linjc16/ctgov huggingface dataset:
The Extended Gestational Age Medical Abortion Study

Study Overview
=================
Brief Summary
-----------------
This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.

Official Title
-----------------
The Extended Gestational Age Medical Abortion Study: The Effectiveness of Medical Abortion With Mifepristone and Misoprostol at 57-63 Days Versus 64-70 Days Gestation

Conditions
-----------------
Medical Abortion

Intervention / Treatment
-----------------
* Drug: Mifepristone and misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intrauterine pregnancy of greater than 56 days and less than 71 days eligible for medical abortion according to study doctor assessment willing and able to sign consent forms speak English or Spanish (in US sites); speak the local language(s) (in international sites) agree to comply with the study procedures and visit schedule

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 64-70 days' gestational age<br>Women whose pregnancies are estimated to have a gestational age of 64-70 days | Drug: Mifepristone and misoprostol<br>* 200 mg oral mifepristone 800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone<br>|
| No Intervention: 57-63 days' gestational age<br>Women whose pregnancies are estimated to have a gestational age of 57-63 days. (Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range.) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion |  | 7-36 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of individual side effects experienced by participants |  | 7-14 days | 
| Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain) |  | 7-14 days | 
| Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began |  | 7-14 days | 
| Average number of missed days of work or school due to the abortion procedure |  | 7-14 days |
NECROtizing Soft Tissue Infections and Their Scoring System

Study Overview
=================
Brief Summary
-----------------
Primary Objective: The primary objective of this study is to develop and validate a clinical risk index score for identifying NSTIs in emergency general surgery patients being evaluated for a severe skin and soft tissue infection. Secondary Objectives: To describe the contemporary microbiology of NSTIs and explore the effects on outcomes and to identify predictors of amputation and mortality.

Detailed Description
-----------------
This study is designed as a multicenter, prospective, observational study. There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center. We plan to complete the data collection and analysis by 12/30/2021.

Official Title
-----------------
Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score

Conditions
-----------------
Necrosis

Intervention / Treatment
-----------------
* Other: Necrotizing soft tissue infections (NSTIs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI Exclusion Criteria: Age <18 years old and age > 89 years Pregnancy Prisoners Below ankle diabetic foot infections complicated by peripheral vascular disease Burn wounds

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Necrotizing soft tissue infections (NSTIs)|There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the presence of necrosis | presence of necrosis-dishwater fluid or deliquescent tissues | up to 30 days | 
| Change in the presence of necrosis | thrombosed vessels or absence of bleeding | up to 30 days | 
| mortality length of time in hospital |  | 30-90 days |
Atrial Fibrillation Cycle Length Measured on Transesophageal Echocardiography

Study Overview
=================
Brief Summary
-----------------
Background: The atrial fibrillation cycle length (AFCL) measured by electrophysiologic study is well known parameter for the maintenance of sinus rhythm after DC cardioversion (DCCV) or ablation therapy. The aim of this study was to test whether a AFCL measured by transesophageal echocardiography (AFCLTEE) could predict the outcome after DCCV. Methods: In 100 consecutive patients with non-valvular AF, TEE will be performed within 6 hours before DCCV. The AFCLTEE was measured by averaging 10 sequential peak to peak intervals of atrial fibrillary waves seen in the pulsed wave Doppler image on the left atrial appendage. The primary endpoint was AF free survival rate at 6 months after DCCV.

Official Title
-----------------
Atrial Fibrillation (AF) Cycle Length Measured on Transesophageal Echocardiography : a Feasible Parameter for Predicting the Recurrence of AF in Patients With AF Converted to Sinus Rhythm After DC Cardioversion

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: atrial fibrillation Exclusion Criteria: moderate or severe mitral stenosis prosthetic heart valve

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 |
| --- | --- | --- |
| AF free survival rate at 6 months after DCCV | Atrial fibrillation free state at 6 months after direct current cardioversion | 6 month |
Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair

Study Overview
=================
Brief Summary
-----------------
Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular techniques are used to treat patients with more complex pathology by using custom-made devices and additional stents. In order to accomplish the technical success on advanced EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of contrast and radiation, compared to conventional EVAR. This study is to assess the feasibility of proper visceral and renal arteries catheterization using a 3D model obtained from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the contrast use and patient radiation exposure while achieving procedure success during Advanced EVAR.

Official Title
-----------------
Image Fusion of Pre-procedural CTA With Real-time Fluoroscopy to Guide Proper Renal and Visceral Arteries Catheterization During Advanced Endovascular Aortic Aneurysms Repair: A Feasibility Study

Conditions
-----------------
Abdominal Aortic Aneurysm (AAA)

Intervention / Treatment
-----------------
* Procedure: Using pre-procedural CTA to guide advanced EVAR procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female >= 18 years; scheduled for advanced EVAR for abdominal aortic aneurysm. Exclusion Criteria: Pregnancy;

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre-procedure image guidance<br> | Procedure: Using pre-procedural CTA to guide advanced EVAR procedure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure success | Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance | within 1 day |
Comparability of Bispectral Index and NeuroSENSE in Aged Patients

Study Overview
=================
Brief Summary
-----------------
The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). Use of such devices is discussed in aged patients. The purpose of this study is to compare Bispectral Index and NeuroSENSE during awake periods and during natural sleep.

Official Title
-----------------
Comparability of Bispectral Index and NeuroSENSE in Aged Patients

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Device: EEG monitoring with Bispectral Index and NeuroSENSE
* Behavioral: Clinical observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients older than 74 years Exclusion Criteria: pace-maker

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- |
| Aged patients<br>EEG monitoring with Bispectral Index and NeuroSENSE | Device: EEG monitoring with Bispectral Index and NeuroSENSE<br> <br> Behavioral: Clinical observation<br>* Patients will be observed during awake periods and during natural sleep.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices | Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices (high concordance when > 0.60%) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices during periods of natural sleep | Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices measured during periods of natural sleep (high concordance when > 0.60%) | 1 year |
Comparison of the Clavien-Dindo and Comprehensive Complication Index

Study Overview
=================
Brief Summary
-----------------
Our aim was to compare 2 postoperative complication scoring systems in predicting length of hospital stay and in-hospital costs after colorectal resections.

Detailed Description
-----------------
Introduction: Postoperative complications are associated with prolonged hospital stay and rise in costs of treatment. The Comprehensive Complication Index (CCI) was developed as a scoring system that does not only take the most severe complication into account, but all complications after surgery. Our aim was to compare the Clavien-Dindo scoring system with the CCI in predicting length of hospital stay (LOHS) and in-hospital costs after colorectal resections.

Official Title
-----------------
Comparison of the Clavien-Dindo and Comprehensive Complication Index Systems for Grading of Surgical Complications After Colorectal Resections.

Conditions
-----------------
Complication of Surgical Procedure, Colorectal Disorders, Clavien Dindo, Comprehensive Complication Index

Intervention / Treatment
-----------------
* Procedure: No intervention was compared


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients that underwent a colorectal resection were included Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative complication after colorectal resection<br>Documentation of all postoperative complications after colorectal resections | Procedure: No intervention was compared<br>* No intervention was compared<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 1 year | 
| Total in-hospital costs |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay |  | 1 year |
Development of a Research Agenda for Rehabilitation Research

Study Overview
=================
Brief Summary
-----------------
An internal research department was established in the course of an organisational reform of the Pension Insurance Institution in 2020 for the evidence-based development of its own services in Austria. The focus is on the transfer of findings into practice and the scientific community. As part of an initial assessment of the current situation, an organisation-specific research agenda is being systematically developed. The project design is based on a multi-perspective and multi-method approach. After obtaining experts' opinions (interview) from different settings and areas, a consensus on necessary fields of action will be worked out after synthesising the results via a Delphi survey.

Official Title
-----------------
Entwicklung Einer Forschungsagenda für Die Reha-Forschung in Der österreichischen Pensionsversicherungsanstalt (PVA) [Development of a Research Agenda for Rehabilitation Research in the Austrian Pension Insurance Institution (PVA)]

Conditions
-----------------
Research Agenda, Conditions Influencing Health Status

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Researchers who conduct scientific research in the field of rehabilitation in Austria, Germany and Switzerland People working in rehabilitation facilities (in therapy or administration) in Austria, Germany and Switzerland Exclusion Criteria: Failure to obtain the declaration of consent

Ages Eligible for Study
-----------------
Maximum Age: 99 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 |
| --- | --- | --- |
| Identification of priorities in applied rehabilitation research | Semi-structured, guideline-based expert interviews with representatives of different stakeholder groups from Austria, Germany and Switzerland are conducted. The transcribed interviews are extracted and evaluated within the framework of a qualitative content analysis according to Gläser & Laudel (2010). Additionally, based on a scoping review on international research priorities and research agendas in the context of rehabilitation, potentially not considered content will be identified and supplemented. | April 2021 - November 2021 | 
| Weighting of the identified priorities in research | A Delphi survey is conducted with (1) the interview partners and rehabilitation researchers and (2) other representatives of different stakeholder groups from Austria, Germany and Switzerland to evaluate the priorities of the developed research field. The experts are consulted repeatedly until a consensus can be obtained. | September 2022 - December 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Research Agenda, Applied Rehabilitation Research, Expert Survey, Expert Interviews, Delphi Survey
Validation of Sleepware G3 Autoscoring Algorithm

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to validate the ability of the Sleepware G3 polysomnography software platform to correctly identify and score sleep related events.

Official Title
-----------------
Validation of Sleepware G3 Autoscoring Algorithm

Conditions
-----------------
Polysomnography Scoring

Intervention / Treatment
-----------------
* Other: PSG Scoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AASM Compliant PSG studies Exclusion Criteria: NA

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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 |
| --- | --- |
| PSG Scoring<br>Retrospective, de-identified PSG studies will be collected and scored by registered polysomnogrpahy technicians. The manually scored studies will be compared to the automatic scoring performed by the new Sleepware Software G3 Autoscoring Algorithm. | Other: PSG Scoring<br>* No participants will be enrolled and no interventions, besides PSG scoring will be utilized.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSG Scoring Validity | The objective of this study is to validate the ability of the Sleepware G3 polysomnography software platform to correctly identify and score sleep related events. Specifically, the study will compare Sleepware autoscoring of respiratory events, sleep staging, leg movements, micro-arousals and desaturations, among possible others events, to manual scoring by two registered polysomnographic technologists (RPSGT). | 6 months |
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder.

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

Intervention / Treatment
-----------------
* Drug: Antidepressant + Placebo
* Drug: Antidepressant + Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18-65 years old Experienced a Major Depressive Disorder with the current episode of minimally 8 weeks in duration. Treatment history of an inadequate response to at least one and no more than three antidepressants.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A1<br> | Drug: Antidepressant + Placebo<br>* Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.<br>|
| Active Comparator: A2<br> | Drug: Antidepressant + Aripiprazole<br>* Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.<br>* Other names: Abilify;|
| No Intervention: A3<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in a depression rating scale at endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in a disability scale and Clinical Global Impression scale at endpoint |  |  |
Exercise Amenorrhea Stress and Bone Health in Adolescents

Study Overview
=================
Brief Summary
-----------------
This study investigates the role of energy balance and stress in the regulation of hypothalamic-pituitary-gonadal axis in adolescent girls across the fitness spectrum.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adolescent girls not taking any medications Exclusion Criteria: Hormonal preparation or birth control within 12 months prior to enrollment Galactorrhea Clinical Depression

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 Years

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

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 |
| --- | --- | --- |