linjc16/ctgov huggingface dataset:
Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports (PBIS)

Study Overview
=================
Brief Summary
-----------------
To conduct a randomized controlled trial of School-Wide Positive Behavioral Interventions and Supports, which is a school-based prevention program aimed at reducing behavior problems in children.

Detailed Description
-----------------
To conduct a group randomized controlled trial of School-Wide Positive Behavioral Interventions and Supports. PBIS is a popular school-based prevention program aimed at reducing behavior problems in children. Staff are trained to implement behavioral focused prevention programs to address issues related to student conduct and discipline problems.

Official Title
-----------------
Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports (PBIS)

Conditions
-----------------
Problem Behavior

Intervention / Treatment
-----------------
* Behavioral: Positive Behavioral Interventions & Supports


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Public Elementary Schools All children attending the schools and staff employed were eligible for inclusion Exclusion Criteria: • None

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: School-Wide (SW)-PBIS intervention<br>SW-PBIS intervention | Behavioral: Positive Behavioral Interventions & Supports<br>* Implementation of the School-Wide Positive Behavioral Interventions and Supports model across 4 school years.<br>* Other names: Positive Behavior Supports;|
| No Intervention: Control<br>Practice as usual | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teacher ratings | teacher ratings of students prosocial behavior, emotion regulation, conduct problems, and aggressive behavior | 5 time points over 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| student discipline data | suspensions, office discipline referrals | 5 time points over 5 years | 
| school climate | teacher and student reports of school climate | 5 time points over 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Problem Behavior
Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To document the incidence of electromagnetic oversensing of ICDs during non-thoracic surgery. To identify any non-thoracic procedure with a higher incidence of generating electromagnetic oversensing. To document the ability of dual chamber ICDs to discriminate electromagnetic oversensing.

Detailed Description
-----------------
Electrocautery devices used during surgery generate a high electromagnetic field with a frequency that may result in ICD oversensing. Oversensing may in turn result in false detection of a ventricular arrhythmia and for the ICD to discharge. Because of this possibility, patients frequently have their ICDs inactivated prior to the procedure. Although oversensing appears to be highly unlikely in clinical practice, vast resources are utilized in the process of deactivating and reactivating ICDs for surgeries. In addition, there are reports of deaths from failure to reactivate ICDs following elective surgery. In this study we intend to document the incidence of oversensing, identify procedures with a higher likelihood of oversensing and evaluate the ability of dual chamber ICDs to discriminate electromagnetic oversensing.

Official Title
-----------------
Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures

Conditions
-----------------
Implantable Cardioverter-Defibrillators

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Medtronic or Boston Scientific single and dual chamber ICDs Exclusion Criteria: Non-thoracic ICD generator placement (abdominal) 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromagnetic oversensing will be reported as a percentage of the total enrolled patients |  | Assessed at time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing |  | Assessed at time of procedure | 
| Incidence of dual chamber ICDs discriminating electromagnetic oversensing. |  | At time of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electromagnetic field, Oversensing, Non-thoracic surgery
Dose Response to Recombinant Factor VIIa When Administered for Bleed

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The purpose of this trial is to investigate the dose response to recombinant factor VIIa in healthy volunteers when administered for bleed.

Official Title
-----------------
Recombinant Activated Factor VII (rFVIIa/NovoSeven) Dose Response Trial in Healthy Volunteers: A Double-Blind, Placebo-Controlled, Cross-over, Dose-Escalation Trial to Investigate the Dose Response to REcombinant Factor VIIa When Administered for Bleeding Following Punch Biopsies in Healthy Volunteers

Conditions
-----------------
Congenital Bleeding Disorder, Healthy

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages Eligible for Study: 18 Years - 60 Years Exclusion Criteria: - -

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

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

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

| Intervention/Treatment |
| --- |
|Drug: activated recombinant human factor VII|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Response to Recombinant Factor VIIa |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rFVIIa, Punch Biopsy, Dose Response, Healthy People Programs
Faster Peritoneal Solute Transfer Rate and Survival in a Pre-APD and Icodextrin Peritoneal Dialysis Cohort

Study Overview
=================
Brief Summary
-----------------
A fast peritoneal solute transfer rate (PSTR) has been linked to worse survival especially in continuous ambulatory peritoneal dialysis (PD) cohort. In more recent cohorts, where automated PD and icodextrin were more widely used, this association disappears. The current study intended to clarify whether fast PSTR is related to worse outcome in this single center cohort with minimal use of APD and no icodextrin and otherwise modern management practice. Our study found that baseline PSTR predicted patient outcome in univariate survival analysis but not in multivariate analysis. The relationship between comorbidity and faster baseline PSTR may partly explain it.

Official Title
-----------------
Faster Peritoneal Solute Transfer Rate and Survival in a Pre-APD and Icodextrin Peritoneal Dialysis Cohort

Conditions
-----------------
Peritoneal Dialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are Han Chinese; Patients prepare for dialysis in our center, and start PD within 3 months after abdominal catheterization; Patients successfully complete the first peritoneal equilibration test(PET); Follow up regularly in our PD center. Exclusion Criteria: Patients from hemodialysis to peritoneal dialysis; Patients who need peritoneal dialysis due to transplant-renal loss;
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| original cohort<br>In the original cohort, 314 patients had catheter implantation between 1st Jan, 2005 to 31st Dec 2009. 269 patients started PD and followed up in our center. 26 patients were excluded due to missing baseline peritoneal membrane function data. 243 patients (n=243, age 53.2±16.3 year) entered the analysis. | |
| validation cohort<br>The validation cohort started PD from 2015 to 2018. It was originally designed for a 12 month observational study around fluid balance. 187 patients were in the validation cohort (age 53.0±15.9 year). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between fast PSTR and worse outcome in PD. | Baseline PSTR predicted patient outcome in univariate survival analysis but not in multivariate analysis. The relationship between comorbidity and faster baseline PSTR may partly explain it. | The data collection time period of the study is over 10 years. |
Impact of Microparticles on Postoperative Complications in Surgical Patients

Study Overview
=================
Brief Summary
-----------------
Microparticles are cellular fragments which are released actively or passively under conditions of inflammation and stress. The impact of surgical operations on quantity and quality of microparticles remains unknown. In this observatory study we investigate quantitative and qualitative aspects of microparticles during cardiac and abdominal operations.

Official Title
-----------------
The Impact of Microparticles on Inflammatory Responses During Visceral and Cardiac Surgery

Conditions
-----------------
Neoplasm, Hepatic, Pancreatic Neoplasms, Colorectal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac or abdominal operations with a minimum expected operative time of 2 hours Exclusion Criteria: Laparoscopic operations emergency operations

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 |
| --- | --- |
| F64<br>We investigate a cohort of 20 consecutive patients undergoing hepatic or pancreatic surgery (Pilot study) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay |  | 30 days | 
| Mortality |  | 30 days |
A Study to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates (MK-0000-078)

Study Overview
=================
Brief Summary
-----------------
A two period pilot study to determine if a graded glucose infusion using a glucose (20% dextrose [D20]) intravenous infusion can be properly implemented and will be well tolerated in healthy subjects.

Official Title
-----------------
An Open-Label, 2-Period, Pilot Study in Healthy Male Subjects to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates

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

Intervention / Treatment
-----------------
* Procedure: Comparator: graded infusion of intravenous glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good health Subject is a non-smoker Exclusion Criteria: Subject has a history of hypertension requiring treatment Subject has a history of cancer Subject's parents of siblings have a history of type 2 diabetes Subject is unable to refrain from the use of any prescription or non-prescription medication Subject consumes excessive amounts of alcohol or caffeine Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1 + Period 2<br>graded infusion of intravenous glucose | Procedure: Comparator: graded infusion of intravenous glucose<br>* A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12mg/kg/min. Procedure will be identical in Period 1 and Period 2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proper implementation and tolerability of a grade glucose infusion using D20 intravenous infusion measured by glucose, insulin and C-peptide levels |  | 0-160 minutes after start of infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose) |  | 0-160 minutes after start of infusion |
Prognostic Factors for Acute Pulmonary Embolism in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Acute pulmonary embolism (PE) is an important cause of in-hospital mortality and may be rapidly fatal if not diagnosed and treated. Despite recent advances in diagnostic and therapeutic modalities, it is still one of the important causes of hospital mortality. Previous several reports have described the variable outcome of patients with PE with reported mortality rate ranging from 8.1% (stable patients) to 25% (with cardiogenic shock) and 65% (post cardiopulmonary resuscitation). Nevertheless, there are no published studies from Korean hospitals that assessed the outcome of acute PE treated in the hospital with IV unfractionated heparin. We conducted this study to determine the outcome, risk factors, clinical characteristics and demographics of patients with acute PE and to identify possible demographic and clinical factors associated with prognosis.

Conditions
-----------------
Acute Pulmonary Embolism (PE)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to the Severance Hospital, Yonsei University Health System with primary diagnosis of PE between January 2008 and December 2012. (diagnosed by CT and treated in the hospital with IV unfractionated heparin) Exclusion Criteria: diagnosis was prior to arrivalor anticoagulation was contraindicated diagnosis was not confirmed by CT

Ages Eligible for Study
-----------------
Minimum Age: 34 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 |
| --- | --- |
| acute PE survivor, acute PE nonsurvivor<br>acute PE survivor, acute PE nonsurvivor (in-hospital death) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognostic factors of overall survival | In-hospital all-cause mortality with acute pulmonary embolism(PE) treated in the hospital with IV unfractionated heparin | change of acute pulmonary embolism(PE) for duration of hospital stay an expected average of 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute PTE, prognostic factors
Berlin Atrial Fibrillation Registry

Study Overview
=================
Brief Summary
-----------------
Investigator-initiated prospective multicentre hospital-based registry to uncover the proportion of self-reported anticoagulation in stroke patients with atrial fibrillation and assessing the proportion of stroke, intracranial bleeding and all-cause death in the short (at 3 months), mid-term (at 12 months) as well as long term (at 24 months) after ischemic stroke or transient ischemic attack in an unselected urban population in Germany. In addition, annual follow-up is planned yearly up to 5 years after enrollment.

Official Title
-----------------
Berlin Cohort Study on Oral Anticoagulation in Patients With Atrial Fibrillation and Acute Ischemic Stroke

Conditions
-----------------
Acute Ischemic Stroke, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke or transient ischemic attack (with clinical deficit on admission or corresponding brain MRI lesion) Age ≥ 18 years Known atrial fibrillation or ECG recording documenting atrial fibrillation during the in-hospital stay for acute ischemic stroke or transient ischemic attack Written or oral informed consent Willingness to take part in the planned follow up examinations Exclusion Criteria: Life expectancy < 1 year (before stroke) Assumed post-stroke life expectancy < 1 month according to stroke severity Chronic anticoagulation for reasons other than atrial fibrillation

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 |
| --- | --- | --- |
| Patient self-reported persistence to oral anticoagulants (novel oral anticoagulants or vitamin K antagonists) in stroke patients with AF at 12 months after ischemic stroke or TIA |  | 12 months |
Long-Term Follow-Up of Patients Undergoing Catheter Ablation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at the OU Medical Center.

Detailed Description
-----------------
The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at this institution, including recurrence of the ablated arrhythmia and any late complications.

Official Title
-----------------
Long-Term Follow-Up of Catheter Ablation

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Procedure: Catheter Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing catheter ablation at the OU Medical Center Exclusion Criteria: Prisoners Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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 |
| --- | --- |
| 1<br>Patients undergoing catheter ablation. | Procedure: Catheter Ablation<br>* Catheter Ablation of arrhythmias<br>* Other names: Investigational ablation catheters;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Arrhythmia Recurrence | Number and % patients with documented arrhythmias recurrences | 0-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Complications From Catheter Ablation | Number and % of patients with major adverse events as recorded in the medical record | 0-10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia, Catheter Ablation