linjc16/ctgov huggingface dataset:
2D Strain of Right Ventricle in Peroperative of Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery . TEE is performed for each patient of cardiac surgery during the operation time . This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction after cardiac surgery.

Detailed Description
-----------------
Monitoring of 2D strain of right ventricle free wall by TEE in perioperative of cardiac surgery : In preoperative time After sternotomy After surgery Inclusions of patients elected for aortic valve surgery without coronary diseases or previous RV dysfunction. Comparison with others echocardiographic parameters of RV evaluation Association with right ventricle insufficiency after cardiac surgery.

Official Title
-----------------
2D Strain of Right Ventricle in Peroperative Cardiac Surgery : Evaluation of Early Signs of RV Dysfunction

Conditions
-----------------
Aortic Valve Disorder

Intervention / Treatment
-----------------
* Procedure: Aortic valve surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient eligible for aortic valve surgery Exclusion criteria: previous right ventricle dysfunction severe coronary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Aortic valve surgery|Aortic valve surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2D strain modification of right ventricle after cardiac surgery |  | up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transesophageal echography, Perioperative cardiac surgery, Aortic valve replacement, 2D strain of right ventricle
Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or 21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.

Official Title
-----------------
What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Ceftazidime
* Drug: Tobramycin
* Drug: Meropenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16 years or older Diagnosis of Cystic Fibrosis Presenting with Infective exacerbation Exclusion Criteria: Unable to give consent Allergy to study medications Intolerance of aminoglycoside antibiotics Pseudomonas resistant to study antibiotics On the active transplant list or FEV1<20% predicted Pregnancy/breast-feeding Co-existent ABPA requiring a change in treatment Co-existent mycobacterial infection A previous participant in the study

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 days<br> | Drug: Ceftazidime<br>* Ceftazidime 2g TDS IV<br>Drug: Tobramycin<br>* Tobramycin 7mg/kg/day OD IV<br>Drug: Meropenem<br>* Meropenem 2g TDS IV<br>|
| Active Comparator: 14 days<br> | Drug: Ceftazidime<br>* Ceftazidime 2g TDS IV<br>Drug: Tobramycin<br>* Tobramycin 7mg/kg/day OD IV<br>Drug: Meropenem<br>* Meropenem 2g TDS IV<br>|
| Active Comparator: 21 days<br> | Drug: Ceftazidime<br>* Ceftazidime 2g TDS IV<br>Drug: Tobramycin<br>* Tobramycin 7mg/kg/day OD IV<br>Drug: Meropenem<br>* Meropenem 2g TDS IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure at completion of antibiotic course |  | 21 days | 
| Time to next exacerbation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Spirometry |  | up to 21 days | 
| Change in inflammatory markers |  | up to 21 days | 
| Change in sputum bacteriology |  | up to 21 days | 
| Adverse effects of study antibiotics |  | Up to 21 days | 
| Quality of life scores |  | Up to 21 days | 
| Change in nutritional status |  | up to 21 days |
To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Official Title
-----------------
A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics of JW0301 to C2105 in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Reference Drug or Test Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Subjects does not meet the Inclusion Criteria

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A randomized, open, single-dose, 2x2 crossover-design clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Test Drug for Period I Reference Drug for Period II | Drug: Reference Drug or Test Drug<br>* Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration<br>|
| Other: Group 2<br>Reference Drug for Period I Test Drug for Period II | Drug: Reference Drug or Test Drug<br>* Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state) | Evaluation PK for Esomeprazole after multiple dose | 0   24h | 
| Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose | Evaluation PD for ambulatory 24hr pH monitor | Baseline versus Multiple dose during 7 days |
Colorectal Surgical Site Infection

Study Overview
=================
Brief Summary
-----------------
Surgical site infection (SSI) is one of the most common postoperative complications in surgery, with high morbidity. In the tertiary-center that the investigators evaluated they had a significant rate of surgical site infection. Because of that the investigators created a care bundle of measures in order to improve the outcomes.

Detailed Description
-----------------
Prospectively the investigators implemented a care bundle of measures with retrospective analysis, to decrease SSI . The superficial, deep and organ/space infections were evaluated and compared before and after care bundle implementation. Between january 1, 2016 and December 31, 2020, 1139 patient records relating to surgical incisions were submitted for analysis.

Official Title
-----------------
Colorectal Surgical Site Infection: a Cohort Study About How Can we Decrease it

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Procedure: Bundle of measures to decreased SSI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients submitted to elective colorectal surgery between 2016, january 1 and 2020, december 31 Age > 18 years At least 30 days of follow-up Exclusion Criteria: Patients submitted to urgent colorectal surgery

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: Bundle of measures to decreased SSI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of surgical site infections | Evaluate the variation of surgical site infections during a period of 5 years | 5 years |
Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2). To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.

Official Title
-----------------
Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

Conditions
-----------------
Healthy Volunteers and Glaucoma Patients

Intervention / Treatment
-----------------
* Drug: MRZ-99030 eye drops 5mg/mL
* Drug: MRZ-99030 eye drops 20mg/mL
* Drug: Placebo to MRZ-99030 eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For stage 1: - Healthy volunteers For stage 2: - Glaucoma patients Exclusion Criteria: For stage 2: - Any relevant eye disease other than glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers low dose<br>MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days. | Drug: MRZ-99030 eye drops 5mg/mL<br> <br> |
| Experimental: Healthy volunteers high dose<br>MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days. | Drug: MRZ-99030 eye drops 20mg/mL<br> <br> |
| Experimental: Glaucoma patients<br>MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days. | Drug: MRZ-99030 eye drops 20mg/mL<br> <br> |
| Placebo Comparator: Placebo<br>Placebo eye drops, 1-3 drops three times per day, duration: 16 days. | Drug: Placebo to MRZ-99030 eye drops<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Day 1 up to day 23 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) |  | Day 1 to day 17 | 
| Maximal plasma concentration (Cmax) |  | Day 1 to day 17 |
Effect of Core Muscles Activation for the Increase of Quality in Cardiopulmonary Resuscitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether core muscle activation is effective in the increase of quality of cardiopulmonary resuscitation.

Conditions
-----------------
Cardiopulmonary Resuscitation

Intervention / Treatment
-----------------
* Other: Core muscle activation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered nurses who have experiences of CPR education Exclusion Criteria: 1. Acute/chronic pain on body 2. History of cardiovascular disease 3. History of vertebral disease including herniated disc 4. Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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: Core muscle activation<br>Core muscle will be activated by physical fitness using plank, crunch and leg extension. | Other: Core muscle activation<br> <br> |
| No Intervention: No core muscle activation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chest compression depth |  | 4 min | 
| lean depth |  | 4 min | 
| high quality chest compressions | frequency of chest compressions satisfying the condition that 5-6cm chest compression depth and lean depth less than 2mm | 4 min | 
| chest compressions rate |  | 4 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| elbow angle | measured by motion sensor during chest compressions | 4 min | 
| muscle fatigue | measured by EMG during chest compressions | 4 min |
The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will increase HRV at the end of the treatment.

Detailed Description
-----------------
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will have equal efficacy in improvement of depressive symptoms and increasement of HRV at the end of the treatment.

Official Title
-----------------
The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: Agomelatine
* Drug: Fluoxentine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asian patients Male or female 18 to 65 years outpatients DSM-IV-TR criteria for Major Depressive Disorder Exclusion Criteria: Patients with cardiac conditions and other physical conditions contraindicated for drug study Shift worker Patients known to be non-responders to fluoxetine treatment Pregnancy, or breastfeeding

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Agomelatine|nan|
|Drug: Fluoxentine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Pittsburgh Sleep Quality Index |  |  | 
| the Leeds Sleep Evaluation Questionnaire |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
agomelatin, prozac, heart rate variability, major depression, sleep, depressive symptoms
Immune Response Study of Influenza Vaccine

Study Overview
=================
Brief Summary
-----------------
An observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to side effects with the vaccine.

Detailed Description
-----------------
A randomized clinical trial will be conducted to describe immune response of seasonal influenza virus vaccine in a single center in China. 200 subjects aged 18-60 years will be enrolled under the premise of informed consent and receive one dose of vaccine. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at 0,7,14,28 days for antibody detection and split vaccine neutralizing antibody detection, determination of cellular immune function in the same time. The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.

Official Title
-----------------
Humoral and Cellular Immune Response Study of Influenza Vaccine

Conditions
-----------------
Influenza Vaccine Allergy, Cell Mediated Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 12-60 years old male or non-pregnant female volunteers clinically healthy as determined by: medical history inquiring and physical examination provide written informed consents before joining the trial Exclusion Criteria: infected with Influenza A virus subtype H1N1(2009), vaccinated with seasonal influenza vaccine, allergic to any ingredient of vaccine, autoimmune disease or immunodeficiency, active malignancy, bleeding disorder, seizure disorder, Guillain-Barre Syndrome, treatment with cytotoxic or immunosuppressive drugs within the past 6 months, receipt of blood products within the past 3 months, administration of any other investigational research agents or live attenuated vaccine within 30 days, administration of subunit or inactivated vaccines within 14 days, axillary temperature over 37.0℃ at the time of vaccination.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza vaccine, immune response, dynamic changes
Validation of the Spanish Version of the Neck Disability Index

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to adapt the Neck Disability Index (NDI)and the Cervical Core Set 6 (CCS6) to the Spanish population. Other objectives are to determine the correlation between intensity of cervical pain, degree of disability, and quality of life; to determine the correlation between the NDI, CCS6 and the Northwick Park Neck Pain Questionnaire; and to determine factors that predict the chronification of disability.

Official Title
-----------------
Validation of the Transcultural Adaptation of the Neck Disability Index in the Spanish Population

Conditions
-----------------
Cervicalgia, Neck Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who visit physician for cervicalgia with or without referred pain must be able to read and write Exclusion Criteria: disease of central nervous system, with or without treatment migraine indications for surgery suspicion of systemic disease

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neck pain, Cervicalgia, Quality of life, Disability