linjc16/ctgov huggingface dataset:
Use of Multiphoton Microscopy in the Diagnosis of Cancer

Study Overview
=================
Brief Summary
-----------------
Multiphoton microscopy (MPM) has been shown to be able to image tissue at a cellular level. Our project will initially evaluated the ability of MPM imaging to distinguish normal bladder urothelium from atypical and malignant urothelium in the ex vivo setting. After development of sufficient criteria, we plan to develop an endoscopic bladder probe that will provide a non-invasive means to image the interior of the bladder at the cellular level, which would provide direct evidence of the presence of tumor without a biopsy. After exhibiting usefulness of MPM imaging for bladder cancer, we will look at other organs beginning with the colon.

Detailed Description
-----------------
Same as above

Official Title
-----------------
Use of Multiphoton Microscopy in the Diagnosis of Cancer

Conditions
-----------------
Bladder Cancer, Prostate Cancer

Intervention / Treatment
-----------------
* Other: Multiphoton microscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone who presents with bladder and/or prostate cancer

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 Years

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

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

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: MPM<br>Subject tissue was reviewed using multiphoton microscopy | Other: Multiphoton microscopy<br>* Use of multiphoton microscopy to diagnose cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| After several delays, the multiphoton microscope has been delivered to Weill Cornell Medical College. We have been using this time to set-up and fine tune the multiphoton microscope. As of current, no negative events have occurred. |  | 10/14/2007 to 2/15/2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder cancer, prostate cancer, multiphoton microscopy
Study on the Population Pharmacokinetics of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The individualized drug delivery system of levetiracetam based on population pharmacokinetics and quantitative pharmacology model in patients with epilepsy complicated by diabetic kidney disease was established. To clarify the clinical feasibility of model-based individualized drug administration scheme.

Detailed Description
-----------------
A quantitative pharmacological model for the development of levetiracetam in epileptic patients with diabetic nephropathy is proposed. First, a model based active levetiracetam based individualized initial dose regimen was established by using clinical simulation techniques. A simulation model was established for patients with diabetes mellitus and kidney disease, including information on patients' gender, age and other factors, diabetes mellitus, renal disease history, creatinine clearance rate, glomerular filtration rate, urinary protein level and blood lipid level. Secondly, the simulated clinical trial combining simulation model and population pharmacokinetic model is used to compare the compliance rate of levetiracetam blood concentration in patients with different dose treatment schemes, so as to obtain the optimal individualized administration scheme. Finally, Bayesian feedback technology is used to improve the passive dose adjustment scheme, and model-based Bayesian feedback technology is used to establish a dose adjustment scheme based on area under curve (AUC), so as to clarify the optimal blood sampling scheme and monitoring method.

Official Title
-----------------
Study on the Population Pharmacokinetics and Individualized Administration of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease

Conditions
-----------------
Epilepsy, Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with seizures and diabetic nephropathy who were treated with levetiracetam. Exclusion Criteria: patients who rejected

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|Epilepsy, treatment with levetiracetam|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood drug concentration | After treating with levetiracetam, blood samples were collected at different time periods | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levetiracetam, Population pharmacokinetics
Heart Rate Control With Esmolol in Septic Shock

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is investigate the effects on systemic hemodynamics and organ function of esmolol when used to maintain heart rate below a predefined threshold in patients with septic shock.

Detailed Description
-----------------
154 septic shock patients with heart rate > of 95 bpm and requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation, will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous esmolol infusion at any doses to maintain heart rate between 95 and 80 bpm b)to a standard treatment without heart rate control(control; each n = 77). In both groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization,data from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72, and 96 hours. The protocol will require that esmolol be infused continuously at any doses to maintain the predefined heart rate threshold until one the following events occur: the patient die, a serious adverse effect attributed to the study drug infusion, or the patient has been discharged from ICU.

Official Title
-----------------
Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: esmolol
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: septic shock criteria presence of heart rate > 95 bpm. Exclusion Criteria: Pregnancy age < 18

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: esmolol<br> | Drug: esmolol<br>* Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.<br>|
| Other: control<br> | Other: control<br>* standard treatment without strict heart rate control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | over a period of 96 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic hemodynamics | systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects. | over a period of 96 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock, esmolol, tachycardia, betablockers
Healthy Planet Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This quality improvement project utilizes Epic Health Planet to increase screening for chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory panels.

Official Title
-----------------
Utilizing Electronic Health Systems to Enhance Screening and Linkage to Care for Chronic Hepatitis B

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Other: Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in the electronic health record Exclusion Criteria: - previously completed hepatitis B screening tests

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatitis B Healthy Planet Arm<br>This is a single arm study where all patients eligible patients will receive a hepatitis B order set | Other: Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody<br>* The hepatitis B tests are released into the electronic medical charts of at-risk patients who have never been screened for chronic hepatitis B using population health tools.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of hepatitis B order panel |  | Within 1 year after placement of the order | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to care of those found to be infected with hepatitis B |  | Within 3 months after a positive HBsAg test |
Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability

Study Overview
=================
Brief Summary
-----------------
This is a randomized trial investigating the use of the IMPELLA RECOVER LP 2.5 compared to Intra-aortic balloon pump (IABP) in patients with Acute Myocardial Infarction.

Official Title
-----------------
RECOVER II Trial: A Prospective Randomized Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: Impella LP 2.5
* Device: Intra-Aortic Balloon Pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent Subject presenting with STEMI undergoing primary PCI Patient presents with at least 1 of the following: Unstable blood pressure Tachycardia and tissue hypoperfusion The need for intravenous pressor or inotropic support Patient presents with STEMI: CK-MB>2x normal Exclusion Criteria: Unwitnessed cardiac arrest Abnormalities of the aorta Recent stroke or TIA Mural thrombus in the left ventricle

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: IMPELLA LP 2.5<br> | Device: Impella LP 2.5<br>* Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5L/min.<br>|
| Active Comparator: Intra-Aortic Balloon Pump<br> | Device: Intra-Aortic Balloon Pump<br>* The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite rate of major adverse events within 30 days or hospital discharge. | Composite rate of major adverse events within 30 days or hospital discharge. | 30 days or discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum CPO increase from baseline. | Maximum CPO increase from baseline. | Treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial Occlusive Disease, Heart Diseases, Myocardial Ischemia, Vascular Disease, Arteriosclerosis, Ischemia
Pokemon Go and Physical Activity

Study Overview
=================
Brief Summary
-----------------
The goal of this study to evaluate the association between Pokemon Go and physical activity through a survey among Pokemon Go players.

Detailed Description
-----------------
Pokemon Go is a location-based reality mobile game for iOS and Android devices developed by Niantic. Making use of GPS and the camera of compatible devices, the game allows players to capture virtual creatures, called Pokemon, who appear on cellphone screens as though in the real world. In order to search and capture the Pokemon, the players needs to go out and become more active. For this reason, the game has great potential to promote physical activity. Nevertheless, there has no study evaluating the potential impact of Pokemon Go on physical activity. The investigator proposes a retrospective online survey. Participants are instructed to enter data of their daily physical activity as reported in iPhone Health App. Number of Steps and % greater than 10,000 steps/day will be compared before and after installing the Pokemon Go app.

Official Title
-----------------
Pokemon Go and Physical Activity Online Survey

Conditions
-----------------
Physical Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who use iPhone and have played Pokemon Go before July 31, 2016 and agree to consent to participate in the survey Exclusion Criteria: Subjects who do not use iPhone Have not played Pokemon Go before July 31, 2016 Unable to provide informed consent
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of steps per day | Number of steps as reported on the iPhone Health app | Between June 15 and July 31, 2016 | 
| Change in number of steps after Pokemon Go | Differences in number of steps per day before and after Pokemon Go | From June 15 to July 31, 2016, assessed up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Greater than 10,000 steps per day | Percent of days in which subjects reached greater than 10,000 steps/day | Between June 15 and July 31, 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mHealth, Pokemon Go
Endothelial Progenitor Cells and Pulmonary Idiopathic Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
Endothelial dysfunction ultimately represents an imbalance between the magnitude of injury and the capacity for repair. Current evidence established that endothelial progenitor cells (EPC) participate in several models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery disease, etc. However EPC in the setting of PAH is less well established. The target of this study is to demonstrate if the number of EPC is increased in a mexican population of patients with PAH.

Official Title
-----------------
The Determination of Endothelial Progenitor Cells in Pulmonary Idiopathic Arterial Hypertension.

Conditions
-----------------
Pulmonary Idiopathic Arterial Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were included in the study if they were in The WHO functional class II to III, and had a mean pulmonary artery pressure >30 mm Hg on right heart catheterization. The ability to walk >50 m during a standardized 6-min walk test. Exclusion Criteria: Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, major bleeding requiring blood transfusion,renal dysfunction, and evidence for malignant diseases were excluded.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>20 patients with idiopathic pulmonary arterial hypertension in the WHO functional class II to III, and had a mean pulmonary artery pressure >30 mm Hg on right heart catheterization able to walk >50 m during a standardized 6-min walk test. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.

Official Title
-----------------
A Phase 2a, Randomized, Placebo-Controlled, Parallel Group, Multiple-Dose Study To Evaluate The Efficacy, Safety, And Tolerability Of 12-Week Oral Administration Of PF-00734200 Tablets To Subjects With Type 2 Diabetes Mellitus On Stable Treatment With Metformin

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: PF-00734200 10 mg QD
* Drug: PF-00734200 20 mg QD
* Drug: PF-00734200 5 mg QD
* Drug: PF-00734200 2 mg QD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes Hb1AC >7%-11% inclusive Male and females 18-70; females must be post-menopausal On a stable dose of metformin hydrochloride Exclusion Criteria: Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse. Women of childbearing potential, pregnant or nursing Evidence of diabetic complications with significant end-organ damage

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo QD<br>|
| Experimental: PF-00734200 10 mg QD<br> | Drug: PF-00734200 10 mg QD<br>* 10 mg QD<br>|
| Experimental: PF-00734200 20 mg QD<br> | Drug: PF-00734200 20 mg QD<br>* 20 mg QD<br>|
| Experimental: PF-00734200 5 mg QD<br> | Drug: PF-00734200 5 mg QD<br>* 5 mg QD<br>|
| Experimental: PF-00734200 2 mg QD<br> | Drug: PF-00734200 2 mg QD<br>* 2 mg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C levels (%) |  | 12 weeks | 
| Evaluation of Dose Response in HbA1c (%) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin and Glucose AUC following a mixed meal tolerance test |  | 12 weeks | 
| Proportion of subjects achieving ADA glycemic goal of Hb A1c <7% |  | 12 weeks | 
| Incidence of Adverse Events |  | 12 weeks |