linjc16/ctgov huggingface dataset:
Massive Transfusion in Trauma Patient Registry

Study Overview
=================
Brief Summary
-----------------
The early use of blood products as a part of Massive Transfusion Protocol (MTP) during trauma resuscitation has been increasingly supported by providers and backed by the literature. However, the incidence of hypocalcemia during MTP has also been recorded and continues to be studied as an exacerbating factor in coagulopathy during trauma.1

Detailed Description
-----------------
Although initially it was thought that the coagulopathy was due to the trauma itself, studies suggest that it is worsened by the transfusion of blood as this is associated with increased hypocalcemia.2,3 The level of hypocalcemia is said to correlate with the amount of blood products transfused, but the number of units needed to produce a particular degree of hypocalcemia remains to be defined.4,5 A standardized value for hypocalcemia due to MTP has yet to be established. Establishing this value would be helpful in determining what level actually affects the rate of mortality.4,6 Some studies suggest intravenous calcium supplement should be considered during massive transfusion while others state this does not make a difference.3 This data repository will serve as a means to aggregate and analyze best practices as relative to MTP in the trauma patient, with specific interest in component best practices, whole blood protocols, and electrolyte/metabolite replacement.

Official Title
-----------------
Massive Transfusion in Trauma Patient Registry

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Behavioral: blood products as a part of Massive Transfusion Protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • ≥18 years old Included in the Methodist dallas medical center(MDMC) trauma registry Flagged for MTP activation and/or >1unit(U) blood product recorded in the first 24 hours Exclusion Criteria: • <18 years old

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: blood products as a part of Massive Transfusion Protocol|This data repository will serve as a means to aggregate and analyze best practices as relative to MTP in the trauma patient, with specific interest in component best practices, whole blood protocols, and electrolyte/metabolite replacement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish a data set that will be permissive of quality improvement studies/observations specific to MTP in the trauma patient. | This data repository will serve as a means to aggregate and analyze best practices as relative to MTP in the trauma patient, with specific interest in component best practices, whole blood protocols, and electrolyte/metabolite replacement. | 5 YEARS |
Study of Human Brain-Gut Axis and Gut Microbiome in Patients With Brain Lesions - Repository for Neuroscience Research

Study Overview
=================
Brief Summary
-----------------
This study explores how microorganisms in the gut can affect the growth and progression of brain tumors.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To establish a Mayo Clinic Florida Brain Tumor-Gut Axis Human Biorepository by sequential collection of fecal, urine, blood, saliva, and/or tissue samples and clinical patient information. II. To use spatial transcriptome/proteomics/multi-omics coupled with microbiome data from various sources including brain tissue and stool samples to understand how microbiota could impact disease development, progression, and treatment response in patients with brain cancer. III. To study the effect of microbiome and potential relationships and/or microbiome reconstruction to impact patient's clinical outcomes including chemo, radiation, immunotherapy and/or cellular therapy. OUTLINE: This is an observational study. Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.

Official Title
-----------------
Study of Human Brain-Gut Axis and Gut Microbiome In Patients With Brain Lesions - Repository for Neuroscience Research

Conditions
-----------------
Malignant Central Nervous System Neoplasm

Intervention / Treatment
-----------------
* Other: Non-Interventional Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study. Exclusion Criteria: Excluded samples will be from patients younger than 18 years old. There are no exclusions due to race/sex.

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 |
| --- | --- |
| Observational<br>Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study. | Other: Non-Interventional Study<br>* Non-interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository | Biological samples such as stool, urine, blood, saliva, and/or tissue will be collected for storage in the Tumor-Gut Axis Biorepository. Samples may be collected at any of the following time periods during study participation: before/after steroid therapy, before/after surgical intervention, before/after radiation therapy, and before/after chemotherapy. | Approximately 1 year, or until samples have been collected based on scheduled treatment. |
Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine y

Study Overview
=================
Brief Summary
-----------------
establishment of a method for extraction and quantification of gingival tissue nicotine in relation to conventional tobacco biomarkers: a pilot study

Detailed Description
-----------------
The study aim to establish a method for extraction and quantification of gingival tissue nicotine. Additionnaly, the relationship between the nicotine tissue intoxication with others smoking indicators will be evaluated as mentionned in the following PICO question: P: Smoker patients I: Biopsie of gingival tissue C: Non-smoker patient O: nicotine dependence test (FTND), salivary cotinine, fibroblast nicotine, number of cigarette consumed per day (NCC) and the pack-year (PY)

Official Title
-----------------
Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine in Relation to Conventional Tobacco Biomarkers: a Pilot Study

Conditions
-----------------
Smoking, Cigarette

Intervention / Treatment
-----------------
* Diagnostic Test: biopsie


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non smokers smokers Exclusion Criteria: not able to have biopsie

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| TEST group<br>smoker patients | Diagnostic Test: biopsie<br>* gingival biopsie<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nicotine | nicotine in gingival fibroblast | baseline | 
| nicotine dependance | Fagerström test for nicotine dependence | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary cotinine |  | baseline | 
| number of cigarette consumed |  | baseline | 
| pack-year |  | baseline |
Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Intranasal administration of ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department.

Detailed Description
-----------------
Ketamine is a well-known medication in children's procedural sedation and analgesia. While it provides good analgesia along with sedation, its injection is painful and causes distress in children. Intranasal administration of Ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department. This will also assess if intranasal administration would affect the depth of sedation and hospital length of stay of this group of patients.

Official Title
-----------------
Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children

Conditions
-----------------
Pain, Intranasal Ketamine

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Sterile water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Children who need to undergo procedural sedation and analgesia Exclusion Criteria: Weight over 33 Kg No Consent from parents/patient Needs immediate procedure due to patient's condition Growth/mental retardation Sensory deficit at the site of intramuscular injection

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 7 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2-group parallel double blind randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intranasal ketamine<br> | Drug: Ketamine<br>* This is medication which is commonly used for sedation in the emergency department. At the analgesic dose, this medication can be used to reduce the pain via other routes such as intranasal.<br>|
| Placebo Comparator: Intranasal sterile water<br> | Drug: Sterile water<br>* Intranasal sterile water was administered via syringe.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intramuscular injection pain | This will be assessed at the time of injection using FLACC scale. | immediately after Intramuscular injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay duration | This will be assessed using modified Ramsay's sedation scale. | 1 hours on average | 
| Adverse effects | This will be assessed using the standard definition of the adverse effects. | 1 hours on average |
Post-stroke Delirium in Ischemic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the predictors of post-stroke delirium, develop and validate a nomogram of post-stroke delirium in the ischemic stroke patients.

Detailed Description
-----------------
Introduction: Post-stroke delirium (PSD) is associated with unfavorable prognosis. Effectively identifying risk factors of PSD and predicting PSD is of essential. Methods: This is a prospective, single-centered, cohort study.

Official Title
-----------------
Risk Factors and Risk Prediction Model for Post-stroke Delirium in Ischemic Stroke Patients

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: Test delirium state


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged ≥18 years old;(2) ischemic stroke, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) scans;(3) patients or their agencies agree to participate in this study. Exclusion Criteria: brain dysfunction caused by non-vascular causes such as traumatic brain injury, brain tumor or metastatic brain tumor;(2) history of serious mental illness such as schizophrenia;(3) unable to cooperate to the assessment as deafness, blindness, aphasia, dysarthria;(4) be in coma [Glasgow Coma Scale (GCS)≤8 points] or sedation [Richmond Agitation Sedation Scale (RASS)<-3 points], and do not ameliorate during study;(5) with incomplete data.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with post-stroke delirium<br>ischemic stroke patients with post-stroke delirium | Diagnostic Test: Test delirium state<br>* use scale to test whether ischemic stroke patients have post-stroke delirium<br>|
| without post-stroke delirium<br>ischemic stroke patients without post-stroke delirium | Diagnostic Test: Test delirium state<br>* use scale to test whether ischemic stroke patients have post-stroke delirium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-stroke delirium |  | The first week of admission |
Application of Artificial Intelligence Deep Learning Technology in Magnetic Resonance Lumbar Imaging

Study Overview
=================
Brief Summary
-----------------
To study the comparative analysis of artificial intelligence deep learning technology in the image quality of under-artificial intelligence (AI) reconstruction images and the original acquisition images of magnetic resonance lumbar spine

Official Title
-----------------
Application of Artificial Intelligence Deep Learning Technology in Magnetic Resonance Lumbar Imaging

Conditions
-----------------
Deep Learning,Lumbar Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Other: no intervention name


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both sexes, aged ≥18 years, with no history of lumbar surgery, underwent lumbar magnetic resonance imaging examination. Exclusion Criteria: With metal implants in the body, claustrophobic, unable to lie flat for 15 minutes, with a history of lumbar surgery.

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

| Intervention/Treatment |
| --- |
|Other: no intervention name|no intervention description|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Application of Artificial Intelligence Deep Learning Technology in Magnetic Resonance Lumbar Imaging | manuscript | 2025.3-2025.6 |
A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of pacitol Inj.(paricalcitol) for secondary hyperparathyroidism with stage 5D chronic kidney disease (CKD 5D) receiving hemodialysis

Official Title
-----------------
A Multi-center, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.(Paricalcitol) for Secondary Hyperparathyroidism With Stage 5D Chronic Kidney Disease (CKD 5D) Receiving Hemodialysis

Conditions
-----------------
Chronic Kidney Disease 5D, Secondary Hyperparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Among hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease (CKD 5D), those who are scheduled to administer Pacitol Inj. according to the product information. Those who voluntarily signed a written personal information collection and usage agreement to participate in this clinical study after receiving an explanation about the objective and methods of the study. Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion. Exclusion Criteria: Those with a history of hypersensitivity reactions to this drug or its components Those with evidence of vitamin D toxicity Those with hypercalcemia at enrollment Pregnant or lactating women Those with evidence of parathyroid adenoma who is scheduled to undergo parathyroidectomy. Those who have been administered with investigational drugs of other clinical trials within 12 weeks from the baseline(Visit 1). Those who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D) |  | 12 weeks after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D) |  | 24 weeks after administration | 
| Proportion of subjects whose intact parathyroid hormone level decreased by more than 30% |  | 12, 24 weeks compared to pre-dose | 
| Incidence of anemia |  | From baseline to 12 weeks or 24 weeks | 
| Change in intact parathyroid hormone |  | 12, 24 weeks compared to pre-dose | 
| Change in Calcium X Phosphorus |  | 12, 24 weeks after administration |
Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin <9 gr/dl , treated with venofer and women treated with ferinject.

Official Title
-----------------
Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia (Hb<9)

Conditions
-----------------
Anemia, Iron Deficiency, Pregnancy Anemia

Intervention / Treatment
-----------------
* Drug: Venofer 200 MG Per 10 ML Injection
* Drug: Ferinject


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancy>24 weeks of gestation anemia with Hb<8 anemia with Hb<9 if symptomatic anemia of previous postpartum hemorrhage Exclusion Criteria: Allergy to one of the study's drugs IV iron treatment in the last month chronic anemia- thalassemia, renal failure Twins pregnancy non iron deficiency anemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: venofer<br>Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with venofer | Drug: Venofer 200 MG Per 10 ML Injection<br>* treat anemia with venofer up to 5 doses<br>|
| Active Comparator: Ferinject<br>Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with ferinject | Drug: Ferinject<br>* ferinject 500 mg, once a week for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio of women with Hb level >11 at delivery | Hb level | at delivery | 
| postpartum Hb level | gr/dl | during 48 hours after delivery |
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy. Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure. All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge. Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.

Official Title
-----------------
Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Device: SEPIOLA System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: calculated CHA2DS2-VASc score of 2 or greater. The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants. documented non-valvular atrial fibrillation Subject suitable for vascular/cardiac intervention procedure suitable LAA anatomical measurements for study device Exclusion Criteria: Subject who requires anticoagulation for a condition other than AF. NYHA classification IV. Complex congenital heart disease. Presence of circumflex coronary artery stent. The subject has a prosthetic valve in any position. atrial septal defect closure or has an ASD/PFO device. presence of intracardiac thrombus. Any cardiac surgery in the past LVEF < 35%. intracardiac thrombus moderate or severe mitral valve stenosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantable device<br>Endomatic SEPIOLA System | Device: SEPIOLA System<br>* Implantation of the SEPIOLA device into the left atrial appendage.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SEPIOLA System Safety | Device and Investigational Procedure Related Serious Adverse Events (SAE) | 7 days, 45 days and 6 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | Confirmation of functional LAA closure | 45 days |