linjc16/ctgov huggingface dataset:
Interstitial Lung Diseases in the Veterans Administration

Study Overview
=================
Brief Summary
-----------------
The primary objective of this research project is to describe the characteristics, diagnosis, management, and outcomes of patients with Interstitial Lung Disease (ILD) who received care at the Veteran's Administration Veterans Integrated Service Network (VISN) 6 Mid-Atlantic Health Care Network (VISN6) (includes North Carolina, Virginia and West Virginia) for up to 5 years.

Official Title
-----------------
Interstitial Lung Diseases in the Veterans Administration Health System - A Retrospective Description of Patient Characteristics, Management, and Outcomes

Conditions
-----------------
Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Interstitial Lung Disease (ILD) ICD-9 code diagnosis 515.0 or 516.3 Exclusion Criteria: Inadequate documentation of patient receiving care for ILD in the health records

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 |
| --- | --- |
| Interstitial Lung Disease<br>Patients will be identified from a specified 5 year period based on an International Classification of Diseases-9 (ICD-9) code diagnosis of Interstitial Lung disease (515) or Idiopathic Pulmonary Fibrosis (516.3). The patients will be obtained from the records of the Veterans Integrated Service Network (VISN) 6: VA Mid-Atlantic Health Care Network. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population |  | up to 5 years | 
| Prevalence of Idiopathic Pulmonary Fibrosis in the VISN6 Veterans Administration Patient Population |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of ICD-9 Codes for diagnosis of Interstitial Lung Disease | Will compare the reported ICD-9 code diagnosis with the diagnosis made after chart review and re-interpretation of the lung imaging and pathology | up to 5 years | 
| Frequency of ICD-9 code diagnosis of Interstitial Lung Disease and clinic consultation with a pulmonary provider |  | up to 5 years | 
| Prevalence of Co-morbid Diabetes Mellitus with Interstitial Lung Disease | Compare the prevalence of diabetes with interstitial lung disease as compared to the prevalence of diabetes in the general VA population | up to five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Electronic Health Records, Computed Tomography, Mortality, Hospitalization, Acute care visits, Anti-inflammatory drug therapies
Wound Healing In Diabetes (WHy) Study

Study Overview
=================
Brief Summary
-----------------
This observational study aims to identify risk factors and molecular mechanisms of impaired wound healing, to guide better foot care in the diabetic population.

Detailed Description
-----------------
Diabetes is linked with vascular complications of the eye, kidney and foot. Barbadians suffer from an unusually high prevalence of diabetic foot complications, which can cause difficult-to-heal foot ulcers and even lead to amputations of the toes or feet.Studies from the CDRC have indicated alarmingly high rates of amputation and mortality due to diabetic foot in Barbados. The goal of this study is to improve early detection of persons at risk of the vascular complications of diabetes through non-invasive scanning and genetic susceptibility tests. The general hypothesis to be tested in this study is that persons with diabetes (PWD) and non-healing foot ulcers are more likely to have a disturbed mechanism for wound-healing than PWD without this particular complication. If the hypothesis is proven correct, this will empower patients and physicians with the diagnostic tests to make early interventions towards avoiding the complications of diabetes.

Official Title
-----------------
Molecular and Genetic Analysis of Disturbed Wound Healing in Barbadians With Diabetic Foot Ulcers

Conditions
-----------------
Impaired Wound Healing, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of diabetes Barbadian national self reported ethnicity of Black/African descent clear knowledge of ulcer history Exclusion Criteria: no clinical diagnosis of diabetes non-national of Barbados self reported ethnicity not Black/African Descent unclear knowledge of ulcer history
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Persons With Diabetes (PWD) who have current non-healing ulcer(s) | |
| Controls<br>Persons With Diabetes (PWD) with no current ulcers and no history of ulcers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic Phenotyping (Haptoglobin and TRAPS) |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive Hyperemia Index and Augmentation Index |  | 18 months | 
| Depression |  | 18 months | 
| Quality of Life |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, vascular, haptoglobin, tumor, necrosis, factor, alpha, traps, impaired, wound, healing, Impaired wound healing in patients with diabetes mellitus
Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma

Study Overview
=================
Brief Summary
-----------------
The main objective is to describe the evolution of patients treated for a primary malignant hepatobiliary tumor (hepatocellular carcinoma or cholangiocarcinoma) over the long course.

Detailed Description
-----------------
The collection of data from patients with CHC and cholangiocarcinomas who are cancers with poor prognosis is a major challenge to improve patients'care (diagnosis, prognosis); facilitate the search for new therapeutic targets and the follow-up of clinical studies; and develop personalized treatments.

Official Title
-----------------
Cohort Study of Patients With Primary Hepatocellular Carcinoma or Cholangiocarcinoma

Conditions
-----------------
Cholangiocarcinoma, Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria : Age ≥ 18 years olds Medical care in Nephrology department since 2015 Cholangiocarcinoma: - Histologically and cytologically documented cholangiocarcinoma, regardless of the stage of the disease Hepatocellular carcinoma: Hepatocellular carcinoma at any stage of the disease, presenting the diagnostic criteria according to the diagnostic criteria of Barcelona : Tumor of more than 1 cm, developed on cirrhosis liver with arterial phase hyperenhancement and washout in the portal venous or delayed phases on CT and MRI Hepatocellular histologically documented Exclusion Criteria: - Lack of patient non-opposition

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 |
| --- | --- |
| patients with Hepatocellular carcinoma<br> | |
| patients with Cholangiocarcinoma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Hepatocellular carcinoma and Cholangiocarcinoma : Overall survival is defined as the survival 5 years after the inclusion. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Hepatocellular carcinoma :Overall survival is defined as the survival after 5 years of inclusion. | 5 years | 
| Disease free survival | Cholangiocarcinoma : 2 and 5 years after surgical resection | 2 and 5 years | 
| Progression time under chemotherapy | Cholangiocarcinoma : Time of progression under chemotherapy is defined by the delay between the start of chemotherapy and tumor progression (appearance of a new lesion or increase in size of more than 30%) | Time of progression under chemotherapy up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, cholangiocarcinoma, cohort
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Skin Ulcer

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Skin Ulcer

Detailed Description
-----------------
This patient funded trial aims to study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Skin Ulcer. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Skin Ulcer

Conditions
-----------------
Skin Ulcer

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Skin Ulcer Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Pre-menopausal women not using contraception Previous organ transplant Hypersensitivity to sulfur
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: Treatment Group (AlloRx)<br>intravenous infusion and intralesional injection of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin Ulcer, stem cell treatment
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.

Official Title
-----------------
An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Etanercept
* Device: Autoinjector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are male or female aged 18-55 years at the time of signing the informed consent form. Exclusion Criteria: Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB4<br>SB4 (etanercept) 50 mg/mL | Drug: Etanercept<br>* Etanercept PFS and Autoinjector<br>Device: Autoinjector<br>* Autoinjector<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Injection site pain score at immediately post injection (within 1 minute) | The change in injection site pain score at immediately post injection (within 1 minute) using an 11-point visual numeric scale | at Week 1 and Week 3 |
Pediatric PET/MR Image Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed Tomography (CT) imaging for the diagnosis of tumors in children and young adults. Sensitivities, specificities and diagnostic accuracies of the different imaging modalities will be compared for significant differences.

Official Title
-----------------
Pediatric PET/MR Image Registry

Conditions
-----------------
Soft Tissue, Lymphoma, Osteosarcoma

Intervention / Treatment
-----------------
* Diagnostic Test: PET/MR imaging
* Diagnostic Test: MR imaging
* Diagnostic Test: PET/CT imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor. We might also include some patients with leukemia if there is concern for a focal lesion in any of their organs. Participant's parents (if participant is under 18) or the participant (if participant is 18 years or older) must willingly give written informed consent prior to any image transfer to the image registry. Exclusion Criteria: Patient has contraindications for MRI or PET/MR. This includes patients with cardiac pacemakers or intracranial vascular clips as well as patients with a blood glucose level > 200 mg/dl. Lack of parental permission (if participant is younger than 18) or lack of informed consent (if participant is at least 18 years of age). Patient has a CNS primary tumor. Pregnant women and fetuses

Ages Eligible for Study
-----------------
Maximum Age: 40 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 |
| --- | --- |
| Image Registry<br>patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor will receive MR imaging, PET/MR imaging (and if available, PET/CT imaging) | Diagnostic Test: PET/MR imaging<br>* undergo PET/MR imaging<br>* Other names: positron emission tomography;Diagnostic Test: MR imaging<br>* Undergo MR imaging<br>* Other names: magnetic resonance imaging;Diagnostic Test: PET/CT imaging<br>* Undergo PET/CT imaging<br>* Other names: computed tomography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of tumors | Number of tumors detected on whole body MRI, PET/MR and (if available) PET/CT scans. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic activity of tumors | Metabolic activity of tumors determined by Standardized Uptake Values (SUV) on PET/MR and (if available) PET/CT scans. | up to 12 months |
Vision Care Intervention for Lower Grade School Children in Taiwan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is making use of school policy- recess outside classroom (ROC7-11) for increasing the time spent outdoor during recess and encouraging children spent time outdoor up to 11 hours in each week to investigate the vision change, myopia onset and progression in these schoolchildren.

Official Title
-----------------
Intervention Program for Vision Care in Lower Grade Schoolchildren

Conditions
-----------------
Myopia, Outdoor Activity, Policy of Recess Outside Classroom

Intervention / Treatment
-----------------
* Behavioral: Outdoor activity in recess time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the students in Grade 1 Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outdoor activity<br>Outdoor activity in recess time | Behavioral: Outdoor activity in recess time<br>* Outdoor activity in recess time<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic refraction |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, Outdoor activity, Recess outside classroom
The Effects of Sedatives on Tobacco Use Disorder

Study Overview
=================
Brief Summary
-----------------
This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability.

Official Title
-----------------
The Effects of Sedatives on Tobacco Use Disorder

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: midazolam intravenous infusion
* Drug: placebo intravenous infusion
* Drug: ketamine intravenous infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: smoke at least 5 cigarettes per day smoked at least 2 years negative urine drug screen for psychoactive drugs and negative breath alcohol concentration live in Little Rock AR or surrounding area Exclusion Criteria: unstable or stable medical condition that would interact with study medication or participation serious head trauma or neurological disorder hypertension, abnormal ECG or metabolic blood results meet criteria for psychosis, schizophrenia, major depressive disorder, or bipolar disorder use of psychoactive drugs or medications BMI > 40 among women, pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: midazolam intravenous infusion<br>single midazolam infusion (0.02 mg/kg over 20 minutes) | Drug: midazolam intravenous infusion<br>* Participants will receive a single drug infusion<br>|
| Placebo Comparator: placebo intravenous infusion<br>single placebo infusion (saline over 20 minutes) | Drug: placebo intravenous infusion<br>* Participants will receive a single placebo infusion<br>|
| Experimental: ketamine intravenous infusion<br>single ketamine infusion (0.5 mg/kg over 20 minutes) | Drug: ketamine intravenous infusion<br>* Participants will receive a single drug infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects | drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported. | about 1 week post infusion |
Stimulation of the Larynx to Treat Unexplained Chronic Cough

Study Overview
=================
Brief Summary
-----------------
Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.

Official Title
-----------------
Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough

Conditions
-----------------
Cough

Intervention / Treatment
-----------------
* Device: Vibrotactile Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18-88 >8 weeks of cough Cough visual analogue scale (VAS): Rating of 30 or greater on a 0-100 cough severity scale Ability to provide informed consent and independently complete questionnaires Ability to read and speak English Exclusion Criteria: Electronic implants (e.g., pacemaker) Currently doing speech therapy for cough Contraindications to safe or effective VTS device use No regular access to wifi internet

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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: Vibrotactile Stimulation<br> | Device: Vibrotactile Stimulation<br>* Small electric motors, similar to a vibrating cell phone or gaming joystick, deliver vibration to the throat. Participants will assess cough symptoms throughout the study period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess usability of VTS device | % of participants indicating agree or strongly agree with statements of usability | 3 weeks | 
| Impact of VTS on cough symptoms | Pre-post comparison of LCQ scores | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic cough