linjc16/ctgov huggingface dataset:
Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this proposed Department of Defense study is to evaluate the effect of Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood pressure of type 2 diabetic patients receiving EECP therapy.

Official Title
-----------------
Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal to or greater than 18 Diagnosis of Type 1 or Type 2 diabetes mellitus Prescribed EECP therapy in the DGMC EECP clinic Medically cleared for EECP therapy TRICARE beneficiary Exclusion Criteria: 1. DGMC EECP clinic patient withou a diagnosis of Type 1 or Type 2 diabetes mellitus

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 |
| --- | --- | --- |
| Change from baseline in TCOM (Transcutaneous oximetry measurement) values |  | At baseline & post intervention, expected to be on average 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hemoglobin A1C laboratory values |  | At baseline & post intervention, expected to be on average 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Disease, hypertension, diabetes mellitus, hemoglobin A1C, peripheral vascular resistance, EECP, Blood pressure, angiogenesis, Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases
Pediatric Normative Movement Analysis Data Collection

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to collect baseline data from a normative population of children that gender and age matches the population of patients expected to be treated by Mary Bridge Children's Therapy Services and seen in the Research and Movement Laboratory. This project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age. Non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session.

Official Title
-----------------
Pediatric Normative Movement Analysis Data Collection

Conditions
-----------------
Pediatric ALL

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 3-18 years Ambulate independently and without the use of assistive devices Perform activities of daily living without physical assistance Tolerate adhesive markers placed on skin and clothing Willing and interested in participating Exclusion Criteria: Neuromuscular disorders such as cerebral palsy, muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, peripheral neuropathy, or other generalized muscle and/or nerve issues Evidence of developmental delays, muscle weakness, decreased muscle tone, joint stiffness, muscle or bone deformity Currently using or has a history of using assistive technology devices, bracing/orthoses, manual or powered mobility equipment Was born pre-term Currently or has a history of taking medication or pharmaceutical treatment related to musculoskeletal side-effects/scenario/diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- |
| Normative<br>50 neurotypical pediatric subjects | Other: Observation<br>* This project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age. Non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Create normative baseline data for typically developing children | Establishing a baseline of pediatric biomechanics is an important step in performing the best possible analyses for our patients. Normative data provides that baseline, and provides the data to explore links within the dense, interconnected behavior of human motion. | 1 year |
The Impact of Continuous Renal Replacement Therapy on the Outcomes of Burn Patients With Early Phase of Sepsis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if early application of CRRT will result in an improvement of clinical outcomes of burn patients during the early phase of sepsis

Detailed Description
-----------------
The impact of Continuous Renal Replacement Therapy (CRRT) on the outcomes of patients with sepsis is controversial, and there is no consensus for the timing and dose of CRRT may improve the outcomes. The purpose of this prospective randomized study is to assess the effect of different CRRT intensity (25ml/kg/h or 50ml/kg/h) on the outcomes of burn patients with early phase of sepsis

Official Title
-----------------
A Randomized Controlled Trial on the Impact of Early Application of CRRT on the Outcomes of Burn Patients With Early Phase of Sepsis

Conditions
-----------------
Burns, Sepsis

Intervention / Treatment
-----------------
* Procedure: Continuous Renal Replacement Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with documented sepsis clinically identified focus of infection associated with at least 2 SIRS -criteria and one or more sepsis-induced organ failures within the 24 hours -prior to inclusion age 18 to 70 years severe burned patients with 50% < TBSA < 85% Exclusion Criteria: cirrhosis child class C too high APACHE II & SOFA score at admission age over 70 years were presence of a malignant tumor, chronic renal insufficiency (serum creatinine > 133 µmol/L), moribund state, receiving immunosuppressive therapy or receiving any kind of renal replacement therapy before randomization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | Procedure: Continuous Renal Replacement Therapy<br>* Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group<br>|
| Experimental: early HV-crrt<br> | Procedure: Continuous Renal Replacement Therapy<br>* Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum cytokine concentrations and clearance | 0, 6, 12 , 24, 48, 96 hours post CRRT | 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 and 90 days survival |  | 90 days |
Acute Comfort and Blur of Systane and Optive

Study Overview
=================
Brief Summary
-----------------
To evaluate drop comfort, acceptability, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population.

Official Title
-----------------
Acute Comfort and Blurring Profile Evaluation Comparing Systane Lubricant Eye Drops to Optive Lubricant Eye Drops

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Systane Lubricant Eye Drops
* Other: Optive Lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, normal eyes OR documented diagnosis of dry eye Exclusion Criteria: Must not have worn contact lenses for 7 days preceding enrollment

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Lubricant Eye Drops<br>Systane Lubricant Eye Drops 1 drop in each eye one time | Other: Systane Lubricant Eye Drops<br>* Systane Lubricant Eye Drops 1 drop each eye once time<br>|
| Active Comparator: Optive Lubricant Eye Drops<br>Optive Lubricant Eye Drops 1 drop each one time | Other: Optive Lubricant Eye Drops<br>* Optive Lubricant Eye Drops 1 drop each eye one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Blur | Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes. | 3 minutes post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye
Study of the Prevalence of Iron Deficiency in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
Despite its known prevalence in Heart Failure, a recent study conducted by Prof. Cacoub (unpublished) on the French national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. In chronic diseases including Heart Failure, Transferrin Saturation Factor is only performed in about 10% of cases while it is recommended for patients with Heart Failure (French Health High Authority 2011). The purpose of this study is to obtain current data on the prevalence of iron deficiency in France in patients with Heart Failure, applying the recommendations of European Society of Cardiology and French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor).

Official Title
-----------------
Study of the Prevalence of Iron Deficiency in Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Diagnostic Test: Iron status testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient, male or female, over 18 years of age Patient present at the hospital on the day of the study Diagnosis of Heart Failure (acute or chronic) regardless of left ventricular ejection fraction (LVEF) Patient with signed consent Exclusion Criteria: Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision Pregnant or breastfeeding woman

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEART FAILURE<br>Patients with Heart Failure diagnosis | Diagnostic Test: Iron status testing<br>* Blood sample for iron status testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete blood iron status | ferritin, Transferrin Saturation Factor | One day |
Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.

Study Overview
=================
Brief Summary
-----------------
In the context of the coronavirus (COVID-19) pandemic, healthcare systems worldwide faced an unprecedented shortage of severe ARDS. Critically affected patients were treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO) for complete respiratory failure early in the pandemic. Due to a shortage of resources in the sense of terminal equipment and adequately trained personnel with appropriate expertise in many countries and regions, a strict selection of suitable patients was made. Repeatedly, it was observed that patients under VV-ECMO also needed several weeks to recover sufficiently to generate device sufficient gas exchange. Due to the scarcity of VV-ECMO resources outside of the pandemic, the question arose whether a prolonged therapy still holds a sufficient prospect of success and what the course of treatment of such patients would be like.

Official Title
-----------------
Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.

Conditions
-----------------
Extracorporeal Membrane Oxygenation Complication, Outcome, Fatal

Intervention / Treatment
-----------------
* Other: Outcome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: veno-venous extracorporeal membrane oxygenation Exclusion Criteria: veno-arterial extracorporeal membrane oxygenation

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 |
| --- | --- |
| prolonged veno-venous extracorporeal membrane oxygenation<br>Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks. | Other: Outcome<br>* Mortality rate of prolonged therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality rate under ongoing veno-venous extracorporeal membrane oxygenation over time | During intensive care treatment (Usually within 25 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding | Number of patients with critical bleeding events during therapy, needing red blood cell transfusion | During intensive care treatment (Usually within 25 weeks) | 
| critical device error | Number of patients with a critical device errors of the veno-venous extracorporeal membrane oxygenation device. | During intensive care treatment (Usually within 25 weeks) |
An Occupational Therapist Fall Prevention Intervention in a Geriatric Primary Care Setting

Study Overview
=================
Brief Summary
-----------------
Purpose of the study: To identify if an intervention focused on decreasing fear of falling (FOF) in a geriatric primary care setting implemented by an occupational therapist (OT) has the potential to decrease falls and improve physical, psychological and social factors related to FOF. The primary research question: Is there an association between fear of falling among geriatric populations and fall prevention interventions that are offered by occupational therapist in a geriatric primary care setting?

Official Title
-----------------
The Association Between Fear of Falling and Fall Prevention Interventions Offered by an Occupational Therapist in a Geriatric Primary Care Setting

Conditions
-----------------
Fall Accident, Fall, Accidental

Intervention / Treatment
-----------------
* Behavioral: Fall Prevention by the Occupational Therapist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cognitively intact with a score of 29/30 or higher on the Orientation Log (standardized assessment tool) living in the community English speaking had a fall or near fall in the past year Exclusion Criteria: received OT services within the past 2 months

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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: Fall Prevention Intervention by OT<br>Fall prevention interventions implemented by an OT in a geriatric primary care setting for a client immediately following the provider visit within the office. | Behavioral: Fall Prevention by the Occupational Therapist<br>* The interventions included education on adaptive equipment for household activities, adaptive equipment for activities of daily living, proper footwear in all environments, proper body mechanics, position changes, home environment set up, high fall risk activities, safety awareness, low vision and home exercises programs. In addition, discussion and education occurred to improve participation in valued occupations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of Falls Efficacy Scale-International (FES-I), standardized measure for fear of falling | The outcome measure is the change between the pre FES-I and post FES-I | One Time visit: 30-50 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fear of falling
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Eye Diseases

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Eye diseases

Detailed Description
-----------------
This patient funded trial aims to study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Eye Diseases. 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. For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

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

Conditions
-----------------
Eye Diseases, Retinitis Pigmentosa, Glaucoma, Diabetic Retinopathy, Macular Degeneration, Traumatic Optic Neuropathy, Optic Atrophy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of eye disease 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 and sub-tenon delivery (total dose 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
-----------------
Eye Diseases, Retinitis Pigmentosa, stem cell treatment, Glaucoma, Diabetic Retinopathy, Macular Degeneration, Traumatic Optic Neuropathy, Optic Atrophy
Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor

Study Overview
=================
Brief Summary
-----------------
In previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure manifested CD4 counts of less than 500 cells/microliter in the immediate (day 1) post-operative period. This study will investigate whether or not Nelfinavir increases those CD4 counts in the post-operative period.

Detailed Description
-----------------
See Brief Summary.

Official Title
-----------------
Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor in the Perioperative Period

Conditions
-----------------
Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Drug: Nelfinavir/placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient undergoing elective (non-emergency) cardiopulmonary bypass for coronary artery bypass grafting, cardiac valve replacement, or both. Exclusion Criteria: A dozen different medical conditions and two dozen medical contraindications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nelfinavir/placebo<br> | Drug: Nelfinavir/placebo<br>* 1250mg/twice each day/four days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter |  | Six days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quantitative measure of inflammatory markers |  | Six days. | 
| Changes in clinical outcomes. |  | Six days. |