linjc16/ctgov huggingface dataset:
Measuring G Protein-coupled Receptor Kinase-2 (GRK2) in the Blood to Diagnose and Treat Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the utility of GRK2 to differentiate between normal patients and patient groups that differ by the presence/absence of HF symptoms, systolic or diastolic left ventricular dysfunction, and risk factors; and to evaluate if a new assay provides similar values as traditional methods for measuring GRK2 levels.

Detailed Description
-----------------
This study seeks to define a beta-adrenergic receptor kinase molecule in the blood and its role as an improved biomarker to be used for the diagnosis, assessment and management of patients with heart failure. We will test blood cell samples for the levels of this molecule, called G protein-coupled receptor kinase-2 (GRK2) using both the existing method of GRK2 quantification in the Koch laboratory and using a prototype enzyme immunoassay (EIA) method being developed by Johnson & Johnson, Ortho-Clinical Diagnostics (OCD).

Official Title
-----------------
Measuring GRK2 in the Blood to Diagnose and Treat Patients With Heart Failure

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal Controls: Individuals without HF, hypertension, diabetes, hyperlipidemia, coronary artery disease or obesity; Group I: Symptomatic Subjects with Reduced LV Function, HF symptoms, EF ≤ 40%. Group II: Asymptomatic Patients with LV dysfunction, no HF symptoms (NYHA class I and ATS score 0 or 1, EF ≤ 40%. Group III: Symptomatic Subjects with Preserved LV Function, HF symptoms, EF ≥ 50%, and diastolic dysfunction. Group IV: Asymptomatic High Risk Subjects - Individuals with normal heart function, no HF symptoms (NYHA class I and ATS score 0 or 1), Preserved LV function (EF ≥ 50%), no diastolic dysfunction. Also possess one or more cardiovascular high risk factors: diagnosis of diabetes; hyperlipidemia; coronary artery disease; renal insufficiency; hypertension; age >70 years Exclusion Criteria Pregnancy Not providing consent Inability to provide consent Participation in a clinical study involving an experimental therapy.

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 |
| --- | --- | --- |
Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory

Study Overview
=================
Brief Summary
-----------------
Our hypothesis is that improved line of sight to patient data, ergonomics, and headset lead shielding in the CCL will lead to behavioral changes in the CCL personnel that will reduce radiation exposure to all members of the team. Further, reducing the burden of large, cumbersome monitors will enable improved use of shielding. Our approach is a single center randomized controlled trial of consecutive patients randomly assigned to one of two groups with group 1 using mixed reality display and group 2 using standard 2D displays to perform diagnostic angiography in the CCL. Radiation exposure will be evaluated at multiple levels including total radiation exposure, exposure of each individual staff member, as well as specific exposure to eyes and head in group 1 versus group 2.

Official Title
-----------------
Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory

Conditions
-----------------
Radiation Injuries

Intervention / Treatment
-----------------
* Device: Mixed reality heads up display


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing diagnostic coronary angiography Exclusion Criteria: acute coronary syndrome, cardiogenic shock, cardiac arrest, planned intervention

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Device: Mixed reality heads up display<br>* Physician will use a mixed reality headset for image guidance of the procedure<br>|
| No Intervention: Group 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation exposure to the physician |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiation exposure to the patient and medical staff |  | up to 24 months |
Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line

Study Overview
=================
Brief Summary
-----------------
In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line.

Detailed Description
-----------------
This study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line. The primary outcome is apoptosis, while the secondary outcome is cell viability.

Official Title
-----------------
Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line: In Vitro Study

Conditions
-----------------
Tongue Neoplasms, Carcinoma

Intervention / Treatment
-----------------
* Drug: luteolin
* Drug: nano-luteolin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Squamous cell carcinoma cell lines (OSCC, TSCC and HNSCC). Luteolin 5,7,3',4'-tetrahydroxy-flavone (MeSH term). Application of luteolin as a chemotherapeutic drug. Exclusion Criteria: Any cancer cell line other than OSCC, TSCC and HNSCC cell lines. Luteolin glycosides.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: luteolin<br>a natural extract derived flavinoids | Drug: luteolin<br>* flavonoid natural extract<br>* Other names: 3',4',5,7-tetrahydroxyflavone;|
| Active Comparator: nano-luteolin<br>nano-particles derived from a natural extract luteolin | Drug: nano-luteolin<br>* nanoparticles of luteolin<br>* Other names: nanoluteolin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression of Caspase 3 to detect apoptosis | fold-changes | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cell viability | micromolar | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TSCC, OSCC, luteolin, nanoluteolin, nanotechnology, oral cancer, apoptosis, PCR, MTT, ELISA reader
Intra-articular Injection of MSC-derived Exosomes in Knee Osteoarthritis (ExoOA-1)

Study Overview
=================
Brief Summary
-----------------
The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. We expect to enrolle 10 patients in this phase 1 trial and the follow-up will be up to 12 months.

Official Title
-----------------
A Phase I Study Aiming to Assess Safety and Efficacy of a Single Intra-articular Injection of MSC-derived Exosomes (CelliStem®OA-sEV) in Patients With Moderate Knee Osteoarthritis (ExoOA-1)

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Biological: Exosomes (sEVs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic knee OA with VAS >50mm Knee OA Kellgren-Lawrence grade II to III Chondromalacia grade I to III Stable joint Exclusion Criteria: Bilateral symptomatic knee OA Local infection Neoplasia Joint replacement Recent use of local steroids BMI > 30

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group - sEVs<br>Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose. | Biological: Exosomes (sEVs)<br>* Exosomes 3-5x10e11 particles/dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Ocurrence of any adverse reactions within 12 months of treatment | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of injection-related pain according to VAS scale (0-100mm) | Pain measured by VAS scale after first week of treatment | 1 week | 
| Incidence of injection-related sinovitis according to effusion grading scale of knee joint | Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment | 1 week | 
| Pain reduction | Change in VAS score after 52 weeks | 52 weeks | 
| Disability reduction | Change in Womac subscale related to function (C) after 52 weeks | 52 weeks | 
| Percentage of responders | According to OMERACT-OARSI Criteria Index Response after 52 weeks | 52 weeks |
Decrease the Frequency of Inappropriate Intravenous Lines in Internal Medicine

Study Overview
=================
Brief Summary
-----------------
Aim: to determine whether a nationwide teaching program delivered to medical doctors can decrease the use of inappropriate intravenous lines in internal medicine

Detailed Description
-----------------
Nationwide multicentre randomized prospective controlled trial enrolling 59 french internal medicine departments. During the first study visit, we collected data of patients with intravenous infusions from each participating centre in order to determine the number and frequency of inappropriate intravenous lines. Using a computerized randomization process (on a 1:1 basis), the participating centres were randomized; Half centres (interventional group) received an educational program consisting of educational material and two educational sessions; the other half did not receive the educational program (control group). The educational program provided medical doctors with posters and slides containing information on valid indications for the prescription and use of intravenous infusions (inability to drink or eat, malabsorption, medication only available intravenously with no oral equivalent). Based on a previous pilot study, we assumed that the the frequency of inappropriate intravenous lines with be approximately 20% at baseline and hypothesize that the nationwide teaching program will decrease this frequency by 50%.

Official Title
-----------------
Effect of a Nationwide Teaching Program on the Frequency of Inappropriate Intravenous Lines in Internal Medicine: A Randomized Controlled Trial

Conditions
-----------------
Acute Medical Patients Hospitalized in Internal Medicine

Intervention / Treatment
-----------------
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Internal medicine department
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Intervention (Teaching program) | Other: Education<br>* Teaching program<br>|
| No Intervention: Control group<br>No teaching program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of inappropriate intravenous infusion in internal medicine department |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
education, intravenous infusion
ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa

Study Overview
=================
Brief Summary
-----------------
The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or severe oligozoospermia after use of ejaculated versus extracted testicular sperms in different cycles for the same patient.

Detailed Description
-----------------
The study was carried out on couples who underwent ICSI in period 2012-2014 for male factor infertility.Patients with semen showing cryptozoospermia were candidates for inclusion in this study. First cycle was done as ICSI with priority to ejaculated sperm; testicular sperm was used if no motile sperm was available. For failed cases a second cycle was repeated using either testicular sperm or ejaculated sperm. Keywords:Cryptozoospermia, ejaculated spermatozoa, testicular spermatozoa, ICSI.

Official Title
-----------------
ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa in Cryptozoospermic or Severe Oligozoospermic Men

Conditions
-----------------
Intracytoplasmic Sperm Injection

Intervention / Treatment
-----------------
* Procedure: Intracytoplasmic sperm injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Couples seeking ICSI. Exclusion Criteria: Couples not seeking ICSI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Testicular tissue versus ejaculate<br>Evaluation of ICSI outcome. | Procedure: Intracytoplasmic sperm injection<br>* Intracytoplasmic sperm injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracytoplasmic sperm injection outcome | Pregnancy rate. | three years |
An Observational Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months.

Official Title
-----------------
A Patient Cohort With Locally Advanced or Metastatic Non-small Cell Lung Cancer Treated With Tarceva (Erlotinib) Monotherapy and Not Progressing After at Least 9 Months

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/=18 years of age Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC, stage III/IV) Treatment with Tarceva monotherapy and not progressing after at least 9 months at the date of study start Exclusion Criteria: Not agreeing to be followed-up (for a maximum of 24 months)

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best treatment response |  | 24 months | 
| Overall survival |  | 24 months | 
| Safety (incidence of adverse events) |  | 24 months | 
| Type of treatment response |  | 24 months | 
| Treatment compliance of patient |  | 24 months |
Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients

Study Overview
=================
Brief Summary
-----------------
The study objective is to improve morbidity and mortality of high-risk critically ill children. Our hypothesis is that a strict ICU glucose control protocol will decrease morbidity and mortality associated with hyperglycemia in a population of high-risk critically ill pediatric patients.

Official Title
-----------------
Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity

Conditions
-----------------
Respiratory Failure, Cardiovascular Failure, Sepsis, Trauma

Intervention / Treatment
-----------------
* Procedure: Strict Glucose Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or Invasive mechanical ventilation Age between 1 mo and 21 yrs Exclusion Criteria: Type I diabetes mellitus Have an illness that requires insulin daily Recipients of solid organ transplants Participation in an experimental trial that might affect outcome Post-operative patients with planned extubation upon recovery Patients on a dopamine infusion of less than 3 mcg/kg/minute

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 21 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

| Intervention/Treatment |
| --- |
|Procedure: Strict Glucose Control|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality rate from the time of enrollment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge |  |  | 
| rates of nosocomial bloodstream infections |  |  | 
| time to resolution of organ failure (mechanical ventilator days and days of vasopressor support) |  |  | 
| change in Pediatric Logistic Organ Dysfunction scores |  |  | 
| requirement of dialysis or hemofiltration for patients with acute renal failure |  |  | 
| volume of blood product transfusions per kilogram body weight (vol/kg). |  |  |
Identifying Skin Biopsy Sites

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to investigate the patient experience during skin biopsy.

Official Title
-----------------
Pilot Study of Skin Biopsy Sites: A Consensus Approach Based on Patient and Physician Interviews

Conditions
-----------------
Identification of Skin Cancer Biopsy Sites

Intervention / Treatment
-----------------
* Other: Survey/Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and Over The subjects are in good health. The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. Patients who have had one or multiple skin biopsies OR board-certified dermatologists. Exclusion Criteria: Under 18 years of age. Subjects who are unable to understand the protocol or give informed consent.

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 |
| --- | --- |
| Physicians<br>Physicians performing skin biopsies | Other: Survey/Interview<br>* Each group will be surveyed and interviewed.<br>|
| Patients<br>Patients who have had skin biopsies | Other: Survey/Interview<br>* Each group will be surveyed and interviewed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Review of Physician and Patient Experience | Subjects will answer a combination of: Open-ended questions and Questions asking for subject to rank possible responses | Last four weeks of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Experience with Skin Biopsy Sites | Physicians will answer a combination of: Open-ended questions, and Questions asking for subject to rank possible responses | First four weeks of study | 
| Patient's Experience with Skin Biopsy Sites | Patients will answer a combination of: Open-ended questions and Questions asking for subject to rank possible responses | First four weeks of study |