linjc16/ctgov huggingface dataset:
Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety profile of the combination of Levosimendan and beta blocker in cardiogenic shock with arrythmia.

Official Title
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Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study

Conditions
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Cardiogenic Shock, Arrythmia

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment Exclusion Criteria: Patient's opposition

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

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 |
| --- | --- | --- |
| To record adverse events and observe the safety profile of patients in cardiogenic shock who received concomitant treatment with Levosimendan and IV beta blocker | Incidence of adverse events leading to discontinuation of beta blocker: bradycardia/high-grade atrioventricular block/hypotension/noradrenaline increase/crystalloid resuscitation | From the start of the beta blocker until 7 days after the start of the Levosimendan treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure cardiac rhythm control; Measure heart rate control; Measure beta blocker dosages administered without adverse effects; Measure veno-arterial extra corporeal membranous oxygenation weaning rate; Measure resuscitation mortality | Description of adverse events related to beta blocker Efficacy of beta blocker (rhythm and/or rate control) Time to resolution after discontinuation of beta blocker in case of adverse event Maximum dosage of well-tolerated beta blocker; Evolution of the haemodynamic profile in the hours following the introduction of the beta blocker Resuscitation mortality Weaning from veno-arterial ECMO at D7 of Levosimendan treatment | From the start of the beta blocker until 7 days after the start of the Levosimendan treatment ; Haemodynamic changes will be recorded every 2 hours from the start of the beta blocker |
Factors Influencing Cardiovascular Prognosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify risks for cardiovascular events in a follow up period of 10 years.

Detailed Description
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Inclusion criteria Age > 50 years volunteers (2 towns of 15000 residents one in the north and one in the south of Greece) End points 5-10 years cardiovascular morbidity and mortality Measurements at baseline Anthropometrics Age (M>55 years; W>65 years) Weight-height- BMI Abdominal obesity (Waist circumference>102 cm(M), >88cm (W) Family history Family history of premature CV disease (M at age<55 years; W at age<65 years) History Smoking Diabetes Mellitus, Established Heart disease: myocardial infarction; angina; coronary revascularization; heart failure Established renal disease [diabetic nephropathy; renal impairment (serum creatinine M>133, W>124 mmol/l); proteinuria (> 300 mg/24 h)] Cerebrovascular disease: ischaemic stroke; cerebral haemorrhage; transient ischaemic attack Peripheral artery disease Advanced retinopathy: haemorrhages or exudates, papilloedema Treatment Measurements Measurements Blood pressure Clinic BP 24h ABPM Home BP Heart Electrocardiographic LVH Echocardiographic LVH Vessels Carotid wall thickening or plaque Carotid-femoral pulse wave velocity Ankle/brachial BP index Lipids or other risk factors Total cholesterol, Tg, HDL, LDL Plasma creatinine, estimated glomerular filtration rate Fasting plasma glucose or postload plasma glucose Microalbuminuria and albumin-creatinine ratio Glucose tolerance test Follow up each 3 year with all the above measurements

Official Title
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Factors Influencing Cardiovascular Prognosis in Hypertensive Patients (Pythia Study)

Conditions
-----------------
Cardiovascular Mortality

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: All age >50 volunteers Exclusion Criteria: None

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for CV events |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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cardiovascular morbidity, mortality community study
Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis

Study Overview
=================
Brief Summary
-----------------
For patients with initially unresectable colorectal liver metastasis (IU-CRLM) receiving effective conversion therapy, disease relapse after conversion hepatectomy is common due to the extensive tumor load. Yet, few studies have focused on the assessment and management of relapse after conversion hepatectomy for IU-CRLM. This study aimed to investigate the impact of surgical management for relapse after conversion hepatectomy in IU-CRLM.

Official Title
-----------------
Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis

Conditions
-----------------
Colorectal Cancer, Liver Metastases

Intervention / Treatment
-----------------
* Procedure: Repeat Liver Surgery
* Procedure: Non-Repeat Liver Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: initially unresectable colorectal liver metastasis (IU-CRLM) received conversion therapy underwent conversion hepatectomy Exclusion Criteria: the histologic type of CRLM was not called adenocarcinoma uncontrollable extrahepatic metastases, such as peritoneal, bone, brain metastasis history of previous hepatectomy the primary tumor was not resected or palliative resection R1 or R2 liver resection

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| repeat liver surgery<br>repeat liver surgery for liver relapse lesions | Procedure: Repeat Liver Surgery<br>* repeat liver surgery included not only hepatectomy, but also ablative treatment, including radiofrequency ablation (RFA) and microwave ablation (MWA)<br>|
| non-repeat liver surgery<br>non-repeat liver surgery, just only systemic palliative chemotherapy | Procedure: Non-Repeat Liver Surgery<br>* Systemic palliative chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Overall survival after the first resection of liver metastatic lesions | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first relapse free survival | relapse free survival after the first resection of liver metastatic lesions | 5 years | 
| second relapse free survival | relapse free survival after the repeat liver surgery of liver metastatic lesions | 5 years | 
| Severe complication rate after resection of primary and metastatic lesions | Grade of III-V complication rate according to Clavien-Dindo | 30 days after surgery |
Korea Surgical Quality Improvement Program

Study Overview
=================
Brief Summary
-----------------
The member of National Evidence-based Healthcare Collaborating Agency and the planning committee of Korean Association of hepato-biliary pancreatic Surgery established the protocol of Korean Surgical Quality Improvement Program (KSQIP) with verifying variables of American College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP and National Clinical Database (NCD) of Japan; demographics, preoperative information, laboratory values, operation finding, general occurrences, postoperative occurrences, and follow-up data to develop post cholecystectomy complication risk model. The 50 surgeons from 20 hospitals have decided to participated in the primary prospective study to apply KSQIP to cholecystectomy. The investigators developed web-based database system (http://www.ksqip.org/gb) and surgical clinical reviewer of each hospital will fill out the case report form. Finally, the investigators will provide a risk-adjusted surgical risk calculator and feedback system for reducing complication.

Official Title
-----------------
Development of Cholecystectomy Complication Predictive Model for Developing the Surgical Quality Improvement Program

Conditions
-----------------
Cholecystectomy

Intervention / Treatment
-----------------
* Procedure: cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis Exclusion Criteria: Under 18 age Who underwent other abdominal surgery simultaneously Gallbladder Cancer, cholangiocarcinoma Who did not agree with participation

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

| Intervention/Treatment |
| --- |
|Procedure: cholecystectomy|Laparoscopic surgery Reverse Trendelenburg position Skin incision and trocar insertion CO2 gas insufflation Intra-abdominal inspection and gallbladder exposure Gallbladder traction Calot triangle exposure Cystic artery and cystic duct isolation Gallbladder bed dissection Bleeding control Gallbladder extraction Trocar removal and wound closure Open surgery Supine position Skin incision Intra-abdominal inspection and gallbladder exposure 5. Gallbladder traction 6. Calot triangle exposure 7. Cystic artery and cystic duct isolation 8. Gallbladder bed dissection 9. Gallbladder extraction 10. Bleeding control 11. Wound closure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of bile leakage and iatrogenic duct injury |  | 1 month |
Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates

Study Overview
=================
Brief Summary
-----------------
This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated according to the 7-8-9 method.

Official Title
-----------------
Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates

Conditions
-----------------
Endotracheal Intubation

Intervention / Treatment
-----------------
* Procedure: Endotracheal tube insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Full term and preterm neonates who were admitted to NICU and needing endotracheal intubation for invasive mechanical ventilation or administration of surfactant. Delivery room intubations were not included as infants are not routinely weighed prior to resuscitation at our hospital. However, infants intubated in the delivery room who were subsequently intubated in the NICU were eligible for inclusion in our study. Exclusion Criteria: - 1. Major upper or lower airway anomalies. 2. Infants with craniofacial, vertebral anomalies. 3. Significant congenital anomalies including cardiac, abdominal or respiratory. 4. Neonates those whose parents declined consent were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The OHL method<br>the ETT insertion depth was estimated according to the OHL method. | Procedure: Endotracheal tube insertion<br>* ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method<br>|
| Active Comparator: The 7-8-9 method<br>the ETT insertion depth was estimated according to the 7-8-9 method. | Procedure: Endotracheal tube insertion<br>* ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of ETTs in abnormal position for each of both insertion depth prediction methods. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation. |  | 28 days |
Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery

Study Overview
=================
Brief Summary
-----------------
Assessment of serum level of glial fibrillary acidic protein (GFAP) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day. Neuropsychological testing before surgery and on 3 or 4 day after surgery. Investigation of relationship between changes of GFAP and scores of neuropsychological tests.

Official Title
-----------------
Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery

Conditions
-----------------
Astrogliosis, Postoperative Cognitive Dysfunction, Postoperative Delirium

Intervention / Treatment
-----------------
* Diagnostic Test: Glial fibrillary acidic protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with different diseases, who require prolonged laparoscopy or open surgery Age more than 60 ASA I-III Informed consent to participate in the study Exclusion Criteria: ASA IV-V Severe neurodegenerative or psychological diseases

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Delayed Neurocognitive decline<br>Patients in whom there is Delayed Neurocognitive Recovery (DNR) after surgery, based on neuropsychological tests or clinically. DNR is defined as follow: 1)decrease of scores of neuropsychological test scores for more than 1 standard deviation (SD) of these tests; 2)clinically - inability of patient to perform test after surgery because of neurocognitive impairment. | Diagnostic Test: Glial fibrillary acidic protein<br>* 3 samples of serum are drawn from patients. The 1st Sample of patient serum is drawn before induction into anesthesia. The 2nd is drawn 24 hours after the 1st one. The 3rd sample is drawn on 3 or 4 postoperative day. All samples collected and preserved in the same temperature as required for ELISA.<br>|
| Normal postop neurocognitive function<br>Patients in whom there is no clinical signs of DNR, defined as in previous group. | Diagnostic Test: Glial fibrillary acidic protein<br>* 3 samples of serum are drawn from patients. The 1st Sample of patient serum is drawn before induction into anesthesia. The 2nd is drawn 24 hours after the 1st one. The 3rd sample is drawn on 3 or 4 postoperative day. All samples collected and preserved in the same temperature as required for ELISA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum GFAP | GFAP(3) - GFAP (1); GFAP (2) - GFAP (1) | 1 year |
Extension to Study HMR1964A/3011 in Belgium

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.

Official Title
-----------------
Multicenter,Open,Uncontrolled,Clinical Extension Trial in Subjects With Type I Diabetes Previously Participating in Study HMR1964A/3011 in Belgium

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: INSULIN GLARGINE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects treated with HOE901 and who, in the judgement of the investigator, have benefited from the use of HOE 901 in a previous clinical study with HOE 901. Subjects treated with HOE 901 in a previous clinical study with HOE 901 for whom a change of basal insulin would destabilise glucose metabolism. Subjects who are likely to comply with the investigator's instructions. Exclusion Criteria: Evidence of an uncooperative attitude. Subject not on adequate contraception, or who is pregnant, or breast feeding. Subject unable to understand informed consent. Patient receiving or likely to receive HOE901 treatment outside of SPC or PI recommendations. Subject becomes pregnant or is planning to become pregnant.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: INSULIN GLARGINE<br>* The subjects will continue the treatment with HOE 901 in the same way as they have done in the previous study. Based on the investigator's assessment and the approved SPC in Belgium/Luxembourg, the dosage can be adjusted individually. HOE 901 is to be injected once daily. HOE 901 must not be mixed with any other insulin, including regular human insulin or fast-acting insulin analogues.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of efficacy parameters between first study visit (V1) and last study visit (V5) |  | Mean time interval: 10 months |
Effects of Pleural Effusion Drainage on Respiratory System Mechanics

Study Overview
=================
Brief Summary
-----------------
The effects of pleural drainage on lung mechanics are unknown. Insertion of esophageal balloon will allow us to measure and assess pleural pressure, and thus assess any possible effects of pleural fluid drainage may have on lung mechanics.

Detailed Description
-----------------
Esophageal balloon will be inserted prior to pleural fluid drainage.

Official Title
-----------------
Effects of Pleural Effusion Drainage on Respiratory System Mechanics in Mechanically Ventilated Patients, as Measured by Esophageal Balloon.

Conditions
-----------------
Pleural Effusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.who are candidates for pleural fluid drainage. Exclusion Criteria: Patients with any of the following were excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.

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 |
| --- | --- |
| candidates for pleural fluid drainage<br>patients who are candidates for pleural fluid drainage. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chest wall and lung compliance | The use of esophageal balloon allows us to partition respiratory system into its components, namely, chest wall and lung compliance. These measurements have not been described so far in patients undergoing pleural fluid drainage. Thus, assessment of esophageal pressure which is a surrogate of pleural pressure will allow us an accurate measurement of the effect of pleural fluid drainage on chest wall and lung mechanics. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenation | We suspect that pleural fluid drainage will be associated with improved chest wall and lung mechanics. If this will be the case, then we expect a concomitant improvement in oxygenation. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung compliance, pleural effusion, esophageal pressure