linjc16/ctgov huggingface dataset:
A Novel Protocol for Labour Induction

Study Overview
=================
Brief Summary
-----------------
The use of foley catheter was tested many times and proved to be effective for induction of labour.

Detailed Description
-----------------
The investigators compare between vaginal misoprostol versus foley catheter plus vaginal isosorbide mononitrate (IMN) for induction of labour

Official Title
-----------------
Foley Catheter Plus Vaginal Isosorbide Mononitrate Versus Vaginal Misoprostol for Induction of Labour:a Randomised Controlled Trial

Conditions
-----------------
Failed Induction of Labor

Intervention / Treatment
-----------------
* Device: foley catheter
* Drug: Misoprostol
* Drug: Vaginal IMN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term or post term pregnancies. Live,singleton fetus. Cephalic presentation. Intact membrane. Bishop score < 6. Not in labour. Medically indicated for labour induction. Primigravida or parity of 3 or less. Exclusion Criteria: Previous caesarean delivery. Malpresentation. Placenta previa. Sever intrauterine growth restriction. Multiple pregnancy. Polyhydramnios. Oligohydramnios. Bishop score 7 or more.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: folye catheter plus vaginal IMN<br>intracervical foley catheter plus vaginal IMN | Device: foley catheter<br>* foley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours<br>Drug: Vaginal IMN<br>* IMN vaginal 40 mg every 4-6 hours<br>|
| Active Comparator: Misoprostol vaginally<br>intravaginal misoprostol | Drug: Misoprostol<br>* misoprostol 50 Ug , vaginally every 4-6 hours<br>* Other names: misoprostol vaginally;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caesarean section rate | caesarean section | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time from induction to delivery | from the insertion of the foley catheter to delivery | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labour induction, Foley catheter, misoprostol, isosorbide mononitrate
Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.

Official Title
-----------------
A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate (Seroquel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian Female and/or male, aged between 18 and 60 years (inclusive) Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: [20.1] paranoid schizophrenia, [20.2] hebephrenic schizophrenia, [20.3] catatonic schizophrenia, [20.5] undifferentiated schizophrenia Exclusion Criteria: CCMD-3 diagnosis of mental retardation Psychosis judged to be the direct physiological effect of an abused medication or substance

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine Fumarate (Seroquel)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PANSS total score at Day 56 (LOCF) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PANSS positive scale score at Day 56 (LOCF) |  |  | 
| Change from baseline in PANSS negative scale score at Day 56 (LOCF) |  |  | 
| Change from baseline in PANSS EC score at day 56 , |  |  | 
| Change from baseline in MADRS total score at Day 56. etc |  |  |
Racial Disparities in Pneumococcal Vaccination in Managed Care

Study Overview
=================
Brief Summary
-----------------
The goal of the study was to determine effectiveness of a telephone reminder to increase pneumococcal vaccination in a managed care population.

Detailed Description
-----------------
Patients randomized to the intervention arm received a telephone call from managed care nurses asking about their pneumococcal vaccination status and whether they would like to be vaccinated. We compared six month follow-up of pneumococcal vaccination in electronic medical records for the intervention versus control group. We tested the percent vaccinated in each randomization arm using chi-square tests for proportions.

Official Title
-----------------
Racial Disparities in Pneumococcal Vaccination in Managed Care: the Effects of Randomized Telephone Outreach

Conditions
-----------------
Pneumococcal Disease Prevention

Intervention / Treatment
-----------------
* Behavioral: phone call from nurses - informational only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - recommended for pneumococcal vaccination according to age or medical comorbidity Exclusion Criteria: - already known to have received pneumococcal vaccine

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

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: phone call from nurses - informational only|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pneumococcal vaccination coverage |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumococcal vaccination coverage with no disease or efficacy outcomes recorded
Concordance of the Quotient Attention Deficit Hyperactivity Disorder (ADHD) System Report With Teacher and Parent Assessments for Symptoms of ADHD

Study Overview
=================
Brief Summary
-----------------
To demonstrate concordance between the Quotient ADHD System Report and standard DSM-IV based parent and teacher reported rating/assessment scales, currently the accepted method of symptom measurement for subjects diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed Description
-----------------
Public school based study for children ages 8 through 14 years of age. Children previously identified and currently receiving an Individualized Education Program (IEP) or 504 accommodations in the classroom setting for symptoms of ADHD. Open enrollment of 30 subjects, both male and female. One study visit in which subjects will perform/receive the following assessments/evaluations: Quotient ADHD System Test Vanderbilt ADHD Diagnostic Teacher Rating Scale Vanderbilt ADHD Diagnostic Parent Rating Scale The primary analytical goal is to examine the extent of agreement of the Quotient ADHD System(either individual measures or in combination) with standard measures (Vanderbilt ADHD Diagnostic Teacher Rating Scale and Vanderbilt ADHD Diagnostic Parent Rating Scale) and to compare this agreement with that seen between the standard measures.

Official Title
-----------------
Concordance of the Quotient ADHD System Report With Teacher and Parent Assessments in School-Aged Children Receiving an Individualized Education Program (IEP) or 504 Accommodations in the Classroom Setting for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A student attending one of three public elementary schools in the New Hampshire School Administrative Unit #44. Age 8 through 14 years old at time of enrollment. Pre-identified as receiving an Individualized Education Program (IEP) or 504 accommodations for symptoms of ADHD in the school setting by the Special Education Coordinator in the school district. A parent/guardian of the child must be willing to participate. Exclusion Criteria: No subject will be excluded from participation based on race, ethnicity, or gender. Anyone meeting inclusion criteria, who are willing to sign consent and participate, will be included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 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
-----------------
Inattention, Hyperactivity, Impulsivity
Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU

Study Overview
=================
Brief Summary
-----------------
The prevalence of and risk factors for pressure ulcers (PUs) in critically ill patients have been poorly studied. The main objective of this study was to describe the prevalence of PUs in critically ill patients. Secondary objectives were to describe PUs, means of prevention of PUs, and factors associated with occurrence of PUs in the ICU.

Detailed Description
-----------------
Pressure ulcers (PUs) among hospitalized patients are associated with a poor prognosis and with a high cost of care. Hospitalization in the ICU is a context where there is a high risk of occurrence of PUs, prevention of which is a priority for ICU teams caring for critically ill patients. However, the literature is inconclusive regarding the prevalence of PUs among critically ill patients and the associated risk factors. The main objective of this study was to describe the prevalence of PUs among critically ill patients hospitalized in the ICU. Secondary objectives were to describe means of prevention of PUs in the ICU and the characteristics of PUs, and to identify factors either related to the ICU or patient characteristics associated with occurrence of PUs in the ICU.

Official Title
-----------------
Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU

Conditions
-----------------
Pressure Ulcer, Critical Care, Intensive Care Unit Syndrome

Intervention / Treatment
-----------------
* Other: Pressure Ulcer Evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
The inclusion criteria were : hospitalization in the ICU age ≥ 18 years. The exclusion criterion was: - refusal to participate in the study by the patient or by the patient's family when the patient was unable to consent.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pressure Ulcer Evaluation|Patient was evaluated according to presence of pressur ulcer or not|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Ulcer Presence on the study day | Presence (1) or absence (0) of pressure ulcer (however grade of pressure ulcer) during the study period which is a 1 Day Study Prevalence | Through study completion, an average of 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of Pressure Ulcer on the study day | Grade (from 1 to 4) of pressure ulcer during the study period which is a 1 Day Study Prevalence | Through study completion, an average of 1 day | 
| Area of Pressure Ulcer on the study day | Area on the patient's body of pressure ulcer during the study period which is a 1 Day Study Prevalence | Through study completion, an average of 1 day |
Dexamethasone for Cardiac Surgery Trial

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double-blind trial, comparing clinical outcomes after the administration of high-dose dexamethasone versus placebo in patients undergoing heart surgery with the use of cardiopulmonary bypass. The primary endpoint is the occurrence of major complications (including all-cause mortality, myocardial infarction, stroke, renal failure, and prolonged mechanical ventilation) in the first 30 days after surgery.

Official Title
-----------------
Dexamethasone for Cardiac Surgery Trial

Conditions
-----------------
Systemic Inflammatory Response Syndrome, Cardiac Diseases, Postoperative Complications

Intervention / Treatment
-----------------
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All types of cardiac surgery in which cardiopulmonary bypass is used Exclusion Criteria: Age under 18 years Life-expectancy < 6 months Emergency operations Re-operations within the same admission

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br> | Drug: Dexamethasone<br>* 1 mg per kg as a single dose before initiation of cardiopulmonary bypass<br>|
| Placebo Comparator: Placebo<br> | Drug: Dexamethasone<br>* 1 mg per kg as a single dose before initiation of cardiopulmonary bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) |  | 30 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart surgery, Cardiopulmonary bypass, Systemic Inflammatory Response Syndrome (SIRS)
Membrane Blue Versus Infracyanine Green

Study Overview
=================
Brief Summary
-----------------
To compare possible toxicities of membrane blue and infracyanine green in vivo by macular function and peripheral visual field.

Official Title
-----------------
Comparison of Macular Function and Visual Fields After Membrane Blue or Infracyanine Green Staining in Vitreoretinal Surgery

Conditions
-----------------
Macular Pucker, Macular Hole

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular pucker or macular hole Exclusion Criteria: Any other retinal disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MB<br> | |
| IFCG<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity, macular thickness and peripheral visual field |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular pucker, Macular hole, Membrane Blue, Infracyanine Green, Peripheral Visual Field
Reduction of Nosocomial Vancomycin -Resistant Enterococci (VRE) Colonization and Infection by Active Surveillance and Intervention of Infection Control

Study Overview
=================
Brief Summary
-----------------
Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial pathogen of health-care associated infection since 1988. Although the new antimicrobial agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the treatment of VRE, but there was not appropriate drugs for eradicating the colonization of VRE. So the active surveillance and strict contact precaution are the best methods for VRE colonization and transmission. This is a one year study program, we select a unit as the study site. First month (January) is the prepare period. Therefore , we collect 3 months (from February to April) baseline data, then interrupted one month(May) for the health care worker's infection control education. Then the intervention period are three months (from June to August), and the last four months(from September to December) are the analysis and evaluation period. In the baseline period, we only do the patient's active surveillance and environmental culture. In the intervention period, beside the patient's active surveillance and environmental culture, we add contact precaution as the infection control method. If patient has VRE infection, we prescribe appropriate antibiotic therapy until the culture result proved no growth of VRE. The aim of this study is to compare and analyze these two period (baseline period and intervention period) for understanding the transmission, risk factors and carriage rate of VRE, as the important guidelines for the VRE infection control in the future.

Official Title
-----------------
Reduction of Nosocomial VRE Colonization and Infection by Active Surveillance and Intervention of Infection Control (no)

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted to RCC unit Exclusion Criteria: if the patients or family refused the exam of anal swab .

Ages Eligible for Study
-----------------
Minimum Age: 20 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
-----------------
for the active surveillance of VRE colinization and infection
Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients

Study Overview
=================
Brief Summary
-----------------
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed.

Official Title
-----------------
Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Procedure: Procedure: Heart Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age 18 and older Active on the transplant list Donor organ with Antibody and NAT (nucleic acid test) positive for HCV HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy. Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject Patients listed for multiple organ transplant (heart and kidney or heart and liver) can be included based on agreement of non-cardiac organ transplant team Exclusion Criteria: Participants co-infected with HIV Donor previously treated with an NS5a containing regimen (if treatment history of donor known) Known allergies or hypersensitivity to DAA or ribavarin Pregnancy and/or actively breastfeeding

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Recipient of HCV positive heart graft<br>A single center, open-label, pilot study examining 10 adult HCV negative heart transplant subjects who will receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after heart transplantation. | Procedure: Procedure: Heart Transplantation<br>* A HCV negative or previously successfully treated recipient who recieves a HCV positive graft will be monitored. Patients who recieve an HCV graft will be treated for HCV according to accepted protocols.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival Rate |  | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV