linjc16/ctgov huggingface dataset:
Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents

Study Overview
=================
Brief Summary
-----------------
This was a single-site RCT to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (PGY-1) internal medicine (IM) and pediatrics residents. The primary outcome was Maslach Burnout Inventory MBI) scores at baseline and 12 month follow-up. Secondary outcomes were feasibility and perceived benefit of the intervention.

Official Title
-----------------
A Randomized Controlled Trial of a Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents

Conditions
-----------------
Burnout

Intervention / Treatment
-----------------
* Behavioral: mindfulness
* Other: standard medical education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Washington University (WUSM) first year residents in internal medicine and pediatrics Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mindfulness<br>3 30 minute in person interventions as well as promotion and involvement of self-guided meditations on the Insight Timer smart phone application | Behavioral: mindfulness<br>* in person and smart phone application mindfulness practice<br>|
| Active Comparator: control<br>standard medical resident education | Other: standard medical education<br>* standard medical education / control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maslach Burnout Inventory (MBI) | burnout score on MBI (score range 0-132); based on three components: emotional exhaustion, depersonalization, and personal accomplishment) | 1 year | 
| feasibility of intervention in graduate medical education | ability to insert into the curriculum without barriers or disruption of other education activities, assessed by interviews from residency leadership | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of intervention | survey to assess opinion of intervention (Likert scale) | 1 year | 
| effect on mindfulness practice | survey question to assess pre and post-intervention frequency of practicing mindfulness | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burnout, medical residents
Genetic Architecture of Plasma T-PA and PAI-1

Study Overview
=================
Brief Summary
-----------------
To determine the effects of six genes on thrombotic risk factors known to be associated with the development of heart disease.

Detailed Description
-----------------
BACKGROUND: Abnormalities in the plasminogen activator system have been implicated in the pathogenesis of arterial and cerebral thrombosis. In particular, elevated plasma levels of plasminogen activator inhibitor-1 (PAI-1), tissue-type plasminogen activator (t-PA), and t-PA/PAI-1 complexes have been found to correlate with increased risk of myocardial infarction (MI) and/or stroke. Vascular fibrinolytic balance is, to a large part, determined by the competing effects of t-PA and PAI-1, and reflects a complex interplay between genetic and environmental factors. The present collaboration focuses on the common hypothesis that the association between activation of the renin-angiotensin-aldosterone system (RAAS) and atherothrombotic events derives from an interaction between the RAAS and the fibrinolytic system. The study is part of an initiative Thrombosis of the Arterial and Cerebral Vasculature: New Molecular Genetic Concepts for Prevention and Treatment which was released in April 1999. The objective of the initiative is to establish collaborative teams of closely interacting investigators with diverse, complementary areas of expertise to elucidate the molecular genetic mechanisms of thrombosis in the arterial and cerebral vasculature. DESIGN NARRATIVE: The investigators will use two population-based samples of unrelated individuals to address their aims: 1) study subjects in the PREVEND study in Groningen, The Netherlands in whom DNA and plasma samples and clinical data have already been collected and 2) an estimated 2000 unrelated study subjects from Ghana, Africa in whom data need to be collected. The collaborative study focuses on the common hypothesis that the association between activation of the renin-angiotensin-aldosterone system (RAAS) and atherothrombotic events derives from an interaction between the RAAS and the fibrinolytic system.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Thrombosis, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Study of Endoscopic Barrett's Esophagus Diagnosis

Study Overview
=================
Brief Summary
-----------------
Barrett's esophagus (BE) is a condition that often occurs in patients who have had GERD for a long time. The researchers are interested in BE because it can sometimes become a cancer in the esophagus. The way that we currently diagnose BE is by performing an upper endoscopy and looking for a change in the color of the esophagus. This color change may represent BE. If the doctor sees this, he/she may take biopsies of this area. Studies have shown that making the diagnosis of BE can be hard to make. One of the reasons why this may be is because doctors may interpret what they see differently during the procedure. In other words, they may see an esophagus that appears normal in color or abnormal in color. The purpose of this study is to compare two doctors' impressions of the appearance of the esophagus during a single endoscopy procedure.

Official Title
-----------------
A Prospective Study on the Interobserver Agreement of Endoscopic Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus, GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of (h/o) GERD Upper GI symptoms such as acid taste in mouth, dysphagia, dyspepsia Screening or surveillance exam for BE Exclusion Criteria: Unable to consent History of esophageal varices

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1<br>Study participants must be older than 18 years of age who are having an endoscopy performed to evaluate symptoms of GERD such as heartburn, acid taste in the mouth, dysphagia, dyspepsia, or those who are having a screening/surveillance exam for BE. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be the interobserver variability in the presence of columnar epithelium as well as the measured lengths. |  | one endoscopy visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of pathology-confirmed BE |  | one endoscopy visit | 
| variables that predict endoscopic interobserver agreement and path-confirmation |  | one endoscopy visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's Esophagus, Upper Endoscopy, Esophageal biopsies, Accuracy, Interobserver Agreement
Non Invasive Measurement of Coagulation in Term and Preterm Neonates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies.

Detailed Description
-----------------
Coagulation abnormalities among neonates aren't common - but can be life threatening. Testing the coagulation system in small babies involves drawing significant amounts of blood (especially in premature babies). Non-invasive testing can help assess and treat term and preterm neonates at risk. Recently, a non-invasive device to assess the blood coagulation status was developed - The Thrombo-Monitor (ThM). The objective of this study is to assess the reliability of this new non-invasive device among term and preterm babies by comparing the result of the ThM reading to coagulation analysis from blood.

Official Title
-----------------
Non Invasive Measurement of Coagulation in Term and Preterm Neonates

Conditions
-----------------
Blood Coagulation Tests

Intervention / Treatment
-----------------
* Device: The Thrombo-Monitor (ThM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn babies - term and preterm Written parental informed consent Exclusion Criteria: Congenital anomalies / chromosomal abnormalities

Ages Eligible for Study
-----------------
Maximum Age: 2 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy newborn babies<br>Healthy newborn babies immediately after birth. | Device: The Thrombo-Monitor (ThM)<br>* Non-invasive measurement of coagulation status and comparison to standard blood coagulation tests. In healthy neonates - immediately after birth, before the administration of vitamin K. Coagulation tests will be done on an umbilical cord blood sample. In sick neonates, coagulation studies will be done according to the medical condition.<br>|
| Sick newborn babies<br>Sick newborn babies whose medical condition indicates performing coagulation tests. | Device: The Thrombo-Monitor (ThM)<br>* Non-invasive measurement of coagulation status and comparison to standard blood coagulation tests. In healthy neonates - immediately after birth, before the administration of vitamin K. Coagulation tests will be done on an umbilical cord blood sample. In sick neonates, coagulation studies will be done according to the medical condition.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of the non-invasive ThM device. |  | From birth up to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coagulation tests, Neonates, Non invasive
Dosimetric Planning Study Comparing Intensity Modulated Radiotherapy (IMRT) and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix

Study Overview
=================
Brief Summary
-----------------
A theoretical planning study to compare the normal tissue irradiation when using intensity modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive treatment of cervical cancer.

Detailed Description
-----------------
Radiotherapy in combination with chemotherapy is the standard treatment of locally advanced cervix cancer, however with traditional techniques large volumes of bowel and bladder are irradiated causing short-term and long-term genito-urinary and gastro-intestinal side effects. IMRT has the potential to conform precisely to the target and spare normal tissues and reduce side effects. However because there are large dose gradients there is the potential to miss the target due to organ motion. Recent studies have documented organ motion and will be used to define the target. Approximately 60 planning scans, previously used to treat patients with cervix cancer, will be used to replan using an IMRT technique and differences in doses to tumour and normal tissues compared.

Official Title
-----------------
Dosimetric Planning Study Comparing IMRT and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix

Conditions
-----------------
Cervix Cancer

Intervention / Treatment
-----------------
* Radiation: IMRT planning
* Radiation: 4-Field Radiation Planning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: last 60 patients treated definitively for cervical cancer at Sunnybrook Odette Cancer Centre Exclusion Criteria: no imaging and no anatomical description of disease
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Other: Cervix Cancer<br>Patients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre | Radiation: IMRT planning<br> <br> Radiation: 4-Field Radiation Planning<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in dose to organs at risk |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Coverage |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervix Cancer, IMRT, Organ Motion, Target Definition
Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.

Detailed Description
-----------------
In this study we want to address the sensitivity and specificity of breath analysis by MCC-IMS in the context of SARS-CoV-2 detection from PCR- proven infected and non-infected subjects. Therefore nasal breath will be aspirated for 10 seconds during normal respiration by a foam cuffed oxygen catheter connected via a 0.22μm filter and a line into the MCC-IMS and directly analyzed without any pre-analytic procedures. The during the proof-of-concept study derived significant peaks for volatile organic compounds will be used for discrimination in a point-of-care approach.

Official Title
-----------------
Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects

Conditions
-----------------
SARS-CoV-2 Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Multicapillary column coupled ion mobility spectrometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospital admission staff members Exclusion Criteria: too sick to comply with study procedures

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2- infected<br>Detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs | Diagnostic Test: Multicapillary column coupled ion mobility spectrometry<br>* sampling of nasal air via a foam cuffed oxygen catheter<br>|
| non infected<br>Lack of detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs | Diagnostic Test: Multicapillary column coupled ion mobility spectrometry<br>* sampling of nasal air via a foam cuffed oxygen catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correct classification of SARS-CoV-2 infected and not infected subjects | correct classification of SARS-CoV-2 infected and not infected subjects | 6 months |
Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)

Study Overview
=================
Brief Summary
-----------------
Current diagnostic tools used in interstitial lung disease (ILD) do not meet the challenges set by the complex pathophysiology of this heterogenous group. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of patients with various ILDs.

Official Title
-----------------
Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)

Conditions
-----------------
Pulmonary Healthy Controls, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Non-specific Interstitial Pneumonia, Sarcoidosis, Granulomatosis With Polyangiitis (Wegener's Disease)

Intervention / Treatment
-----------------
* Device: multiple breath washout tests
* Device: impulse oscillometry
* Device: body plethysmography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: known or suspected interstitial lung disease Exclusion Criteria: pregnancy inability to participate

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| interstitial lung disease<br>patients with known or suspected ILD such as idiopathic pulmonary fibrosis, non-specific interstitial pneumonia, sarcoidosis, granulomatosis with polyangiitis | Device: multiple breath washout tests<br> <br> Device: impulse oscillometry<br> <br> Device: body plethysmography<br> <br> |
| pulmonary healthy controls<br>patients without known or suspected pulmonary disease | Device: multiple breath washout tests<br> <br> Device: impulse oscillometry<br> <br> Device: body plethysmography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung clearance index (LCI) as determined by multiple breath washout |  | 30 minutes | 
| airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repeatability of lung clearance index (LCI) |  | 30 minutes |
Feeding Trial in the Obese Critical Care Population

Study Overview
=================
Brief Summary
-----------------
This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.

Detailed Description
-----------------
Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.

Official Title
-----------------
Enteral Formula Tolerance in the Obese Critical Care Population

Conditions
-----------------
Critical Illness, Obesity

Intervention / Treatment
-----------------
* Other: enteral formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Surgical or Medical intensive care unit (ICU) patient Body mass index (BMI) ≥ 30 Exclusion Criteria: pregnant or lactating unable to access gastrointestinal (GI) tract for feeding via tube other contraindication to tube feeding admitted with burns severe head trauma

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 |
| --- | --- |
| critically ill obese adults<br>Age ≥ 18 years, body mass index (BMI) ≥ 30, in intensive care unit (ICU) requiring tube feeding ≥ 3 days | Other: enteral formula<br>* Complete feeding of study enteral formula, route and regime prescribed by the physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to feeding goal achievement | on all participants | up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal measures assessment | on all participants | daily for up to 11 days | 
| percent of nutrition goal met | on all participants | up to 5 days | 
| serum biochemical markers assessment | on all participants | daily for up to 11 days | 
| assessment of frequency and nature of adverse events | on all participants | daily for up to 11 days |