linjc16/ctgov huggingface dataset:
Impact of Acquired FXIII Deficiency on Morbidity and Mortality

Study Overview
=================
Brief Summary
-----------------
Observational prospective study aiming to assess acquired FXIII deficiency implications in morbidity and mortality

Detailed Description
-----------------
All patients admitted to a large tertiary hospital with FXIII levels below 70% during their hospital stay are assessed. Data regarding patient background, blood transfusion, morbidity and mortality is registered.

Official Title
-----------------
Impact of Acquired FXIII Deficiency on Morbidity and Mortality Among Hospitalized Patients

Conditions
-----------------
Acquired Factor XIII Deficiency Disease

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FXIII levels < 70% Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Factor XIII deficiency<br>Patients admitted to hospital with FXIII levels below 70% during their hospital stay | Other: Data collection<br>* Only data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut-Point levels of FXIII | The investigators aim to find a laboratory parameter, a cut-point plasma level of FXIII, to identify an increased in morbidity and mortality in a mixed cohort of hospitalized patients | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Factor XIII, Blood transfusion, Mortality
ProMRI 3T ENHANCED Master Study

Study Overview
=================
Brief Summary
-----------------
The investigation is designed to provide supporting evidence for the clinical safety of the Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3 Tesla MR conditions .

Official Title
-----------------
ProMRI 3T ENHANCED Master Study

Conditions
-----------------
Safety of MR (Magnetic Resonance)-Conditional ICDs

Intervention / Treatment
-----------------
* Device: Implantable Cardioverter Defibrillator therapy
* Other: Magnetic Resonance Imaging (MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implanted with Implantable Cardioverter Defibrillator (ICD) system according to Clinical Investigational Plan (CIP) ICD system was implanted in the pectoral region Implantation at least 5 weeks prior to enrollment date Patient body height ≥ 140 cm Age ≥ 18 years Right Ventricular pacing threshold (at 0.4 ms) measurable and ≤ 2.0 V Written informed consent Able and willing to complete MRI testing Able and willing to complete all testing required by the clinical protocol Available for all follow-up visits at the investigational site Exclusion Criteria: Standard contraindication for MRI scans Patient shows signs of a twiddler's syndrome, i.e. fiddles with implant Explantation, exchange or reposition of ICD or lead within 5 weeks prior to enrollment date Charging status of the battery is Elective Replacement Indicator (ERI) or End of Service (EOS) MRI scan within 5 weeks prior to enrollment date R-wave sensing amplitude < 6.5 millivolt Lead impedance less than 200 or greater than 1500 Ohm Life expectancy of less than six months Cardiac surgery in the next six months Pregnant or breastfeeding Participation in another interventional clinical investigation

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

| Intervention/Treatment |
| --- |
|Device: Implantable Cardioverter Defibrillator therapy|Tachycardia Fast Heart Beat|
|Other: Magnetic Resonance Imaging (MRI)|MRI scan of the head and lower body parts|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure |  | 1 Month | 
| Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI | Evaluate the percentage of ICD leads with an increase in the pacing threshold ratio measured between the Pre-MRI and 1-month post-MRI | 1 Month | 
| Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI | Evaluate the percentage of ICD leads with a decrease in the sensing amplitude ratio measured between the Pre-MRI and 1-month post-MRI | 1 Month |
DLCS for Predicting Neoadjuvant Chemotherapy Response

Study Overview
=================
Brief Summary
-----------------
The early noninvasive screening of patients suitable for neoadjuvant chemotherapy (NCT) is essential for personalized treatment in locally advanced gastric cancer (LAGC). The aim of this study was to develop and visualized a radio-clinical biomarker from pretreatment oversampled CT images to predict the response and prognosis to NCT in LAGC patients.

Official Title
-----------------
Deep Learning Radio-clinical Signatures for Predicting Neoadjuvant Chemotherapy Response and Prognosis From Pretreatment CT Images of LAGC Patients

Conditions
-----------------
Neoadjuvant Chemotherapy, Gastric Cancer, CT Images, Deep Learning, Tumor Regression Grade

Intervention / Treatment
-----------------
* Other: develop and visualized a radio-clinical signatures from pretreatment oversampled CT images


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) patients with GC/EGJC confirmed by pathological examination; 2) patients who underwent D2 lymphadenectomy; 3) patients who received at least two cycles of preoperative chemotherapy; 4) patients with negative resection margins; and 5) patients with complete CT image data and clinical data. Exclusion Criteria: 1) patients unable to undergo D2 radical gastrectomy after neoadjuvant therapy; and 2) patients with incomplete CT images and clinical data.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: develop and visualized a radio-clinical signatures from pretreatment oversampled CT images|develop and visualized a radio-clinical signatures from pretreatment oversampled CT images to predict the neoadjuvant chemotherapy response and prognosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor regression grade | Tumor regression grade | 3 months |
Isolated Deficits of the Lateral Semicircular Canal

Study Overview
=================
Brief Summary
-----------------
There are only a few cases of isolated lateral canal deficit described in the literature. This study would focus on this group of patients in order to establish an evolving profile, a recovery behavior that we could compare to that in the literature. In addition, the evolving profile as well as the other clinical criteria identified would allow investigators to make hypotheses as to the pathology responsible for a given evolutionary profile. The population studied is represented by adult patients admitted by the emergency consultation service of otolaryngology of the University Hospitals of Strasbourg for an acute unilateral vestibular deficit whose examination at the VHOT shows a reduced and isolated gain of a lateral semicircular canal.

Official Title
-----------------
Evolutionary Profile of Isolated Lateral Semicircular Canal Deficits on the Video Head Impulsed Test (VHIT)

Conditions
-----------------
Peripheral Vestibular Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Major patient Man or woman Patient who has given their consent to the use of their data. Patient treated in the ENT department for dizziness between June 2020 and July 2021. Non-inclusion criteria Patient who expressed his opposition to participating in the study Inability to provide the subject with enlightened information (difficulties in understanding the subject, cognitive disorders) Subject under safeguard of justice Subject under guardianship or guardianship Neurological signs on clinical examination

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Establish the evolutionary profiles of patients with isolated lateral canal involvement |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral Vestibular Disorder, Lateral semicircular canal, Video Head Impulsed Test
Need for the Assessment and Consultation Team (ACT) Following Anesthetic Care

Study Overview
=================
Brief Summary
-----------------
The goal of this study was to identify the etiology of events and demographics of patients that experience complications requiring activation of the Rapid Response Team (RRT) during the first 24 h following anesthetic care.

Official Title
-----------------
Etiology of Post-anesthetic and Post-sedation Events on the Inpatient Ward: Data From a Rapid Response Team at a Tertiary Care Children's Hospital

Conditions
-----------------
Cardiovascular Diseases, Respiratory Diseases, Neurologic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any study subject that experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility. Exclusion Criteria: Any study subject that has not experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility.
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 |
| --- | --- | --- |
| Identifying post-operative criteria for activation of Rapid Response Teams (RRTs) in caring for the pediatric population using Pediatric Early Warning Scores (PEWS) | To retrospectively identify the etiologies associated with a need to engage Rapid Response Teams (RRTs) to promote frequent assessments and early interventions among clinically deteriorating hospitalized pediatric patients. | 24 hours post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assessment and Consultation Team (ACT), Rapid Response Team (RRT), Perioperative complications, Respiratory insufficiency, ASA status
Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Detailed Description
-----------------
This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting. Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000. The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.

Official Title
-----------------
Alogliptin (Nesina) Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Alogliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with Haemoglobin A1c (HbA1c) [Japan Diabetes Society (JDS) value] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication. Exclusion Criteria: -Patients contraindicated for alogliptin. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury. Patients with a history of hypersensitivity to any ingredient of alogliptin.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alogliptin<br>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care. | Drug: Alogliptin<br>* Alogliptin tablets<br>* Other names: SYR-322;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had One or More Adverse Events |  | Up to Month 36 | 
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 36) relative to baseline. | Baseline, and final assessment point (up to Month 36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline. | Baseline, and final assessment point (up to Month 36) |
Psycho-esthetic Impact of Tattoo Technology as Part of Mammary Reconstruction After Surgery Against Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode. The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola tattoo realized following standard care.

Detailed Description
-----------------
Tattoo is realized as standard car as part of mammary reconstruction after surgery of patient suffering from breast cancer. We try to measured : Tattooed patient's satisfaction degree with qualitative questionnaire using four level satisfaction scale (very satisfied, satisfied, dissatisfied, very dissatisfied) Evaluate from patient and jury, the tall, form, color and areola position defects Evaluate professional jury's satisfaction degree regarding this areola tattoo technology, with the same patient criteria

Official Title
-----------------
Areola Tattoo: the End of a Long Therapeutic Process. A Patient's Quality of Life Dedicated Technology

Conditions
-----------------
Breast Cancer, Right or Left Breast Mammary Reconstruction, Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast

Intervention / Treatment
-----------------
* Procedure: Tattoo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer Exclusion Criteria: Two breasts operated patient surgical reconstruction
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with 1 year non-invasive technology areola tattoo<br>Women with 1 year non-invasive technology areola tattoo realized in standard care as part of 1 breast mammary reconstruction following an operated breast cancer | Procedure: Tattoo<br>* tattoo device with EC standards, and sterile single-use only needle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction degree with qualitative questionnaire about them areola tattoo realized after surgery as part of breast cancer treatment |  | 1 year after areola tattoo have been realized following standard care |
Role of Lung Ultrasound in Predicting Weaning Outcomes

Study Overview
=================
Brief Summary
-----------------
We aimed to verify the potencial role of bedside lung ultrasound findings of critically ill patients candidates to liberation from mechanical ventilation in predicting weaning outcomes. The analysis will be taken in two times: immediately before and at the and spontaneous breathing trial.

Official Title
-----------------
B-lines at Lung Ultrasound Predicts Weaning Failure From Mechanical Ventilation

Conditions
-----------------
Ventilator Weaning, Ultrasonography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive mechanical ventilation > 24 hours Eligibility to weaning from mechanical ventilation Exclusion Criteria: Tracheostomy

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 |
| --- | --- | --- |
| Weaning Failure |  | Participants will be followed up til weaning success or weaning failure at the end of spontaneous breathing trial. In case of weaning success, then they will be followed for more 48 hours to detect extubation failure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, weaning, ultrasonography
Influence of Different Parameters on Extubation Time After Cardiac Surgery.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery.

Detailed Description
-----------------
The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery. Several parameters of ventilation and infusion were recorded during surgery. A statistical analysis will be performed to determine if one of many of these are significant. The investigator does not assign specific interventions to the study participants, so the present study is observational and not interventional.

Official Title
-----------------
Influence of Different Parameters on Extubation Time After Cardiac Surgery.

Conditions
-----------------
Thoracic Surgery

Intervention / Treatment
-----------------
* Other: Duration of intubation
* Diagnostic Test: Evolution of the renal function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients for elective cardiac surgery Exclusion Criteria: Emergency procedures

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient at risk for OSA scheduled for Cardiac surgery<br>Patients with a positive STOP-Bang and DES-OSA score (that means patients at risk for OSA) | Other: Duration of intubation<br>* Time between intubation in the operating room and exhumation in the Intensive Care Unit.<br>Diagnostic Test: Evolution of the renal function<br>* Evolution of the renal function in the next two days<br>|
| Patient not at risk for OSA scheduled for Cardiac surgery<br>Patients with a negative STOP-Bang and DES-OSA score (that means patients not at risk for OSA) | Other: Duration of intubation<br>* Time between intubation in the operating room and exhumation in the Intensive Care Unit.<br>Diagnostic Test: Evolution of the renal function<br>* Evolution of the renal function in the next two days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of extubation | Time when extubation is performed | 2 Days |
Multi-center Study of Deep Learning AI in Breast Mass

Study Overview
=================
Brief Summary
-----------------
This multi-center study intends to evaluate the value of the detection and differential diagnosis of breast mass using deep learning AI-based real-time ultrasound examination.

Detailed Description
-----------------
As the most common cancer expected to occur all over the world, extensive population screening plays a very important role in the early diagnosis and prognosis of the breast cancer. X-ray and ultrasound are the most commonly used screening methods, and ultrasound is especially important for Asian women with dense breasts. However, ultrasound is greatly affected by the operator's skill and experience, and the diagnostic accuracy varies greatly. Artificial intelligence (AI) is a new method emerging in recent years, active in many medical fields and can effectively improve the diagnostic efficiency. However, previous researches on the application of AI in ultrasound are focused on single or multi-modality static ultrasound images. This multi-center study intends to evaluate the value of the detection and differential diagnosis of breast mass using deep learning AI-based real-time ultrasound examination.

Official Title
-----------------
A Multi-center Study of Breast Mass Screening and Diagnosis Using Deep Learning AI-based on Real-time Ultrasound Examination

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Device: Yizhun BUSMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females who undergo ultrasound examination for a complaint of breast lesion; The breast lesion that will obtain definite pathological diagnosis or follow-up at least two years. Exclusion Criteria: The breast lesion that has received CNB or FNA; The breast cancer patient who has received neoadjuvant chemotherapy.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Yizhun BUSMS|During the breast scanning, Yizhun BUSMS uses different color box to identify the breast lesion, and the box color indicates the risk grade of the lesion.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of breast mass using deep learning AI-based real-time ultrasound examination | Pathology as a gold standard, to evaluate the diagnostic performance (sensitivity, specificity and accuracy) | 12 months |