, Hyper: >5.5 mmol/L) Calcemia (Hypo: <8.8 mg/dL, Normo: 8.8-10.6 mg/dL, Hyper: >10.6 mg/dL) Magnesemia (Hypo: <1.9 mg/dL, Normo: 1.9-2.5 mg/dL, Hyper: >2.5 mg/dL) Phosphatemia (Hypo: <2.5 mg/dL, Normo: 2.5-4.5 mg/dL, Hyper: >4.5 mg/dL) The number of patients in all types of electrolyte imbalance will be determined. The effect of the type of electrolyte imbalance on mortality, APACHE-II score and length of invasive ventilation and hospital stay will be evaluated. | 2 years |