linjc16/ctgov huggingface dataset:
VisAR Augmented Reality Navigation of Ventriculostomy

Study Overview
=================
Brief Summary
-----------------
This study is intended to evaluate the feasibility of using VisAR augmented reality surgical navigation during placement of an external ventricular drain (EVD). The investigators are interested in confirming the design of the VisAR headset is compatible with this bedside procedure.

Detailed Description
-----------------
A secondary objective of this study is to compare the accuracy of freehand EVD navigation, the current standard of care, with VisAR augmented reality surgical navigation. The intent is to demonstrate the advantages to the patient by the use/application of this next generation navigation technology.

Official Title
-----------------
VisAR Augmented Reality Navigation of Ventriculostomy

Conditions
-----------------
Brain Trauma, Obstructive Hydrocephalus, Subarachnoid Hemorrhage

Intervention / Treatment
-----------------
* Device: VisAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18 years and older, determined to need an external ventricular drain (EVD) or ventriculostomy catheter by the attending neurosurgeon secondary to a variety of pathologies, including obstructive hydrocephalus, trauma and subarachnoid hemorrhage. Exclusion Criteria: Patients less than 18 years of age. Pregnant women. Prisoners.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VisAR Navigation<br>Patients randomly assigned to this arm will have their EVD placed using VisAR navigation. | Device: VisAR<br>* The study device is a Microsoft HoloLens which uses Novarad's proprietary software and is collectively known as VisAR.<br>|
| No Intervention: Freehand Navigation<br>Patients randomly assigned to this arm will have their EVD placed using freehand navigation, the typical standard of care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining navigation system accuracy based on anatomical location and Kakarla scoring system. | The accuracy of VisAR in placement of EVDs primary assessment will be graded based on the anatomical location of the EVD, known as the Kakarla scoring system. The Kakarla scoring system has 3 grades of accuracy of placement based on the location of the catheter tip. | During surgery |
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
In preparation for the randomized clinical trial of a new behavioral intervention for preteens with type 1 diabetes and their parents, the study is first enrolling adolescents with type 1 diabetes to create videos about living well with type 1 diabetes. The videos will be used in the intervention materials for the randomized clinical trial.

Official Title
-----------------
Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Teen Videos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-reported type 1 diabetes diagnosis for ≥ 1 year, age 14-17 at consent, English fluency, living in the United States Exclusion Criteria: major psychiatric or developmental disorders in youth or parents that would interfere with capacity for informed consent or participation, major medical comorbidities that would confound outcomes (e.g., cancer, cystic fibrosis).

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: For the first phase of this project, all teen participants will create videos about living well with type 1 diabetes. The videos will be used in the upcoming randomized clinical trial of the new intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Teen Videos<br>All participants in the teen video phase of this project will make brief videos about living well with type 1 diabetes. Guidance will be provided about requirements for the videos. Participants may make up to 4 brief videos. The videos will be used in the upcoming clinical trial of the new behavioral intervention. | Behavioral: Teen Videos<br>* All participants in the Teen Videos will create videos about living well with diabetes, which will be used in the upcoming clinical trial of a new behavioral intervention.<br>* Other names: EMPoWER Teen Videos;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic and Medical Information Questionnaire | Only demographic information and limited diabetes treatment information will be collected about participants in the teen videos portion of this study. Participants will complete a brief questionnaire developed by the study team, which will request self-reported information about participant demographics (e.g., race, ethnicity, gender) and medical information (e.g., time since diabetes diagnosis, current treatments). | Baseline |
Exosome as the Prognostic and Predictive Biomarker in EBC Patients

Study Overview
=================
Brief Summary
-----------------
This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients

Official Title
-----------------
Development of a Prognostic and Predictive Biomarker for Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy Using Exosome

Conditions
-----------------
Triple Negative Breast Cancer, HER2-positive Breast Cancer

Intervention / Treatment
-----------------
* Procedure: exosome and ctDNA evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early breast cancer Planned neoadjuvant chemotherapy Triple negative breast cancer or HER2-positive breast cancer Exclusion Criteria: Stage IV breast cancer Hormone receptor positive breast cancer
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CtDNA/Exosome evaluation<br> | Procedure: exosome and ctDNA evaluation<br>* Serial exosome and ctDNA evaluation during follow up period between neoadjuvant chemotherapy and surveillance after curative surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic biomarker for EBC | Positive predictive value of ctDNA/Exosome for BC recurrence | 60 months |
Liver Biomarkers in Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
The main goal of the Liver Biomarkers in Anorexia Nervosa (LIBAN) study is to determine the prevalence of liver fibrosis in patient with Anorexia Nervosa.

Detailed Description
-----------------
Prevalence of hepatic fibrosis will be non-invasively investigated, in the Anorexia Nervosa inpatient population, using the Fibroscan ®. Furthermore, liver blood markers will be assessed.

Official Title
-----------------
Assessment of Liver Damage Using the Fibroscan in Patients With Anorexia Nervosa

Conditions
-----------------
Anorexia Nervosa

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Patient over 15 years old Diagnosis of Restricted Eating Disorders including Anorexia Nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Admission to the endocrinology, diabetology and nutrition department of the Nantes University Hospital. Exclusion Criteria : Chronic active viral hepatitis Hemochromatosis Other genetic, autoimmune, toxic or drug-induced hepatitis Treatment with a drug known to induce fatty liver disease (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals) unless the dose has been stable for ≥ 3 months Excessive alcohol consumption (≥ 30 grams per day in men, ≥ 20 grams per day in women)

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Non applicable (NA)<br>Patients with Anorexia Nervosa hospitalized for malnutrition | Diagnostic Test: Fibroscan<br>* Fibroscan is a non-invasive device that allows liver exploration painlessly, quickly (a few minutes) and with immediate results. A probe placed on the skin generates an elastic wave completely painlessly and the device measures its speed of propagation in the liver. Liver stiffness is calculated from this speed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fibrosis prevalence in patients with Anorexia nervosa | Liver stiffness will be assessed using Fibroscan (kPA) within the 24 hours following admission to the endocrinology, diabetology and nutrition department. | Day one | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Fibrosis, Liver Steatosis, Enteral Refeeding, Anorexia Nervosa
Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars

Study Overview
=================
Brief Summary
-----------------
the study will be done to evaluate the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars

Detailed Description
-----------------
the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars for the following patients which include: Healthy children aged from 6 to 8 years who will be classified as Class I or II Children according to the American Society of Anaesthesiologists (ASA) will be included. Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.

Official Title
-----------------
Clinical and Digital Radiographic Evaluation of Simvastatin Versus MTA in Pulpotomy of Immature Permanent Vital Molars: A18 Month Randomized Controlled Trial

Conditions
-----------------
Pulp Exposure, Dental

Intervention / Treatment
-----------------
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children aged from 6 to 8 years Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded. Deep carious lesions of the first permanent immature molars with signs & symptoms of reversible pulpitis will be included Normal radiographic findings and immature roots

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: simvastatin<br>Drug The drug powder will be mixed with distilled water to form a paste applied in the pup chamber of immature permanent molars over the pulp stump | Drug: Simvastatin<br>* pulpotomy of immature permanent teeth<br>* Other names: Mineral Trioxide Aggregate;|
| Experimental: Mineral Trioxide Aggregate<br>Dental material It is a regenrative endodontic material prepared as apoweder that mixed with distilled water to form a paste applied in the pup chamber of immature permanent molars over the pulp stump | Drug: Simvastatin<br>* pulpotomy of immature permanent teeth<br>* Other names: Mineral Trioxide Aggregate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of pain | clinical assessment | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentin wall thickness | radiographic assessment | 18 months |
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study

Study Overview
=================
Brief Summary
-----------------
Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease. Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+). The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study

Official Title
-----------------
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study

Conditions
-----------------
Mitral Regurgitation

Intervention / Treatment
-----------------
* Procedure: mitral valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study group: presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013; presence of moderate residual mitral regurgitation at discharge. Control group: presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013; presence of residual mitral regurgitation of at least mild grade at discharge. 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 |
| --- | --- |
| Suboptimal repair<br>Patients discharged with a residual mitral regurgitation of at least moderate (2+)degree | Procedure: mitral valve repair<br>* conservative surgery to treat mitral regurgitation. A mitral valve plasty is performed according to the most appropriate technique<br>|
| Optimal repair<br>Patients discharged with a residual mitral regurgitation of mild (1+) or less degree (trace or 0) | Procedure: mitral valve repair<br>* conservative surgery to treat mitral regurgitation. A mitral valve plasty is performed according to the most appropriate technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | through study completion, a minimum of 6 years |
Early Lymph Node Metastasis in T1/2 Stage Colorectal Cancer: Molecular and Clinical Insights

Study Overview
=================
Brief Summary
-----------------
The prognostic implications of lymph node metastasis in colorectal cancer patients at an early stage, specifically T1/2 stage, are relatively unfavorable. Therefore, understanding the clinical and molecular traits relevant to metastasis in T1/2 stage are of substantial clinical importance.

Detailed Description
-----------------
Patients were classified based on their lymph node staging, with an ancillary categorization into MSI-H and MSS subgroups. A comparative mutational study was performed among these groups, incorporating risk stratification and Receiver Operating Characteristic curve analysis, with the aim of discerning the predictability of clinical features integrated with molecular characteristics for early metastasis in T1/2 stage colorectal cancer.

Official Title
-----------------
Early Lymph Node Metastasis in T1/2 Stage Colorectal Cancer: Molecular and Clinical Insights

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18-75 years old; Clinical staged T2; Histologically proven colon or rectal adenocarcinoma. Exclusion Criteria: Patients over 80 years of age; Recurrent colorectal cancer; Multiple primary tumors; Distant metastasis.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with lymph node metastasis<br>T1/2N+ patients | |
| Patients without lymph node metastasis<br>T1/2N- patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSI status | (I) MSI-High (MSI-H) if two or more mononucleotide markers in tumor tissue had size variations of ≥3bp compared to normal tissue; (II) MSI-Low (MSI-L) if a single mononucleotide marker in tumor tissue exhibited a size variation of ≥3bp compared to normal tissue; (III) Microsatellite Stable (MSS) if there were no size variations of ≥3bp in mononucleotide markers in tumor tissue compared to normal tissue. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Somatic Mutation Distribution | targeted NGS | through study completion, an average of 1 year | 
| Tumor Mutation Burden (TMB) | targeted NGS | through study completion, an average of 1 year |
Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to create a longitudinal cohort of those with Sickle Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS, assess for differences in those with varying quantities of HbS and assess for potential clinical complications of SCT.

Official Title
-----------------
Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)

Conditions
-----------------
Sickle Cell Trait

Intervention / Treatment
-----------------
* Other: Biologic Specimen Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are willing to voluntarily participate and sign the study consent Know/suspect they have SCT and are willing to get tested to confirm/learn about their SCT status Be willing and able to participate in the 2- year study plan. Adults ages 18-65 Exclusion Criteria: Unwilling to sign consent Known end-stage renal disease or dialysis Known SCD (including sickle cell-beta thalassemia) People who do not have SCT

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Individuals with sickle cell trait<br> | Other: Biologic Specimen Collection<br>* Participants will have blood and urine collected annually at Baseline, Year 1 and Year 2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin variant quantification | Determine range of variability in baseline %HbS in SCT subjects and relationship of baseline %HbS to markers of hemolysis (LDH, reticulocytes, haptoglobin), coagulopathy (D-dimer), and renal disease (urine albumin/creatinine ratio) | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cell rheology | Identify range of variation in baseline RBC rheological parameters in SCT subjects and relationship to %HbS, other baseline clinical parameters | Through study completion, an average of 2 years | 
| Natural History | Evaluate the frequency of hemolysis Evaluate potential for and progression of chronic kidney disease and albuminuria Evaluate the relative risk of thrombosis based on medical history Evaluate the prevalence of episodes of pain or exercise-related symptoms | Through study completion, an average of 2 years |