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Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-80.0, Cerebrovascular Accident Patients may be enrolled in the study only if they meet all of the following Diagnosis of acute ischemic stroke with onset between 3 and 24 hours prior to planned start of study drugs. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia, and not otherwise attributable to ICH or another disease process. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 24 hours are not eligible if their first symptoms started more than 24 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be intact. A careful history is important to determine when the patient was last without the presenting deficits Disabling neurological deficit attributable to the acute stroke at the start of study drugs NIHSS less than or equal to 16 Evidence on PWI MRI of a perfusion defect corresponding to the acute stroke syndrome of at least 2cm in diameter in both long and short axis in any slice. The PWI will be assessed by relative mean transit time (MTT) images. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion defect is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal DWI are eligible Age 18 years, inclusive Patients will be excluded from the study for any of the following reasons General Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final assessment in this trial Time interval since stroke onset of less than 24 hours impossible to determine with high degree of confidence Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage Evidence of acute myocardial infarction defined as having at least two of the following three features: 1.) Chest pain suggestive of cardiac ischemia; 2.) EKG findings of ST elevation of greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3.) Elevated troponin I Contraindication to MRI scan Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test Patients who would refuse blood transfusions if medically indicated Stroke Related | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Cardiomyopathy, Hypertrophic HCM Patients HCM defined as maximal LV wall thickness by echocardiography greater than 13mm in the absence of other causes of LVH or greater than 15mm asymmetrical LV wall thickness if there is a history of mild hypertension (defined as systolic less than 160mmHg and diastolic less than 100mHg) controlled for greater than 6 months Non-obstructive HCM Age greater than or equal to 21 years Patients with LV obstruction treated by LV myotomy and myectomy or percutaneous septal alcohol ablation that meet are eligible for this study HCM Patients LV outflow obstruction noted during Doppler echocardiography at rest or with Valsalva maneuver defined as instantaneous peak gradient greater than 30 mmHg Hemodynamically significant valvular disorders, history of significant coronary obstruction (greater than 50% in any single artery), angina symptoms, myocardial ischemia on an imaging stress test or evidence of prior myocardial infarction. Patients older than 40 years of age with effort induced anginal symptoms typical of coronary insufficiency and a coronary distribution of myocardial ischemia on an imaging stress test will be considered for the study if coronary angiography rules out significant obstructive coronary disease Chronic atrial fibrillation Cardiac pacemaker or other metallic implant unsafe for MRI Uncontrolled hypertension Dependence on a beta blocker that cannot be withdrawn Dependence on a calcium blocker that cannot be withdrawn Current use of digoxin History of digitalis intolerance | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Acute Ischemic Stroke Acute ischemic stroke, any territory, with an appropriate neuroradiologic study (head CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke Onset of symptoms of qualifying stroke within 48 hours prior to randomization. In patients receiving thrombolytic therapy for the acute stroke, such as tissue-type plasminogen activator (tPA), administration of study drug may not start until at least 24 hours after completion of thrombolytic therapy Significant motor impairment of the leg, as indicated by a NIHSS score ≥2 on item 6 Inability to walk without assistance Females who are pregnant, breast-feeding, or of childbearing potential and not using medically acceptable and effective contraception Clinical evidence of VTE at screening Any evidence of active bleeding on the basis of clinical judgment Prior history of intracranial hemorrhage (including that at screening) Spinal or epidural analgesia or lumbar puncture within the preceding 24 hours Thrombolytic therapy (e.g., tPA) or intra-arterial thrombolytic therapy within the preceding 24 hours.Thrombolytic therapy is permitted for treatment of the acute stroke but must have been completed 24 hours prior to randomization Comatose at screening (NIHSS score ≥2 on item 1a) Known or suspected cerebral aneurysm or arteriovenous malformation Confirmed malignancy that may pose an increased risk for bleeding or otherwise compromise follow-up or outcome assessment (e.g., lung cancer) Impaired hemostasis, i.e., known or suspected coagulopathy (acquired or inherited); baseline platelet count <100,000/mm3; aPTT 1.5 X the laboratory upper limit of normal; or international normalized ratio(INR) >1.5 | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Hypertension, Pulmonary Pilot: The pilot study will enroll two groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), and 2) age, gender, and race matched control subjects for each patient Main: The main study will enroll three groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), 2) patients with PH ascribed to a nonvascular injury process, and 3) age, gender, and race matched control subjects for each PAH patient. Subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. There is no based on race or gender FOR The for this study are as follows Patients diagnosed with IPAH Patients diagnosed with secondary pulmonary hypertension known to have histopathology similar to the primary form or PAH. Clinical conditions causing pulmonary hypertension with histopathology similar to the primary form are listed below i. Eisenmenger Syndrome ii. Collagen vascular disease iii Liver disease with portal hypertension iv. Toxin induced injury (anorexic agents, rapeseed oil) FOR WITH Pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test) Age less than 18 years Inability to provide informed written consent for participation in the study Mean PA less than or equal to 25mmHg or PVR less than 3 wood units PCW greater than 16 mmHg unless increase accounted for by increased transpulmonary gradient greater than or equal to 10 mmHg Patients receiving more than 1 year of oral therapy or more than 6 months of IV therapy FOR WITH The are as follows Patients diagnosed with pulmonary hypertension not known to have histopathology similar to the primary form. Etiologies are listed below | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 80.0-999.0, Hypertension Aged 80 or older Sitting systolic BP 160-199 mmHg AND sitting diastolic BP < 110 mmHg Known accelerated hypertension (retinal haemorrhages or exudates or papilloedema) Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin only Renal failure (serum creatinine of more than 150 µmol/l) Previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (Ischaemic cerebral and cardiac events do not although the patient must be neurologically and cardiologically stable.) Condition expected to severely limit survival, e.g. terminal illness Known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause) Gout Clinical diagnosis of dementia Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable) Unable to stand up or walk | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-65.0, Migraine With Typical Aura Patients must have a current history of migraine with typical aura where the aura is usually followed by headache according to the International Headache Society (IHS) criteria Patients are male or female. N.B. When female patients are treated for migraine attacks with triptans then the required precautions and safety measures should be taken in order to prevent pregnancy Patients with an age between 18 and 65 years Patients must have experienced 1-4 moderate (grade 2) or severe (grade 3) migraine attacks per month for at least two months prior to entry into the study Patients must be willing to keep their prophylactic drug treatment for migraine unchanged Patients must be able to distinguish migraine headaches from other headache types (e.g. tension-type headaches) at the onset of a migraine attack Patients must be able to understand and complete the diary card Patients must be willing and able to give written informed consent prior to entry into the study Patients must be willing and able to carry the Migraid and, if necessary, apply it in a public place Migraine patients with a typical aura but without any migraine headache thereafter Patients with a history suggestive of ischaemic heart disease (IHD) or any present evidence of ischaemic heart disease (like angina pectoris, previous myocardial infarction, documented silent ischaemia, Prinzmetal's angina), or symptoms consistent with IHD Patients suffering from coronary vasospasm or any atherosclerotic disease (cerebrovascular disease [CVD], peripheral vascular disease [PVD] or Raynaud’s disease) which places them at increased risk of coronary ischaemia Patients with a history of cerebrovascular accident (CVA) or transient ischaemic attacks (TIA) Patients with a supine diastolic blood pressure of > 95 mm Hg and/or systolic blood pressure > 160 mm Hg (treated or untreated) at Visit 1 Patients with a history of epilepsy or structural brain lesions which lower their convulsion threshold Patients with tension-type headaches > 15 days/month in either of the two months prior to the study Current abuse of opioid analgesics or other psychotropic drugs. History (within the past year) or current abuse of ergotamine (abuse as defined as > 10 mg/week). Current abuse of alcohol (according to local recommendations) or other drugs Patients suffering from any severe concurrent medical condition which may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in a clinical study Patients with a history of ophthalmoplegic, basilar or hemiplegic migraine | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 65.0-999.0, Brain Infarction Hypertension Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs) Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging Secondary hypertension Atrial fibrillation History or signs of cerebral disorders other than cerebrovascular disease Malignant tumor Chronic renal failure Severe congestive heart failure Hyperkalemia Stenosis of bilateral renal artery | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 21.0-85.0, Albuminuria Mild to moderate hypertension Type 2 diabetes mellitus Presence of protein in the urine (albuminuria) Kidney disease not caused by diabetes or hypertension Renal artery stenosis Myocardial infarction or stroke within the last 6 months Type 1 diabetes mellitus Pregnant or lactating females Cancer within the last 5 years | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 70.0-85.0, Aged Systolic Hypertension Outpatients aged over 70 years and less than 85 years, regardless of sex Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks Previously untreated patients or patients who are on other therapy that can be converted to valsartan Patients with secondary hypertension or malignant hypertension Patients with seated systolic blood pressure of over 200 mmHg Patients with seated diastolic blood pressure of over 90 mmHg Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry Patients with severe heart failure (NYHA functional classification III and IV) Patients with severe aortic stenosis or valvular disease Patients with atrial fibrillation, atrial flutter, or serious arrhythmia Patients with renal dysfunction with serum creatinine level of over 2 mg/dL Patients with serious liver dysfunction | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 40.0-80.0, Hypertension type 2 diabetes elevated blood pressure and pulse pressure albuminuria Severe hypertension History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm Liver, kidney (not caused by diabetes), or pancreas disease Type 1 diabetes or uncontrolled type 2 diabetes Allergy to certain medications used to treat high blood pressure Other protocol-defined inclusion/ | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 40.0-70.0, Hyperlipidemia TC:220~270mg/dl Male: 40-70 years old/ female: postmenopausal-70 years old <40kg in weight History of CHD(angina, MI, post-PTCA/CABG, etc.) History of CVA(stroke, TIA, etc.) Underlying malignant tumor | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Atrial Fibrillation Radiofrequency Catheter Ablation Patients requiring MV surgery with at least 6 month history of atrial fibrillation Patients with sick sinus syndrome Hyperthyroidism Permanent pacemaker Previous cardiac surgery | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 75.0-999.0, Acute Myocardial Infarction Subjects of 75 or more years of age Diagnosis of AMI: chest pain or any symptom of myocardial ischemia of, at least, 20 minutes of duration, not responding to nitrate therapy, an evolution period of less than 6 hours after symptom onset until randomization process, and, at least, one of the following alterations ST-elevation >=2 mm in 2 or more precordial leads ST-elevation >=1 mm in 2 or more anterior leads Complete de novo (or probably de novo) left bundle branch block (LBBB) Subject should be able to give informed consent prior to randomization process and should agree to fulfill all procedures described in the protocol, including follow-up after hospital discharge. A written consent signed by a close relative with witness is also acceptable Documented contraindication to the use of fibrinolytics. 1.1. Internal active bleeding or known history of hemorrhagic diathesis 1.2. History of previous CVA of any kind or at any time 1.3. Intracranial tumor, arteriovenous malformation, aneurysm or cerebral aneurysm repair 1.4. Major surgery, parenchymal biopsy, ocular surgery or severe traumatism in the 6 weeks prior to randomization 1.5. Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to randomization 1.6. Confirmed arterial hypertension with a reliable measurement of systolic AP >180 mmHg or diastolic AP >110 mmHg 1.7. Known thrombocytopenia < 100.000 platelets/mL 1.8. Prolonged (>20 minutes) or traumatic cardiopulmonar resuscitation (CPR) in the 2 weeks prior to randomization 1.9. History or signs suggesting aortic dissection Cardiogenic shock Estimated door-to-needle time >120 minutes Administration of fibrinolysis in the 14 days prior to randomization Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hours prior to randomization Administration of any Low Molecular Weight Heparin (LMWH) in the 8 hours prior to randomization Actual oral anticoagulant treatment Suspected AMI secondary to occlusion of one lesion treated previously with a percutaneous coronary intervention (within the previous 30 days for angioplasty or conventional stent and within the previous 12 months for coated stents) Dementia or acute confusional state at the time of randomization Subject incapacity or unwillingness to give informed consent -at least, verbally | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 65.0-999.0, Atrophy Community living Caucasian woman ≥ 65 years; live expectation > 2 years secondary osteoporosis CVD-events including stroke Participation in other studies Medication with impact on bone during the last 2 years bisphosphonates parathormone strontium HRT, anabolic steroids calcitonin natriumflourides | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Hypertension Males or females, 18 years of age or older Acute ischemic cerebral stroke (IS) with uncontrollable hypertension that may need to be controlled for the purpose of considering thrombolytic therapy or anticoagulation therapy Intracerebral hemorrhagic (ICH) stroke patients, including subarachnoid hemorrhage (SAH) (surgically treated or not), any territory with an appropriate study (head CT scan or MRI scan) providing results consistent with this diagnosis, who may require the control of hypertension or control of blood pressure Allergy to Nicardipine or known hypersensitivity to Nicardipine Chronic renal failure or Creatinine blood sample levels> 2.0 Impaired hepatic function defined as a two times value of liver enzymes Severe left ventricular dysfunction defined as ventricular ejection fraction < 30% Patients or authorized representative who refused be enrolled into this study Advanced aortic stenosis Pregnant or nursing women will not be enrolled in this study No patient will be allowed to be enrolled in this study more than once Patients may not be enrolled into other clinical studies during their involvement with this study | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Hypertension Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 The following patients will be eligible for study participation Patients with either type 1 or type 2 diabetes. Diabetes will be defined as those patients presently taking either oral hypoglycemic agents or insulin therapy (oral hypoglycemic agents to all drugs in the drug classes of: alpha-glucosidase inhibitors, biguanides, meglitinides, sulfonylureas, thiazolidinediones and adjunctive therapy) taken for >6 months to rule-out steroid-induced diabetes and gestational diabetes Patients will be excluded from the study if they Do not provide or are unable to provide written informed consent Refuse or are unlikely to attend follow-up visits for BP measurements Are institutionalized Are <18 years of age Do not understand English Enrolled in other diabetes or hypertension trials Subjects will be recruited whether or not they are receiving antihypertensive therapy | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-85.0, Acute Ischemic Stroke Patients must meet all of the criteria Diagnosis of acute ischemic stroke with onset less than 4.5 hours prior to the planned start of intravenous alteplase. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 4.5 hours are not eligible if their first symptoms started more than 4.5 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be at baseline Disabling neurological deficit attributable to acute ischemic stroke in the middle cerebral artery territory NIHSS less than or equal to 18 for left hemisphere strokes, NIHSS less than or equal to 16 for others Evidence of MCA occlusion (stem or branch) prior to drug administration by TCD, CTA or MRA Age 18-85 years, inclusive Able to sign informed consent For MRI Arm only Screening MRI diagnostic of focal cerebral ischemia corresponding to the clinical deficits. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion deficit is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal appearing DWI are eligible Evidence on PWI MRI or a perfusion defect corresponding to the acute stroke syndrome. The PWI will be assessed by relative mean transit time (MTT) images obtained prior to the start of rt-TPA therapy Patients will be excluded from study participation for any of the following reasons Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 30) assessment in this trial Absence of acoustic window to insonate the MCA on the involved side Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage Evidence of acute myocardial infarction defined as having at least two of the following three features: 1) Chest pain suggestive of cardiac ischemia; 2) EKG findings of ST elevation of more greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3) Elevated troponin I Acute Pericarditis Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2) High clinical suspicion of septic embolus | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-65.0, Lung Cancer Heart Disease COPD Healthy sedentary smokers (> 4 per day for at least one year) Ages 18 to 65 years Must be able to give informed consent Must live in the area for the next 3 months Willing to use the nicotine patch to attempt smoking cessation Must receive consent to participate from primary care physician Cannot read or write fluently in the English language Pregnancy or plans to attempt pregnancy minutes or more per week of moderate or vigorous physical activity Smokes cigars, pipes, or uses smokeless tobacco at least once per week Currently in a quit smoking program Currently using NRT of any kind or using any other quit smoking method or treatment Never had an adverse reaction to the nicotine patch resulting in discontinuation of use Poor willingness or inability to comply with protocol requirements An employee of the Centers for Behavioral and Preventive Medicine Previous participant in Commit to Quit or Fit to Quit smoking cessation studies | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 65.0-999.0, Type 2 Diabetes type 2 diabetes managed by diet or metformin only A1c < 8.5% treated with insulin or oral agents other than metformin in the past 6 months evidence of diabetic complications including coronary artery disease, stroke, transient ischemic attacks, peripheral vascular disease, nephropathy, retinopathy, or neuropathy type 1 diabetes or a history suggestive of a secondary causes of diabetes A1c ≥ 8.5% participated in another clinical trial within the past 30 days | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 65.0-999.0, Type 2 Diabetes Type 2 diabetes > 3 months duration Male or female Over 65 years of age Diet controlled only HgbA1C < 8.5% Treatment with oral hypoglycemic agents or insulin or the likelihood of requiring treatment with these during the study Anemia hgb below 130 g/L (males) and below 120 g/L (females) Taking medications that known to interfere with glucose metabolism eg systemic corticosteriods, non-selective beta blockers Known or suspected allergy to glyburide, sulfa drugs or GlucoNorm impaired liver function, as shown by but not limited to AST and/or ALT > 2x the upper limit of normal Impaired renal function, as shown by but not limited to serum creatinine > 133 µmol/L (males) or 124 µmol/L (females) Participated in another clinical trial within the past 30 days | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Contrast Induced Nephropathy Subjects age 18 and over and of either gender Scheduled to receive CT scan with intravenous contrast dye Non diabetics or subjects with type 1 or 2 diabetes mellitus Written informed consent Subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded Subjects who have received n-acetylcysteine or sodium bicarbonate pre CT scan will not be excluded Pregnant or lactating women End-stage renal disease (on hemodialysis or peritoneal dialysis) A known history of acute renal failure Subjects receiving glucophage/metformin or glucovance Subjects who cannot give written informed consent Subjects receiving peritoneal dialysis or hemodialysis Subjects enrolled in another investigational drug study ≤ 30 days of enrollment into the present study Subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine Subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin Age < 18 years | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Seasonal Influenza Vaccine Subjects eligible for enrollment into this study are male and female adults who were ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry available for all the visits scheduled in the study and able to comply with all study requirements in good health as determined by medical history physical examination clinical judgment of the investigator Written informed consent had to be obtained from all the subjects before enrollment in the study after the nature of the study had been explained Subjects were not to be enrolled into the study if at least one of the following was fulfilled Any serious chronic or acute disease such as Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy Congestive heart failure Advanced arteriosclerotic disease Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below) Insulin dependent diabetes mellitus Acute or progressive hepatic disease Acute or progressive renal disease | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-70.0, Atrial Fibrillation History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance Age between 18 and 70 years Failure of at least one Class I or III rhythm control drug Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study Structural heart disease of clinical significance including Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair) Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction <40% measured by acceptable cardiac testing Left atrial diameter >55 mm Moderate to severe mitral or aortic valvular heart disease Stable/unstable angina or ongoing myocardial ischemia Myocardial infarction (MI) within 3 months of enrollment Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm) | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-65.0, Schizophrenia Schizoaffective Disorder Bipolar Disorder Patients must be male or female, age 18-65 Patients must have a definitive diagnosis by DSM-IV of schizophrenia, bipolar or schizoaffective disorder Patients can be receiving inpatient or outpatient treatment at time of enrollment Patients must have been treated with (Mellaril) thioridazine, (Risperdal) risperidone or (Seroquel) quetiapine at least three months at time of enrollment Patients must be able to provide written informed consent Patients with a primary diagnosis other than schizophrenia, schizoaffective or bipolar disorder Patients who are currently taking other medications that have been shown to prolong the QTC, including tricyclic antidepressants, fluoroquinolones or antiarrythmics Patients unable to provide written informed consent | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-80.0, Stroke Cerebrovascular Accident Sudden focal neurological deficit attributable to a stroke Clearly defined time of onset, allowing initiation of intravenous treatment within 3 hours of symptoms onset and intra-arterial treatment within 6 hour of symptoms onset Age between 18 and 80 years Disability preceding stroke consistent with a modified Rankin scale score of 2-4 (see glossary for Rankin scale) Coma at onset Severe stroke as assessed clinically (e.g. NIHSS>25) Rapidly improving neurological deficit or minor symptoms Seizure at onset of stroke Clinical presentation suggestive of a subarachnoid hemorrhage (even of CT scan is normal) or condition after subarachnoid hemorrhage from aneurysm Previous history of or suspected intracranial hemorrhage Previous history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) Septic embolism, bacterial endocarditis, pericarditis Acute pancreatitis | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 16.0-999.0, Hypertrophic Cardiomyopathy Any patient that is hemodynamically stable and is identified to have hypertrophic cardiomyopathy based on prior symptoms, 2D ECHO findings, genetic testing, and/or ECG voltage criteria Patients that have signed informed consent after understanding the risks and benefits of participation. Individual age 16-17 with the consent and approval of a parent and /or legal guardian Patients with prior history of myocardial infarction, CAD demonstrated by stress test or angiogram, and/or CABG will be excluded from this study Any patient that has undergone invasive treatment at the time of enrollment including procedures such as myomectomy and/or septal ablation. However, already enrolled subjects who have these procedures post-enrollment into the study will be eligible for future scans Patients encountering any significant symptoms, chest pain, or who are hemodynamically unstable Any patient with an ICD or pacemaker Patients who are underage and do not have the consent of a parent and/or legal guardian | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Patent Foramen Ovale Stroke Patent foramen ovale-(PFO) recurrent stroke failed antiplatelet/anticoagulant therapy International normalized ration (INR) outside of 2-3 intracardiac thrombus (subjects may be enrolled after resolution of thrombus) | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Atrial Fibrillation for Atrial Fibrillation group Male or female at least 18 years old Subjects with a history of or current Atrial Fibrillation Subjects able to give informed consent for Controls Male or female at least 18 years old Subjects with no history of Atrial Fibrillation Subjects able to give informed consent | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Stroke, Acute Subject For in the study, subjects must fulfill all of the following Written Informed Consent Eighteen years of age or older Symptoms consistent with acute stroke (ischemic or hemorrhagic) Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours) Subject The following is the sole criterion for from the study Unlikely to complete study through 90-day follow-up | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-85.0, Cardiovascular Diseases Hypertension Hyperlipidemia Hyperglycemia Adults 18-85 years Signed consent | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 65.0-999.0, Type 2 Diabetes Clinical diagnosis of type 2 diabetes Impaired renal or liver function Cardiac disease Subjects with metal implants Hypertension Diabetes complications Exogenous insulin therapy | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 30.0-85.0, Ischemic Stroke Patent Foramen Ovale Age 30-85 Ischemic stroke within 30 days Glasgow outcome scale ≥ 3 No contraindications to warfarin/aspirin Basal INR > 1.4 Post-procedural stroke Severe carotid atherosclerosis Cardioembolic stroke Contraindications to transesophageal echocardiography | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Hypertension Outpatients attending neurology specialty centers, either with or without history of stroke, receiving hypertension medication Secondary hypertension patients Patients not receiving hypertension medication | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-80.0, Stroke Age between 18 and 80 years Onset of symptoms until call at least 30 min prior to the end of the approved time window for thrombolysis (and not after awakening) Clinical signs of ischemic stroke with suddenly occurring, measurable neurological deficits defined as impairment of language, motor function, facial palsy or asymmetry Patient is willing to participate voluntarily and to sign a written informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relative Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make undoubtfully clear that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet Age younger than 18 or older than 80 years Non-acute onset of symptoms No focal stroke-like symptoms Pregnant patients | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 70.0-999.0, Orthostatic Hypotension Diabetes Mellitus Type 2 diabetes mellitus age (70 years and older) Known autonomic dysfunction Neurodegenerative diseases Current malignancy Living in a nursing-home Irregular pulse | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-75.0, Prostate Cancer Age of patients: up to 75 years Men scheduled for radical prostatectomy due to prostate cancer Patients who are able and willing to give consent and able to attend all study visits Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) Severely abnormal coagulation (INR>1.5) Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP > 100 on medication), and patients with cardiac pacemakers Severe cerebrovascular disease (multiple CVA or CVA within 6 months) Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.) Any rectal pathology preventing probe insertion, (as active proctitis, ulcerative colitis, fissure ani, diverticulitis, previous rectal surgery, IBD, etc…) Any spinal pathology that prohibits maintaining supine position for more then an hour Any previous radiation to the pelvis | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-80.0, Stroke Female or male inpatients Age: 18-80 years If female, patient must not be pregnant Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze,vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes haemorrhage Onset of symptoms within 3 hours prior to initiation of rt-PA administration Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure or migraine disorder Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtful that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. A written consent has to be obtained as soon as possible Willingness and ability to comply with the protocol Evidence of intracranial haemorrhage (ICH) on the CT-scan Violation of not approved by clinical study director or study safety officer Failure to perform or to evaluate screening or baseline examinations Hospitalisation (except for study purposes) or change of concomitant medication 4 weeks prior to screening or during screening period Participation in another therapeutic clinical trial 3 months before baseline Patients with any history of prior stroke and concomitant diabetes Prior stroke within the last 3 months Platelet count of below 100x103/mm3 Blood glucose <50 or >400 mg/dl (<2.77 or >22.15 mmol/L) Known haemorrhagic diathesis | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Cryptogenic Stroke Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours Negative brain image for hemorrhagic stroke In sinus rhythm at time of enrollment Know history of atrial fibrillation Previous implanted cardiac device (ppM or ICD) Serious illness making it unlikely to survive one year Known secondary cause of stroke | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Stroke Age > 18 years Seen at UCSF Medical Center for cryptogenic stroke or high-risk TIA Onset of stroke or TIA symptoms within the previous 60 days Definite small-vessel etiology by history or imaging Source found on vascular imaging of possible culprit vessels Source found by echocardiography (TEE not required) History of atrial fibrillation Atrial fibrillation on admission ECG Atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required) Obvious culpable systemic illness such as endocarditis Patient unable to provide written, informed consent | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 2.0-90.0, Aged elderly subjects over the age 65 years who had not received pneumococcal vaccination adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination) children subjects over the age of 2 years with no previous history of pneumococcal vaccination immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 70.0-999.0, Hypertension Age >= 70 years Systolic office blood pressure >= 160 mmHg Systolic home blood pressure >= 155 mmHg Diabetes Mellitus Atrial fibrillation Dementia Renal failure requiring dialysis Life expectancy of less than 1 year Disabling stroke Contraindication for MRI or anti-hypertensive medication Systolic blood pressure > 220 mmHg | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-70.0, Hypertension Type 2 Diabetes Mellitus Regardless of whether they are currently receiving antihypertensive therapy, systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg Whether or not use oral hypoglycemic agents or insulin injections, the fasting plasma is higher than 7.0 mmol/L, or postprandial blood glucose higher than 11.1 mmol/L With life-threatening disease With the various effects of metabolic diseases such as hyperthyroidism, hypothyroidism, etc Stroke, myocardial infarction and other serious cardiovascular and cerebrovascular diseases occurred within 3 months Serum creatinine level higher than 176.8 mmol/L Dementia or severe cognitive decline Unable to do a long-term follow-up or do not agree to participate in this trial | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 19.0-999.0, Stroke Patients presenting to the emergency Signs and symptoms of acute ischemic stroke: impairment of language, motor function, cognition and/or gaze, vision or neglect Patients with an NIH Stroke Scale score > 4 Age less than 19 Patient symptomatic for greater than five hours. Intravenous thrombolytic therapy must be instituted within three hours of symptom onset in order to minimize the risk of Intracerebral or symptomatic hemorrhage; other interventions such as intra-arterial thrombolytic therapy and clot retrieval allow for a six-hour window. One hour is an achievable time for arrival to institution of therapy, therefore a five-hour limit on enrollment allows the greatest number of patients the possibility of therapy Inability to verify a clear onset of symptoms. As noted, time elapsed since the patient's last known baseline state is correlated to Intracerebral and symptomatic hemorrhage, and therapy is approved only for patients with a clear time of onset | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 40.0-75.0, Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease) Able to provide a written informed consent <75 years of age, but >40 years of age Able to hold breath for at least 10 seconds Sinus rhythm New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) Greater than 6 hours since presentation to ED BMI >40 kg/m2 Impaired renal function as defined by serum creatinine >1.5 mg/dL* Elevated troponin-T (> 0.09 ng/ml) Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) Known allergy to iodinated contrast agent Currently symptomatic asthma Documented or self-reported cocaine use within the past 48 hours (acute) | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-90.0, Stroke Foramen Ovale, Patent years old patients signed informed consent all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke all patients with an alternative aetiology of the initial stroke all patients in whom the percutaneous closure of the PFO is contraindicated all patients with a known allergy to aspirin and or clopidogrel | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Palpitations Age 18 years or older Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness) Terminates before presentation to hospital Episodes occur at a frequency of less than once every two weeks Never previously caught on ECG or ambulatory monitoring Normal resting ECG Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR >1.6, ongoing infection, sepsis or fever, etc Palpitations suggestive of extrasystoles (single missed or dropped beats) Known or suspected severe valvular or myocardial heart disease An audible heart murmur Any abnormality on the surface ECG Thyrotoxicosis Patients who refuse an ILR when offered will not be included in either limb of the study | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 30.0-75.0, Acute Myocardial Infarction Male or female patients aged 30 to < 75 years inclusive Patients presenting within 12 hours with symptoms presumed secondary to an acute myocardial infarction lasting at least 20 minutes and accompanied by ECG evidence of > 1mm of ST elevation in 2 or more limb leads or > 2mm in 2 or more contiguous precordial leads or suspected new left bundle branch block will be eligible Patients must be in the hospital or the emergency department and able to receive the study medication within 12 hours of onset of symptoms Females of child-bearing age, not using a generally accepted method of contraception must have a negative urine pregnancy test Written informed consent should be sought from the patient prior to in the study. If unable to do so, informed verbal consent will be obtained. If neither is possible, a legally acceptable representative (relative) should provide written consent NB Verbal or written consent should be followed by written informed consent from the patient at the earliest subsequent opportunity Previous administration of staphylokinase Active bleeding or known hemorrhagic diathesis Any history of stroke, transient ischemic attack, dementia, or structural CNS damage e.g. neoplasm, aneurysm, AV malformation Major surgery or trauma within the past 3 months Significant hypertension i.e. SBP 180 mm Hg and/or DBP 110 mm Hg at any time from admission to randomization Current treatment with vitamin K antagonists resulting with an INR > 1.5 Anticipated difficulty with vascular access Prolonged (>10 min) cardiopulmonary resuscitation or cardiogenic shock Patients who have participated in an investigational drug study within the past 30 days Pregnancy or lactation, parturition within the previous 30 days | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-75.0, Chagas Cardiomyopathy Cardiac Arrhythmia Stroke Left Ventricular Function Systolic Dysfunction Cardiac Death Clinically stable outpatients with at least 10 years of regular outpatients follow-up and positive epidemiological history and serological confirmation of Chagas disease with ate least two immunological tests Any degree of atrioventricular block or non-sinus rhythm Previous documented acute coronary events (due to documented obstructive epicardial coronary vessels) Chronic obstructive pulmonary disease Rheumatic valvular heart disease Alcohol addiction Thyroid dysfunction Abnormal serum electrolytes and biochemical abnormalities | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 35.0-70.0, Erectile Dysfunction Due to Arterial Insufficiency Subject must be undergoing coronary or peripheral angiography for suspected or known coronary or peripheral atherosclerotic disease Subject must be male ≥ 35 and ≤ 70 years old Subject must provide written informed consent before any study-related procedures are performed Subject must agree to comply with study procedures and follow-up for the entire length of the study Subject is unable to safely attempt sexual intercourse secondary to severe cardiac disease or other health condition Subject has a life expectancy of < 12 months Subject's serum creatinine is > 2.5 mg/dl Subject has known aorto-iliac occlusive disease, previous AAA endograft procedure or open surgical procedure Subject has history of prostatic carcinoma requiring surgery (i.e., prostatectomy), pelvic radiation, or hormonal/chemotherapy Subject has a history of myocardial infarction, stroke, life-threatening arrhythmia, or unstable angina requiring hospitalization within 3 months (90 days) prior to enrollment Subject has had exposure to PDE5 inhibitor (per subject's concomitant medication list) within the 72 hours prior to the scheduled baseline angiography Subject has a history of renal transplantation Subject has a penile implant Subject has become unstable or has received a maximum radiation dose, increased procedure time, and/or maximum contrast dose (in the Investigator's opinion) from the primary angiographic procedure that would compromise the safety of the subject by proceeding with enrollment into the study | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 20.0-95.0, Osteonecrosis Osteoarthritis Osteoarthritis of hip joint requiring total hip arthroplasty Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism Multi-systemic inflammatory arthritis which debilitates patients other than hip joint | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Coronary Artery Disease The patient is male or female ≥ 18 years of age The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain) The patient is scheduled for coronary angiography, with possible angioplasty The patient is able to tolerate dual anti-platelet therapy with aspirin and clopidogrel for a minimum of 30 days and is on those medications at the time of the PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI) The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent The patient does not present with any form of illness or condition that in the investigator's opinion would impair the results of the study Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment Patients in cardiogenic shock Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI Known history of heparin-induced thrombocytopenia Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study Pregnant women or nursing mothers | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 1.5-999.0, Stroke Computerized Tomography (CT) or Magnetic resonance imaging (MRI) verified cryptogenic stroke or TIA > 18 years of age the ability to provide a written consent prior or known AFIB AF found during work up including 24 hour telemetric monitoring | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Contrast Induced Acute Kidney Injury For specific aim 1 Subjects with reduced kidney function Adult (>18 years of age) men and women All races and ethnicities Chronic kidney disease stage 3 with an estimated GFR by MDRD formula between 30 ml/min/1.73 m2 Being scheduled for a coronary angiography study as part of their clinical care For specific aim 2 Subjects with normal kidney function Adult (>18 years of age) men and women | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-80.0, Patent Foramen Ovale Subjects who have had a cryptogenic stroke within the previous 3 months, radiologically verified Subjects who have been diagnosed with a high-risk* Patent Foramen Ovale (PFO), echocardiographically verified (*PFO size ≥ 2 mm or atrial septal aneurysm or hypermobility by TEE) Subjects willing to participate in follow-up visits Absence of other potential causes of stroke Any identifiable cause of thromboembolic cause other than PFO Subjects with intracardiac thrombus or tumor, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis Subjects with significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis and coagulopathy Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina Subjects who have a non-vascular origin of the neurological symptoms after brain imaging (CT scan or MRI) History of intracranial bleeding, confirmed arterio-venous malformation,aneurysm or uncontrolled coagulopathy Pre-existing neurological disorders or intracranial disease, e.g. multiple sclerosis Subjects with left ventricular aneurysm or akinesis Subjects with atrial fibrillation/atrial flutter (chronic or intermittent) Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Hypertension Stroke Adult patients (age greater or equal to 18 years) Hypertensive patients, with a sitting Systolic Blood Pressure above 140 mmHg or 130 mmHg in diabetics and high/very high risk patients, according to ESC/ESH Guidelines Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice Patients with at least one of the following conditions Newly diagnosed hypertension Inability to tolerate other antihypertensive medications, or Lack of response to current antihypertensive medication(s) Any contraindication to eprosartan or the excipients (according to the local label) | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Hemodialysis Hyperphosphatemia hemodialysis patients with hyperphosphatemia who require phosphate binders hemodialysis for more than 3 months patients who have at least one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus) intact-PTH > or = 240pg/mL life expectancy > 1 year with written informed consent contraindications to lanthanum carbonate and calcium carbonate swallowing disorders severe GI disorders history of obstructed bowels history of IHD/stroke within 6 months before randomization NYHA classification Ⅲ-Ⅳ severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution require treatment of arrhythmia severe malnutrition malignancy of any type within the last five years | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Atrial Fibrillation atrial fibrillation scheduled for catheter ablation contraindication to magnetic resonance imaging pregnancy life expectancy of less than six months participation in another trial that would conflict with this trial | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 35.0-999.0, Acute Coronary Syndrome Coronary Artery Disease Cardiac Death Myocardial Infarction Patient is in Sinus Rhythm Typical or atypical chest pain lasting more than 5 min in the last 24 hs Estimated pre-test probability of significant coronary artery disease more than 15% Absence of ECG changes suggestive of myocardial ischemia (ST-segment deviation >1 mm or T Wave inversion > 4 mm in at least two contiguous leads) Negative initial troponins I at admission (<0.05 ng/ml) Known allergy to iodinated contrast Known renal insufficiency or Creatinine >1.5 mg/dl at admission History of known coronary artery disease or prior myocardial revascularization Any of the following:hemodynamic instability, persistent chest pain despite treatment, Systolic blood pressure <100 mm Hg Cardiac arrhythmia with rapid or irregular ventricular response Inability to perform an exercise test Patient is incapable of providing informed consent | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 35.0-85.0, Hypertension Stroke aged 35 to 85 years hypertensive patients who had an ischemic stroke patients aged below 35 years or above 86 years patients who had a hemorrhagic stroke patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics (7) patients with a severe stroke (NIH stroke scale > 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (AST or ALT ≥ 100); (10) patients with severely impaired renal function (serum creatinine ≥ 2.0 mg/dL); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Atrial Fibrillation Atrial Flutter Patient meets the approved FDA indication to receive the ICM Patient is suspected, based on demographics, to be at high risk of having AF, as determined by the clinical investigator Patient has a CHA2DS2-VASc score ≥ 2 [Note: stroke/TIA criterion as part of the CHA2DS2-VASc score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.] Patient is 18 years of age or older Patient has a life expectancy of 18 months or more Patient has a documented history of AF or atrial flutter Patient has a symptom complex consistent with an arrhythmia (where an ICM may have an alternate indication for use) Patient had an ischemic stroke or TIA within past year prior to enrollment Patient has a history of a hemorrhagic stroke Patient is currently implanted with a permanent pacemaker, insertable loop recorder, implantable defibrillator, cardiac resynchronization therapy device (pacemaker or defibrillator) NYHA Class IV Heart Failure patient Patient had heart surgery within previous 90 days prior to enrollment Patient had an MI within the previous 90 days prior to enrollment Patient is taking chronic immunosuppressant therapy Patient is taking an anti-arrhythmic drug | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-65.0, Paroxysmal Atrial Fibrillation paroxysmal atrial fibrillation, symptomatic atrial fibrillation other than PAF, asymptomatic, previous AF ablation | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Atrial Fibrillation Age >= 18 years CHADS2 score >=2 Sinus rhythm Cardiac Implantable Electronic Device Atrial fibrillation Severe heart valve disease Anticoagulation therapy Pregnancy | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Ischemic Stroke Atrial Fibrillation Transient Ischemic Attacks Transient Cerebrovascular Events Patients >18 years of age Signs and symptoms suggestive of acute ischemic stroke or TIA Arrival to the emergency department or hospital within 8 hrs of symptom onset or last known normal time Head CT or MRI ruling out other pathology such as vascular malformation, hemorrhage, tumor or abscess which would likely be responsible for presenting neurologic symptoms Consent must be obtained Any central nervous system infection, i.e. meningitis or encephalitis in the past 30 days Any form of head trauma, stroke or intracranial hemorrhage in the past 30 days Known primary or metastatic cancer involving the brain Active Cancer defined as a diagnosis of cancer, within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer Autoimmune diseases: such as lupus, rheumatoid arthritis, Crohn's disease, ulcerative colitis Active infectious diseases (eg. HIV/AIDS, hepatitis C) Any underlying medical condition which in the opinion of the investigator would prohibit the patient from providing informed consent Major surgery within three months prior to the index event | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope Any patient regardless of the age of gender Any non-correctable secondary cause of increase or decrease in blood pressure or a pathology that alters the prognosis before the entrance of the patient into this registry nephropathy prior to the admission familial dyslipidemia previous gastric bypass pre-existing heart failure chemotherapy-induced cardiotoxicity arrhythmogenic right ventricular dysplasia long QT syndrome hypertrophic cardiomyopathy | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Pulmonary Embolism Patients with massive PE aged 18 years or older with confirmed PE and able to give informed consent will be included in the study. PE is defined according to current guidelines as adult patients presenting with signs and symptoms suggestive of PE plus imaging documentation on computed tomography angiography. Massive PE was defined as acute PE with sustained hypotension (systolic blood pressure<90 mm Hg for at least 15 minutes or requiring inotropic support, not due to a cause other than PE, such as arrhythmia, hypovolemia, sepsis, or left ventricular [LV] dysfunction), pulselessness, or persistent profound bradycardia (heart rate<40 bpm with signs or symptoms of shock) Patients with prior intracranial hemorrhage, known structural intracranial cerebrovascular disease (eg, arteriovenous malformation), known malignant intracranial neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent surgery encroaching on the spinal canal or brain, and recent significant closed-head or facial trauma with radiographic evidence of bony fracture or brain injury were excluded from the study | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 70.0-90.0, Atrial Fibrillation Stroke Hypertension Diabetes To be eligible for the study subjects must fulfil the following at Living address in Region Zealand, Region of Southern Denmark or the Capital Region of Denmark (study subjects from other regions of Denmark who actively contact the study for participation can be included if they wish to participate) 90 years of age at the time of screening and in addition the study subject should be clinically evaluated to be biologically a potential candidate for anti-coagulation therapy and additionally have at least one of the diseases mentioned below Known diabetes mellitus (type 1 or type 2, with or without medical therapy) History with hypertension with or without a therapy that may reduce blood pressure (i.e., an increased blood pressure at randomization is not required) Heart failure: New York Heart Association (NYHA) class II-IV or a reduced left ventricular ejection fraction (< 0.50) Previous diagnosed stroke (preferably diagnosed in hospital and verified by imaging; previous (TIA, transitory ischemic attack, is not considered an criterion; a specific time interval from previous stroke to time is not required) Concerning the four qualifying diseases the study subject is considered qualified for study if he has a history of one of the diseases (for example subject is now normotensive on life-style correction or medical therapy and similarly if blood glucose has been normalised upon life-style corrections or medical therapy) Uncorrected, congenital heart disease or severe valvular stenosis, obstructive cardiomyopathy, active myocarditis, constrictive pericarditis Recipient of any major organ transplant (e.g. lung, liver, heart or kidney) Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months before randomization or clinical evidence of current malignancy with the following exceptions: Basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable, localized disease with a life expectancy of > 2.5 years in the opinion of the investigator) Known to be human immunodeficiency virus (HIV) positive with an expected survival of less than 5 years due to HIV infection Renal failure treated with permanent dialysis Recent (within 3 months) history of alcohol or drug abuse based on self-reporting Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study Known atrial fibrillation irrespective of its type (paroxysmal, persistent, long-lasting persistent or permanent) Ongoing therapy with OAC or newer OAC (whereas therapy with platelet inhibitors such as acetyl-salicylic acid, clopidogrel, persantine is not considered as an exclusion) Patients who have a pacemaker (including cardiac resynchronization therapy-pacemaker, CRT-P) or implantable cardioverter defibrillator (ICD), including a Cardiac Resynchronization Therapy defibrillator (CRT-D) | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Permanent Atrial Fibrillation To be eligible, each patient must be in the following condition Permanent atrial fibrillation (>6 months) which has been considered unsuitable for ablation or failed ablation Narrow QRS ≤ 110 ms Severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control At least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below) New York Heart Association (NYHA) class IV and systolic blood pressure <80 mmHg despite optimized therapy severe concomitant non-cardiac disease need for surgical intervention myocardial infarction within the previous 3 months previous implanted devices (PM/ICD/CRT) | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 60.0-999.0, Transient Arthropathy of Hip y/o/ and more Both sexes Schedule for total hip replacement Patient with previous bedsore Patients under 60 y.0 Previous CVA | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-80.0, Acute Ischaemic Stroke or less years old patients with acute stroke produced by a main artery occlusion NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment) Patients receiving EVT or IVT within 4.5 hours after onset EVT or IVT contraindication Previous neurological impairment, severe concomitant disease or poor prognosis Pregnancy or breastfeeding Known hypersensitivity to any study drugs Severe organic disease for which there is not risk compensation | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Stroke Atrial Fibrillation Premature Atrial Complexes admitted with ischemic stroke at a single center time from diagnose to maximum 7 days written informed consent or surrogate informed consent eligible age > 18 years hemorrhagic stroke terminal illness and expected lifespan of less than 6 months any physical or mental condition which make the patients unsuitable for participation in the study known with a pacemaker anticoagulation treatment of other reasons than atrial fibrillation | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Cryptogenic Embolic Stroke Active Cancer Subjects with acute ischemic stroke who presented within 7 days from symptom onset Subjects with unknown cause of stroke despite of initial evaluation including electrocardiogram and brain imaging upon admission Subjects who performed brain magnetic resonance image (MRI) and MR angiography (MRA), cardiac work-ups (12-lead electrocardiography, transthoracic and/or transesophageal echocardiography with injection of agitated saline (or agitated saline transcranial Doppler monitoring), and 24-hour Holter and/or telemonitoring) Subjects with informed consent Subjects with single subcortical infarction Subjects with primary brain tumor | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-80.0, Stroke Female or male in-patient Age 18 years Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition, gaze, vision and/or neglect. Ischemic stroke is defined as an event characterized by sudden onset of acute focal neurological deficit, presumed to be caused by cerebral ischemia, after CT scan of hemorrhage Onset of symptoms within 3 hours prior to initiation of thrombolysis treatment Stroke symptoms present for at least 30 minutes that had not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder Patients are willing to receive thrombolysis treatment and to give informed consent with regard to retrieval of data and follow up procedures, according to the regulations in participating countries Willingness and ability to comply with the study protocol Evidence of intracranial hemorrhage (ICH) on the CT-scan Symptoms of ischemic attack began more than 3 hours prior to infusion start or when time of symptom onset is unknown Minor neurological deficit or symptoms rapidly improving before start of infusion Severe stroke as assessed clinically and/or by appropriate imaging techniques Seizure at onset of stroke Symptoms suggestive of subarachnoid hemorrhage, even if the CT-scan is normal Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory Patients with any history of prior stroke and concomitant diabetes Prior stroke within the last 3 months Platelet count of below 100,000/mm³ | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 41.0-999.0, Ischemic Stroke Patients with a recent ischemic stroke or transient ischemic attack (TIA) with brain infarction on brain imaging No history of atrial fibrillation or finding of atrial fibrillation on standard inpatient monitoring (electrocardiogram, telemetry, 24-hour Holter monitor) Have a presumed stroke etiology: Lacunar or small vessel thrombosis, extra-cranial or intracranial atherosclerotic stenosis or dissection, arteriopathy or vasculitis, hypercoagulable state, aortic arch plaque with or without mobile elements, or evidence of a low-risk cardiac source (e.g., patent foramen ovale with or without atrial septal aneurysm and with or without evidence of venous thromboembolic source) Have virtual CHADS2 score ≥3 or Have 2 or more of the following co-morbidities: obstructive sleep apnea, coronary artery disease, (Chronic Pulmonary Obstructive Disease (COPD), hyperthyroidism, Body Mass Index> 30, prior myocardial infarction, prolonged PR interval (>175 ms) or renal impairment (GFR 30-60) Patient or legally authorized representative who is willing to sign written consent form Patient is ≥40 years old (patients younger than 40 years old have a very low likelihood of having atrial fibrillation and are therefore excluded from the study) Patient can have the device implanted within 7 days of the incident ischemic event Documented history of AF or atrial flutter Evidence of a high-risk cardiac source of embolism (Left Ventricular or Left Atrial thrombus or "smoke," emboligenic valvular lesion or tumor) Untreated hyperthyroidism Myocardial infarction or coronary bypass grafting within 1 month prior to the stroke/TIA Valvular disease requiring immediate surgical intervention Permanent indication for anticoagulation at enrollment Permanent oral anticoagulation contraindication Already included in another clinical trial that will affect the objectives of this study Life expectancy is less than 1 year Pregnancy. Urine or serum pregnancy test is required for women of child bearing potential to pregnancy | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-80.0, Myocardial Infarction Ischemic cardiac pain of >= 20 minutes and <= 6 hours Age 18 years Ability to give informed consent (witnessed verbal or written) Ability to follow protocol and comply with follow -up requirements Current participation in another clinical trial Patient will be ineligible for pre hospital administration of actilyse if any of the following apply Acute myocardial infarction (AMI) treated with a thrombolytic agent within the preceding 4 days BP (blood pressure) > 180/100 mmHg (on one measurement) Significant bleeding disorder within the past 6 months Major surgery, biopsy of a parenchymal organ, or significant trauma (including any trauma associated with the current AMI) within 3 months History of stroke, transient ischaemic attack, or central nervous system structural damage (e.g. neoplasm, aneurysm, intracranial surgery) Oral anticoagulation Recent (within 10 days) non compressible vascular puncture | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Death Stroke Myocardial Infarction previously cardiac operation, CABG or AVR Previous Atrial fibrillation | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 70.0-999.0, Sarcopenia Diabetes Mellitus Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the of the American Diabetes Association Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the of the European Working Group on Sarcopenia in Older People (EWGSOP) Healthy volunteers: no diabetes, no sarcopenia and none of the (overall population) acute diseases chronic obstructive pulmonary disease (COPD) conditions associated with sarcopenia/altered body composition (e.g. disability, altered endocrine function, chronic diseases, nutritional deficiencies, cancer) obesity (body mass index ≥30 kg/m2) moderate-severe hepatic disease chronic kidney disease (estimated glomerular filtration rate <30 ml/min per 1.73m2) metal prostheses recent or ongoing infection inability or unwillingness to provide informed consent | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Stroke Atrial Fibrillation Arrhythmias, Cardiac Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke or TIA occurring within the previous 90 days. The event must be either an arterial ischemic stroke confirmed by neuroimaging; or transient ischemic attack with diffusion weighted positive lesion on MRI At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitoring is desired to screen further for the possibility of occult paroxysmal atrial fibrillation/flutter Age 18 years or older Informed consent from the patient The patient is expected to survive at least 6 months Any previously documented atrial fibrillation or atrial flutter, i.e. a past history of atrial fibrillation/flutter or atrial fibrillation/flutter detected on ECG, Holter, or telemetry following the index stroke/TIA event (a remote history of transient perioperative atrial fibrillation is not exclusionary) Planned carotid endarterectomy or carotid artery stenting within 90 days Any condition for which there is already an indication for long term anticoagulation Pacemaker or implantable cardioverter defibrillator device Work-up for stroke that has already included extended (>48 hour) external ECG (excluding telemetry) Stroke and/or comorbid illness will prevent completion of planned follow-up assessments | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 20.0-80.0, Type 2 Diabetes 80 years of age Type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months) in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day HbA1c between 7.0% and 10.0% ability to understand and use smartphone application type 1 diabetes or patients using insulin pump severe complications (stage IV,V chronic kidney failure, diabetic food complications, unstable angina pectoris, MI or stroke, surgical procedure of coronary & peripheral artery within recent 6 months) uncontrolled hypertension pregnant woman, fertile woman who will not use contraception unable to use application during treatment taking medication which can affect on glucose level alcohol abuse or dependency over 2.5 times from the upper limit of liver enzyme level DKA(diabetic ketoacidosis) or HHS(Hyperglycemic hyperosmolar syndrome) history during recent 6 months | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-80.0, Atrial Fibrillation Stroke Systemic Embolism 80 years Have documented AF episodes The occurrence of ischemic stroke, TIA or systemic thromboembolism in the previous 1-6 months Having at least one of the following major risk factors of stroke: HT, DM, or HF, or having two of the following minor factors of stroke: ≥65 y, vascular disease, or female Capable of understanding and signing the CRF Reversible AF Modified Rankin score ≥4 Having a history of rheumatic, severe valvular heart disease or heart valve replacement Having symptomatic carotid artery disease Having another disease which requires lifelong warfarin therapy Medical conditions limiting expected survival to <1 year Women of childbearing potential (unless post-menopausal or surgically sterile) Participation in any other clinical mortality trial Unable to give informed consent | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Resident Education and Assessment of Difficult and High Acuity Scenarios That Focus on Cardiac Anesthesia Resident physicians who have completed at least one month of cardiac rotation are included.This high fidelity simulation lab course if offerred to every resident that meets the criteria.This is a part of their educational activity.At the beginning of the course they are given the option to participate in the survey.If they do not wish to participate in the survey it will not affect their education.Participitaion in the survey is purely voluntary Resident physicians that did not wish to participate in filling out the survey or not able to fill out the survey | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Atrial Fibrillation Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-999.0, Stroke Prevention and Control Atrial Fibrillation Patients ≥18 years of age diagnosed with non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent) Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care Patients who have given their informed consent in writing Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires Patients who started anticoagulant therapy for non-valvular atrial fibrillation with a direct oral anticoagulant | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 60.0-999.0, Hypertension Atrial Fibrillation Female and male outpatients aged 60 years and older Patients having being diagnosed with arterial hypertension For patients without a history of AF diagnosis, the decision to perform electrocardiography testing, either standard 12-lead ECG or ambulatory ECG, at the study visit has been made as per the investigator's routine practice Patients with available medical records Written signed and dated informed consent Presence of any condition/circumstance which in the opinion of the investigator would make the patient unfit to participate in the study or would compromise the quality of the study data (e.g., non-native speaker or patient who does not understand the local language unless reliable interpreter services are available; failure to cooperate due to major psychiatric disturbances, dementia, or substance use disorder) Patients currently participating in any investigational program with interventions outside of routine clinical practice or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 18.0-90.0, Atrial Fibrillation Primary and secondary diagnosis with AF The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included Patients younger than 18 and older than 90 years of age | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-75.0, Asthma Lung Diseases Patients with asthma; specific vary for each study | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.0-999.0, Chest Pain Sickle Cell Anemia Males or females 18 to 65 years of age Diagnosis of sickle cell disease (electrophoretic documentation of SS homozygosity is required) or identification as a normal volunteer Hematocrit greater than 18% (with an absolute reticulocyte count greater than 100,000/ml) Hematocrit 18-21% (with an absolute reticulocyte count greater than 100,000/ml): Only 100 ml of blood may be drawn. The study subject may be re-entered in the study after four weeks (with repeat full screening labs) Clinically unstable sickle cell anemia defined by the following Having greater than two acute pain crises in the last two months; on hydroxyurea or butyrate therapy any time in the last 12 months; or blood transfusion within last three months, or % hemoglobin A greater than 20% Age less than 18 years or greater than 65 years Current pregnancy or lactation Inability to exercise the anterior tibialis muscle Active cigarette smoker-defined as the inhalation of smoke from any tobacco product in the last one month Medical conditions: diabetes mellitus; coronary artery disease; peripheral vascular disease; migraine headaches in the last 12 months; history of previous CVA or stroke; or creatinine greater than 1.0 mg/dL MRI Exclusions: cardiac pacemaker or implantable defibrillator; aneurysm clip; neural stimulator (e.g. TENS-Unit); any type of ear implant; or metal in the eye (e.g. from machining); any implanted device (e.g. insulin pump, drug infusion device); or any metallic foreign body, shrapnel, or bullet Hematocrit less than or equal to 18 percent: will not be eligible for the study; may return for evaluation at a later date No aspirin or non-steroidal anti-inflammatory drugs (no and caffeine the day of the study.) Patients on opiates and acetaminophen will not be excluded | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.0-999.0, Healthy Hypercapnia Any normal volunteer above the age of 18 years old who is capable of giving informed consent Subjects will be excluded if they have contraindications to MR scanning, such as the following: aneurism clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, chochlear implant, ocular foreign body (e.g., metal shavings), or insulin pump. Also, subjects will be excluded if they have panic disorder or migrane (because of possible complications with CO2 inhilation), or if they have cirrhosis, are on high dose aspirin therapy, or have an allergy to acetazolamide injection). Subjects will be excluded if they have allergies to sulfonamide drugs or if they have a chronic respiratory illness | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 0.0-999.0, Healthy Hypercapnia Any healthy normal volunteer above the age of 18 who is capable of giving informed consent Subjects will be excluded for the following reasons They have contraindications to MR scanning, such as the following: aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular foreign body (e.g., metal shavings), or insulin pump They have panic disorder or migraine (because of possible complications with CO2 inhalation) They have cirrhosis, any renal dysfunction, or a chronic respiratory illness (such as asthma) They have allergies to sulfonamide drugs or cyclo-oxygenase inhibitors (NSAIDS) | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 21.0-55.0, Asthma Mild to moderate persistent asthma (NAEPP 1997 revised guidelines) Current use of inhaled beta-2 agonists or steroid inhaler therapy only (No use of prednisone in past 3 months) No use of products (i.e. antacids, laxatives, supplements) containing more than 50 mg Mg daily in the last 3 months No current use of theophylline, leukotriene antagonists, or other systemic immunomodulating compounds Nonsmoker No concurrent pulmonary disease (pulmonary hypertension, cystic fibrosis, sarcoidosis, bronchiectasis, hypersensitivity pneumonitis, restrictive lung disease, abnormal DLCOva) No concurrent medical diagnoses (alcoholism, coronary artery disease, diabetes, HIV infection, chronic hepatitis, uncontrolled hypertension, chronic renal failure or a psychiatric disorder that is judged to make full participation difficult) Not pregnant or lactating | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 15.0-85.0, Rhinitis, Allergic, Seasonal Asthma, Bronchial Non-smoker A 2-year documented history of seasonal allergic rhinitis A 1-year documented history of chronic asthma Positive allergy testing Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 8.0-17.0, Asthma Allergy Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97) Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6 Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2) Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16) Positive house dust mite skin prick test, with a more than 3 mm infiltrate Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial Active smoking Dogs or cats in the home Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 2.0-10.0, Asthma All patients must have a known history of asthma and present to the hospital/clinic with severe acute exacerbation Male or female patients 2 to 10 years of age Parents or legal guardians of patients must sign an Informed Consent Form prior to participation in the trial Patients with known or suspected hypersensitivity to study drugs Patients with medical condition that would contraindicate the use of beta2-adrenergic or anticholinergic medications Patients with first wheezing episode only Prior intubation for asthma for more than 24 hours Patients who used ipratropium within six hours prior to consultation Patients with concurrent stridor or possible presence of intra-thoracic foreign body Patients with disease known to have chronic effect on respiratory function ( e.g., cystic fibrosis or cardiac disease) Patients requiring immediate resuscitation or airway intervention With psychiatric disease or psychosocial problems Patients on other investigational drugs or have used any other investigational drugs within the past month | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 18.0-50.0, Asthma Allergy Normal lung function, defined as (Knudson 1976/1984 predicted set) FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > 80 % of predicted values Evidence of allergy to house dust mite Oxygen saturation of > 94 % Normal blood pressure (Systolic between 150 Diastolic between 90-60 mm Hg) Symptom Score (defined in section "f") no greater than 20 (out of a possible 60) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3 IgE within the following ranges and body weights for omalizumab dosing: IgE ≥30-700 int. units/mL, and weight 30-90 kg A history of significant chronic illnesses (to diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma, hypertension) Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose, polyethylene glycol) Positive pregnancy test at time of initial screening Medications which may impact the results of the ozone challenge, interfere with any other medications potentially used in the study (to steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics) Mega doses of vitamins and supplements, homeopathic/naturopathic medicines Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 2 weeks. Documentation of normal lung function (as defined in "Specific Criteria") must be met Unspecified illnesses, which in the judgment of the investigator increase the risk associated with ozone inhalation challenge, will be a basis for exclusion Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable | 1 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 1.0-5.0, Asthma Children ages 1 years, enrolled in one of the designated SPARK child care centers Children under the age of 1 year Children whose parents do not want to participate Children whose child care centers do not want to participate | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 1.0-2.5, Asthma Allergic Sensitization Diagnosed with eczema (atopic dermatitis) Family history of eczema, allergic rhinitis, or asthma Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean Weigh at least 9.5 kg (20.9 lbs) Parent or guardian willing to provide informed consent Allergy to house dust mite, cat, or timothy grass Born prematurely (before 36th week's gestation) Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during the first year of life Chronic pulmonary disease Chronic disease requiring therapy Past or current treatment with systemic immunomodulator medication Past or current treatment with allergen-specific immunotherapy Received 10 or more days of systemic steroids in the 3 months prior to study entry Orofacial abnormalities that are likely to interfere with the subject's ability to take study treatment Participated in another clinical study within the 3 months prior to study entry | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 2.0-10.0, Asthma Asthma Receives asthma care at a clinic in Western Washington Has access to the internet at home Does not speak or read English | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 4.0-12.0, Asthma Allergies A child will be included in the HEAL intervention study if he or she Is a male or female child four to twelve years old, inclusive, at the time of recruitment, living in Orleans Parish or surrounding areas impacted by flooding Has previously been given a diagnosis of asthma by a healthcare provider and who has symptoms as described below (Criteria 3) for more than one year Is currently receiving long-term asthma control therapy, as reported at baseline, and either has symptoms consistent with persistent asthma (criterion 3a, see below) or has evidence of uncontrolled disease (criterion 3b); or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma (criterion 3a) and also has evidence of uncontrolled disease (criterion 3b) . Evidence of persistent asthma as defined by the National Asthma Education and Prevention Program (NAEPP) of the National Heart Lung and Blood Institute Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma (1997), which includes: asthma symptoms 3 or more days per week during the last two weeks, sleep disturbed due to asthma at least 3 times in the past month, or albuterol use (Metered Dose Inhaler or nebulizer) for quick relief at least 8 times in the past two weeks, not including use as a preventive for exercise . Evidence of uncontrolled disease as defined by at least one of the following additional i. One asthma-related unscheduled visit to an emergency department (ED), urgent care (UC), or clinic in the previous 12 months ii. One asthma-related overnight hospitalization in the previous 12 months iii. One or more bursts of oral corticosteroids or equivalent in the previous 12 months Has a parent or legal guardian willing to sign the written informed consent prior to initiation into the study A child will be excluded from the HEAL intervention study if she or he Is defined as having mild intermittent asthma at baseline evaluation Has had a life-threatening asthma exacerbation in the last 5 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure Has significant medical illnesses other than asthma such as: any hematologic, endocrine, respiratory (other than asthma) or cardiac condition requiring daily medications; significant neurological disorder requiring daily medications; any clotting disorder; any obvious severe mental retardation that prohibits the child or the child s caregiver from answering questions or following instructions; any autoimmune disease; any immune deficiency; or any other serious medical condition including Juvenile diabetes mellitus, hypo or hyper thyroidism, hemophilia, Von Willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, or diagnosed allergic bronchopulmonary aspergillosis Has not had a home evaluation completed within 4-6 weeks of the Screening Visit (may be re-screened) Lives with a foster parent Has caregiver (typically the parent or guardian) who does not have access to a phone Plans to move out of the recruitment area over the next year | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 1.0-999.0, Influenza Participants should be informed and assent to participate in this study. For children, informed consent should be provided by their parents or legal guardians. Children aged from 10 years old to 18 years old will be asked to assent Adults or children older than 1 year old Satisfying above definition of cases and controls Infants younger than 12 months For any cases or controls who need proxy, they should be excluded under below situations Proxy can not provide sufficient information for this study, or Proxy refuses to participate in this study, or No suitable proxy can be found | 2 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 6.0-14.0, Asthma, Bronchial Patient is male or female, 6-14 years of age with mild persistent asthma Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc Patient has asthma diagnosed by a doctor Patient is hospitalized Patient has had major surgery or participated in another clinical trial in the last 4 weeks Patient has been on a breathing tube for asthma | 0 |
A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air. | eligible ages (years): 12.0-999.0, Rhinitis, Allergic, Seasonal male or female subjects ≥ 12 years year history of seasonal allergic rhinitis documented hypersensitivity to local seasonal allergens (grass pollen) documented pollen-induced asthma without acute ongoing exacerbation of asthma or allergic rhinitis no continuous ongoing treatment for rhinitis or asthma non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity symptomatic rhinitis or asthma due to tree pollens currently treated by specific grass pollen immunotherapy suffering from non-allergic asthma chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids contraindication for salbutamol use | 2 |
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