linjc16/ctgov huggingface dataset:
Cardiopulmonary Effects of Particulate Exposure

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess cardiac rate and respiratory responses and rhythm after workplace exposure to combustion particulates. A repeated measurement study is being performed on acute boilermakers (apprentices and journeymen). A stratified analysis is then done on those with and without chronic bronchitis, after adjustment for relevant covariates.

Detailed Description
-----------------
Population-based epidemiologic studies of communities in the United States have revealed a consistent association between ambient particulate air pollution and increases in morbidity and mortality. The observed increases result from both respiratory and cardiovascular diseases. Similar associations have been observed for rates of hospital admissions for respiratory and cardiovascular diseases for subjects over age 65. These ambient exposures are to low levels of particulates, many times lower than occupational exposures faced by workers in a variety of industries, including manufacturing, construction, transportation and electric-power generation. The objective of this proposal is to investigate the role of occupational exposure to particulates in the development of respiratory and cardiac responses in boilermakers. We will employ a detailed, continuous-exposure assessment to PM2.5 with repeated measures of biologic and physiologic markers of response. Specific hypotheses to be tested will include: (1) occupational exposure to fuel-oil ash particulates induce airway inflammation as reflected in increased expired NO, and airflow obstruction as reflected in decreases in peak flow (PEFR) and FEV1; (2) particulate exposure will result in acute changes in cardiovascular function, as reflected in changes in heart rate, heart-rate variability and blood pressure; (3) particulate exposures result in increased serum fibrinogen levels, a known risk factor for cardiovascular disease; and (4) chronic bronchitis predisposes particulate-exposed workers to changes in cardiac function. The results of this study will have important implications for preventive efforts aimed at reducing morbidity and mortality from occupational exposure to respirable particulates.

Conditions
-----------------
Respiratory Tract Diseases, Cardiac Diseases, Bronchitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Adults; Over 18; Boilermakers

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Particulates, Air Pollution, Cardiopulmonary Disease, Lung, Inflammation
Trans-aortic Valve Replacement and Renal Infarction

Study Overview
=================
Brief Summary
-----------------
Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve replacement

Detailed Description
-----------------
Each patient will undergo Magnetic Resonance assessment of the kidneys before the TAVR. on the third to 7th day after the ATVR, a second MRI to the kidneys will be performed. we will assess the changes and new lesions between both MRI tests and will perform a qualitative and quantitative measurement.

Official Title
-----------------
Trans-catheter Aortic Valve Replacement and Renal Infarction Among Patients With Severe Aortic Stenosis

Conditions
-----------------
Renal Infarction

Intervention / Treatment
-----------------
* Diagnostic Test: Magnetic Resonance test for kidney


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe symptomatic aortic stenosis Patient is able to lay down supine for 20 min (the time needed to perform the MRI) without any difficulties. Exclusion Criteria: Patient is on chronic renal replacement therapy (Dialysis) Documented Thrombus in the left ventricle or left atria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Magnetic Resonance test for kidney|Magnetic Resonance test for kidney|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Renal Infarction | New low signal intensity lesions on diffusion weighted images on MRI. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematuria | New hematuria on urine test. | one year | 
| Elevation in Blood Pressure | Delta of more than 5% | one year | 
| Elevation in Plasma Renin Activity | Delta of more than 5% | one year | 
| Elevation in Aldosteron level | Delta of more than 5% | one year |
A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in healthy male subjects

Official Title
-----------------
A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD1656 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD1656
* Drug: AZD1656


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to hepatitis C virus. Exclusion Criteria: Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the Investigational Product History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group) | Drug: AZD1656<br>* Dose escalation to achieve maximum tolerated dose<br>|
| Experimental: 2<br>2 oral doses of AZD1656 given to 2 groups together with food | Drug: AZD1656<br>* Oral single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (AE's, BP, pulse, lab variables, and ECG) |  | Safety variables taken repeatedly during 24 hours on study day sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions | 
| Pharmacodynamic variables |  | Blood samples taken repeatedly during 24 hours on study day sessions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, pharmacokinetics, pharmacodynamics, AZD1656, tolerability, Healthy Volunteers
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to find out whether the inclusion of internal mammary node irradiation in regional nodal irradiation improves outcomes in women with node-positive breast cancer.

Detailed Description
-----------------
This is a multicenter, prospective, randomized phase 3 trial. Patients with node-positive breast cancer without distant metastases were included. All patients underwent breast conservation surgery or mastectomy with axillary lymph node dissection before irradiation. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.

Official Title
-----------------
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Radiation: Internal mammary node irradiation
* Radiation: No internal mammary node irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Women with histologically confirmed node-positive breast cancer who had undergone modified radical mastectomy or breast-conserving surgery and axillary dissection with ≥8 nodes removed. Exclusion Criteria: Neoadjuvant chemotherapy Bilateral breast cancer Distant metastasis History of other malignancy Involvement of supraclavicular nodes or internal mammary nodes at diagnosis

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internal mammary node irradiation<br> | Radiation: Internal mammary node irradiation<br>* Regional nodal irradiation including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery<br>|
| Active Comparator: No internal mammary node irradiation<br> | Radiation: No internal mammary node irradiation<br>* Regional nodal irradiation not including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of overall survival |  | 7 years | 
| breast cancer-specific survival |  | 7 years | 
| Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3 |  | 7 years |
Digital Assessment of a Full Digital Implant-Prosthetic Workflow for a Prefabricated Single Implant-Supported Restoration

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to evaluate the accuracy of a prefabricated digitally planned provisional restoration on a single- implant placed with a fully guided surgical protocol.

Detailed Description
-----------------
Fifteen dental implants were placed in partially edentulous patients with single bounded lower posterior edentulous area selected from those admitted to the Prosthodontics Department, Faculty of Dentistry, Alexandria University. A full digital implant-prosthetic protocol was followed and a quantitative evaluation of the accuracy of the protocol was performed using computer software and superimposition of the planned and post-operative images was done.

Official Title
-----------------
Digital Assessment of a Full Digital Implant-Prosthetic Workflow for a Prefabricated Single Implant-Supported Restoration (A Clinical Trial)

Conditions
-----------------
Dental Implants

Intervention / Treatment
-----------------
* Other: Virtual Implant Planning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients missing lower first molar unilaterally or bilaterally. Presence of full or nearly full complement of opposing natural teeth. Exclusion Criteria: If teeth adjacent to the planned implant site showed infections, endodontic or periodontal problems. Patients with a debilitating systemic disease, bone diseases, radiotherapy or chemotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Implant Planning<br> | Other: Virtual Implant Planning<br>* According to the virtual implant plan, a CAD/CAM tooth supported surgical guide will be fabricated to place the dental implant with a fully guided surgical protocol.The surgical guide will be manufactured from a photopolymer resin using a 3D printing machine. A hex- shaped metal sleeve will be inserted in the surgical guide with the flat surface located buccally so that it will help in orientation of the implant hex during the implant placement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D- Deviation of the implant | The 3D deviation will be calculated by a software taking into consideration the deviation on each direction set as follows: x= buccolingual error, y= mesiodistal error, and z= apicocoronal error, using Pythagorean Theorem: 3D deviation= square root of (x squared + y squared + z squared) | 3 months |
Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Effects of BMS-823778 on Atherosclerotic Plaque Inflammation as Measured by Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET) in Patients With Atherosclerotic Cardiovascular Disease

Conditions
-----------------
Atherosclerotic Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: BMS-823778
* Drug: BMS-823778
* Drug: Placebo matching with BMS-823778


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event On stable statin dose Clinically stable at time of screening and randomization Exclusion Criteria: Women of child bearing potential Medical conditions that would impact the absorption of the study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Treatment A: BMS-823778 (2mg)<br> | Drug: BMS-823778<br>* Capsules, Oral, 2mg, Once daily, 1 year<br>|
| Experimental: Treatment B: BMS-823778 (15mg)<br> | Drug: BMS-823778<br>* Capsules, Oral, 15mg, Once daily, 1 year<br>|
| Placebo Comparator: Treatment C: Placebo<br> | Drug: Placebo matching with BMS-823778<br>* Capsules, Oral, 0mg, Once daily, 1 year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of BMS-823778 versus placebo on carotids and/or ascending aortic will be measured by fluorodeoxyglucose (FDG) uptake in the index vessel as by positron emission tomography (PET) imaging |  | Day 168 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices) | Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices): total vessel area, wall area, wall thickness, and wall area/total vessel area ratio (normalized wall index), based on the average of the right and left carotids, measured by Magnetic Resonance Imaging (MRI) | Day 364 | 
| Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores |  | Approximately up to 60 weeks |
Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.

Official Title
-----------------
Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma

Conditions
-----------------
Kidney Neoplasms

Intervention / Treatment
-----------------
* Drug: SU-011,248


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer. The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given. Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function Exclusion Criteria: Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen; Prior surgical resection of or irradiation to the only site of measurable disease; Ongoing severe hematuria; Other active second malignancy; Cardiovascular diseases or conditions within the last 12 months; Known brain metastases; Known HIV-positive or AIDS-related illness; Pregnant or breast-feeding women; Current participation in other clinical trials; Other severe acute or chronic medical conditions.

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 |
| --- |
|Drug: SU-011,248|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated. |  |  |
New Methods to Detect a Decrease in Heart Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the changes in heart function during onset of spinal anesthesia using a new and less invasive method, the LidcoTMplus.

Detailed Description
-----------------
The incidence of hypotension during onset of spinal anesthesia in elderly patients varies from 27% to 80% depending on which definition being used. Studies of cardiac output (CO) has shown that it is maintained or only slightly decreased . Unfortunately, the time-resolution in these studies is often several minutes, and the description of changes is consequently often a start-to-end relation rather than a description of the dynamic changes during onset of spinal anesthesia. A recent advance in measuring CO is the LiDCOTMplus hemodynamic monitor, which has proved reliable compared to pulmonary artery catheters in various intensive care settings. This monitor allows for beat-to-beat measuring during various procedures and thus early warning of hemodynamic events. Another method with potential for early warning of decreased perfusion is near-infrared spectroscopy (NIRS). NIRS is used for continuous and non-invasive monitoring of cerebral oxygen saturation (ScO2) and even a small reduction has recently shown to predict maternal hypotension during caesarian section. The aim of our study was to describe the changes in CO during onset of spinal anesthesia in elderly patients using a method with high time-resolution. We also attempted to evaluate NIRS as predictor of hemodynamic events.

Official Title
-----------------
Cardiac Output Changes During Onset of Spinal Anesthesia in Elderly Patients

Conditions
-----------------
Orthopedic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 60 years or older Elective orthopedic or plastic lower limp surgery in spinal anesthesia Exclusion Criteria: Body weight <40 kg Currently in treatment with lithium Evidence of aortic valve regurgitation

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
Fracture Evaluated in Emergency Room by Ultra Sound

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare fracture diagnostic, conventional x-ray versus ultrasound.

Detailed Description
-----------------
to compare fracture diagnostic, conventional x-ray versus ultrasound in an emergency room department.

Official Title
-----------------
Fracture Evaluated in Emergency Room by Ultra Sound

Conditions
-----------------
Fracture, Ultrasonography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent trauma to the wrist, ankle or fingers clinical exam by ER staff and x-ray indication. informed concent Exclusion Criteria: open fracture wounds unstable fractures requiring cast immobilisation before x-ray multi traumatised patients

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 |
| --- | --- |
| ultrasound wrist<br> | |
| ultrasound finger<br> | |
| ultrasound ankle<br> | |

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

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