linjc16/ctgov huggingface dataset:
Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT)

Study Overview
=================
Brief Summary
-----------------
One of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the United States experiencing this condition. Hypertension is significantly more prevalent in African Americans compared to European Americans. Importantly, hypertension is a modifiable stroke risk factor. This proposal will use a community-based participatory research approach to perform a randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure in an urban African American community in Flint, Michigan.

Detailed Description
-----------------
This is a randomized controlled trial of text messaging and blood pressure self-monitoring to reduce blood pressure.

Official Title
-----------------
REACH OUT: to Reduce High Blood Pressure

Conditions
-----------------
Hypertension, Stroke

Intervention / Treatment
-----------------
* Behavioral: Text Messaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>18 y/o) participants with BP ≥140/90 who have mobile phones with text-messaging capability. Exclusion Criteria: Adult who is illiterate, non-English speaking, pregnant, incarcerated/ institutionalized resident, or has a pre-existing condition that makes follow-up for 6 months unlikely.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No text messages, hypertensive<br>Participants who have high blood pressure, who are randomized to health information (do not receive text messages). | |
| Experimental: Text messages, hypertensive<br>Participants who have high blood pressure, who are randomized to receive text messages. | Behavioral: Text Messaging<br>* hypertensive participants will be randomized to receive tailored, motivational text messages<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Systolic Blood Pressure |  | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Diastolic Blood Pressure |  | Baseline to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension treatment, stroke prevention
Pediatric Disease Registry in Essential Thrombocythaemia (ET)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the progression of ET in children (aged 6-17years inclusive) over a period of 5 years maximum. The study will also assess how children are diagnosed, treatment options for those children with symptoms and events related to their ET and the outcomes of those treatments.

Official Title
-----------------
Multicentre Paediatric Disease Registry in Essential Thrombocythaemia

Conditions
-----------------
Essential Thrombocythemia (ET)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 6 years or over and less than 18 years patient has ET according to the WHO criteria as guidance Exclusion Criteria: Interventional clinical study participation

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Treatment effects on platelet count in children ages 6-17 years inclusive. |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive |  | 60 months |
Warfarin Versus Aspirin in Patients With Atrial Fibrillation and Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators examine whether aspirin or warfarin is useful for atrial fibrillation patients with chronic kidney disease.

Detailed Description
-----------------
randomised open labelled prospective study We enroll patients with CHADS2 score 1 non-valvular AF with chronic kidney disease, and analyze all thromboembolic event or major bleeding event during follow-up period. Warfarin group take dose adjusted warfarin (target INR 2.0-3.0) and aspirin group take aspirin 100mg daly. Thromboembolic events: Ischemic stroke or systemic arterial occlusion Major bleeding: gastrointestinal bleeding or intracranial bleeding (code 430, code 431, code 432 by ICD-9-CM codes) -> Only the first event of each case will be used for the analysis

Official Title
-----------------
A Randomized Controlled Prospective Trial of Warfarin Versus Aspirin for Stroke Prevention in Patients With Atrial Fibrillation and Chronic Kidney Disease

Conditions
-----------------
Atrial Fibrillation, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: warfarin
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CHADS2 score 1 nonvalvular atrial fibrillation patients with chronic kidney disease Exclusion Criteria: HAS-BLED ≥30 History of syncope or seizure within 1 year History of major bleeding event within 6 months BP>180/100 Abnormal prothrombin time Hypersensitivity of aspirin or warfarin Folstein mini mental state examination score <26 Taking or had taken other anticoagulants

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: warfarin<br>medication | Drug: warfarin<br>* anticoagulation<br>|
| Active Comparator: aspirin<br>medication | Drug: Aspirin<br>* antiplatelet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic event | Ischemis stroke and systemic thromboembolism | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding |  | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
warfarin, aspirin
Pharmacodynamic Parameters of Two Different Doses of Cefepime

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetics is the study of the disposition of drugs in the body, while pharmacodynamics considers the interaction of the drug at the site of infection over time. Mathematical models of antibiotic pharmacodynamics are sometimes used to predict if antibiotic doses are sufficient to treat infection with organisms of different minimal inhibitory concentrations of the antibiotic. Based on these models, there has been speculation that the antibiotic cefepime dosed at one gram every 12 hours, is insufficient to kill all organisms within the susceptible range. This study of patients treated with cefepime will involve the collection of blood to determine cefepime concentrations, and determine if those concentrations are effective in killing the bacteria at the site of infection.

Detailed Description
-----------------
This will be a non-interventional study in that the antibiotic and its dose will be chosen by the treating team not the investigators. Patients on cefepime who have ventilator-associated pneumonia or bacteremia will be invited to participate in the study. Blood samples will be taken to determine the pharmacokinetic profile of the drug. Blood cultures will be repeated in patients with bacteremia to determine clearance of infection. A mini-BAL will be repeated in patients with ventilator-associated pneumonia to determine clearance of pneumonia.

Official Title
-----------------
Pharmacodynamic Parameters of Two Different Doses of Cefepime

Conditions
-----------------
Pneumonia, Infection, Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults of at least 18 years of age or older Culture proven ventilator associated pneumonia (VAP) or bacteremia caused by a cefepime susceptible gram negative pathogen: Bacteremia is defined as at least one positive blood culture VAP is defined by at least 10,000 cfu/ml of an organism from a bronchoalveolar lavage sample Cefepime therapy (1 or 2 grams intravenously [IV] every [q] 8 hours or q 12 hours) initiated as part of standard of care Exclusion Criteria: Concomitant VAP or bacteremia with a cefepime resistant organism Concomitant therapy with an antimicrobial agent active against gram negative bacilli other than a single dose of aminoglycoside Patients requiring surgical or interventional drainage of purulent collections Pregnant or lactating women Dialysis patients Contraindication to blood sampling Cystic fibrosis

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventilator associated pneumonia
Prognostic Value of Soluble Urokinase-type Plasminogen Activator Receptor in Valvular Heart Disease

Study Overview
=================
Brief Summary
-----------------
This study investigates the association between level of suPAR and valvular heart disease in patients who have severe aortic stenosis or severe aortic regurgitation using commercially available suPARnostic standard enzyme-linked immunosorbent assay (ViroGates, Denmark)

Official Title
-----------------
Prognostic Value of Soluble Urokinase-type Plasminogen Activator Receptor in Valvular Heart Disease

Conditions
-----------------
Severe Aortic Stenosis or Severe Aortic Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 19 yrs Severe aortic stenosis or severe aortic regurgitation Agree to consent for self Can follow-up for the next 2 years Exclusion Criteria: Pre-existing acute kidney injury Pre-existing end stage kidney disease: estimated glomerular filtration rate (eGFR) ≤15 ml/min/1.73m2 or receiving renal replacement therapy On ECMO or IABP Life expectancy < 12 months Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 99 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 |
| --- | --- |
| Patients with severe aortic stenosis or severe aortic regurgitation<br>Patients with severe aortic stenosis or severe aortic regurgitation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse clinical outcomes | Composite of all-cause death, cardiovascular mortality, and worsening of kidney function | Immediate post operation | 
| Number of participants with adverse clinical outcomes | Composite of all-cause death, cardiovascular mortality, and worsening of kidney function | 2 years after recruiting |
Biomarkers in Patients With Pneumonia

Study Overview
=================
Brief Summary
-----------------
To identifying biomarkers in patients with pneumonia

Detailed Description
-----------------
The aim of this study is to identify the biomarkers in patients with pneumonia. These biomarkers can distinguish community-acquired pneumonia, hospital-acquired pneumonia, severe pneumonia, bacterial infection, virus infection and fungal infection. Furthermore, these biomarkers can identify the efficacy of treatment in patients with different interventions.

Official Title
-----------------
Biomarkers and Associated Outcomes in Patients With Pneumonia

Conditions
-----------------
Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy patients without any diseases - Exclusion Criteria:Age less than 18 years -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | Mortality is defined the patient died in hospital. | From diagnosis of pneumonia to discharge from hospital or up to 90 days, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe pneumonia | The pneumonia deteriorated and reached the criteria of severe pneumonia. Severe pneumonia was diagnosed according to the guideline published by ATS. | From diagnosis of pneumonia to discharge from hospital or up to 90 days, whichever came first | 
| initial treatment failure | Initial treatment failure means the patients' condition progressively deteriorated although comprehensive treatment was administrated. As a result, the treatment should be changed or the patient required admission to ICU. | From diagnosis of pneumonia to discharge from hospital or up to 90 days, whichever came first |
Symptom Collection of Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study is conducted to collect the symptoms of lung cancer patients and to observe the relationship with proteomics.

Official Title
-----------------
A Study on Symptom Collection of Patients With Lung Cancer.

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult over 18 years old Patients are scheduled for surgery with lung cancer diagnosis. ECOG status score 0 to 2 Individual who can read and understand Korean Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: Patient who was diagnosed with lung cancer in the past. Individuals who are judged inappropriate for the study

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 |
| --- | --- | --- |
| Pattern identification | Pattern identification by Body constitution questionnaire(BCQ) BCQ(+) is a questionnaire that is comprised of nineteen questions with one-to-five rating scales, making the range of total score to be between nineteen and ninety-five points with the cut-off score of 30.5 points for Yang-Xu. BCQ(-) is composed of another set of nineteen questions with the same five-point Likert scales, with the cut-off score of 29.5 points for Yin-Xu. BCQ(s) consists of twenty-three questions with the same Likert scale cut-off score of 26.5 points for Stasis. | For 1 year |
A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)

Study Overview
=================
Brief Summary
-----------------
The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.

Official Title
-----------------
A Phase I Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: MK0683, vorinostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chemotherapy-naive patients who are histologically or cytologically diagnosed NSCLC with stage IIIB (not applicable of radical thoracic radiation) or stage IV Patients with normal organ function and bone marrow function Exclusion Criteria: Given radical thoracic radiation for NSCLC or radiation for other than original lesion within 3 weeks Any peripheral neuropathy above grade 2 Any ascites, pleural effusion or pericardiac effusion which requires treatment Any uncontrolled concomitant illness Pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0683, vorinostat|vorinostat 300 mg or 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Dose Limited Toxicity at First Cycle | Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment. | 25 Days (first cycle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC(0-24 hr)) at Day 4 | Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour. | Day 4 | 
| Area Under the Curve (AUC(0-24 hr)) at Day 5 | Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour. | Day 5 | 
| Maximum Concentration (Cmax) at Day 4 | Maximum Concentration (Cmax) = the maximum plasma concentration of the drug | Day 4 | 
| Maximum Concentration (Cmax) at Day 5 | Maximum Concentration (Cmax) = the maximum plasma concentration of the drug | Day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Small Cell Lung Cancer (NSCLC)
Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus

Study Overview
=================
Brief Summary
-----------------
To explore clinical effectiveness of PHILOS plate fixation and hemi-shoulder arthroplasty in treating three or four-part fractures of proximal humerus

Detailed Description
-----------------
From April 2015 and April 2017, patients from multi-center aged over 60 years old with three and four-part fractures of proximal humerus were treated with Proximal Humerus Internal Locking System(PHILOS) and hemi-shoulder arthroplasty in multi-center. All the patients received the same rehabilitation course. At 6 months after surgery, postoperative complications were observed, EQ-5D was used to evaluate quality of life, and ASES score was used to assess functional outcomes.

Official Title
-----------------
A Multi-center Study on Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus.

Conditions
-----------------
Humeral Fracture, Proximal

Intervention / Treatment
-----------------
* Procedure: Hemi-shoulder Arthroplasty
* Procedure: PHILOS Plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: three or four part fractures of proximal humerus Exclusion Criteria: Severe comminuted fractures of proximal humerus past history of injured-side shoulder surgery Patients who cannot tolerate surgery

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PHILOS Plate<br>three or four-part fractures of proximal humerus treated with internal fixation | Procedure: PHILOS Plate<br>* PHILOS plate treating three or four-part fractures of proximal humerus<br>|
| Hemi-shoulder arthroplasty<br>three or four-part fractures of proximal humerus treated with hemi-shoulder arthroplasty | Procedure: Hemi-shoulder Arthroplasty<br>* Hemi-shoulder Arthroplasty treating three or four-part fractures of proximal humerus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications were observed | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D | EQ-5D was used to evaluate quality of life | 6 months after surgery | 
| ASES score | ASES was used to assess functional outcomes | 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Humeral Fractures, Proximal, Arthroplasty, Shoulder Replacement, Bone Plates