linjc16/ctgov huggingface dataset:
Development and Efficacy Evaluation of Integrated Chronic Care and Health Promotion Model for Patients With Coronary Artery Disease in Taiwan

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this project is to examine whether the integrated health care program as the intervention group can reduce the recurrence and mortality of coronary artery-related diseases than the traditional one as the comparison group.

Conditions
-----------------
Acute Myocardial Infarction, Stable Angina

Intervention / Treatment
-----------------
* Behavioral: Integrated health care team
* Other: Traditional group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who suffered from acute myocardial infarction or stable angina with intervention (CABG or PTCA) Exclusion Criteria: Age > 85 yrs old. Worse short-term prognosis (e.g.cancer, congestive heart failure NYHA IV) Any systemic disease which will limit the exercise program (e.g. bed-ridden stroke) Unable to participate in the trial due to any logic reasons

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Comparison group<br> | Other: Traditional group<br>* CAD education fryers<br>|
| Experimental: Integrated health care team<br> | Behavioral: Integrated health care team<br>* CAD education fryers, drugs counseling, diet intervention, individualized exercise program, body weight control, smoking cessation program, and distant CAD care monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, non-fatal MI, non-fatal stroke, recurrent angina, emergency room (ER) visit due to any CV-related diseases or readmission due to any CV-related diseases confirmed by the physicians. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP, lipid, glucose, EBM drugs and self-care efficacy | Blood pressure < 140/90 mmHg (< 130/80 mmHg in the diabetics and patients with chronic kidney disease) Hypercholesterolemia：LDL < 100 mg/dl Diabetic：HbA1c < 7% Smoking cessation rate Adherence rate of EBM medication including anti-platelet agent, beta-blocker, RAS blocker and lipid-lowering agent. Efficacy of self care | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intervention, CABG or PTCA
PCR Based CEUS in BI RADS 4A Nodules

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).

Detailed Description
-----------------
The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed and PCR scores were calculated to evaluated the added value in BI-RADS 4A nodules.

Official Title
-----------------
Principal Component Regression Based Contrast Enhanced Ultrasound Evaluating System in the Management of BI-RADS 4A Breast Nodules

Conditions
-----------------
PCA, Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with BI-RADS 4A breast lesion Exclusion Criteria: (i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: imaging|ultrasound and contrast enhanced ultrasound for BI RADS4A breast modules|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgery or biopsy | According to the PCR result, if it's positive, the nodule category was maintained, however, if it's negative, the nodule was downgraded. all nodules were submitted to biopsy or biopsy. | up to 3 months |
AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience

Study Overview
=================
Brief Summary
-----------------
The utilization of AlloSure to help guide immunosuppression management in solid organ transplant recipients diagnosed with COVID-19

Detailed Description
-----------------
An observational case series of patients with solid organ transplants who have been admitted with suspected COVID-19 utilizing AlloSure dd-cf DNA to help guide immunosuppression management balancing the treatment of sepsis and avoiding allograft rejection.

Official Title
-----------------
AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience

Conditions
-----------------
Solid Organ Transplant Rejection, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver, Heart, Lung or Kidney organ transplant recipient with a suspected or confirmed diagnosis of COVID-19 Exclusion Criteria:
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 |
| --- | --- | --- |
| Assessing the utility of AlloSure dd-cfDNA to guide clinical immune-optimization for transplant patients with COVID-19 | AlloSure dd-cfDNA blood draw values | 6 months |
Assessment of Chest Compression Depth Obtained Using the Smartphone Application as an Educational Tool With New Attachment Device

Study Overview
=================
Brief Summary
-----------------
To improve the quality of CPR education, we want to assess the validity and reliability of the feedback depth measured by smartphone applications according to the smartphone attachment sites as an educational tool. However, in the prior study, armband method showed overestimated chest compression depth. The reason of the overestimation was analyzed that the weight of the smartphone amplified the inertial force to produce additional linear movement. In this study, we will make new device to fix the smartphone on the arm and on the hand and compare the chest compression depth between CPR manikin and smartphone application.

Official Title
-----------------
Assessment of Chest Compression Depth Obtained Using the Smartphone Application as an Educational Tool With New Attachment Device

Conditions
-----------------
Basic Cardiac Life Support

Intervention / Treatment
-----------------
* Device: Grasp method
* Device: Armband-in-hand method
* Device: Armband-on-arm method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BLS provider or instructor Exclusion Criteria: one who has physical problem in chest compression

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PocketCPR;Grasp method<br>Subject grasp a smartphone in the hand and compress the chest of manikin. | Device: Grasp method<br> <br> |
| Active Comparator: PocketCPR;Armband-in-hand method<br>Grab the smartphone-contained-armband in hand when performing chest compression | Device: Armband-in-hand method<br> <br> |
| Active Comparator: PocketCPR;Armband-on-arm method<br>Fix the smartphone-contained-armband on upperarm when performing chest compression | Device: Armband-on-arm method<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of validity of Chest compression depth by smartphone application,PocketCPR |  | Through study completion, average 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Basic Cardiac Life Support, Education, Feedback
Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether CP-741,952 is effective in the treatment of obesity and to determine 12 week safety and toleration.

Detailed Description
-----------------
Following review of the preliminary data from completed study A7081004, the development program for CP-741,952 was terminated on 15 March 2007. Primary reasons for program termination included a lack of significant efficacy at all doses investigated and an increased incidence of mild to moderate elevations in serum transaminases, primarily alanine aminotransferase (ALT), and liver fat content, in treated compared to placebo subjects. A synopsis will be created and will include greater detail on these findings.

Official Title
-----------------
A 12-Week, Phase 2A, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-741,952 On Weight Loss In Otherwise Healthy Overweight And Obese Adult Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: CP-741,952


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI of 30-40 kg/m2 Exclusion Criteria: Women of childbearing potential

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-741,952|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss, toleration, safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumference, serum lipids |  |  |
FujiLAM Prospective Evaluation Trial

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of the FujiLAM test will be assessed using a microbiological reference standard, an extended microbiological reference standard and a composite reference standard among inpatient and outpatient people living with HIV (PLHIV).

Official Title
-----------------
Prospective Multicentre Evaluation of the Accuracy and Diagnostic Yield of the Fujifilm SILVAMP TB LAM (FujiLAM) Test for the Diagnosis of Tuberculosis in People Living With HIV

Conditions
-----------------
Diagnosis of Tuberculosis in People Living With HIV

Intervention / Treatment
-----------------
* Device: Fujifilm SILVAMP TB LAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult PLHIV (≥18 years), irrespective of their CD4 count and antiretroviral therapy (ART) status, at risk of having pulmonary and/or extra-pulmonary TB Inpatients: irrespective of TB symptoms Outpatients: at least one of the symptoms suggestive of TB (as defined by WHO*) written informed consent willingness to have a trial follow-up visit at 2-3 and 6 months after enrolment (e.g. not planning to relocate) Exclusion Criteria: Current anti-TB treatment * Any anti-TB treatment within 60 days prior to enrolment Any isoniazid preventive therapy within 6 months prior to enrolment * Patients starting anti-TB treatment at the time of enrolment will not be excluded from the trial provided that all trial specimens are collected before starting the 3rd dose of treatment.

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

| Intervention/Treatment |
| --- |
|Device: Fujifilm SILVAMP TB LAM|Fujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS. |  | Day 1 | 
| Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS. |  | Day 1 | 
| Diagnostic yield, with 95% confidence interval, of FujiLAM test among eMRS positive patients and AlereLAM, Smear and Ultra (sputum, urine) as comparators (on Day 1 specimens). |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberculosis, PLHIV
Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.

Official Title
-----------------
A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on a Basal/Bolus Regimen

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 1 diabetes Duration of diabetes for at least 12 months Treatment with insulin aspart for at least 3 months before trial start Body Mass Index (BMI) below 35.0 kg/m2 HbA1c below 12.0% Exclusion Criteria: Total insulin dosage more than 1.4 IU/kg/day Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator) Known hypoglycaemia unawareness as judged by the investigator Known hypersensitivity or allergy

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

| Intervention/Treatment |
| --- |
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin aspart antibodies |  | After 6 months treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| HbA1c |  |  |
Postpartum Hemorrhage: Incidence and Risk Factors

Study Overview
=================
Brief Summary
-----------------
Postpartum hemorrhage(PPH) is a major cause of maternal morbidity and mortality across the world. Incidence of PPH varies in the literature from 2 to 10%, most recent studies find around 10% of PPH and 2% of severe PPH. In this study, the incidence of PPH in the maternal ward of the CHU Brugmann will be analyzed. This is a tertiary maternal ward with a high proportion of high risk pregnancies with around 3000 admissions per year. Primary aim of this study is to evaluate the epidemiology of PPH in the CHU Brugmann, incidence and possible underlying causes will be identified and compared to the current literature. A data mining technique will be used to construct a prediction model for PPH.

Official Title
-----------------
Incidence and Risk Factors of Postpartum Hemorrhage at the Brugmann University Hospital in Comparison to the Literature

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Pregnant women who have given birth vaginally or by cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who have given birth vaginally or by cesarean section at the CHU Brugmann between January 1, 2020 and August 31, 2022 ≥ 18 years Exclusion Criteria: Age ≤ 18 years Age > 60 years delivery before 25th week of pregnancy delivery outside of the hospital abortion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pregnant women who have given birth vaginally or by cesarean section|Full-term pregnant women who have given birth vaginally or by cesarean section with PPH. Descriptive statistics and possible causal factors|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PPH | Descriptive statistics of incidence (%) of PPH occuring during the first 48h after delivery. | 48 hours |
Prevention of Persistence of Bacterial Vaginosis

Study Overview
=================
Brief Summary
-----------------
This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.

Official Title
-----------------
Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Drug: intravaginal metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 18-40 yrs old abnormal vaginal discharge or malodor positive QuickVue test positive KOH whiff test Positive finding of clue cells greater than or equal to 20% on wet mount Able to give informed consent willing to abstain from alcohol during the 5 day therapy and 1 day following Exclusion Criteria: immunocompromised women symptomatic VVC pregnancy or positive pregnancy test menstruating or breastfeeding women other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks women with MPC, PID

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>intravaginal metronidazole 750mg + 200mg miconazole | Drug: intravaginal metronidazole<br>* high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg<br>|
| Active Comparator: 2<br>intravaginal metronidazole 750mg | Drug: intravaginal metronidazole<br>* high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg<br>|
| Active Comparator: 3<br>intravaginal metronidazole 37.5mg | Drug: intravaginal metronidazole<br>* high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights |  | 28 days after therapy initiation |