linjc16/ctgov huggingface dataset:
Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases

Study Overview
=================
Brief Summary
-----------------
This study intends to investigate the relevant risk factors of perioperation complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems. Hypothesis:Preoperative parameters could predict postoperative complications.

Detailed Description
-----------------
This study intends to investigate the relevant risk factors of perioperative complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems. We hope that the benefits will include less patients becoming seriously postoperative complications and mortality after teeth extraction surgery.We also hope the information will help doctors understand the preoperative risks better and therefore make better informed decisions.This may also reduce the overall cost of surgery for patients and hospitals.

Official Title
-----------------
Risk Factors and Prediction Model of Elderly Patients With Cardiovascular Diseases Undergoing Teeth Extraction Surgery

Conditions
-----------------
Cardiovascular Diseases, Elderly Patients, Tooth Extraction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1.Adults ≥60 years age 2.Males with cardiac diseases 3.Females with cardiac diseases 4.Listed for teeth extraction surgery - Exclusion Criteria: 1.patient with malignant arrhythmia 2.Age <60 years age 3.Adults with learning disabilities or dementia 4.Patient unwilling/unable to consent 5.Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 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 |
| --- | --- |
| older people with cardiac diseases<br>undergoing teeth extraction surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac complications | the cardiac complications during or after dental extraction,such as cardiac events, perioperative SBP ≥180 mmHg, diastolic blood pressure ≥120 mmHg, heart rate ≥120 beats per minute and increase in blood pressure by 20% or above relative to the baseline. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular diseases, Prediction model, Dental extraction, Elderly patients
Dexmedetomidine Infusion in Hypospadias Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for intraoperative and postoperative analgesia.

Official Title
-----------------
An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine and Fentanyl
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 1-12 years undergoing hypospadias repair Exclusion Criteria: Allergy to Dexmedetomidine Preoperative use of sedatives or analgesics cardiac diseases Children with mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Active Comparator: Fentanyl<br>This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable. | Drug: Fentanyl<br>* This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.<br>|
| Experimental: Dexmedetomidine and Fentanyl<br>This group received a combination of Dexmedetomidine (1 ug/kg) and Fentanyl (1.79 ug/kg). Total number of patients in this group 24. | Drug: Dexmedetomidine and Fentanyl<br>* Dexmedetomidine in a dose of 1 ug/kg initial dose then continuous infusion of 0.7 ug/kg/hr . Combined with Fentanyl at a dose of 2 ug/kg initially plus boluses of fentanyl to keep the patient hemodynamically stable.<br>* Other names: Precedex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative and postoperative fentanyl requirement (in microg/kg) |  | 6/2008-1/2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, Fentanyl, Pain, Pediatrics
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

Conditions
-----------------
Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: brimonidine/timolol fixed combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes Patient requires IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical condition Contraindication to beta-adrenoceptor antagonist or brimonidine therapy

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: brimonidine/timolol fixed combination|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP |  |  |
Comparison of Two Liraglutide Formulations in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).

Official Title
-----------------
A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 2 Formulation of Liraglutide at pH 7.7 (Formulation 3) and the Phase 3 Formulation at pH 8.15 (Formulation 4)

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments BMI (Body Mass Index) of 18.0-27.0 kg/m^2, both inclusive Exclusion Criteria: History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator Impaired renal function Any clinically significant abnormal ECG, as judged by the Investigator Active hepatitis B and/or active hepatitis C Positive human immunodeficiency virus (HIV) antibodies Known or suspected allergy to trial product(s) or related products Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures Use of any prescription or non-prescription medication, except for paracetamol and vitamins, as judged by the Investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Formulation 3<br> | Drug: liraglutide<br>* One single dose of 6.25 mg/mL administered subcutaneously<br>|
| Experimental: Formulation 4<br> | Drug: liraglutide<br>* One single dose of 6.0 mg/mL administered subcutaneously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (0-t) |  |  | 
| Cmax, maximum concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve |  |  | 
| tmax, time to reach Cmax |  |  | 
| t½, terminal half-life |  |  | 
| Terminal elimination rate constant |  |  | 
| Adverse events |  |  |
The Effect of Esomeprazole and Fundoplication on Airways

Study Overview
=================
Brief Summary
-----------------
Evaluate the prevalence of bronchial responsiveness (BHR) among patients with gastroesophageal reflux disease (GERD). Investigate correlation between bronchial reactivity and the severity of GERD, and similarly investigate the correlation between exhaled nitric oxide (NO) and the severity of GERD. Compare the effects of esomeprazole 40 mg twice daily and Nissen fundoplication on bronchial reactivity, exhaled NO, pulmonary function and quality of life.

Official Title
-----------------
The Effect of Esomeprazole and Nissen Fundoplication on Bronchial Responsiveness, Quality of Life, Exhaled Nitric Oxide and Pulmonary Function in Patients With Gastroesophageal Reflux Disease

Conditions
-----------------
Airway Responsiveness

Intervention / Treatment
-----------------
* Drug: esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 of age Diagnosis of gastroesophageal reflux disease Compliance to perform methacholine inhalation challenge (judged by the investigator) Exclusion Criteria: Known allergy to esomeprazole or any other PPI Use of systemic corticosteroids within 3 weeks before any study visit Pregnancy (in a written informed consent patients are asked to assure that they are not pregnant and they are also told to immediately stop the study medication if they become pregnant during the study) Incapability to keep a 3-week washout with usual antireflux medication prior to the first visit Regular use of PPI or H2-RA medication 3 months after fundoplication

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 |
| --- |
|Drug: esomeprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparative Study Between Thrombosis Prophylaxis Protocols

Study Overview
=================
Brief Summary
-----------------
Background: Compare the American and Brazilian protocols for prophylaxis of deep vein thrombosis (DVT), seeking to draft a new protocol, more comprehensive and applicable. Methods: A prospective study was conducted over a year, covering 212 patients, comparing the protocols on the stratification of risk of DVT, and the type of prophylaxis indicated. A new protocol was proposed, applied and compared to previous.

Detailed Description
-----------------
Not desired

Official Title
-----------------
Comparative Study Between American and Brazilian Protocols for Deep Venous Thrombosis Prophylaxis: a New Proposal

Conditions
-----------------
Prophylaxis of Deep Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent plastic surgery in the Hospital of the Medical School of Botucatu, in the period of one year Exclusion Criteria: refusal to participate in the research protocol
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Submitted to the American protocol for prophylaxis of deep vein thrombosis | |
| 2<br>Submitted to the Brazilian protocol for prophylaxis of deep vein thrombosis | |
| 3<br>Submitted to the SBCP modified protocol for prophylaxis of deep vein thrombosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prevalence of Fetal Congenital Anomalies Among Pregnant Women Attending University Hospital

Study Overview
=================
Brief Summary
-----------------
Congenital anomalies occur in 2-3% of births. They account for 20-30% of perinatal deaths. The aim is to assess the prevalence of fetal malformations in pregnant women attending University hospital

Detailed Description
-----------------
This prospective cohort study of 20225 pregnant women attended Obstetrics Department of Beni-Suef University Hospital during period (January 2016 to January 2019). A full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit): ▪ Females presented early in first trimester were scheduled for routine first trimester scan in accordance with international society of ultrasound in obstetrics and gynecology guidelines. ▪ Females presented early in second trimester were scheduled for a routine second trimester scan. ▪ Females presented afterwards, had a routine ultrasound scan for fetal malformations.

Official Title
-----------------
Fetal Congenital Anomalies Among Egyptian Pregnant Women Attending University Hospital

Conditions
-----------------
Fetal Anomaly

Intervention / Treatment
-----------------
* Device: Ultrasound scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy Exclusion Criteria: Medical conditions, chronic drug intake.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasound scan|A full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of fetal malformations in pregnant women | Females presented early in first trimester were scheduled for routine first trimester scan in accordance with international society of ultrasound in obstetrics and gynecology guidelines. ▪ Females presented early in second trimester were scheduled for a routine second trimester scan. ▪ Females presented afterwards, had a routine ultrasound scan for fetal malformations. | Up to 37 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fetal anomalies
Heart Rate Variability in Children With Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Using a prospective cohort of children admitted to the PICU, the investigators will determine HRV monitoring is feasible, if a decreased HRV in the 7 days following moderate or severe TBI in children is associated with a worse outcome 6 months post-TBI and investigate HRV as a tool that can predict adverse events (neurological crisis) within 2 days following TBI.

Detailed Description
-----------------
This is a single center prospective cohort study of 15 children <18 years, admitted to the PICU at the CHU Sainte-Justine (CHUSJ) with moderate or severe TBI (<24 hours). Neurodevelopment outcome of children will be evaluated 6 months post TBI.

Official Title
-----------------
Heart Rate Variability in Children With Traumatic Brain Injury and Neurological Outcome

Conditions
-----------------
Traumatic Brain Injury, Child Development

Intervention / Treatment
-----------------
* Diagnostic Test: HRV monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <18 years admitted to the PICU at the CHUSJ moderate TBI (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8) as - - assessed 30 minutes after TBI or upon arrival in the emergency room written parental consent. Exclusion Criteria: children fulfilling brain death criteria at the time of PICU admission (GCS 3 and loss of all brain stem reflexes) children with a pacemaker or with previously diagnosed arrhythmia (HRV monitoring not reliable) inflicted trauma (different underlying pathophysiology) patients or parents who do not speak or read English or French.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: HRV monitoring|HRV monitoring derived from electrocardiogram|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of the time with reliable HRVmonitoring in children with TBI | Feasibility of having a reliable capture and analysis of HRV 7 days post TBI | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events preceded by a decreased HRV | Adverse events will be defined as increased intracranial pressure, decreased CPP, seizure and cardiac arrest | 1 year | 
| HRV and neurological outcome | The primary outcome of neurological and functional outcome will be assessed by the Pediatric Glasgow Outcome Scale Extended (P-GOSE) 6 months post TBI. P-GOSE is an 8-point ordinal scale (1= best outcome) The score will be classified as favourable (P-GOSE 1 or 2, or decreased of P-GOSE of 1 point post PICU (∆ P-GOSE ≤1) or unfavourable (P-GOSE ≥3 or ∆ P-GOSE ≥2) | 1.5 year |
Study to Investigate Efficacy and Safety of a New Oral Contraceptive

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
Multi-center , Open, Uncontrolled Study to Investigate the Efficacy and Safety of a 4 Phasic Oral Contraceptive SH T00658 in a 28-day Regimen for 20 Cycles in Healthy Female Volunteers

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Any condition that might interfere the outcomes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)<br>* per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unintended pregnancies |  | 20 treatment cycles each consisting of 28 days and follow-up period of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event collection |  | 20 treatment cycles each consisting of 28 days |
Prospective Cohort Study of Association of Insulin Resistance/Steatosis With Hepatic Fibrosis in CHB and NAFLD

Study Overview
=================
Brief Summary
-----------------
Hepatic steatosis and insulin resistance are associated with severity of fibrosis in non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is not well established. The aim was to investigate the relationship between insulin resistance, hepatic steatosis, and fibrosis in patients with CHB.

Detailed Description
-----------------
acoustic radiation force impulse elastography

Official Title
-----------------
Association Between Insulin Resistance and Hepatic Fibrosis in Combined Chronic Hepatitis B and Non-alcoholic Fatty Liver Disease

Conditions
-----------------
Chronic Hepatitis B, Hepatic Fibrosis, Fatty Liver

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hepatitis B patients With evidences of hepatic steatosis on ultrasonography or pathology Exclusion Criteria: significant alcohol consumption or other known liver diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| HBV without FL<br>Chronic hepatitis B without steatosis | |
| HBV with FL<br>Chronic hepatitis B patients with steatosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance and fibrosis indices | Measurement for insulin resistance and fibrosis index for hepatic fibrosis assessment | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis B, Hepatic fibrosis, Steatosis