Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Heart and Blood Diseases

Neoplasms

Nervous System Diseases

Diabetes Mellitus

Syndrome

Cognitive Dysfunction

Coronary Artery Disease

Coronary Disease

Myocardial Infarction

Infarction

Neoplasm Metastasis

Metabolic Syndrome

Angina Pectoris

Angina, Unstable

Ischemia

Necrosis

Myocardial Ischemia

Heart Diseases

Vascular Diseases

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Pain

Chest Pain

Neurologic Manifestations

Herbal and Botanical

All Drugs and Chemicals

Olive

Dietary Intervention with a Low fat diet: \<30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; \<10% saturated fatty acids)

Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; \<10% saturated fatty acids).

Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; \<10% SAT).

Mediterranean Diet

Low fat diet: \<30% fat (12% MUFA; 6-8%PUFA; \<10% SAT)

Low Fat Diet

Francisco Perez-Jimenez, MD,PhD

The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.

Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: \<30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; \<10% SAT) and b) Mediterranean Diet: \>35% fat (22% MUFA; 6% PUFA ; \<10% SAT).

Primary Objective:

Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).

Secondary Objectives:

Those related in the Outcome Measures section of this webpage

CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease

Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed

Influence of genetic data in the development clinical outcomes

Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables

Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease

Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function

Additional secondary objectives will be carried out in light of current and/or future knowledge of ischemic heart disease risk factors, prognostic factors and pathophysiological pathways, and will include, but not be limited to, endothelial function, inflammation, cell biology, molecular biology, proteomics, genetics and epigenetics

Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years.

Data from clinical and/or diagnostic tests will be analyzed

Concentration of LDL cholesterol in blood samples

Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study

Study of the metabolism of carbohydrates during the trial

Study of blood pressure in response to the study

Cognitive decline will be evaluated by validated questionnaires

Incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event.

Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest

Incidence of type 2 Diabetes Mellitus during the study

Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study

Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.

Study of relationship between existing or new Arrhythmias on clinical events

Individual apparition of hard cardiovascular events:

* myocardial infarction
* revascularization
* ischemic stroke
* documented peripheral artery disease
* cardiovascular death

Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc.

Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc

Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc

Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied

Metabolism of advanced glycation end products.

Impact of mineral metabolism on atherosclerosis

Cardiac function studies by Echocardiography at baseline and during the study

Study of endothelial microparticles (vesicles formed from endothelial cells membrane after injury). The quantification of the EPCs and EMPs will be performed by flow cytometry

27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function

Hospital Universitario Reina Sofia de Cordoba

Chief of Internal Medicine Unit

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Pleural Effusion

Pleurisy

Pleural Diseases

Respiratory Tract Diseases

Patients with a pleural effusion with unknown origin after a VATS thoracoscopy is classified as nonspecific pleuritis.

Nonspecific pleuritis after VATS thoracoscopy

Simon Reuter, MD, PhD

The investigators want to determine the incidence of malignant disease, type of malignant disease and overall survival in patients diagnosed with NSP after VATS.

Using Landspatientregisteret (LPR) (the National Patient register) the investigators will identify patients who have received a thoracoscopic pleural-biopsy using the SKS-codes KGAC01 and/or KGAA31 and/or KGAC00. From LPR and Cancerregisteret (the National Cancer-register) the investigators will receive diagnosis and additional descriptive data. From dødsårsagsregisteret (the National cause-of-death-register) death date and further descriptive data will be acquired.

Patients with NSP will be identified as patients with no diagnosis six months after pleural-biopsy, despite a thorough investigation.

Patients with a malignant effusion and non-malignant effusion (with known cause) will be used for survival analysis and comparison.

Data Data will be registered in the individual patients CRF (Case Report File) (digital) and will be transferred to a database-program for further processing. Background-variables will be used to describe the study population. Only study-coordinators will have access to data. All data including back-up will be stored and kept in a locked cupboard in a locked room. Only study coordinators possess relevant keys.

Statistics The investigators define significance level (α) as 0.05, and power (β) as 0.80. Descriptive data will be analysed using nonparametric statistics: Chi2-test for categorical data and Mann-Whitney for discrete data. Statistical significance is defined as: p-value \< 0.05.

The overall survival of patients with NSP will be analysed using a Caplan-Meier plot and comparison of NSP patients to patients with malignant pleural-effusion the investigators use the Logrank test.

All statistical tests is conducted using STATA14 (4905 Lakeway Dr., College Station, TX 77845).

Ethics This study will not require the approval from Videnskabsetisk komité (the Health Research Ethics Committee), but approval will be sought from Datatilsynet (the Danish Data Protection Agency).

All results will be stored and analysed by computer, and the patients' anonymity will be secured according to the national laws. The data will be stored (anonymised), after completion of the study: data containing cpr.-numbers will be stored behind double-lock at the department.

No patients or investigators have economic incentives for completing the project.

Economy

Expenses related to gathering of data including contact with LPR, Dødsårsagsregisteret and the Danish Cancer Register are already financed through primary investigators PhD-project.

Publication The results from the study will be presented at international scientific congresses and published in international journals. Positive as well as negative results will be published. The scientists right to freely publish the results cannot be limited. All information will be passed anonymously.

The order of authors will follow the Vancouver Declaration, and will thus reflect the amount and significance of work relevant to the specific manuscript.

Natural History of Nonspecific Pleuritis Diagnosed After Video-assisted-thoracoscopic-surgery

Comparison of patients with a benign cause, a malignant cause and nonspecific pleuritis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention	NCT00924937	Myocardial Infa... Unstable Angina Malignancy Cognitive Decli... Diabetes Mellit... Metabolic Syndr...	Mediterranean D... Low Fat Diet	20 Years - 75 Years	Hospital Universitario Reina Sofia de Cordoba
Natural History of Nonspecific Pleuritis Diagnosed After Video-assisted-thoracoscopic-surgery	NCT03270228	Pleural Effusio...	Nonspecific ple...	16 Years -	Naestved Hospital
Natural History of Nonspecific Pleuritis Diagnosed After Video-assisted-thoracoscopic-surgery	NCT03270228	Pleural Effusio...	Nonspecific ple...	16 Years -	Naestved Hospital

Spots Global Cancer Trial Database for incidence of cancer