linjc16/ctgov huggingface dataset:
Study to Investigate Adherence of Patients to Clodronate (Bonefos) Treatment

Study Overview
=================
Brief Summary
-----------------
Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary hypothesis generating objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).

Official Title
-----------------
BONA (Adherence of Patients to Bonefos Therapy). Prospective Observational Non-interventional Study of Adherence of Patients to Bonefos Medication in Relation to Analgesic Effect and Incidence of Skeletal Events

Conditions
-----------------
Breast Neoplasms, Prostatic Neoplasms, Multiple Myeloma, Osteolysis

Intervention / Treatment
-----------------
* Drug: Clodronate (Bonefos, BAY94-8393)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors Bone metastases Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos. By agreeing to usage of patients diaries and goodwill with accounting of tablets Exclusion Criteria: According to SmPC (Summary of Product Characteristics) Bonefos.

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 |
| --- | --- |
| Group 1<br> | Drug: Clodronate (Bonefos, BAY94-8393)<br>* Random group of patients in oncology clinic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to treatment with oral clodronate (PDC, proportion of days covered). |  | 12 months of therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy evaluation of the therapy based on incidence of skeletal events |  | 12 months | 
| Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clodronate, Compliance
Use of the Triggering Receptor Expressed on Myeloid Cells-1 (TREM-1) in the Diagnosis of Pleural Effusion

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to evaluate the level of TREM-1 in different kinds of pleural effusion.

Detailed Description
-----------------
The triggering receptor expressed on myeloid cells-1 (TREM-1) is a member of the immunoglobulin superfamily, and its expression is upregulated on phagocytic cells in the presence of bacteria or fungi. Several experiments by Bouchon and colleagues showed that TREM-1 mediates the acute inflammatory response to microbial products. Human tissues infected with bacteria are infiltrated with neutrophils and macrophages that express high levels of TREM-1. Conversely, TREM-1 is only weakly expressed in samples from patients with noninfectious inflammatory disorders. In addition, TREM-1 is shed from the membrane of activated phagocytes and can be found in a soluble form in body fluids. The presence of a soluble form of TREM-1 in samples of bronchoalveolar lavage fluid from mechanically ventilated patients has been shown to be a good indicator of infectious pneumonia.

Official Title
-----------------
Evaluation of the Triggering Receptor Expressed on Myeloid Cells-1 (TREM-1) as a Diagnostic Tool for Patients With Pleural Effusion

Conditions
-----------------
Pleural Effusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of pleural effusion Pleural effusion proved by chest sonography Exclusion Criteria: Conditions for which thoracentesis are contraindicated Pregnancy

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

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
-----------------
pleural effusion, TREM-1
Safety and Efficacy of MCG for Diagnosing Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
A magnetocardiograph (MCG) is a medical device capable of recording the magnetic fields that arise from the electrical activity of the heart. It was developed for the general purpose as a noninvasive, non-contact diagnostic tool of obstructive coronary artery disease (CAD), and especially of cardiac ischemia. The overall objective of the present study is to demonstrate the efficacy of this MCG device in the diagnosis of lack of oxygen to an area of the heart (as in an Heart attack) in patients presenting with chest pain.

Detailed Description
-----------------
The CMI-2409 magnetocardiograph (MCG) is an FDA-approved medical device capable of noninvasive recording of magnetic fields arising from the electrical activity of the heart. This system was developed by CMI for the general purpose of noninvasive, non-contact diagnostics of obstructive coronary artery disease (CAD), and especially of cardiac ischemia. The overall objective of the present study is to demonstrate the efficacy of this MCG device and of the associated MCG method for the detection and diagnosis of ischemia in chest pain patients. The primary objective is to demonstrate that the diagnostic accuracy of the MCG device and method is equivalent to or better than that of a standard 12-lead ECG for detecting the presence of ischemia in patients presenting with chest pain of unknown etiology. In this study the rest MCG data will be analyzed and compared to the results of a rest ECG.

Official Title
-----------------
Safety and Efficacy of the CMI Magnetocardiograph Model 2409 for Diagnosing Coronary Heart Disease

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Device: Magnetocardiograph


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects with chest pain syndrome or angina equivalent

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Magnetocardiograph|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint will be final clinical diagnosis of ischemia by the primary treating physician. This decision will be based upon evaluation of symptoms, clinical presentation, 12-lead ECG, cardiac enzymes (Troponin I or CKMB). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Correlation of MCG with anatomic patency and TIMI flow on coronary angiography |  |  | 
| 2. Correlation of MCG with functional and laboratory tests |  |  |
Voyager I: Patient Discharge Using the AB5000 Portable Driver System

Study Overview
=================
Brief Summary
-----------------
The AB Portable Driver System will allow patients supported with the Circulatory Support System to be discharged home when their medical condition improves to an ambulating status and will continue to receive the assistance of the AB 5000 ventricle for their heart recovery.

Official Title
-----------------
Voyager I: Patient Discharge Using the AB5000 Portable Driver System

Conditions
-----------------
Acute Cardiac Dysfunction

Intervention / Treatment
-----------------
* Device: AB Portable Driver System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is an AB5000 Circulatory Support System patient (in accordance FDA-approved indications for use) who is suffering acute cardiac dysfunction and is potentially recoverable; The subject is male or female, age 18 years or older; The subject is able to ambulate unassisted; The subject is on stable oral anticoagulation over 7 days (INR 2-4) with no active bleeding; The subject is willing and able to read, understand and sign the study specific informed consent form; The subject agrees to comply with study protocol requirements, including all follow-up visits and completion of Qol and NIH stroke scale assessments. Exclusion Criteria: The subject, pre-device implant, is qualified as a transplant candidate. There is an absence of a trained companion. There is an absence of a psycho-social support. The subject has an inadequate home environment, such as poor access which may hinder movements. The subject has experienced hypotension in last 24 hours based on two consecutive readings spaced by 8 hours with systolic blood pressures < 90 mmHg. The subject requires respiratory assistance. The subject has an active infection (positive blood culture and/or body T ≥ 38 degrees C, and/or WBC ≥ 12K/µL). The subject requires tube feeding. The subject has any other medical condition requiring hospitalization.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AB Portable Driver System|Evaluate the safety and performance of the AB Portable Driver System in home environment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, Quality of life assessment, NIH Stroke Scale Assessments, and patient outcome after readmission |  | Pre-discharge, 30 days post-discharge, 90 days or re-admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient receiving AB5000 ventricle potentially recoverable
Prediction of 30-Day Readmission Using Machine Learning

Study Overview
=================
Brief Summary
-----------------
This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict the likelihood of 30-day readmission throughout a patient's admission. This algorithm was then validated in a validation cohort.

Official Title
-----------------
Prediction of 30-Day Readmission Using Machine Learning

Conditions
-----------------
Infection, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma, Gout Flare, Chronic Kidney Diseases, Hypertensive Urgency, Atrial Fibrillation Rapid, Anticoagulants; Increased

Participation Criteria
=================
Eligibility Criteria
-----------------
Was a subject in the Brigham and Women's Home Hospital study and has a completed record in the study's database.

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 |
| --- | --- |
| Training<br>A subset of patients that are used to train the machine learning algorithm. | |
| Validation<br>A subset of patients that are held back and used to validate the algorithm's accuracy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Day Readmission [ yes / no ] | Unplanned hospital admission within 30 days of having been discharged | From date of admission to 30-days post-discharge (31 to 54 days) |
Dietary Metabolic Signatures in Health Study

Study Overview
=================
Brief Summary
-----------------
The associations between food nutrition and safety factors with the risk of chronic diseases are still unclear. This study is conducted in Jinhua, a city with a high prevalence of chronic diseases in China, to assess relations between food nutrition and safety factors and chronic diseases.

Detailed Description
-----------------
Investigations of associations of food nutrition and safety factors with the risk of chronic diseases are limited and studies in China are still lacking. The investigators aim to collect basic characteristics of participants at baseline, including sex, age, smoking, exercise, marriage, education level, dietary factors, and so on, to assess the association of food nutrition and safety factors including various food items, dietary fatty acids, and internal biomarkers of food contaminants such as acrylamide and 3-MCPD with various chronic diseases in a Chinese middle-aged and elderly population. We will use multi-omics technology to investigate the causal mechanisms. Results from this study will be valuable for chronic diseases prevention in China.

Official Title
-----------------
Dietary Metabolic Signatures in Health Study （DMSHS）

Conditions
-----------------
Chronic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject aged ≥45 and ≤74 years old Subject has complete data on diet and follow-up time Exclusion Criteria: • had the major illness that had made personal life disabled

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Numbers of participants with metabolic syndrome | metabolic syndrome | From entry into the study (baseline:2018-2022) until 2022] | 
| Numbers of participants with obesity | Obesity | From entry into the study (baseline:2018-2022) until 2022] | 
| Numbers of participants with diabetes | Diabetes | From entry into the study (baseline:2018-2022) until 2022] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food safety, Food nutrition, Food contaminant, Mult-omics, Chronic diseases
Clinical Observational Registry of Patients With Left Bundle Branch Block

Study Overview
=================
Brief Summary
-----------------
The electromechanical dyssynchrony induced by the presence of LBBB is in some patients, but not all, the cause of progressive left ventricular systolic dysfunction and heart failure. Aims To investigate the clinical, ECG, imaging-derived features in a large cohort of patients affected by LBBB on ECG. To identify predictors of LBBB-induced LV systolic dysfunction and predictors of outcome in this population. To derive data which may have an impact on therapeutic management.

Official Title
-----------------
Registro Osservazionale Dei Pazienti Con Blocco Della Branca Sinistra

Conditions
-----------------
Left Bundle Branch Block (LBBB) on ECG

Intervention / Treatment
-----------------
* Diagnostic Test: ECG, Echocardiogram, Magnetic resonance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LBBB on ECG Exclusion Criteria: Previous extensive anterior myocardial infarction Previous cardiac surgery or transcatheter aortic valve implantation (TAVI) Congenital structural heart disease Patients implanted with permanent right ventricular stimulation devices and permanent pacing Denial to consent

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 |
| --- |
|Diagnostic Test: ECG, Echocardiogram, Magnetic resonance|Clinical and instrumental follow-up|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular dysfunction | Echocardiographic left ventricular ejection fraction - EF (%) | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse cardiovascular events (e.g., heart failure) | Heart failure (incidence and prevalence) Hospitalizations due to heart failure MACE | 20 years |
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to 10% hypersensitivity response was considered acceptable.

Official Title
-----------------
Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Open Label, Normal Volunteer Study

Conditions
-----------------
Drug Hypersensitivity

Intervention / Treatment
-----------------
* Drug: Vitrase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Avoid disallowed meds throughout study Exclusion Criteria: Known hypersensitivity to hyaluronidase and/or bee sting Atopic individuals assessed by med history Topical/systemic corticosteroids within 30 days Concurrent use of antihistamines or anti-inflammatory during study Active or chronic disease likely to affect immune function History of alcohol/drug abuse within 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitrase<br>a single intradermal dose of 3 USP Units of Vitrase (ovine hyaluronidase) at one site and the same volume of saline at a distant site for comparative control | Drug: Vitrase<br> <br> * Other names: ovine hyaluronidase;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity | hypersensitivity to Vitrase following a single intradermal injection of 3 USP Units Vitrase | 1-2 days |
Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)

Study Overview
=================
Brief Summary
-----------------
Main hypothesis: microbiological diagnossis off severe community acquired pneumonia can be performed by non invasive or semi invasive microbiological tools, semi invasive tools including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB). A microbiological diagnosis could improve antibiotic therapy efficacy and improve patient's outcome. These Two strategies have never been prospectivally evauated. Aim of the study: To evaluate 2 diagnostic strategies: non invasive or semi invasive including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB)for the care of patients admitted in intensive care for severe community acquired pneumonia and receiving an empirical antibiotic therapy as recommanded by 2001 American thoracic guidelines Type of study randomized multicentric controlled open study

Detailed Description
-----------------
Type of study randomized multicentric controlled open study Number of patients: 200 patients (100 patients in each group)admitted in ICU for SCAP Number of center : 5 Clinical strategies under evaluation : Group A: semi-invasive strategy: FOB within 24 hours after ICU admission Group B: non-invasive strategy: no FOB within 24 hours after ICU admission Evaluation criteria: Main criteria: Changes in initial empirical antibiotic treatment according to microbiological results obtained in each group. others FOB related complications Microbiological results Type of antibiotic treatment modifications ICU outcome and outcome at day 28 Duration of antibiotic therapy and nimber of days without antibiotics at day 28 after inclusion

Official Title
-----------------
Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings

Conditions
-----------------
Community Aquired Pneumonia

Intervention / Treatment
-----------------
* Procedure: FOB protected distal microbiological samplings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New radiological infiltrate SCAP clinical diagnosis admitted in ICU Admitted in hospital for less than 24 hours Aged 18 or older Signed informed consent Exclusion Criteria: Pregnancy Muribond patients Previuos hospitalisation within One month Neutropenia None HIV status

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: FOB protected distal microbiological samplings|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |