linjc16/ctgov huggingface dataset:
Evaluation of the Signa Excite 3.0 T MRI Excite for Detection and Characterization of Liver Lesions

Study Overview
=================
Brief Summary
-----------------
Primary Objective: 1. To compare the efficacy of 1.5T vs. 3T T1 and T2-weighted MR images sequences for the detection and evaluation of liver lesions.

Detailed Description
-----------------
Magnetic resonance imaging is taken with scanners at different magnetic field strength. The current practice at UTMDACC is to perform these exams at 1.5 Tesla. Tesla is the unit of strength of the magnetic field. This study will compare the images taken at the standard 1.5 Tesla (T) magnetic field with those at the newer 3.0T magnetic field. You are already scheduled to receive a standard 1.5 T MR of the liver area as requested by your doctor. As part of this study, you will then be asked to return on a separate date to have a similar exam performed with the Signal 3.0T Excite MR scanner. You will return within a two week period from the date of your first MRI examination. The examination will be performed in a machine that looks similar to the 1.5T scanner. It will also take about the same amount of time as the examination at 1.5T. The images taken by both scanners will be evaluated and compared. After you have had the second scan, your participation in this study will be over. If there are new findings identified with the new scan your doctor will be notified. This is an investigational study. The 3.0T scan will be performed free of charge. A total of 20 patients will take part in this study All will be enrolled at UTMDACC. This protocol is partially funded by a research grant from General Electric Medical Systems (GEMS).

Official Title
-----------------
Evaluation of the Signa Excite 3.0 T MRI Excite for Detection and Characterization of Liver Lesions

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Procedure: Signa Excite 3.0 T MRI Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a liver lesion larger than 1cm detected by a prior imaging modality. Patients have been scheduled and are eligible for an MRI of the abdomen or MRI of the liver or MRI of the kidney examination. Exclusion Criteria: 1) Patients who are unable to cooperate with breath hold.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Signa Excite 3.0 T MRI Scan<br>Signa Excite 3.0 T MRI Scan | Procedure: Signa Excite 3.0 T MRI Scan<br>* Signa Excite 3.0 T MRI scan within a two week period from the date of receiving standard 1.5 T MR of the liver area.<br>|

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
-----------------
Liver Cancer, Magnetic Resonance Imaging, Signa Excite 3.0T MRI Scan
Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin

Study Overview
=================
Brief Summary
-----------------
Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis

Detailed Description
-----------------
Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.

Official Title
-----------------
Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin

Conditions
-----------------
Cataract Senile, Endophthalmitis, Antibiotic Side Effect, Safety Issues

Intervention / Treatment
-----------------
* Drug: Levofloxacin Ophthalmic
* Drug: Moxifloxacin Ophthalmic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eyes undergoing uncomplicated cataract surgery by phacoemulsification Exclusion Criteria: Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracameral levofloxacin<br>0.5% unpreserved solution | Drug: Levofloxacin Ophthalmic<br>* 0.1 ml of unpreserved 0.5% levofloxacin<br>|
| Experimental: Intracameral moxifloxacin<br>0.5% unpreserved solution | Drug: Moxifloxacin Ophthalmic<br>* 0.1 ml of unpreserved 0.5% moxifloxacin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Cell Count | Change in endothelial cell count as measured by specular microscopy | 3 months | 
| Central Retina Thickness | Change in central retinal thickness as measured by spectral domain optical coherence tomography | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Onset of Adverse events following intervention | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
levofloxacin, moxifloxacin, prophylaxis, endophthalmitis, cataract surgery
Patient Centered Outcomes Study

Study Overview
=================
Brief Summary
-----------------
Several questions exist when looking at ventral hernias: what is the baseline quality of life and abdominal wall function among patients with or without a ventral hernia? what is the clinical significance of a ventral hernia seen on radiography but not on clinical examination (e.g. occult hernia)? what is the natural history of quality of life of patients with and without a ventral hernia? what is the impact of disclosure of presence or absence of a ventral hernia on quality of life? Answering these questions can provide valuable information on the impact of surgery with or without subsequent ventral hernia on a patient's abdominal wall function and quality of life.

Official Title
-----------------
Patient Centered Outcomes Among Patients With and Without Ventral Hernia

Conditions
-----------------
Hernia, Ventral

Intervention / Treatment
-----------------
* Behavioral: Disclosure timing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 years or older Patients at LBJ Hospital Patients who received a CT of the abdomen Exclusion Criteria: Children (under age 18 years old) Any patient in any vulnerable population (e.g pregnant women, prisoners, etc.)

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disclosure before<br>Patients will be told that a hernia was found on CT before the follow-up survey is administered. | Behavioral: Disclosure timing<br>* When patients are told that a hernia was present on the CT scan<br>|
| Experimental: Disclosure after<br>Patients will be told that a hernia was found on CT after the follow-up survey was administered. | Behavioral: Disclosure timing<br>* When patients are told that a hernia was present on the CT scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Centered Outcomes (PCO) | Difference in PCO from initial survey to follow-up survey | Consent to 1 year follow-up |
Systematic Screening for COPD in Tabacology Consultation

Study Overview
=================
Brief Summary
-----------------
COPD is a very common disease, an estimated 3 million people are affected in France. Unfortunately, this pathology is under-diagnosed. Several reasons can be mentioned: the banality of the symptoms or the several comorbidities. Screening faces a major difficulty: the realization of a spirometry. Various studies have shown the complexity of the implementation of mass screening in cities by mini-spirometry. The COPD World Health Days allow this mass screening but without visibility on the actual entry into a care pathway. The objective of this study is to assess the impact of systematic screening for COPD during a tabacology consultation

Official Title
-----------------
Impact of Systematic Screening for COPD in Tabacology Consultation

Conditions
-----------------
Smoking Cessation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over 45 years old, followed in Tabacology unit at CHRU of BREST - No COPD patient or COPD patients not followed for more than 3 years (considered out of care) No opposition filed Exclusion Criteria: Patients already followed for COPD Contraindication to spirometry Refusal to participate

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD DIAGNOSIS | The COPD diagnosis is preformed using a spirometry | one day |
Screening Contrast-enhanced Mammography

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to compare the diagnostic performance of two diagnostic methods, namely CESM and MRI, in the evaluation of a lesion suspicious of breast cancer in 300 Quebec women referred for the investigation of breast cancer. breast lesion suspected of cancer. All suspicious lesions will be evaluated by these two diagnostic imaging and by TNM. Then, radiologists will respectively interpret diagnostic imaging, without knowing the result of the other imaging in parallel with the study. The sensitivity, specificity, positive predictive value and negative predictive value for his diagnostic imaging will then be determined. Histopathological confirmation by biopsy or surgery will be used as a standard value.

Official Title
-----------------
Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion at Screening

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged 18 and over At least one breast lesion with BIRADS classification 5 Exclusion Criteria: Refusal to perform the biopsy or surgery Pregnant or possibly pregnant woman Usual contraindication to contrast product Significant kidney failure Allergy to contrast medium hyperthyroidism Usual contraindications to MRI

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value for breast cancer | To measure sensitivity, specificity, positive predictive value and negative predictive value for CESM and MRI using histopathological confirmation as a standard value. | Breast cancer screening | 
| Diagnostic value for suspicious breast lesion | To determine the ability of diagnostic imaging to identify other breast masses suspicious of cancer. | Breast cancer screening |
Integration of NAVOY® Sepsis in an Electronic Health Record System

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.

Official Title
-----------------
Integration and Evaluation of a Machine Learning Algorithm for Sepsis Prediction in an Electronic Health Record System - a Prospective Observational Study

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is admitted to the ICU during the enrolment period. The subject is 18 years of age or older at the time of admission to the ICU. Exclusion Criteria: None.

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 |
| --- | --- |
| Observational Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NAVOY® Sepsis prediction performance | NAVOY® Sepsis prediction output within the simulated environment will be monitored and compared to the observed fulfilment of Sepsis-3 diagnosis criteria and sepsis specific management. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integration validation | A technical checklist will be used in order to validate the integration between NAVOY® Sepsis and the electronic health record system. | 6 months | 
| NAVOY® Sepsis prediction results | The NAVOY® Sepsis predictions results indicate if the subject is at risk of developing sepsis within the coming hours. The results are not made available to ICU staff. | 6 months | 
| Fulfilment of Sepsis-3 criteria | The dimensions of the Sepsis-3 diagnosis criteria that the subjects meet during their ICU stay. | 6 months | 
| Sepsis specific management | Actions taken at the ICU specifically as part of sepsis detection, prevention, or treatment. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, ICU, prediction, decision support, machine learning, intensive care
Paratracheal Force Required for Occluding the Upper Esophagus

Study Overview
=================
Brief Summary
-----------------
In this study, the median paratracheal force for occluding the upper esophagus are evaluated in anesthetized and paralyzed patients using the up-and-down technique.

Official Title
-----------------
Paratracheal Force Required for Occluding the Upper Esophagus in Anesthetized and Paralyzed Patients

Conditions
-----------------
Anesthesia Intubation Complication

Intervention / Treatment
-----------------
* Other: Application of paratracheal force


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are scheduled for elective surgery under general anesthesia Exclusion Criteria: diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus aspiration tendency history of carotid artery diseases or cerebrovascular diseases suspicious of thrombus in carotid artery on ultrasonographic examination

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Sequential Assignment
Interventional Model Description: Paratracheal force for occluding the upper esophagus is evaluated using the up-and-down sequential method.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Different paratracheal force<br>Esophageal occlusion is assessed by inserting an esophageal stethoscope under different paratracheal forces. | Other: Application of paratracheal force<br>* An esophageal stethoscope is inserted into the upper esophagus under the application of different paratracheal force in anesthetized and paralyzed patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median paratracheal force | Esophageal occlusion is evaluated under different paratracheal force by inserting the esophageal stethoscope | During 1 min after the completion of anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 95% paratracheal force | Esophageal occlusion is evaluated under different paratracheal force by inserting the esophageal stethoscope | During 1 min after the completion of anesthesia induction |
Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate effects of a 16-week supplementation with a polyphenol rich extract, Sinetrol® Xpur, on fat mass accumulation and body weight management improvement.Subjects were overweight or obese and received polyphenol supplement or placebo. A 4-week follow-up as performed to evaluate its effect after supplementation stop.

Conditions
-----------------
Change in Total Body Fat Mass Percentage Loss Versus Body Weight

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Sinetrol® Xpur


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: overweight or obese (25 kg.m-2<BMI<42.5kg.m-2) healthy Exclusion Criteria: metabolic or chronical disease with treatments (i.e.: diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, infectious disease, asthma, anxiety and depression) food allergy to the ingredients of the product (grapefruit, orange, caffeine, guarana) involved in the prior 6 months in a chronic treatment program, eating disorders history, subjected to weight reduction by surgery start or quit smoking, high alcohol consumption pregnant, breastfeeding, wanting to have a baby, menopausal women

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br> <br> |
| Experimental: Verum<br>Sinetrol® Xpur | Dietary Supplement: Sinetrol® Xpur<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total body fat percentage loss versus bodyweight |  | week1; week16; week20 |
An Observational Pilot Study to Develop a Behavioral Economics Electronic Health Record Module to Guide the Care of Older Adults With Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will develop a new electronic health record module to improve guideline-compliant care of older adults with diabetes. The module will incorporate effective behavioral economics (BE) principles to improve the degree to which care of older adults is compliant with Choosing Wisely guidelines; this generally involves less aggressive targets for HbA1c, and reductions of medications other than metformin. The implementation of the module will ultimately be triggered by medication prescribing in EPIC. The BE principles include suggesting alternatives to medications, requiring justification, setting of appropriate default order sets, and incorporation of anchoring and checklists to guide behavior. The study will involve provider workflow analysis based on observation, module user testing, and live usability testing with direct observation and semi-structure interviews.

Detailed Description
-----------------
The primary objective of this study is to develop a scalable, EHR customization toolkit that applies BE insights to promote appropriate diabetes care in older adults based on the American Geriatric Society's Choosing Wisely Guideline, as to assess the acceptability of the resulting module.

Official Title
-----------------
An Observational Pilot Study to Develop a Behavioral Economics Electronic Health Record Module to Guide the Care of Older Adults With Diabetes

Conditions
-----------------
Diabete Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Providers in NYU outpatient primary care, geriatrics, or endocrine clinics at NYU who care for older adults with diabetes Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Compliance with Choosing Wisely guidelines measured by number of reductions of medications | The implementation of the module will ultimately be triggered by medication prescribing in EPIC. | 60 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability measured by module user testing with direct observation and semi structured interviews |  | 60 Months |