linjc16/ctgov huggingface dataset:
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)

Study Overview
=================
Brief Summary
-----------------
To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.

Detailed Description
-----------------
MEGA Study is the first prospective, randomized, controlled trial conducted in Japan to evaluate the primary preventive effect of pravastatin against CHD in daily clinical practice. Because the dose of pravastatin used in the MEGA Study was 10-20 mg/day, which is consistent with the approved doses in Japan and lower than the doses used in previous large-scale clinical trials.

Official Title
-----------------
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Behavioral: Diet
* Drug: Diet+pravastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TC:220～270mg/dl Male: 40-70 years old/ female: postmenopausal-70 years old <40kg in weight Exclusion Criteria: FH History of CHD(angina, MI, post-PTCA/CABG, etc.) History of CVA(stroke, TIA, etc.) Underlying malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Diet|nan|
|Drug: Diet+pravastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization] |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia, coronary heart disease, prevention, stroke, pravastatin
Healthy Moms Alcohol Intervention

Study Overview
=================
Brief Summary
-----------------
The study proposes to test the efficacy of a primary care-based brief intervention with women who resumed heavy drinking during the post-partum period and who used alcohol during a previous pregnancy. The trial will also examine the effects of tobacco use, illicit drug use, depression and domestic violence on alcohol use.

Official Title
-----------------
Brief Alcohol Intervention: The Healthy Moms Project.

Conditions
-----------------
Fetal Alcohol Syndrome, Pregnancy, Alcoholism

Intervention / Treatment
-----------------
* Behavioral: counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women of childbearing age (18-40) who drank alcohol during their previous pregnancy and who report drinking above recommended limits in the post partum period. Exclusion Criteria: N/A

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: counseling|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim is to conduct a randomized test of the efficacy of brief physician/nurse advice in reducing alcohol use, alcohol-related harm, and fetal alcohol exposure in subsequent pregnancies in a sample of high-risk post partum pts. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To est. the prevalence of drinking in ethnic div. pop. post partum women who are pts in 60 practices in Dane, Waukesha, and Milwaukee counties;the effect of age, race, tobacco use, marital status, partner alcohol use, and readiness-to-change; |  |  |
Efficacy and Safety of Sacubitril/Valsartan in African American Patients With Heart Failure With Reduced Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
There is limited long-term evidence specific to AAs with HFrEF on sacubitril/valsartan therapy. Plasma NT-proBNP levels are lower in AA individuals as compared to Caucasian individuals in general. However, the mechanism of action of sacubitril specifically targets the activity of BNP. Therefore, there is the potential that the mechanism of action of sacubitril/valsartan may be less effective in AAs.

Detailed Description
-----------------
To assess the efficacy and safety of sacubitril/valsartan in AA patients with HFrEF by comparing the outcomes of AA patients on ARNI therapy plus SOC (with or without hydralazine/isosorbide [H-IDSN]) to AA patients receiving ACEi/ARB therapy plus SOC (with or without H-ISDN).

Official Title
-----------------
Efficacy and Safety of Sacubitril/Valsartan in African American Patients With Heart Failure With Reduced Ejection Fraction

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

Intervention / Treatment
-----------------
* Drug: sacubitril/valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identified as AA NYHA class II-IV symptoms Left ventricle EF <40% Receiving stable doses of standard therapy, including ACE inhibitors or ARBs, ARNI (within a month from discharge), combination H-ISDN, beta blockers, digoxin, spironolactone, and diuretics as tolerated. Patient must have minimum of three months follow-up Exclusion Criteria: Patients not meeting inclusion criteria

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sacubitril/valsartan|Sacubitril belongs to a class of drugs called neprilysin inhibitors and valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). They work by relaxing blood vessels so that blood can flow more easily, which makes it easier for your heart to pump blood to your body.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite CV mortality or HF hospitalization | Composite CV mortality or HF hospitalization | April 2017 to August 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CV mortality | Individual components | April 2017 to August 2020 | 
| HF hospitalization | Individual components | April 2017 to August 2020 | 
| All-cause mortality | Individual components | April 2017 to August 2020 | 
| New atrial fibrillation | Individual components | April 2017 to August 2020 | 
| Renal function decline | Individual components | April 2017 to August 2020 | 
| Change in EF | Individual components | April 2017 to August 2020 | 
| Change in NYHA classification | Individual components | April 2017 to August 2020 |
PICO Dressings for Emergency Laparotomy

Study Overview
=================
Brief Summary
-----------------
SSI (Surgical Site Infection) rate is an important consideration after emergency laparotomy. SSIs carry a high financial burden for health institutes with the cost of major SSIs after emergency laparotomy to add an additional cost of £10000-£15000 per patient. NICE has recommended the use of PICO dressings for the reduction of SSI rate as a cost-neutral. The purpose of this study was to review the current SSI rate, assess the patient risk factors for development of SSIs and evaluate if the use of PICO dressings as per NICE guidelines will reduce the SSI rate.

Official Title
-----------------
The Use of PICO Dressings for Patients Undergoing Emergency Laparotomy

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Device: PICO dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All emergency midline laparotomy Laparoscopic converted open Exclusion Criteria: - Reoperation with 28 days of index laparotomy

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 |
| --- | --- |
| Standard surgical dressings (Clearpore)<br> | |
| NPWT dressing (PICO)<br> | Device: PICO dressing<br>* Negative Pressure Wound Therapy device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSI Day 7 | Presence of SSI | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSI Day 7 | Presence of SSI | Day 28 | 
| Length of stay | Length of stay | through study completion, an average of 6 months | 
| Surgical site complications | Number of participants with other complications of the wound to include dehiscence and burst abdomen | Day 28 | 
| Reoperation | Number of participants undergoing reoperation | Day 28 | 
| SSI grading | SSI grading as per Southampton scoring system (if applicable) (Grade 0-5 with 5 being worse outcome) | Day 28 | 
| Length of antibiotic therapy | Duration of post-operative antibiotic therapy | Day 28 |
Tear Film Evaluation After Phacoemulsification

Study Overview
=================
Brief Summary
-----------------
To compare tear film differences between surgical eyes and nonsurgical eyes in patients who had cataract surgery by phacoemulsification in one eye.

Detailed Description
-----------------
All participants granted their written informed consent to participate in the research protocol.

Official Title
-----------------
To Investigate Tear Film Change After Phacoemulsification With SS-OCT

Conditions
-----------------
Cortical Senile Cataract

Intervention / Treatment
-----------------
* Procedure: cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age-related cataract without surgery history and dry eye symptoms history Exclusion Criteria: diseases influencing tear secretion (such as Sjögren syndrome, Steve-Johnson syndrome, diabetes, thyroid disease, etc.); history of ocular surgeries or nuclear hardness IV and V, which required the use of larger phacoemulsification energy; use of drugs that affect tear secretion and stability (such as glaucoma medications, artificial tears, corticosteroid drugs, etc.); or presence of ocular diseases (such as Pterygium, blepharitis, uveitis, glaucoma, lacrimal apparatus, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| surgery group<br>patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye | Procedure: cataract surgery<br>* All patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye<br>|
| control group<br>patients' other eye that did not have surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phacoemulsification influence on the postoperative tear functions |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract ,tear film,SS-OCT
Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis

Study Overview
=================
Brief Summary
-----------------
Necrotizing enterocolitis (NEC) is a serious gastrointestinal disorder that primarily affects preterm infants. About 10% of babies less than 32 weeks gestation at birth will develop it. Overall, 30% of babies who develop NEC will die from it, with many others developing long term gastrointestinal problems. The most important factor in its development is a premature intestinal tract. Epidermal growth factor (EGF) is an important growth factor in the development and maintenance of the gastrointestinal tract. This study will look for a relationship between EGF levels in premature babies and the development of NEC.

Official Title
-----------------
Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis

Conditions
-----------------
Necrotizing Enterocolitis, Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational Age greater than 23 weeks at birth Birth weight greater than 500 grams Age less than 72 hours of life

Ages Eligible for Study
-----------------
Maximum Age: 72 Hours

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
-----------------
Enterocolitis
Feasibility and Outcomes of Older Patients Hospitalization

Study Overview
=================
Brief Summary
-----------------
Hospitalization is a traumatic event for the patient and his family at any age nevertheless in the older age. One of its consequences is the difficulty to resume previous activity of daily living especially in older (over 75 years) patients. Sub acute completes the acute phase of the hospitalization and its main purpose is to improve the patient's functional status and quality of life. There are not enough clinical trails to proof this assumption. The purpose of our study is to compare the outcome of acute and sub-acute hospitalization programs by a randomized controlled prospective intervention study. Outcome measures will comprise activity of daily living, functional status, re-hospitalization and utilization of medical services following the hospitalization.Study hypothesis is that sub-acute hospitalization will improve outcomes and will cost less.

Conditions
-----------------
Cellulitis, Community-Acquired Pneumonia, Exacerbation of Chronic Heart Failure, Exacerbation of Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: sub-acute hospitalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 65 Hemodynamic, nutritional and respiratory stability eligibility for sub- acute hospitalization Exclusion Criteria: Oncological active disease uncorrectable hypoxemia (oxygen saturation 90%), suspected myocardial ischemia presence of an acute illness, other than the target illness

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: sub-acute hospitalization|nan|

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
-----------------
Subacute care, Activities of Daily Living, Cognition assessment, Mood assessment, Incontinence control
Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) in Patients With Head and Neck Tumor

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the feasibility of higher and prolonged dose escalation concentrated in the intra-tumoral regions which are FDG-avid after two weeks of radiotherapy.

Official Title
-----------------
Phase I Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) With Patients With Head and Neck Tumor

Conditions
-----------------
Head and Neck Tumor

Intervention / Treatment
-----------------
* Procedure: 18F-FDG-PET radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and neck tumor Aged > 18 years

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 18F-FDG-PET radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor recurrences |  |  |
Remote Speech Analysis in HF Patients Undergoing Haemodialysis

Study Overview
=================
Brief Summary
-----------------
This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.

Official Title
-----------------
A Non-Intervantional Study to Create a Patient Recordings and Clinical Database Using the Cordio System

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

Intervention / Treatment
-----------------
* Device: Cordio Medical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload. Class C Heart Failure patient with reduced EF CHF (EF<40%) and NYHA 2-3. Patients with dyspnea clinically related to pulmonary congestion Patient with more than 3 months HF disease duration. The patient is willing to participate as evidenced by signing the written informed consent. Male or non-pregnant female patient Exclusion Criteria: Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia). Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit. Patients likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit or baseline functional capacity of NYHA 4. Patients with evidence of active Infection. Patient with severe alcohol or drug use. Psychological instability, inappropriate attitude or motivation. Patient with life threatening debilitating disease other than cardiac. Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

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 |
| --- | --- |
| HF patients<br>HF patients will use the Cordio Medical app to record in their hospital visits and at home. | Device: Cordio Medical<br>* Recording to an app, no interference to the regular care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CHF patients with and without acute lung accumulation. in R&D Database | The objective of the study is to create a recordings database of CHF patients with and without acute lung accumulation. | throughout study, upto 60 days per patient |
Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level

Study Overview
=================
Brief Summary
-----------------
Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the gray zone (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA gray zone level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.

Official Title
-----------------
Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are willing to sign the informed consent and agree to comply with the study procedures. Age from 20 to 99 years old Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months Exclusion Criteria: Age < 20 years Refuse to sign the informed consent form Received regional anesthesia and general anesthesia within one month Previous cancer history Autoimmune diseases Chronic inflammatory diseases Diagnosed with colorectal polyps or adenomas Acute inflammatory or infectious diseases in three months Other diseases decided by PI

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Male

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gray Zone Group<br>The gray zone group PSA between 4.00 to 10.99 ng/ml. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating tumor cells detection | Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA gray zone level | Prior to prostate biopsy |